Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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1
ORAL COMPOSITIONS AND METHODS OF MANUFACTURE
FIELD OF THE DISCLOSURE
The present disclosure relates to flavored products intended for human use.
The products are
configured for oral use and deliver substances such as flavors and/or active
ingredients during use. Such
products may include tobacco or a product derived from tobacco, or may be
tobacco-free alternatives.
BACKGROUND
Tobacco may be enjoyed in a so-called "smokeless" form. Particularly popular
smokeless tobacco
products are employed by inserting some form of processed tobacco or tobacco-
containing formulation into
the mouth of the user. Conventional formats for such smokeless tobacco
products include moist snuff, snus,
and chewing tobacco, which are typically formed almost entirely of
particulate, granular, or shredded tobacco,
and which are either portioned by the user or presented to the user in
individual portions, such as in single-use
pouches or sachets. Other traditional forms of smokeless products include
compressed or agglomerated forms,
such as plugs, tablets, or pellets. Alternative product formats, such as
tobacco-containing gums and mixtures
of tobacco with other plant materials, are also known. See for example, the
types of smokeless tobacco
formulations, ingredients, and processing methodologies set forth in US Pat.
Nos. 1,376,586 to Schwartz;
4,513,756 to Pittman et at.; 4,528,993 to Sensabaugh, Jr. et al.; 4,624,269 to
Story et al.; 4,991,599 to Tibbetts;
4,987,907 to Townsend; 5,092,352 to Sprinkle, III et al.; 5,387,416 to White
et al.; 6,668,839 to Williams;
6,834,654 to Williams; 6,953,040 to Atchley et at; 7,032,601 to Atchley et
al.; and 7,694,686 to Atchley et
al.; US Pat. Pub. Nos. 2004/0020503 to Williams; 2005/0115580 to Quinter et
al.; 2006/0191548 to Strickland
et at; 2007/0062549 to Holton, Jr. et al.; 2007/0186941 to Holton, Jr. et at;
2007/0186942 to Strickland et at;
2008/0029110 to Dube et at; 2008/0029116 to Robinson et al.; 2008/0173317 to
Robinson et al.;
2008/0209586 to Neilsen et at; 2009/0065013 to Essen et al.; and 2010/0282267
to Atchley, as well as
W02004/095959 to Amarp et at, each of which is incorporated herein by
reference.
Smokeless tobacco product configurations that combine tobacco material with
various binders and
fillers have been proposed more recently, with example product formats
including lozenges, pastilles, gels,
extruded forms, and the like. See, for example, the types of products
described in US Patent App. Pub. Nos,
2008/0196730 to Engstrom et al.; 2008/0305216 to Crawford et al.; 2009/0293889
to Kumar et at;
2010/0291245 to Gao et al; 2011/0139164 to Mua et at; 2012/0037175 to Cantrell
et at; 2012/0055494 to
Hunt et at; 2012/0138073 to Cantrell et at; 2012/0138074 to Cantrell et at;
2013/0074855 to Holton, Jr.;
2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et al.; 2013/0274296 to
Jackson et at; 2015/0068545 to
Moldoveanu et at; 2015/0101627 to Marshall et al.; and 2015/0230515 to Lampe
et at, each of which is
incorporated herein by reference.
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All-white snus portions are growing in popularity, and offer a discrete and
aesthetically pleasing
alternative to traditional snus. Such modern "white" pouched products may
include a bleached tobacco or
may be tobacco-free.
BRIEF SUMMARY
The present disclosure generally provides oral products and processes for
preparing such oral
products. The products are intended to impart a taste when used orally, and
typically also deliver active
ingredients to the consumer, such as nicotine. Such products may also impart
desirable organoleptic properties
when inserted into the oral cavity of a user of these products.
Accordingly, in one aspect, the disclosure provides oral products including at
least one active
ingredient in an amount of about 10 percent or less by weight, at least one
sugar alcohol in an amount from
about 25% to about 45% by weight, and a gum in an amount from about 35% to
about 55% by weight, based
on the total weight of the product, the product being in the form of a
pastille. In some embodiments, the at
least one active ingredient may be selected from the group consisting of a
nicotine component, botanicals,
nutraceuticals, stimulants, amino acids, vitamins, cannabinoids,
carmabitnimetics, terpenes, and
combinations thereof. In certain embodiments, the at least one active
ingredient may be selected from the
group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin
136, vitamin B12 (or other B
vitamins), vitamin C, lemon balm extract, ginseng, citicoline, sunflower
lecithin, and combinations thereof.
In certain other embodiments, the at least one active ingredient may include a
combination of
caffeine, taurine, and ascorbic acid. In such embodiments of oral products,
for example, the caffeine may be
present in an amount of about 2% to about 4% by weight, the taurine may be
present in an amount of about
2% to about 4% by weight, and the ascorbic acid may be present in an amount of
about 1% to about 3% by
weight, based on the total weight of the product. In some embodiments of oral
products, the at least one
active ingredient may include theanine, ganuna-aminobutyric acid, and lemon
balm. In such embodiments,
for example, the theanine may be present in an amount of about 2% to about 4%
by weight, the gamma-
aminobutyric acid may be present in an amount of about 2% to about 4% by
weight, and the lemon balm
may be present in an amount of about 1% to about 3% by weight, based on the
total weight of the product.
In still other embodiments of oral products, the at least one active
ingredient may include caffeine, theanine,
and ginseng. In such embodiments, for example, the caffeine may be present in
an amount of about 2% to
about 4%, the theanine may be present in an amount of about 2% to about 4%,
and the ginseng may be
present in an amount of about 0.1% to about 1% by weight, based on the total
weight of the product.
In some aspects of the disclosure, oral products may include at least one
active ingredient, including
combinations of active ingredients, being present in an amount in the range of
about 6% to about 8% by
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weight based on the total weight of the product. In some embodiments, oral
products as described herein
may be substantially free of a tobacco material. In some embodiments, oral
products as described herein
may be substantially free of nicotine or a nicotine-derived component.
In some embodiments of oral products, the at least one suoar alcohol may be
selected from the
group consisting of erytluitol, arabitol, ribitol, isomalt, maltitol, Mato!,
iditol, mannitol, xylitol, lactitol,
sorbitol, and combinations thereof. In certain embodiments, the least one
sugar alcohol may be selected from
the group consisting of isomalt, maltitol, erythritol, and combinations
thereof. In such embodiments, for
example, the at least one sugar alcohol may include isomalt in an amount from
about 20% to about 35% by
weight, maltitol in an amount from about 1% to about 10% by weight, and
erythritol in an amount from
about 0.1% to about 2% by weight, based on the total weight of the product.
In some embodiments, the gum may be selected from the group consisting of gum
arabic, xanthan
gum, guar gum, ghatti gum, gum tragacanth, karaya gum, locust bean gum, gellan
gum, and combinations
thereof. In some embodiments, oral products as described herein may include an
additive, or combinations
of additives, selected from the group consisting of flavorants, sweeteners,
additional binders, emulsifiers,
disintegration aids, humectants, salts, and mixtures thereof. In some
embodiments, the oral product may
have an outer coating coated thereon. In some embodiments, the water content
of the oral product may be in
the range of about 5% to about 20% by weight based on the total weight of the
oral product. In certain
embodiments, the water content of the oral product may be in the range of
about 5% to about 10% by weight
based on the total weight of the oral product.
In one or more aspects, the disclosure may provide oral products having
various ingredients
included therein. For example, in some embodiments, an oral product may
include (i) a sugar alcohol in an
amount in the range of 25% to 45% by weight, based on the total weight of the
composition; (ii) a gum in an
amount in the range of about 35% to about 55% by weight; (iii) at least one
active ingredient in an amount
of about 10% or less by weight; (iv) a humectant in an amount in the range of
about 0.1% to about 5% by
weight; (v) a salt in an amount in the range of about 0.1% to about 5% by
weight; (vi) a flavoring agent in an
amount in the range of about 0.1% to about 5% by weight; (vii) a water content
in the range of about 5% to
about 10% by weight; and (viii) at least about 0.01% by weight of a sweetener.
Some aspects of the present disclosure relate to methods of manufacturing oral
products, for
example, such as product in the form of a pastille and/or a lozenge. In some
embodiments, for example,
methods of manufacturing pastille products may include mixing a gum and at
least one active ingredient to
provide a combined mixture thereof; adding water, at least one additive, and
at least one flavoring agent to
the combined mixture to provide and aqueous mixture; separately adding at
least one sugar alcohol to the
aqueous mixture to provide an oral composition; heating the oral composition;
depositing the oral
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composition into a mold; and curing the oral composition to provide an oral
product in the form of a pastille.
In some embodiments, such methods may include heating the heated gum to a
temperature in the range of
about 40 C to about 80 C. In some embodiments, the at least one sugar alcohol
may be heated to a
temperature in the range of about 160 C to about 190 C and then cooled to a
temperature in the range of
about 120 C to about 150 C prior to being added to the aqueous mixture. In
some embodiments, the oral
composition is heated in the heating step to a temperature in the range of
about 60 C to about 80 C.
Some aspects of the disclosure relate to oral products having at least one
active ingredient in an
amount of about 10 percent or less by weight based on the total weight of the
product, a sugar alcohol, and a
gum, the product being in the form of a pastille. In some embodiments, the
active ingredient may be present
in an amount of about 1 weight percent or less. In some embodiments, the sugar
alcohol may comprise
smbitol. In sonic embodiments, the sugar alcohol may be selected from the
group consisting of erythritol,
arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol,
lactitol, soibitol, and combinations
thereof In some embodiments, the gum may be gum arabic. In some embodiments,
the gum may be selected
from the group consisting of gum arabic, xanthan gum, guar gum, ghatti gum,
gum tragacanth, karaya gum,
locust bean gum, gellan gum, and combinations thereof
In some embodiments, the at least one active ingredient may be selected from
the group consisting
of a nicotine component, botanicals, nutraceuticals, stimulants, amino acids,
vitamins, cannabinoids,
cannabimimetics, terpenes, and combinations thereof. In some embodiments, the
oral product may include a
tobacco material. In certain other embodiments, the oral product may be
substantially free of a tobacco
material. In some embodiments, oral products of the present disclosure may
include an additive selected
from the group consisting of flavorants, sweeteners, additional binders,
emulsifiers, disintegration aids,
humectants, salts, and mixtures thereof.
In some embodiments, the oral product may have an outer coating coated
thereon. In some
embodiments, the oral product may include a buffering agent and/or a pH
adjuster in an amount sufficient to
adjust the pH of the oral product to be in the range of about 5.0 to about
7Ø hi some embodiments, the
buffering agent and/or the pH adjuster may be citric acid, for example. In
some embodiments, the water
content of the oral product may be in the range of about 5 weight percent to
about 20 weight percent based
on the total weight of the oral product. In some embodiments, the oral product
may include at least about 30
weight percent of at least one sugar alcohol, at least about 40 weight percent
of a at least one gum, at least
about 2 weight percent of at least one humectant, at least about 0.05 weight
percent of at least one
sweetener, and at least about 0.1 weight percent of at least one flavoring
agent, based on the total weight of
the composition.
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In some aspects, the disclosure provides oral products that may be in the form
of a lozenge. For
example, in some embodiments, the disclosure provides oral products including
at least one active ingredient
in an amount of 10 weight percent or less, a sugar substitute in an amount of
at least about 80 weight
percent; and a sugar alcohol syrup, the oral product being in the form of a
lozenge. In some embodiments,
5 the active ingredient may be present in an amount of 1 weight percent or
less. In some embodiments, the
sugar substitute may be a non-hygroscopic sugar alcohol capable of forming a
glassy matrix. In some
embodiments, the sugar substitute may be isomalt, for example. In some
embodiments, the sugar substitute
may be present in an amount of at least about 85 weight percent. In some
embodiments, the sugar substitute
may be present in an amount of at least about 90 weight percent. In some
embodiments, the sugar substitute
may be present in an amount of at least about 95 weight percent. In some
embodiments, the sugar alcohol
syrup is inaltitol syrup.
In some embodiments, oral products according to the present disclosure may
include an additive
selected from the group consisting of flavorants, sweeteners, additional
filler components, emulsifiers,
disintegration aids, humectants, salts, and mixtures thereof. In some
embodiments, oral products as
described herein may include a buffering agent and/or a pH adjuster in an
amount sufficient to adjust the pH
of the oral product to be in the range of about 5.0 to about 7Ø In some
embodiments, the buffering agent
and/or the pH adjuster may be citric acid, for example. In some embodiments,
the water content of the oral
lozenge product may be in the range of about 0.1 weight percent to about 5
weight percent based on the total
weight of the oral product.
In some embodiments, the active ingredient may be selected from the group
consisting of a nicotine
component, botanicals, nutraceuticals, stimulants, amino acids, vitamins,
cannabinoids, cannabimimetics,
topenes, and combinations thereof. In some embodiments, the oral product may
include a tobacco material.
In some embodiments, the tobacco material is in the form of an ultrafiltered
tobacco extract. In certain other
embodiments, the oral product may be substantially free of a tobacco material.
In some embodiments, oral
products of the present disclosure may include at least one active ingredient
in an amount of 2 weight
percent or less, a sugar substitute in an amount of at least about 80 weight
percent, at least about 2 weight
percent of at least one humectant, at least about 0.1 weight percent of the
sugar alcohol syrup, at least about
0.1 weight percent of at least one flavoring agent, and at least about 0.05
weight percent of at least one
sweetener, based on the total weight of the composition.
The disclosure includes, without limitations, the following embodiments.
Embodiment 1: An oral product, the oral product comprising at least one active
ingredient in an
amount of about 10 percent or less by weight based on the total weight of the
product, a sugar alcohol, and a
gum, the product being in the form of a pastille.
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Embodiment 2: The oral product of embodiment 1, wherein the at least one
active ingredient is
selected from the group consisting of a nicotine component, botanicals,
nutraceuticals, stimulants, amino
acids, vitamins, cannabinoids, camiabimimetics, terpenes, and combinations
thereof.
Embodiment 3: The oral product of any of embodiments 1 to 2, wherein the
active ingredient
comprises a nicotine component in an amount of about 1 weight percent or less.
Embodiment 4: The oral product of any of embodiments 1 to 3, further
comprising a tobacco
material.
Embodiment 5: The oral product of any of embodiments! to 3, wherein the oral
product is
substantially free of a tobacco material.
Embodiment 6: The oral product of any of embodiments 1 to 5, wherein the sugar
alcohol is selected
from the group consisting of erythritol, ambito], ribitol, isornalt, maltitol,
dulcitol, iditol, mannitol, xylitol,
lactitol, sorbitol, and combinations thereof.
Embodiment 7: The oral product of any of embodiments 1 to 6, wherein the sugar
alcohol comprises
sorbitol.
Embodiment 8: The oral product of any of embodiments 1 to 7, wherein the gum
is selected from
the group consisting of gum arable, xanthan gum, guar gum, ghatti gum, gum
tragacanth, karaya gum, locust
bean gum, gellan gum, and combinations thereof.
Embodiment 9: The oral product of any of embodiments 1 to 8, wherein the gum
is gum arable.
Embodiment 10: The oral product of any of embodiments 1 to 9, further
comprising an additive
selected from the group consisting of flavorants, sweeteners, additional
binders, emulsifiers, disintegration
aids, humectants, salts, and mixtures thereof.
Embodiment 11: The oral product of any of embodiments 1 to 10, wherein the
oral pastille product
has an outer coating coated thereon.
Embodiment 12: The oral product of any of embodiments 1 to 11, further
comprising a buffering
agent and/or a pH adjuster in an amount sufficient to adjust the pH of the
oral product to be in the range of
about 5.0 to about 7Ø
Embodiment 13: The oral product of any of embodiments 1 to 12, wherein the
buffering agent
and/or the pH adjuster is citric acid.
Embodiment 14: The oral product of any of embodiments 1 to 13, wherein the
water content of the
oral product is in the range of about 5 weight percent to about 20 weight
percent based on the total weight of
the oral product.
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Embodiment 15: The oral product of any of embodiments 1 to 14, comprising: at
least about 30
weight percent of sugar alcohol, based on the total weight of the composition;
at least about 40 weight
percent of a at least one gum; at least about 2 weight percent of at least one
humectant; at least about 0.05
weight percent of at least one sweetener, and at least about 0.1 weight
percent of at least one flavoring agent.
Embodiment 16: An oral product configured for oral use, the oral product
comprising at least one
active ingredient in an amount of 10 weight percent or less, a sugar
substitute in an amount of at least about
80 weight percent; and a sugar alcohol syrup, the oral product being in the
form of a lozenge.
Embodiment 17: The oral product of embodiment 16, wherein the at least one
active ingredient is
selected from the group consisting of a nicotine component, botanicals,
nutraceuticals, stimulants, amino
acids, vitamins, cannabinoids, cannabimimetics, teipenes, and combinations
thereof.
Embodiment 18: The oral product of any of embodiments 16 to 17, wherein the at
least one active
ingredient comprises a nicotine component in an amount of about 1 weight
percent or less.
Embodiment 19: The oral product of any of embodiments 16 to 18, further
comprising a tobacco
material.
Embodiment 20: The oral product of any of embodiments 16 to 19, wherein the
tobacco material is
in the form of an ultrafiltered tobacco extract.
Embodiment 21: The oral product of any of embodiments 16 to 18, wherein the
oral product is
substantially free of a tobacco material.
Embodiment 22: The oral product of any of embodiments 16 to 21, wherein the
sugar substitute is a
non-hygroscopic sugar alcohol capable of forming a glassy matrix.
Embodiment 23: The oral product of any of embodiments 16 to 22, wherein the
sugar substitute is
isomalt.
Embodiment 24: The oral product of any of embodiments 16 to 23, wherein the
sugar substitute is
present in an amount of at least about 85 weight percent.
Embodiment 25: The oral product of any of embodiments 16 to 24, wherein the
sugar substitute is
present in an amount of at least about 90 weight percent.
Embodiment 26: The oral product of any of embodiments 16 to 25, wherein the
sugar substitute is
present in an amount of at least about 95 weight percent.
Embodiment 27: The oral product of any of embodiments 16 to 26, wherein the
sugar alcohol syrup
is maltitol syrup.
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Embodiment 28: The oral product of any of embodiments 16 to 27, further
comprising an additive
selected from the group consisting of flavorants, sweeteners, additional
filler components, emulsifiers,
disintegration aids, humectants, salts, and mixtures thereof.
Embodiment 29: The oral product of any of embodiments 16 to 28, further
comprising a buffering
agent and/or a pH adjuster in an amount sufficient to adjust the pH of the
oral product to be in the range of
about 5.0 to about TO.
Embodiment 30: The oral product of any of embodiments 16 to 29, wherein the
buffering agent
and/or the pH adjuster is citric acid.
Embodiment 31: The oral product of any of embodiments 16 to 30, wherein the
water content of the
oral product is in the range of about 0.1 weight percent to about 5 weight
percent based on the total weight
of the oral product.
Embodiment 32: The oral product of any of embodiments 16 to 31, comprising at
least about 80
weight percent of the sugar substitute; at least about 2 weight percent of at
least one humectant; at least
about 0.1 weight percent of the sugar alcohol syrup; at least about 0_1 weight
percent of at least one
flavoring agent; and at least about 0.05 weight percent of at least one
sweetener.
Embodiment 33: Use of at least one active ingredient in an oral product,
wherein the active
ingredient is present in an amount of 10 percent or less by weight based on
the total weight of the product.
Embodiment 34: Use of at least one active ingredient in the oral product of
embodiment 33, wherein
the oral product is substantially free of a tobacco material.
Embodiment 35: Use of at least one active ingredient in the oral product of
any of embodiments 33
to 34, wherein the oral product is in the form of a pastille or in the form of
a lozenge.
Embodiment 36: Use of a nicotine component in an oral product, wherein the
nicotine component is
present in an amount of 1 percent or less by weight based on the total weight
of the product.
Embodiment 37: Use of a nicotine component in the oral product of embodiment
36, wherein the
oral product is substantially free of a tobacco material.
Embodiment 38: Use of a nicotine component in the oral product of any of
embodiments 36 to 37,
wherein the oral product is in the form of a pastille or in the form of a
lozenge.
Embodiment 39: An oral product, the oral product comprising at least one
active ingredient in an
amount of about 10 percent or less by weight, at least one sugar alcohol in an
amount from about 25% to
about 45% by weight, and a gum in an amount from about 35% to about 55% by
weight, based on the total
weight of the product, the product being in the form of a pastille.
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Embodiment 40: The oral product of embodiment 39, wherein the at least one
active ingredient is
selected from the group consisting of a nicotine component, botanicals,
nutraceuticals, stimulants, amino
acids, vitamins, cannabinoids, camiabimimetics, terpenes, and combinations
thereof.
Embodiment 41: The oral product of any of embodiments 3940, wherein the at
least one active
ingredient is selected from the group consisting of caffeine, marine, GABA,
theanine, tryptophan, vitamin
B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower
lecithin, and combinations
thereof.
Embodiment 42: The oral product of any of embodiments 39-41, wherein the at
least one active
ingredient comprises a combination of caffeine, taurine, and ascorbic acid,
optionally further comprising
trisodium citrate.
Embodiment 43: The oral product of embodiment 42, wherein the caffeine is
present in an amount
of about 2% to about 4% by weight, the taurine is present in an amount of
about 2% to about 4% by weight,
and the ascorbic acid is present in an amount of about 1% to about 3% by
weight, based on the total weight
of the product.
Embodiment 14: The oral product of any of embodiments 3941, wherein the at
least one active
ingredient comprises theanine, gamma-aminobutyric acid, and optionally lemon
balm.
Embodiment 45: The oral product of embodiment 44, wherein the theanine is
present in an amount
of about 2% to about 4% by weight, the gamma-aminobutyric acid is present in
an amount of about 2% to
about 4% by weight, and the lemon balm is present in an amount of about 1% to
about 3% by weight, based
on the total weight of the product.
Embodiment 46: The oral product of any of embodiments 39-41, wherein the at
least one active
ingredient comprises caffeine, theanine, and optionally ginseng.
Embodiment 47: The oral product of embodiment 46, wherein the caffeine is
present in an amount
of about 2% to about 4%, the theanine is present in an amount of about 2% to
about 4%, and the ginseng is
present in an amount of about 0.1% to about 1% by weight, based on the total
weight of the product.
Embodiment 48: The oral product of any of embodiments 39-47, wherein the at
least one active
ingredient is present in an amount in the range of about 6% to about 8% by
weight based on the total weight
of the product.
Embodiment 49: The oral product of any of embodiments 3948, wherein the oral
product is
substantially free of a tobacco material.
Embodiment 50: The oral product of any of embodiments 3949, wherein the oral
product is
substantially free of nicotine or a nicotine-derived component.
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Embodiment 51: The oral product of any of embodiments 39-50, wherein the at
least one sugar
alcohol is selected from the group consisting of erythritol, arabitol,
ribitol, isomalt, maltitol, duleitol, iditol,
marmite], xylitol, lactitol, sorbitol, and combinations thereof.
Embodiment 52: The oral product any of embodiments 39-51, wherein the least
one sugar alcohol is
5 selected from the group consisting of isomalt, maltitol, erythiitol, and
combinations thereof.
Embodiment 53: The oral product of any of embodiments 39-52, wherein the at
least one sugar
alcohol comprises isomalt in an amount from about 20% to about 35% by weight,
maltitol in an amount
from about 1% to about 10% by weight, and erythritol in an amount from about
0.1% to about 2% by
weight, based on the total weight of the product.
10 Embodiment 54: The oral product of any of embodiments 39-53,
wherein the gum is selected from
the group consisting of gum arabic, xanthan gum, guar gum, ghatti gum, gum
tragacanth, karaya gum, locust
bean gum, gellan gum, and combinations thereof
Embodiment 55: The oral product of any of embodiments 39-54, further
comprising an additive
selected from the group consisting of flavorants, sweeteners, additional
binders, emulsifiers, disintegration
aids, hurnectants, salts, and mixtures thereof.
Embodiment 56: The oral product of any of embodiments 39-55, wherein the oral
pastille product
has an outer coating coated thereon.
Embodiment 57: The oral product of any of embodiments 39-56, wherein the water
content of the
oral product is in the range of about 5% to about 20% by weight based on the
total weight of the oral
product.
Embodiment 58: The oral product of any of embodiments 39-57, wherein the water
content of the
oral product is in the range of about 5% to about 10% by weight based on the
total weight of the oral
product
Embodiment 59: An oral product, comprising: a sugar alcohol in an amount in
the range of 25% to
45% by weight, based on the total weight of the composition; a gum in an
amount in the range of about 35%
to about 55% by weight; at least one active ingredient in an amount of about
10% or less by weight; a
humectant in an amount in the range of about 0.1% to about 5% by weight; a
salt in an amount in the range
of about 0.1% to about 5% by weight; a flavoring agent in an amount in the
range of about 0.1% to about
5% by weight; a water content in the range of about 5% to about 10% by weight;
and at least about 0.01%
by weight of a sweetener.
Embodiment 60: A method of preparing an oral product, the method comprising:
mixing a gum and
at least one active ingredient to provide a combined mixture thereof; adding
water, at least one additive, and
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at least one flavoring agent to the combined mixture to provide an aqueous
mixture; separately adding at
least one sugar alcohol to the aqueous mixture to provide an oral composition;
heating the oral composition;
depositing the oral composition into a mold; and curing the oral composition
to provide an oral product in
the form of a pastille.
Embodiment 61: The method of embodiment 60, wherein the gum is heated to a
temperature in the
range of about 40 C to about 80 C.
Embodiment 62: The method to any of embodiments 60-61, wherein the at least
one sugar alcohol is
heated to a temperature in the range of about 160 C to about 190 C and then
optionally cooled to a
temperature in the range of about 120 C to about 150 C prior to being added to
the aqueous mixture.
Embodiment 63: The method of any of embodiments 60-62, wherein heating the
oral composition
comprises heating to a temperature in the range of about 60 C to about 80 C.
Embodiment 64: The method of any of embodiments 60-63, wherein the at least on
active ingredient
is selected from the group consisting of a nicotine component, botanicals,
nutraceuticals, stimulants, amino
acids, vitamins, cannabinoids, cannabimimetics, terpenes, and combinations
thereof.
Embodiment 65: The method of any of embodiments 60-64, wherein the at least
one sugar alcohol is
selected from the group consisting of erythritol, arabitol, ribitol, isomalt,
maltitol, dulcitol, iditol, marmitol,
xylitol, lactitol, sorbitol, and combinations thereof
Embodiment 66: The method of any of embodiments 60-65, wherein the at least
one additive
selected from the group consisting of flavorants, sweeteners, additional
binders, emulsifiets, disintegration
aids, humectants, salts, and mixtures thereof.
Embodiment 67: An oral product, the oral product comprising an active
ingredient in an amount of
10 weight percent or less, a sugar substitute in an amount of at least about
80 weight percent; and a sugar
alcohol syrup, the oral product being in the form of a lozenge.
Embodiment 68: The oral product of embodiment 67, wherein the at least one
active ingredient is
selected from the group consisting of a nicotine component, botanicals,
nutraceuticals, stimulants, amino
acids, vitamins, cannabinoids, cannabimimetics, terpenes, and combinations
thereof.
Embodiment 69: The oral product of any one of embodiments 67-68, wherein the
at least one active
ingredient is selected from the group consisting of caffeine, taurine, GABA,
theanine, ttyptophan, vitamin
B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower
lecithin, and combinations
thereof.
Embodiment 70: The oral product of any one of embodiments 67-69, wherein the
at least one active
ingredient comprises a combination of caffeine, taurine, and ascorbic acid.
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Embodiment 71: The oral product of embodiment 70, wherein the caffeine is
present in an amount
of about 2% to about 4% by weight, the taurine is present in an amount of
about 2% to about 4% by weight,
and the ascorbic acid is present in an amount of about 1% to about 3% by
weight, based on the total weigh
of the product.
Embodiment 72: The oral product of any one of embodiments 67-69, wherein the
at least one active
ingredient comprises theanine, garnma-aminobutyric acid, and optionally lemon
balm.
Embodiment 73: The oral product of embodiment 72, wherein the theanine is
present in an amount
of about 2% to about 4% by weight, the gamma-aminobutyric acid is present in
an amount of about 2% to
about 4% by weight, and the lemon balm is present in an amount of about 1% to
about 3% by weight, based
on the total weight of the product.
Embodiment 74: The oral product of any one of embodiments 67-69, wherein the
at least one active
ingredient comprises caffeine, theanine, and optionally ginseng.
Embodiment 75: The oral product of embodiment 74, wherein the caffeine is
present in an amount
of about 2% to about 4%, the theanine is present in an amount of about 2% to
about 4% by weight, and the
ginseng is present in an amount of about 0.1% to about 1% by weight, based on
the total weight of the
product
Embodiment 76: The oral product of any one of embodiments 67-75, wherein the
at least one active
ingredient is present in an amount in the range of about 6% to about 8% by
weight based on the total weight
of the product.
Embodiment 77: The oral product of any one of embodiments 67-76, wherein the
oral product is
free of a tobacco material.
Embodiment 78: The oral product of any one of embodiments 67-77, wherein the
oral product is
free of nicotine or a nicotine-derived component.
Embodiment 79: The oral product of any one of embodiments 67-78, further
comprising a tobacco
material.
Embodiment 80: The oral product of any one of embodiments 67-79, wherein the
sugar substitute is
a non-hygroscopic sugar alcohol capable of forming a glassy matrix.
Embodiment 81: The oS product of any one of embodiments 67-80, wherein the
sugar substitute is
isomalt.
Embodiment 82: The oral product of any one of embodiments 67-81, wherein the
sugar substitute is
present in an amount of at least about 85 weight percent.
Embodiment 83: The oral product of any one of embodiments 67-82, wherein the
sugar substitute is
present in an amount of at least about 90 weight percent.
Embodiment 84: The oral product of any one of embodiments 67-83, wherein the
sugar substitute is
present in an amount of at least about 95 weight percent.
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Embodiment 85: The oral product of any one of embodiments 67-84, wherein the
sugar alcohol
syrup is maltitol syrup.
Embodiment 86: The oral product of any one of embodiments 67-85, further
comprising an additive
selected from the group consisting of flavorants, sweeteners, additional
filler components, emulsifiers,
disintegration aids, humectants, salts, and mixtures thereof.
Embodiment 87: The oral product of any one of embodiments 67-86, further
comprising a buffering
agent and/or a pH adjuster in an amount sufficient to adjust the pH of the
oral product to be in the range of
about 5.0 to about 7Ø
Embodiment 88: The oral product of any one of embodiments 67-87, wherein the
water content of
the otal product is in the range of about 0.1 weight percent to about 5 weight
percent based on the total
weight of the oral product.
Embodiment 89: The oral product of any one of embodiments 1-88, wherein the at
least one active
ingredient comprises:
theanine;
theanine and tryptophan; or
theanine and vitamin B6, vitamin B12, or both.
Embodiment 90: The oral product of embodiment 89, comprising theanine and one
or both of
vitamins 86 and vitamin B12.
Embodiment 91: The oral product of any one of embodiments 1-90, further
comprising magnesium,
such as magnesium in an amount by weight from about 0.1% to about 2%, or from
about 0.2 to about 1%,
based on elemental magnesium.
These and other features, aspects, and advantages of the disclosure will be
apparent from a reading
of the following detailed description together with the accompanying drawings,
which are briefly described
below. The invention includes any combination of two, three, four, or more of
the above-noted
embodiments as well as combinations of any two, three, four, or more features
or elements set forth in this
disclosure, regardless of whether such features or elements are expressly
combined in a specific embodiment
description herein. This disclosure is intended to be read holistically such
that any separable features or
elements of the disclosed invention, in any of its various aspects and
embodiments, should be viewed as
intended to be combinable unless the context clearly dictates otherwise.
DETAILED DESCRIPTION
The present disclosure will now be described more fully hereinafter with
reference to example
embodiments thereof. These example embodiments are described so that this
disclosure will be thorough
and complete, and will fully convey the scope of the disclosure to those
skilled in the art. Indeed, the
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disclosure may be embodied in many different forms and should not be construed
as limited to the
embodiments set forth herein; rather, these embodiments are provided so that
this disclosure will satisfy
applicable legal requirements. As used in this specification and the claims,
the singular forms "a," "an," and
"the" include plural referents unless the context clearly dictates otherwise.
Reference to "dry weight
percent" or "dry weight basis" refers to weight on the basis of dry
ingredients (i.e., all ingredients except
water). Reference to "wet weight" refers to the weight of the mixture
including water. Unless otherwise
indicated, reference to "weight percent" of a mixture reflects the total wet
weight of the mixture (i.e.,
including water).
The disclosure provides products configured for oral use and processes for
preparing such oral
products. Oral products as described herein may generally include a mixture of
ingredients in the form of a
composition. For example, in some embodiments, the compositions provided
herein may include one or
more active ingredients (e.g., a tobacco material and/or nicotine) and one or
more additives (e.g., a filler, a
binder component, a flavorant, etc..) that combine to form a product
configured for oral use.
Oral products as described herein may be provided in various different forms
and with various
combinations of ingredients. Particularly, in prefentd embodiments, products
of the present disclosure may
be provided in one of two forms, for example, in the form of a pastille-type
product or a lozenge-type
product The pastille- and lozenge-type products =cording to embodiments of the
present disclosure may be
configured for oral use and advantageously can provide different
characteristics and properties upon
insertion into the oral cavity of a user of that product. Certain products can
exhibit, for example, one or more
of the following characteristics: crispy, granular, chewy, syrupy, pasty,
fluffy, smooth, and/or creamy. In
certain embodiments, the desired textural property can be selected from the
group consisting of
adhesiveness, cohesiveness, density, dryness, fracturability, graininess,
gumminess, hardness, heaviness,
moisture absorption, moisture release, mouthcoating, roughness, slipperiness,
smoothness, viscosity,
wetness, and combinations thereof.
The term "configured for oral use" as used herein means that the product is
provided in a form such
that during use, saliva in the mouth of the user causes one or more of the
components of the product (e.g.,
flavoring agents and/or nicotine) to pass into the mouth of the user. In one
embodiment, the product is
adapted to deliver components to a user through mucous membranes in the user's
mouth and, in addition,
said component is an active ingredient (including, but not limited to, for
example, nicotine) that can be
absorbed through the mucous membranes in the mouth when the product is used.
In some embodiments, the
product may be adapted to deliver flavor components to a user in addition to
the active ingredient.
The products comprising the compositions of the present disclosure may be
dissolvable. As used
herein, the terms "dissolve," "dissolving," and "dissolvable" refer to
compositions having aqueous-soluble
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components that interact with moisture in the oral cavity and enter into
solution, thereby causing gradual
consumption of the product. According to one aspect, the dissolvable product
is capable of lasting in the
user's mouth for a given period of time until it completely dissolves.
Dissolution rates can vary over a wide
range, from about 1 minute or less to about 60 minutes. For example, fast
release mixtures typically
5 dissolve and/or release the active substance in about 2 minutes or less,
often about 1 minute or less (e.g.,
about 50 seconds or less, about 40 seconds or less, about 30 seconds or less,
or about 20 seconds or less).
Dissolution can occur by any means, such as melting, mechanical disruption
(e.g., chewing), enzymatic or
other chemical degradation, or by disruption of the interaction between the
components of the mixture. In
some embodiments, the product can be meltable as discussed, for example, in US
Patent App. Pub. No.
10 2012/0037175 to Cantrell et al. In other embodiments, the products do
not dissolve during the product's
residence in the user's mouth.
In some embodiments, the products disclosed herein may be in the form of a
dissolvable and lightly
chewable pastille product for oral use. As used herein, the term "pastille"
refers to a dissolvable oral
product made by solidifying a liquid or gel composition, such as a composition
that includes a gelling or
15 binding agent, so that the final product is a haidened solid gel. In
certain embodiments, the pastille products
of the disclosure are characterized by sufficient cohesiveness to withstand
light chewing action in the oral
cavity without rapidly disintegrating. The pastille products of the disclosure
typically do not exhibit a highly
deformable chewing quality as found in conventional chewing gum. See, for
example, the smokeless
tobacco pastilles, pastille formulations, pastille configurations, pastille
characteristics and techniques for
formulating or manufacturing pastilles set forth in US Pat. Nos. 9,204,667 to
Cantrell et al.; 9,775,376 to
Cantrell et al.; 10,357,054 to Marshall et al.; which are incorporated herein
by reference.
Alternatively, in some embodiments, the products disclosed herein may be in
the form of a
dissolvable lozenge product configured for oral use. Example lozenge-type
products of the invention have
the form of a lozenge, tablet, microtab, or other tablet-type product. See,
for example, the types of nicotine-
containing lozenges, lozenge formulations, lozenge formats and configurations,
lozenge characteristics and
techniques for formulating or manufacturing lozenges set forth in US Pat, Nos.
4,967,773 to Shaw;
5,110,605 to Achaly a; 5,733,574 to Dam; 6,280,761 to Santus; 6,676,959 to
Andersson et at.; 6,248,760 to
Wilhelmsen; and 7,374,779; US Pat Pub, Nos. 2001/0016593 to Wilhelmsen;
2004/0101543 to Liu et at;
2006/0120974 to Mcneight; 2008/0020050 to Chau et at; 2009/0081291 to Gin et
al.; and 2010/0004294 to
Axelsson et al.; which are incorporated herein by reference. Such lozenge-type
products, in some
embodiments, may exhibit translucence or transparency. The desired
transparency or translucency of the
product can be quantified by any known method. For example, optical methods
such as turbidimetry (or
nephelometry) and colorimetty may be used to quantify the cloudiness (light
scattering) and the color (light
absorption), respectively, of the products. Translucency can also be confirmed
by visual inspection by
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simply holding the product up to a light source and determining if light
travels through the material or
product in a diffuse manner.
Oral products of the present disclosure may be provided in the specific
physical forms noted above
(e.g., such as in the form of a pastille or a lozenge) by altering the water
content, for example, the water
content of the products may be provided within a specified range so as to
dictate the final form of the
product The water content of the products described herein, prior to use by a
consumer of the product, may
vary within such ranges according to the desired properties and
characteristics, in addition to dictating the
final form of the product. For example, pastille-type products typically
possess a water content in the range
of about 5 to about 20 weight percent, based on the total weight of the
composition. Preferably, the moisture
content of a pastille product, as present within a single unit of product
prior to insertion into the mouth of the
user, is within the range of about 5 to about 25 weight percent, often about 8
to about 20 weight percent,
more often about 10 to about 15 weight percent, based on the total weight of
the product unit. In some
embodiments, the moisture content of a pastille product may be at least about
5 weight percent, at least
about 10 weight percent, at least about 15 weight percent, or at least about
20 weight percent, based on the
total weight of the product.
Alternatively, lozenge-type products typically possess a water content in the
range of about 0.1 to
about 5 weight percent, based on the total weight of the composition.
Preferably, the moisture content of a
lozenge product, as present within a single unit of product prior to insertion
into the mouth of the user, is
less than about 5 weight percent, less than about 3 weight percent, less than
about 2 weight percent, or less
than about 1 weight percent, based on the total weight of the product unit. In
some embodiments, the
moisture content of a lozenge product as described herein may be within the
range of about 0.1 to about 5
weight percent, about 0.5 to about 3 weight percent, Of about 1 to about 2
weight percent, based on the total
weight of the product.
As noted above, the pastille- and lozenge-type products of the present
disclosure may incorporate
various different additives in addition to at least one active ingredient and
may be prepared according to a
variety of different methods commonly known in the art for preparing pastille-
and lozenge-type products.
Example compositions, products, and methods of preparing such products will be
detailed herein below.
Pastille products
Pastille products of the present disclosure typically include a composition
comprising at least one
active ingredient in an amount of less than about 10 weight percent (e.g., a
nicotine compound), a gum, and
a sugar alcohol as a filler component. Any active ingredient (e.g., a tobacco
material and/or an active
ingredient) as discussed herein below is meant to be suitable for use as an
active ingredient in the pastille
compositions according to the present disclosure. Such active ingredients may
be added as a singular active
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ingredient, or in combinations with one or more other active ingredients. In
some embodiments, the active
ingredient may be provided in liquid form or in a dry powder or particulate
form. As noted above, the active
ingredient typically is present in an amount from about 0.1 weight percent to
about 10 weight percent, such
as, e.g., from about 0.1 weight percent, about 0.5 weight percent, about 1
weight percent, about 1.5 weight
percent, about 2 weight percent, about 2.5 weight percent, about 3 weight
percent, about 3.5 weight percent,
about 4 weight percent, or about 4.5 weight percent, to about 5.5 weight
percent, about 6 weight percent,
about 65 weight percent, about 7 weight percent, about 7.5 weight percent,
about 8 weight percent, about
8.5 weight percent, about 9 weight percent, about 9.5 weight percent, or about
10 weight percent, based on
the total weight of the composition. In some embodiments, the active
ingredient may be present in an
amount of less than about 10 weight percent, less than about 9 weight percent,
less than about 8 weight
percent, less than about 7 weight percent, less than about 6 weight percent,
less than about 5 weight percent,
less than about 4 weight percent, less than about 3 weight percent, less than
about 2 weight percent, or less
than about 1 weight percent, based on the total weight of the composition.
A gum (or combination of two or more gums) may be employed in amounts
sufficient to provide the
desired physical attributes and physical integrity to the pastille products.
In some embodiments, the gum
may function as a binder component in the oral product. A representative
amount of gum may make up at
least about 5 percent or at least about 10 percent of the total weight of the
pastille composition. In certain
embodiments, the gum(s) of the composition will be present in an amount of at
least about 30 weight
percent, at least about 35 weight percent, at least about 40 weight percent,
at least about 45 weight percent,
or at least about 50 weight percent, based on the total weight of the
composition. In some embodiments, the
gum in the composition may be present in an amount of about 35 weight percent
to about 55 weight percent,
based on the total weight of the composition. Preferably, the total amount of
gum within the pastille product
will not exceed about 55 percent of the total weight of the composition.
Often, the amount of gum within a
desirable composition will not exceed about 65 percent, and frequently will
not exceed about 60 percent, of
the total weight of the composition.
In certain embodiments, the gum includes a natural gum. Particularly, natural
gums (e.g., such as
gum arabic) may be incorporated into the pastille products as a softener.
Advantageously, use of a natural
gum as a softener provides the desired textural qualities nececcary for
forming pastille compositions,
particularly those described herein. Particularly, it should be noted that
increasing the amount of a natural
gum (e.g., gum arable) while, subsequently, decreasing the amount of sugar
alcohol can advantageously
increase softness in the resulting pastille product. As used herein, a natural
gum refers to polysaccharide
materials of natural origin that are useful as softening agents.
Representative natural gums derived from
plants, which are typically water soluble to some degree, include xanthan gum,
guar gum, gum arabic, ghatti
gum, gum tragacanth, karaya gum, locust bean gum, gellan gum, and combinations
thereof. Preferably, gum
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arabic may be used as an example natural gum which provides the above noted
softening characteristics
when incorporated into the pastille compositions of the present disclosure.
In some embodiments, the gum can optionally include a tobacco-derived material
in the form of a
binder, which can he combined with one or more additional binder components.
For example, in one
particular embodiment, the gum component comprises gum arabic in combination
with a tobacco-derived
binder as described herein. In such embodiments, the amount of tobacco-derived
binder within the
composition is at least about 0.5 percent oral least about 1 percent or at
least about 1.5 percent, on a weight
basis of the composition_ An example weight range is about 0.5 to about 10
weight percent more often
about 1 to about 5 weight percent.
As noted above, pastille products of the present disclosure may comprise at
least one sugar alcohol
in the form of a filler component. Sugar alcohols are particularly
advantageous as filler components in the
pastilles of the disclosure because such materials contribute some sweetness
and do not disrupt the desired
chewable characteristics of the final product. Sugar alcohols are polyols
derived from monosaccharides or
clisaccharides that have a partially or fully hydrogenated form. Example sugar
alcohols have between about
4 and about 20 carbon atoms and include erythritol, arabitol, fibitol,
isomalt, maltitol, dulcitol, iditol,
mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g.,
hydrogenated starch hydrolysates). In
some embodiments, isomalt may be incorporated as the sole filler component A
sugar alcohol is typically
added to compositions of the disclosure in the form of an aqueous solution or
suspension, such as a solution
or suspension with a solids content of about 50 to about 90 weight percent.
Combinations of a sugar alcohol
with a further filler component can also be used. A filler component often
fulfills multiple functions, such
as enhancing certain organoleptic properties such as texture and mouthfeel,
enhancing cohesiveness or
compressibility of the product, and the like. When present, a representative
amount of filler, whether an
organic and/or inorganic filler, may make up at least about 10 percent, at
least about 20 percent, or at least
about 25 percent, based on the total weight of the composition. Preferably,
the amount of filler within the
composition will not exceed about 50 percent, and frequently will not exceed
about 40 percent, of the total
weight of the composition. A typical filler range is about 15 weight percent
to about 50 weight percent,
about 25 weight percent to about 45 weight percent, or about 30 weight percent
to about 40 weight percent
Lozenge products
Lozenge products of the present disclosure typically include composition
comprising at least one
active ingredient in an amount of less than about 2 weight percent (e.g., a
nicotine compound), a sugar
substitute in an amount of at least about 80 weight percent, and a sugar
alcohol syrup. Any active ingredient
(e.g., a tobacco material and/or an active ingredient) as discussed herein
below is meant to be suitable for
use as an active ingredient in the lozenge compositions provided herein. Such
active ingredients may be
added as a singular active ingredient, or in combinations with one or more
other active ingredients. In some
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embodiments, the active ingredient may be provided in liquid form or in a dry
powder or particulate form.
As noted above, the active ingredient typically is present in an amount from
about 0. 1 weight percent to
about 10 weight percent, such as, e.g., from about 0.1 weight percent to about
10 weight percent, such as,
e.g., from about 0.1 weight percent, about 0.5 weight percent, about 1 weight
percent, about 1.5 weight
percent, about 2 weight percent, about 2.5 weight percent, about 3 weight
percent, about 3.5 weight percent,
about 4 weight percent, or about 4.5 weight percent, to about 5.5 weight
patent, about 6 weight percent,
about 6.5 weight percent, about 7 weight percent, about 7.5 weight percent,
about 8 weight percent, about
8.5 weight percent, about 9 weight percent, about 9.5 weight percent, or about
10 weight percent, based on
the total weight of the composition. In some embodiments, the active
ingredient may be present in an
amount of less than about 10 weight percent, less than about 9 weight percent,
less than about 8 weight
percent, less than about 7 weight percent, less than about 6 weight percent,
less than about 5 weight percent,
less than about 4 weight percent, less than about 3 weight percent, less than
about 2 weight percent, or less
than about 1 weight percent, based on the total weight of the composition.
In some embodiments, the lozenge product comprises a sugar substitute. The
sugar substitute is
typically provided in pure, solid form (e.g., granular or powdered form). In
certain embodiments, the sugar
substitute is thy, comprising a very low water content. For example, the sugar
substitute can comprise less
than about 5% water by weight, less than about 3% water by weight, less than
about 2% water by weight, or
less than about 1% water by weight.
The sugar substitute can be any sugarless material (i.e., sucrose-free
material) and can be natural or
synthetically produced. The sugar substitute used in the products described
herein can be nutritive or non-
nutritive. For example, the sugar substitute is commonly a sugar alcohol.
Sugar alcohols that may be
useful according to the present invention include, but are not limited to,
eiytluitol, threitol, arabitol, xylitol,
ribotol, mamitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol,
polyglycitol, and mixtures thereof. For
example, in certain embodiments, the sugar alcohol is selected from the group
consisting of eiythritol,
sorbitol, and isomak. The amount of sugar substitute in the lozenge
compositions can vary, but is typically
at least about 75%, at least about 80%, at least about 85%, or at least about
90%, or at least about 95% by
weight of the composition.
In certain embodiments, the sugar substitute is capable of forming a glassy
matrix. The formation
of a glassy matrix is commonly characterized by a translucent/transparent
appearance. Typically, the sugar
substitute is substantially non-hygroscopic. Non-hygroscopic materials
typically do not absoib, adsorb,
and/or retain a significant quantity of moisture from the air. For example, in
some embodiments, the sugar
substitute exhibits a weight gain of water of less than about 50% upon
exposure to conditions of 25 C, 80%
relative humidity for two weeks. Typically, the sugar substitute exhibits a
weight gain of less than about
30%, less than about 20%, less than about 10%, less than about 5%, less than
about 2%, or less than about
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1% upon exposure to conditions of 25 C, 80% relative humidity for two weeks.
Non-hygroscopic materials
can provide the benefit of reducing the tendency of the lozenge product to
tacldfy upon exposure to
humidity.
ht certain embodiments, the sugar substitute comprises one or more sugar
alcohols. For example, in
5 one embodiment, the won substitute is isomalt. IsomaIt is a disaccharide
that is typically made by
enzymatic rearrangement of sucrose into isotnaltulose, followed by
hydrogenation to give an equimolar
composition of 6-0-a-D-glucopyranosido-D-sotbitol (1,6-GPS) and 1-0-a-D-
glucopyranosido-D-marmitol-
dihydrate (1,1-GPM-dihydrate).
In some embodiments, the lozenge products of the present disclosure may
comprise a syrup, e.g., a
10 sugar syrup or a sugar alcohol syrup. "Sugar alcohol syrup" as used
herein is intended to refer to a thick
solution of sugar alcohol in water, e.g., having greater than about 40%
solids, preferably having greater than
about 50% solids, greater than about 60% solids, greater than about 70%
solids, or greater than about 80%
solids. Typically, the solid content of the sugar alcohol syrup primarily
comprises the named sugar alcohol
(i.e., maltitol syrup typically comprises greater than about 80%, greater than
about 85%, or greater than
15 about 90% by weight maltitol on a thy basis). Sugar alcohol syrups are
generally prepared by heating a
solution of the sugar alcohol in water and cooling the mixture to give a
viscous composition. The resulting
syrup is typically characterized by a relatively high concentration of sugar
alcohol and relatively high
stability (i.e., the sugar alcohol typically does not crystallize from
solution, e.g., at room temperature).
The syrup, e.g., sugar alcohol syrup, desirably is capable of affecting the re-
crystallization of a
20 melted sugar substitute. One example sugar alcohol syrup that is
particularly useful according to the present
disclosure is maltitol syrup. Other sugar alcohol syrups can be used,
including, but not limited to, corn
syrup, golden syrup, molasses, xylitol, mannitol, glycerol, erythritol,
threitol, arabitol, ribitol, mannitol,
sorbitol, dulcitol, iditol, Small., lactitol, and polyglycitol syrups. Such
sugar alcohol syrups can be prepared
or can be obtained from commercial sources. For example, maltitol syrups are
commercially available from
such suppliers as Corn Products Specialty Ingredients. Although sugar alcohol
syrups may be preferred,
sugar syrups can, in certain embodiments, be used in place of or in
combination with the sugar alcohol
syrup. For example, in some embodiments, corn syrup, golden syrup, and/or
molasses can be used.
The amount of sugar alcohol syrup added to the lozenge composition mixture is
typically that
amount required to slow recrystallization of the sugar substitute in melted
form. It should be noted that it
may be possible to vary the amount of sugar alcohol syrup depending on the
composition of the remaining
ingredients to ensure that the recrystallization is sufficiently slow to
provide a material with the desired
characteristics (e.g., a desired level of translucency/transparency).
Accordingly, the amount of sugar alcohol
syrup can vary, but typically ranges from about 0.1% to about 2%, often from
about 0.5% to about 1.5%,
and more often about 1% by weight of the smokeless tobacco product mixture. In
certain embodiments, the
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amount of sugar alcohol syrup is higher, for example, up to about 2% by weight
of the mixture, up to about
5% by weight of the mixture, up to about 10% by weight of the mixture, or up
to about 20% by weight of the
mixture
Active ingredient
The compositions and products as disclosed herein includes one or more active
ingredients. As used
herein, an "active ingredient" refers to one or more substances belonging to
any of the following categories:
API (active pharmaceutical ingredient), food additives, natural medicaments,
and naturally occurring
substances that can have an effect on humans. Example active ingredients
include any ingredient known to
impact one or more biological functions within the body, such as ingredients
that furnish pharmacological
activity or other direct effect in the diagnosis, cure, mitigation, treatment,
or prevention of disease, or which
affect the structure or any function of the body of humans (e.g., provide a
stimulating action on the central
nervous system, have an energizing effect, an antipyretic or analgesic action,
or an otherwise useful effect on
the body). In some embodiments, the active ingredient may be of the type
generally referred to as dietary
supplements, nutraceuticals, "phytochetnicals" or "functional foods." These
types of additives are sometimes
defined in the art as encompassing substances typically available from
naturally-occurring sources (e.g.,
botanical materials) that provide one or more advantageous biological effects
(e.g., health promotion, disease
prevention, or other medicinal properties), but are not classified or
regulated as drugs.
Non-limiting examples of active ingredients include those falling in the
categories of botanical
ingredients, stimulants, amino acids, nicotine components, and/or
pharmaceutical, nutraceutical, and
medicinal ingredients (e.g., vitamins, such as A, B3, 136, 1112, and C, and/or
cannabinoids, such as
tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these categories is
further described herein
below. The particular choice of active ingredients will vary depending upon
the desired flavor, texture, and
desired characteristics of the particular product
In certain embodiments, the active ingredient is selected from the group
consisting of caffeine, taurine,
GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm
extract, ginseng, citicoline,
sunflower lecithin, and combinations thereof. For example, the active
ingredient can include a combination
of caffeine, theanine, and optionally ginseng. In another embodiment, the
active ingredient includes a
combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon
balm extract. In a further
embodiment, the active ingredient includes theanine, theanine and tryptopban,
theanine and one or more of B
vitamin B6 and vitamin B12, or tryptoplian, theanine and one or more of B
vitamin B6 and vitamin B12. In a
still further embodiment, the active ingredient includes a combination of
caffeine, taurine, and vitamin C,
optionally further including one or more B vitaimins (e.g., vitamin B6 or
B12). A magnesium salt (e.g.,
magnesium gluconate) could be added to any of the above combinations,
particularly combinations also
including theanine.
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The particular percentages of active ingredients present will yaw depending
upon the desired
characteristics of the particular product. Typically, an active ingredient or
combination thereof is present in a
total concentration of at least about 0.001% by weight of the composition,
such as in a range from about
0.001% to about 20%. In some embodiments, the active ingredient or combination
of active ingredients is
present in a concentration from about 0.1% w/w to about 10% by weight, such
as, e.g., from about 0.5% w/w
to about 10%, from about 1% to about 10%, from about 1% to about 5% by weight,
based on the total weight
of the composition. In some embodiments, the active ingredient or combination
of active ingredients is present
in a concentration of from about 0.001%, about 0.01%, about 0.1%, or about 1%,
up to about 20% by weight,
such as, e.g., from about 0.001%, about 0.002%, about 0.003%, about 0.004%,
about 0.005%, about 0.006%,
about 0.007%, about 0.008%, about 0.009%, about 0.01%, about 0.02%, about
0.03%, about 0.04%, about
0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1%, about
0.2%, about 0.3%, about
0.40/, about 0.5% about 0.6%, about 0.7%, about 0.8%, or about 0.904 to about
1%, about 2%, about 3%,
about 4 43, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about
11%, about 12%, about
13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, or
about 20% by weight, based
on the total weight of the composition. Further suitable ranges for specific
active ingredients are provided
herein below.
Botanical
In some embodiments, the active ingredient comprises a botanical ingredient.
As used herein, the term
"botanical ingredient" or "botanical" refers to any plant material or fungal-
derived material, including plant
material in its natural form and plant material derived from natural plant
materials, such as extracts or isolates
from plant materials or treated plant materials (e.g., plant materials
subjected to heat treatment, fermentation,
bleaching, or other treatment processes capable of altering the physical
and/or chemical nature of the material).
For the purposes of the present disclosure, a "botanical" includes, but is not
limited to, "herbal materials,"
which refer to seed-producing plants that do not develop persistent woody
tissue and are often valued for their
medicinal or sensory characteristics (e.g., teas or tisanes). Reference to
botanical material as "non-tobacco"
is intended to exclude tobacco materials (i.e., does not include any Nicotiana
species). In some embodiments,
the compositions as disclosed herein can be characterized as free of any
tobacco material (e.g., any
embodiment as disclosed herein may be completely or substantially free of any
tobacco material). By
"substantially free" is meant that no tobacco material has been intentionally
added. For example, certain
embodiments can be characterized as having less than 0.001% by weight of
tobacco, or less than 0.0001%, or
even 0% by weight of tobacco.
When present, a botanical is typically at a concentration of from about 0.01%
w/w to about 10% by
weight, such as, e.g., from about 0.01% w/w, about 0.05%, about 0.1%, or about
0.5%, to about 1%, about
2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or
about 10')/0, about 11%,
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about 12%, about 13%, about 14%, or about 15% by weight, based on the total
weight of the composition.
The botanical materials useful in the present disclosure may comprise, without
limitation, any of the
compounds and sources set forth herein, including mixtures thereof Certain
botanical materials of this type
are sometimes referred to as dietary supplements, nutraceuticals,
"phytochemicals" or "fiunctional foods."
Certain botanicals, as the plant material or an extract thereof, have found
use in traditional herbal medicine,
and are described further herein. Non-limiting examples of botanicals or
botanical-derived materials include
ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, Chai-hu,
chamomile, cherry blossom,
chlorophyll, cinnamon, citrus, cloves, cocoa, cordyceps, curcumin, damiana,
Dorstenia arifolia, Dorstenia
odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo
biloba, ginseng (e.g., Panax
ginseng), green tea, Griffonia simplicffolia, guarana, cannabis, hemp, hops,
jasmine, Kaempferia parviflora
(Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein,
maca, matcha, Nardostachys
chinensis, oil-based extract of Viola odorata, peppermint, quercetin,
resveratrol, Rhizottta gastrodiae,
Rhodiola, rooibos, rose essential oil, rosemary, , Sceletium tortuosum,
Schisandra, Skullcap, spearmint extract,
Spikenard, teipenes, tisanes, turmeric, Turnera aphrodisiaca, valerian, white
mulberry, and Yerba mate.
In some embodiments, the active ingredient comprises lemon balm. Lemon balm
(Melissa
officinalis) is a mildly lemon-scented herb from the same family as mint
(Latniaceae). The herb is native to
Europe, North Africa, and West Asia. The tea of lemon balm, as well as the
essential oil and the extract, aie used
in traditional and alternative medicine. In some embodiments, the active
ingredient comprises lemon balm extract.
In some embodiments, the lemon balm extract is present in an amount of from
about 1 to about 4% by weight,
based on the total weight of the composition.
In some embodiments, the active ingredient comprises ginseng. Ginseng is the
root of plants of the
genus Pan ax, which are characterized by the presence of unique steroid
saponin phytochemicals (ginsenosides)
and gintonin. Ginseng finds use as a dietary supplement in energy drinks or
herbal teas, and in traditional medicine.
Cultivated species include Korean ginseng (P. ginseng), South China ginseng
(P. notoginseng), and American
ginseng (P. quinquefolius). American ginseng and Korean ginseng vary in the
type and quantity of various
ginsenosides present. In some embodiments, the ginseng is American ginseng or
Korean ginseng. In specific
embodiments, the active ingredient comprises Korean ginseng. In some
embodiments, ginseng is present in an
amount of from about 0.4 to about 0.6% by weight, based on the total weight of
the composition.
Stimulants
In some embodiments, the active ingredient comprises one or more stimulants.
As used herein, the
term "stimulant" refers to a material that increases activity of the central
nervous system and/or the body, for
example, enhancing focus, cognition, vigor, mood, alertness, and the like. Non-
limiting examples of stimulants
include caffeine, theacrine, theobromine, and theophy Hine. Theactine (1,3,7,9-
tetramethyluric acid) is a purine
alkaloid which is structurally related to caffeine, and possesses stimulant,
analgesic, and anti-inflammatory
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effects. Present stimulants may be natural, naturally derived, or wholly
synthetic. For example, certain
botanical materials (g-uarana, tea, coffee, cocoa, and the like) may possess a
stimulant effect by virtue of the
presence of e.g., caffeine or related alkaloids, and accordingly are "natural"
stimulants. By "naturally derived"
is meant the stimulant (e.g., caffeine, theacrine) is in a purified form,
outside its natural (e.g., botanical) matrix.
For example, caffeine can be obtained by extraction and purification from
botanical sources (e.g., tea). By
"wholly synthetic", it is meant that the stimulant has been obtained by
chemical synthesis. In some
embodiments, the active ingredient comprises caffeine. In some embodiments,
the caffeine is present in an
encapsulated form. On example of an encapsulated caffeine is Vitashure,
available from Balchem Corp., 52
Sunrise Park Road, New Hampton, NY, 10958,
When present, a stimulant or combination of stimulants (e.g., caffeine,
theaciine, and combinations
thereof) is typically at a concentration of from about 0.1% w/w to about 15%
by weight, such as, e.g., from
about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,
about 0.7%, about 0.8%, or
about 0.9%, to about le/o, about 2%, about 3%, about 4%, about 5%, about 6%,
about 7%, about 8%, about
9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by
weight, based on the total
weight of the composition. In some embodiments, the composition comprises
caffeine in an amount of from
about 1.5 to about 6% by weight, based on the total weight of the composition;
Amino acids
In some embodiments, the active ingredient comprises an amino acid. As used
herein, the term "amino
acid" refers to an organic compound that contains amine (-NH2) and carboxyl (-
COOH) or sulfonic acid
(SO3H) functional groups, along with a side chain (R group), which is specific
to each amino acid. Amino
acids may be proteinogenic or non-proteinogenic. By "proteinogenic" is meant
that the amino acid is one of
the twenty naturally occurring amino acids found in proteins. The
proteinogenic amino acids include alanine,
arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid,
glycine, histicline, isoleucine, leucine,
lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan,
tyrosine, and valine. By "non-
proteinogenic" is meant that either the amino acid is not found naturally in
protein, or is not directly produced
by cellular machinery (e.g., is the product of post-tranlational
modification). Non-limiting examples of non-
proteinogenic amino acids include gamma-aminobutyric acid ((MBA), taurine (2-
aminoethanesulfonic acid),
theanine (L-y-glutarnylethylainidc), hyclroxyproline, and beta-alanine. In
some embodiments, the active
ingredient comprises theanine. In some embodiments, the active ingredient
comprises GABA. In some
embodiments, the active ingredient comprises a combination of theanine and
(MBA. In some embodiments,
the active ingredient is a combination of theanine, GABA, and lemon balm. In
some embodiments, the active
ingredient is a combination of caffeine, theanine, and ginseng. In some
embodiments, the active ingredient
comprises &urine. In some embodiments, the active ingredient is a combination
of caffeine and taurine.
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Without being bound by any theory of operation, it is believed that certain
amino acids, such as
theanine, tryptophan, GAB A, or taurine, can have beneficial impact on mood,
anxiety level, focus, or cognitive
performance, particularly when combined with other active ingredients, such as
caffeine or certain botanicals.
When present, an amino acid or combination of amino acids (e.g., theanine,
taurine, (MBA,
5 tryptophan, and combinations thereof) is typically at a concentration of
from about 0.01% w/w to about 15%
by weight, such as, e.g., from about from about 0.1% w/w, about 0.2%, about
0.3%, about 0.4%, about 05%
about 0.6%, about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%,
about 3%, about 4%, about 5%,
about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about
13%, about 14%, or
about 15% by weight, based on the total weight of the composition.
10 In one embodiment, the at least one active ingredient comprises
tryptophan in an amount by weight
from about 0.03% to about 1%, or from about 0.05% to about 0.5%.
Vitamins
hi some embodiments, the active ingredient comprises a vitamin or combination
of vitamins. As used
herein, the term "vitamin" refers to an organic molecule (or related set of
molecules) that is an essential
15 micronutrient needed for the proper functioning of metabolism in a
mammal. There are thirteen vitamins
required by human metabolism, which are: vitamin A (as all-trans-retinol, all-
trans-retinyl-esters, as well as
all-trans-beta-carotene and other provitamin A carotenoids), vitamin B1
(thiamine), vitamin B2 (riboflavin),
vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine),
vitamin 87 (biotin), vitamin 89
(folic acid or folate), vitamin B12 (cobalamins), vitamin C (ascorbic acid),
vitamin D (cakiferols), vitamin E
20 (tocopherols and tocotrienols), and vitamin K (quinones). In some
embodiments, the active ingredient
comprises vitamin C. In some embodiments, the active ingredient is a
combination of vitamin C, caffeine, and
taurine.
When present, a vitamin or combination of vitamins (e.g., vitamin 86, vitamin
812, vitamin E,
vitamin C, or a combination thereof) is typically at a concentration of from
about 0.0001% to about 6% by
25 weight, such as, e.g., from about 0.0001, about 0.001, about 0.01%,
about 0.02%, about 0.03%, about 0.04%,
about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1%
w/w, to about 0.2%, about
0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%,
about 1%, about 2%, about
3%, about 4%, about 5% , or about 6% by weight, based on the total weight of
the composition.
In some embodiments, the active ingredient comprises vitamin 86 in an amount
from about 0.008%
to about 0.06% by weight, or from about 0.01% to about 0.04% by weight
hi some embodiments, the active ingredient comprises vitamin 812 in an amount
from about 0.0001%
to about 0.007% by weight, or from about 0.0005% to about 0.001% by weight.
In some embodiments, the active ingredient comprises a combination of vitamin
B6 and vitamin B12
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in a total amount by weight from about 0.008% to about 0.07%.
Antioxidants
In some embodiments, the active ingredient comprises one or more antioxidants.
As used herein, the
term "antioxidant" refers to a substance which prevents or suppresses
oxidation by terminating free radical
reactions, and may delay or prevent sonic types of cellular damage.
Antioxidants may be naturally occulting
or synthetic. Naturally occurring antioxidants include those found in foods
and botanical materials. Non-
limiting examples of antioxidants include certain botanical materials,
vitamins, polyphenols, and phenol
derivatives.
Examples of botanical materials which are associated with antioxidant
characteristics include without
limitation acai berry, alfalfa, allspice, annatto seed, apricot oil, basil,
bee balm, wild bergamot, black pepper,
blueberries, borage seed oil, bugleweed, cacao, calamus mot, catnip, catuaba,
cayenne pepper, chaga
mushroom, chervil, cinnamon, dark chocolate, potato peel, grape seed, ginseng,
gingko biloba, Saint John's
Wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile,
cloves, cocoa powder, cranberry,
dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose,
feverfew, ginger, goldenseal,
hawthorn, hibiscus flower, jiaogulan, lcava, lavender, licorice, marjoram,
milk thistle, mints (menthe), oolong
tea, beet mot, orange, oregano, papaya, pennyroyal, peppermint, red clover,
rooibos (red or green), rosehip,
rosemary, sage, clary sage, savory, spearmint, spirulina, slippery elm balk,
sorghum bran hi-tannin, sorghum
grain hi-tannin, sumac bran, comfrey leaf and root, goji berries, gutu kola,
thyme, turmeric, uva ursi, valerian,
wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa,
bacopa mormiera, withania
somnifera, Lion's mane, and silybum marianum. Such botanical materials may be
provided in fresh or thy
form, essential oils, or may be in the form of an extracts. The botanical
materials (as well as their extracts)
often include compounds from various classes known to provide antioxidant
effects, such as minerals,
vitamins, isoflavones, phytoesterols, allyl sulfides, ilithiolthiones,
isothiocyanates, indoles, lignans,
flavonoids, polyphenols, and carotenoids. Examples of compounds found in
botanical extracts or oils include
asembie acid, peanut endocatb, resveratrol, sulforaphane, beta-carotene,
lycopene, lutein, co-enzyme Q,
earnitine, quercetin, kaempferol, and the like. See, e.g., Santhosh et al.,
Phytomedicine, 12(2005) 216-220,
which is incorporated herein by reference.
Non-limiting examples of other suitable antioxidants include citric acid,
Vitamin E or a derivative
thereof, a tocopherol, epicatechol, epigallocatechol, epigallocatechol
gallate, elythothic acid, sodium
erythothate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B,
theaflavin digallate, phenolic acids,
glycosides, quercitrin, isoquercitrin, hyperoside, polyphenols, catechoLs,
resveratrols, olettropein, butylated
hydroxyanisole (BHA), butylated. hydroxytoluene (BHT), tertiary
butylhydniquinone (TBHQ), and
combinations thereof.
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When present, an antioxidant is typically at a concentration of from about
0.001% w/w to about 10%
by weight, such as, e.g., from about 0.001%, about 0.005%, about 0.01% w/w,
about 0.05%, about 0.1%, or
about 0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,
about 7%, about 8%, about
9%, or about 10%, based on the total weight of the composition.
Nicotine component
In certain embodiments, the active ingredient comprises a nicotine component.
By "nicotine
component" is meant any suitable form of nicotine (e.g., free base or salt)
for providing oral absorption of at
least a portion of the nicotine present. Typically, the nicotine component is
selected from the group consisting
of nicotine free base and a nicotine salt. In some embodiments, the nicotine
component is nicotine in its free
base form, which easily can be adsorbed in for example, a microcrystalline
cellulose material to form a
microcrystalline cellulose-nicotine carrier complex. See, for example, the
discussion of nicotine in free base
form in US Pat. Pub. No. 2004/0191322 to Hansson, which is incorporated herein
by reference.
In some embodiments, at least a portion of the nicotine component can be
employed in the form of a
salt. Salts of nicotine can be provided using the types of ingredients and
techniques set forth in US Pat. No.
2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12: 43-54
(1983), which are incorporated
herein by reference. Additionally, salts of nicotine am available from sources
such as Waltz and Bauer, Inc.
and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically, the
nicotine component is selected
from the group consisting of nicotine free base, a nicotine salt such as
hydrochloride, &hydrochloride,
monotartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride.
In some embodiments, at least a portion of the nicotine can be in the form of
a resin complex of
nicotine, where nicotine is bound in an ion-exchange resin, such as nicotine
polacrilex, which is nicotine bound
to, for example, a polymethacrllic acid, such as Amberlite IRP64, Purolite
C1151-1MR, or Doshion P551. See,
for example, US Pat. No. 3,901,248 to Lichtneckezt etal., which is
incorporated herein by reference. Another
example is a nicotine-polyacrylic carbomer complex, such as with Carbopol
974P. In some embodiments,
nicotine may be present in the form of a nicotine polyaciylic complex.
Typically, the nicotine component (calculated as the free base) when present,
is in a concentration of
at least about 0.001% by weight of the composition, such as in a range from
about 0.001% to about 10%. In
some embodiments, the nicotine component is present in a concentration from
about 0.1% w/w to about 10%
by weight, such as, e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about
0.4%, about 0.5% about 0.6%,
about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about
4%, about 5%, about 6%,
about rh, about 8%, about 9%, or about 10% by weight, calculated as the free
base and based on the total
weight of the composition. In some embodiments, the nicotine component is
present in a concentration from
about 0.1% w/w to about 3% by weight, such as, e.g., from about 0.1% w/w to
about 2.5%, from about 0.1%
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to about 2.0%, from about 0.1% to about 13%, or from about 0.1% to about 1% by
weight, calculated as the
free base and based on the total weight of the composition.
hi some embodiments, the products or compositions of the disclosure can be
characterized as free of
any nicotine component (e.g., any embodiment as disclosed herein may be
completely or substantially free of
any nicotine component). By "substantially free" is meant that no nicotine has
been intentionally added,
beyond trace amounts that may be naturally present in e_g., a botanical
material. For example, certain
embodiments can be characterized as having less than 0.001% by weight of
nicotine, or less than 0.0001%, or
even 0% by weight of nicotine, calculated as the free base.
In some embodiments, the active ingredient comprises a nicotine component
(e.g., any product or
composition of the disclosure, in addition to comprising any active ingredient
or combination of active
ingredients as disclosed herein, may further comprise a nicotine component).
Cannabinoids
In some embodiments, the active ingredient comprises one or more carmabinoids.
As used herein, the
term "cannabinoid" refers to a class of diverse chemical compounds that acts
on cannabinoid receptors, also
known as the endocannabinoid system, in cells that alter neurotransmitter
release in the brain. Ligands for
these receptor proteins include the endocannabinoids produced naturally in the
body by animals;
phytocaimabinoids, found in cannabis; and synthetic camiabinoids, manufactured
artificially. Carmabinoids
found in cannabis include, without limitation: camiabigerol (CBG),
cannabicluomene (CBC), camtabicliol
(CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL),
cannabicyclol (CBL),
cannabivaiin (CBV), tetrahydrocannabivaiin (THCV), cannabidivarin (CBDV),
cannabichromevarin
(CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM),
cannabinerolic acid,
cannabidiolic acid (CBDA), camtabinol propyl variant (CBNV), cannabitriol
(CBO), tetrahydrocannabinolic
acid (THCA), and tetrahydrocamiabivarinic acid (THCV A). In certain
embodiments, the cannabinoid is
selected from tetrahydrocannabinol (THC), the primary psychoactive compound in
cannabis, and cannabidiol
(CBD) another major constituent of the plant, but which is devoid of
psychoactivity. All of the above
compounds can be used in the form of an isolate from plant material or
synthetically derived.
Alternatively, the active ingredient can be a cannabimimetic, which is a class
of compounds derived
from plants other than cannabis that have biological effects on the
endocannabinoid system similar to
cannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin (also
classified as terpenes),
cyanidin, curcumin (tumeric), catechin, quercetin, salvinorin A, N-
acylethanolamines, and N-alkylarnide
lipids.
When present, a cannabinoid (e.g., CBD) or caimabimimetic is typically in a
concentration of at least
about 0.1% by weight of the composition, such as in a range from about 0.1% to
about 30%, such as, e.g.,
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from about 0.1%, about 0.2%, about 03%, about 0.4%, about 0.5% about 0.6%,
about 0./%, about 0.8%, or
about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,
about 7%, about 8%, about
9%, about 10%, about 15%, about 20%, or about 30% by weight, based on the
total weight of the composition.
Terpenes
Active ingredients suitable for use in the present disclosure can also be
classified as terpenes, many
of which are associated with biological effects, such as calming effects.
Terpenes are understood to have the
general formula of (OHs% and include monoterpenes, sesquiterpenes, and
diterpenes. Terpenes can be
acyclic, monocyclic or bicyclic in structure. Some terpenes provide an
entourage effect when used in
combination with cannabinoids or camiabimimetics. Examples include beta-
caryophyllene, linalool,
limonene, beta-citronellol, linalyl acetate, pinene (alpha or beta), geraniol,
carvone, eucalyptol, menthone, iso-
menthone, piperitone, myreene, beta-bourbonene, and germacrene, which may be
used singly or in
combination.
Pharmaceutical ingredients
hi some embodiments, the active ingredient comprises an active pharmaceutical
ingredient (API). The
API can be any known agent adapted for therapeutic, prophylactic, or
diagnostic use. These can include, for
example, synthetic organic compounds, proteins and peptides, polysaccharides
and other sugars, lipids,
phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrate),
neurotransmitters or
precursors thereof (e.g., serotonin, 5-hydroxyttyptophan, oxitriptan,
acetykholine, dopamine, melatonin), and
nucleic acid sequences, having therapeutic, prophylactic, or diagnostic
activity. Non-limiting examples of
APIs include analgesics and antipyretics (e.g., acetylsalicylic acid,
acetaminophen, 3-(4-
isobutylphenyl)propanoic acid), phosphatidylserine, nwoinositol,
docosahexaenoic acid (DHA, Omega-3),
arachidonic acid (AA, Omega-6), S-adenosylmethionine (SAM), beta-hydroxy-beta-
methylbutyrate (H1vII3),
citicoline (cytidine-5'-diphosphate-choline), and cotinine. In some
embodiments, the active ingredient
comprises citicoline. In some embodiments, the active ingredient is a
combination of citicoline, caffeine,
theanine, and ginseng. In some embodiments, the active ingredient comprises
sunflower lecithin. In some
embodiments, the active ingredient is a combination of sunflower lecithin,
caffeine, theanine, and ginseng.
The amount of API may vary. For example, when present, an API is typically at
a concentration of
from about 0.001% w/w to about 10% by weight, such as, e.g., from about 0.01%,
about 0.02%, about 0.03%,
about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%,
about 0.1% w/w, about
0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%,
about 0.9%, or about 1%, to
about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about
9%, or about 10% by weight,
based on the total weight of the composition.
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In some embodiments, the composition is substantially free of any API. By
"substantially free of any
API" means that the composition does not contain, and specifically excludes,
the presence of any API as
defined herein, such as any Food and Drug Administration (FDA) approved
therapeutic agent intended to treat
any medical condition.
5 Advantageously, in some embodiments, the compositions and
products of the present disclosure
(irrespective of their physical form, e.g., a pastille-type product or a
lozenge-type product) may provide the
active ingredient(s) contained therein (e.g., nicotine) in relatively low
amounts when compared to traditional
smokeless tobacco products commonly known in the art. It should be noted that
embodiments particularly
including nicotine in relatively low amounts advantageously provides
compositions and products having a
10 mom desirable delivery profile of active nicotine and improved
organoleptic properties when those products
am inserted into the oral cavity of a user of those products. For example,
oral products of the present
disclosure may exhibit improved flavor characteristics, improved appearance
(e.g., translucency or
transparency), and improved mouthfeel when compared to traditional smokeless
tobacco products having
higher amounts of nicotine or tobacco materials incorporated therein. Such
improvements are achieved by
15 providing oral products with lower amounts of active ingredients
therein. For example, the compositions and
products as described herein may comprise an active ingredient in the form of
a nicotine component in an
amount of less than about 2 weight percent, based on the total weight of the
composition. In some
embodiments, the oral product may comprise a nicotine component in an amount
of less than about 2 weight
percent, less than about 1.75 weight percent, less than about 1.5 weight
percent, less than about 1.25 weight
20 percent, less than about 1.0 weight percent, less than about 0.75 weight
percent, less than about 0.50 weight
percent, or less than about 0.25 weight percent, based on the total weight of
the composition.
Tobacco material
In some embodiments, oral products according to the present disclosure may
further comprise a
tobacco material. The tobacco material can vary in species, type, and form.
Generally, the tobacco material
25 is obtained from for a harvested plant of the Nicoliana species. Example
Nicotiana species include N.
tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N. forgetiana, N.
glauca, N. glutinosa, N. gossei, N.
kawakarnii, N. lurightiana, N. langsdorffi, N. otophom, N. setchelli, N.
sylvestris, N. tomentosa, N.
tomentosiformis, N. undulata, N. x sanderae, N. africana, N. amplexicaulis, N.
benavidesii, N. bonariensis,
N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N. occidentalis, N.
paniculata, N. plurnbaginifolia,
30 N. raimondii, N. rosttlata, N. simulans, N. stocktonii, N. suaveolens,
N. umbratica, N. velutina, N.
wigandioides, N. acatilis, N. acuminata, N. attenuata, N. benthamiana, N.
cavicola, N. clevelandii, N.
cordifolia, N. corymbosa, N. fragrans, N. goodspeeclii, N. linearis, N.
miersii, N. nudicaulis, N. obtusifolia,
N. occidentalis subsp. Hersperis, N. pauciflora, N. petunioides, N.
quadrivalvis, N. repanda, N. rotturidifolia,
N. solanifolia, and N. spegazzinii. Various representative other types of
plants from the Nicatiana species
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are set forth in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); US
Pat. Nos. 4,660,577 to
Sensabaugh, Jr. et at.; 5,387,416 to White et at, 7,025,066 to Lawson et al.;
7,798,153 to Lawrence, Jr. and
8,186,36010 Marshall et at.; each of which is incorporated herein by
reference. Descriptions of various
types of tobaccos, growing practices and harvesting practices are set forth in
Tobacco Production, Chemistry
and Technology, Davis et al. (Eds.) (1999), which is incorporated herein by
reference.
Nicotiana species from which suitable tobacco materials can be obtained can be
derived using
genetic-modification or crossbreeding techniques (e.g., tobacco plants can be
genetically engineered or
crossbred to increase or decrease production of components, characteristics or
attributes). See, for example,
the types of genetic modifications of plants set forth in US Pat. Nos.
5,539,093 to Fitzanaurice et at.;
5,668,295 to Wahab et at; 5,705,624 to Fitzmaurice et al.; 5,844,119 to Weigl;
6,730,832 to Dominguez et
at.; 7,173,170 to Liu et al.; 7,208,659 to Colliver et at. and 7,230,160 to
Benning et at.; US Patent Appl. Pub.
No. 2006/0236434 to Conkling et at; and PCT W02008/103935 to Nielsen et at.
See, also, the types of
tobaccos that are set forth in US Pat. Nos. 4,660,577 to Sensabaugh, Jr. et
al.; 5,387,416 to White et al.; and
6,730,832 to Dominguez et al., each of which is incorporated herein by
reference.
The Nicotiana species can, in some embodiments, be selected for the content of
various compounds
that are present therein. For example, plants can be selected on the basis
that those plants produce relatively
high quantities of one or more of the compounds desired to be isolated
therefrom. In certain embodiments,
plants of the Nicotiana species (e.g.. Galpao commun tobacco) are specifically
grown for their abundance of
leaf surface compounds. Tobacco plants can be grown in greenhouses, growth
chambers, or outdoors in
fields, or grown hydroponically.
Various parts or portions of the plant of the Nicotiana species can be
included within the
compositions as disclosed herein. For example, virtually all of the plant
(e.g., the whole plant) can be
harvested, and employed as such. Alternatively, various parts or pieces of the
plant can be harvested or
separated for further use after harvest. For example, the flower, leaves,
stem, stalk, roots, seeds, and various
combinations thereof, can be isolated for further use or treatment. In some
embodiments, the tobacco
material comprises tobacco leaf (lamina). The compositions disclosed herein
can include processed tobacco
parts or pieces, cured and aged tobacco in essentially natural lamina and/or
stem form, a tobacco exnact,
extracted tobacco pulp (e.g., using water as a solvent), or a mixture of the
foregoing (e.g., a mixture that
combines extracted tobacco pulp with granulated cured and aged natural tobacco
lamina).
In certain embodiments, the tobacco material comprises solid tobacco material
selected from the
group consisting of lamina and stems. The tobacco that is used for the
mixtuure most preferably includes
tobacco lamina, or a tobacco lamina and stem mixture (of which at least a
portion is smoke-treated).
Portions of the tobaccos within the mixture may have processed forms, such as
processed tobacco stems
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(e.g., cut-rolled stems, cut-rolled-expanded stems or cut-puffed stems), or
volume expanded tobacco (e.g.,
puffed tobacco, such as dry ice expanded tobacco (DIET)). See, for example,
the tobacco expansion
processes set forth in US Pat. Nos. 4,340,073 to de la Bunk et al.; 5,259,403
to Guy et al.; and 5,908,032 to
Poindexter, et al.; and 7,556,047 to Poindexter, et al., all of which are
incorporated by reference. In
addition, the d mixture optionally may incorporate tobacco that has been
fermented. See, also, the types of
tobacco processing techniques set forth in PCT W02005/063060 to Atchley et
al., which is incorporated
herein by reference.
The tobacco material is typically used in a form that can be described as
particulate (i.e., sluedded,
ground, granulated, or powder form). The manner by which the tobacco material
is provided in a finely
divided or powder type of form may vary. Preferably, plant parts or pieces are
conuninuted, ground or
pulverized into a particulate form using equipment and techniques for
grinding, milling, or the like. Most
preferably, the plant material is relatively dry in form during grinding or
milling, using equipment such as
hammer mills, cutter heads, air control mills, or the like. For example,
tobacco parts or pieces may be
ground or milled when the moisture content thereof is less than about 15
weight percent or less than about 5
weight percent. Most preferably, the tobacco material is employed in the form
of parts or pieces that have an
average particle size between 1.4 millimeters and 250 microns. In some
instances, the tobacco particles may
be sized to pass through a screen mesh to obtain the particle size range
required. If desired, air classification
equipment may be used to ensure that small sized tobacco particles of the
desired sizes, or range of sizes,
may be collected. If desired, differently sized pieces of granulated tobacco
may be mixed together.
The manner by which the tobacco is provided in a fmely divided or powder type
of form may vary.
Preferably, tobacco parts or pieces are comminuted, ground or pulverized into
a powder type of form using
equipment and techniques for grinding, milling, or the like. Most preferably,
the tobacco is relatively dry in
form during grinding or milling, using equipment such as hammer mills, cutter
heads, air control mills, or
the like. For example, tobacco parts or pieces may be ground or milled when
the moisture content thereof is
less than about 15 weight percent to less than about 5 weight percent. For
example, the tobacco plant or
portion thereof can be separated into individual parts or pieces (e.g., the
leaves can be removed from the
stems, and/or the stems and leaves can be removed from the stalk). The
harvested plant or individual parts
or pieces can be further subdivided into parts or pieces (e.g., the leaves can
be shredded, cut, comminuted,
pulverized, milled or ground into pieces or parts that can be characterized as
filler-type pieces, granules,
particulates or fine powders). The plant, or parts thereof, can be subjected
to external forces or pressure
(e.g., by being pressed or subjected to roll treatment). When carrying out
such processing conditions, the
plant or portion thereof can have a moisture content that approximates its
natural moisture content (e.g., its
moisture content immediately upon harvest), a moisture content achieved by
adding moisture to the plant or
portion thereof, or a moisture content that results from the drying of the
plant or portion thereof For
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example, powdered, pulverized, ground or milled pieces of plants or portions
thereof can have moisture
contents of less than about 25 weight percent, often less than about 20 weight
percent, and frequently less
than about 15 weight percent.
For the preparation of oral products, it is typical for a harvested plant of
the Nicotiana species to be
subjected to a curing process. The tobacco materials incorporated within the
compositions for inclusion
within products as disclosed herein are those that have been appropriately
cured and/or aged. Descriptions of
various types of curing processes for various types of tobaccos are set forth
in Tobacco Production,
Chemistty and Technology, Davis et at. (Eds.) (1999). Examples of techniques
and conditions for curing
flue-cured tobacco are set forth in Nestor et at., Beitrage Tabakforsch. Int.
20, 467-475 (2003) and US Pat.
No. 6,895,974 to Peek, which are incorporated herein by reference.
Representative techniques and
conditions for air curing tobacco are set forth in US Pat. No. 7,650,892 to
Groves et al.; Roton et al.,
Beitrage Tabakforsch. kit. 21, 305-320 (2005) and Staaf et al., Beitrage
Tabakforsch. Int.. 21,321-330
(2005), which are incorporated herein by reference. Certain types of tobaccos
can be subjected to alternative
types of curing processes, such as fire curing or sun curing.
In certain embodiments, tobacco materials that can be employed include flue-
cured or Virginia (e.g.,
K326), burley, sun-cured (e.g., Indian Kumool and Oriental tobaccos, including
Katerini, Prelip, Komotini,
Xanthi and Yambol tobaccos), Maryland, dark, dark-fired, dark air cured (e.g.,
Madole, Passanda, Cuban ,
Jatin and Bezuki tobaccos), light air cured (e.g., North Wisconsin and (lalpao
tobaccos), Indian air cured,
Red Russian and Rustica tobaccos, as well as various other rare or specialty
tobaccos and various blends of
any of the foregoing tobaccos.
The tobacco material may also have a so-called "blended" form. For example,
the tobacco material
may include a mixture of parts or pieces of flue-cured, burley (e.g., Malawi
burley tobacco) and Oriental
tobaccos (e.g., as tobacco composed of, or derived from, tobacco lamina, or a
mixture of tobacco lamina and
tobacco stem). For example, a representative blend may incorporate about 30 to
about 70 parts burley
tobacco (e.g., lamina, or latnina and stem), and about 30 to about 70 parts
flue cured tobacco (e.g., stem,
lamina, or lamina and stem) on a weight basis. Other example tobacco blends
incorporate about 75 parts
flue-cured tobacco, about 15 parts burley tobacco, and about 10 parts Oriental
tobacco; or about 65 parts
flue-cured tobacco, about 25 parts burley tobacco, and about 10 parts Oriental
tobacco; or about 65 parts
flue-cured tobacco, about 10 parts burley tobacco, and about 25 parts Oriental
tobacco; on a weight basis.
Other example tobacco blends incorporate about 20 to about 30 parts Oriental
tobacco and about 70 to about
80 parts flue-cured tobacco on a weight basis.
Tobacco materials used in the present disclosure can be subjected to, for
example, fermentation,
bleaching, and the like. If desired, the tobacco materials can be, for
example, irradiated, pasteurized, or
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otherwise subjected to controlled heat treatment Such treatment processes are
detailed, for example, in US
Pat. No. 8,061,362 to Mua et at, which is incorporated herein by reference. In
certain embodiments,
tobacco materials can be treated with water and an additive capable of
inhibiting reaction of asparagine to
form acrylamide upon heating of the tobacco material (e.g., an additive
selected from the group consisting of
lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid,
aspartic acid, proline, phenylalanine,
valine, arginine, compositions incorporating di- and trivalent cations,
asparaginase, certain non-reducing
saccharides, certain reducing agents, phenolic compounds, certain compounds
having at least one free thiol
group or functionality, oxidizing agents, oxidation catalysts, natural plant
extracts (e.g., rosemary extract),
and combinations thereof. See, for example, the types of treatment processes
described in US Pat. Pub. Nos.
8,434,496,3,944,072, and 8,991,403 to Chen et at, which are all incorporated
herein by reference. In
certain embodiments, this type of treatment is useful where the original
tobacco material is subjected to heat
in the processes previously described.
At least a portion of the tobacco material employed in the tobacco composition
or product can have
the form of an extract. In some embodiments, all of the tobacco material
employed in the tobacco
composition or product may be in the form of an extract, e.g., such as a
tobacco-derived nicotine extract.
Tobacco extracts can be obtained by extracting tobacco using a solvent having
an aqueous character such as
distilled water or tap water. As such, aqueous tobacco extracts can be
provided by extracting tobacco with
water, such that water insoluble pulp material is separated from the aqueous
solvent and the water soluble
and dispersible tobacco components dissolved and dispersed therein. The
tobacco extract can be employed
in a variety of forms. For example, the aqueous tobacco extract can be
isolated in an essentially solvent free
form, such as can be obtained as a result of the use of a spray drying or
freeze drying process, or other
similar types of processing steps. Alternatively, the aqueous tobacco extract
can be employed in a liquid
form, and as such, the content of tobacco solubles within the liquid solvent
can be controlled by selection of
the amount of solvent employed for extraction, concentration of the liquid
tobacco extract by removal of
solvent, addition of solvent to dilute the liquid tobacco extract, or the
like. Example techniques for
extracting components of tobacco are described in US Part, Nos. 4,144,895 to
Fiore; 4,150,677 to Osborne,
Jr. et al.; 4,267,847 to Reid; 4,289,147 to Wildman et al.; 4,351,346 to
Brununer et al.; 4,359,059 to
Brummer et at; 4,506,682 to Muller, 4,589,428 to Keritsis; 4,605,016 to Soga
et at; 4,716,911 to Poulose et
al.; 4,727,839 to Niven, Jr. et at; 4,887,618 to Bernasek et at; 4,941,484 to
Clapp et al.; 4,967,771 to Fagg
et al.; 4,986,286 to Roberts et al.; 5,005,593 to Fagg et at; 5,018,540 to
Grubbs et al.; 5,060,669 to White et
al.; 5,065,775 to Fagg; 5,074,319 to White et al.; 5,099,862 to White et at;
5,121,757 to White et al.;
5,131,414 to Fagg; 5,131,415 to Munoz et al.; 5,148,819 to Fagg; 5,197,494 to
Kramer; 5,230,354 to Smith
et at.; 5,234,008 to Fagg; 5,243,999 to Smith; 5,301,694 to Raymond et at;
5,318,050 to Gonzalez-Pain et
at; 5,343,879 to Teague; 5,360,022 to Newton; 5,435,325 to Clapp et at;
5,445,169 to Brinkley et at;
6,131,584 to Lauteibach; 6,284,875 to Turpen et al.; 6,298,859 to Kierulff et
al.; 6,772,767 to Mua et at.;
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6,817,97010 Beth et al.; 6,906,172 to Bratcher et al.; 7,034,128 to Turpen et
al.; 7,048,211 to Bratcher et al.;
and 7,337,782 to Thompson, all of which are incorporated by reference herein.
According to the present disclosure, the Nicotiana plant or portion thereof
(as described herein
above) is typically subjected to processing intended to provide improved
clarity of the tobacco material. In
5 certain embodiments, the tobacco material used in the products of the
invention is in the form of an extract,
such as an aqueous extract of a tobacco material. Improved clarity of a
tobacco extract can be obtained, for
example, by removing high molecular weight components from the tobacco
extract. In certain
embodiments, high molecular weight components that are beneficially removed
according to the present
invention include, but are not limited to, high molecular weight Maillard
browning polymers, proteins,
10 polysaccharides, certain pigments, and bacteria. Various methods can be
used for this purpose, including
size exclusion chromatography, microfiltration, ultrafiltration,
nanofiltration, reverse osmosis, and
combinations thereof. Ideally, the tobacco extract may undergo an
ultrafiltration process in order to provide
an ultrafiltered tobacco extract. Example filters, methods and processes for
ultrafiltration of tobacco
materials are set forth in US Patent Nos, 9,084,439 to Holton Jr. and
9,901,113 to Holton Jr.; the entirety of
15 which are incorporated herein by 'reference.
According to the present disclosure, the ultrafiltration process is designed
to achieve a tobacco
extract having a decreased level of suspended solids, and thus an increased
level of clarity. For example,
depending on the molecular weight cutoff of the filters, the ultrafiltered
extract may comprise only
compounds with molecular weights below about 50,000, below about 25,000, below
about 10,000 Da, below
20 about 7,500 Da, below about 5,000 Da, below about 2,500 Da, or below
about 1,000 Da The ultrafiltered
extract typically comprises primarily sugars, nicotine, and amino acids.
The ultrafiltered extract exhibits a level of improvement in clarity over the
non-ultrafiltered extract.
Clarity of the extract, and oral products incorporating such extracts
according to the present disclosure, is
typically defined in terms of translucency. As used herein, "translucent" or
"translucency" refers to
25 materials allowing some level of light to travel therethrough diffusely.
In certain embodiments, certain
materials of the invention (e.g., certain tobacco extracts or final smokeless
tobacco products made
therefrom) can have such a high degree of clarity that the material can be
classified as "transparent" or
exhibiting "transparency," which is defined as a material allowing light to
pass freely through without
significant diffusion. The clarity of the ultrafiltered extract is such that
there is some level of translucency as
30 opposed to opacity (which refers to materials that are impenetrable by
light).
The improvement in clarity of the ultrafiltered extract over the non-
ultrafiltered extract can be
quantified by any known method. For example, optical methods such as
turbidimetty (or nephelometry) and
colorimetry may be used to quantify the cloudiness (light scattering) and the
color (light absorption),
respectively, of the ultrafiltered extract or products made therefrom.
Translucency can also be confirmed by
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visual inspection by simply holding the material (e.g., extract) or product up
to a light source and
detennining if light travels through the material or product in a diffuse
manner.
In certain embodiments, the ultrafiltered extract is analyzed by contacting
the extract with light and
measuring the percent of light that has not been absorbed and/or dispersed by
the extract. The measurement
can be done, for example, using a standard spectrophotometer at a given
wavelength. The
spectrophotometer is typically calibrated with &ionized water, which is
assigned a transparency value of
100%. Acceptable levels of translucency/transparency at a given wavelength in
the ultrafifterod extract can
vary. Typically, the ultrafiltered extract has a translucency of greater than
about 5%, greater than about
10%, greater than about 15%, greater than about 20%, greater than about 25%,
greater than about 30%,
greater than about 40%, greater than about 50%, greater than about 600%,
greater than about 60%, greater
than about 70%, greater than about 80%, or greater than about 90%. Typically,
the ultrafiltered extract will
not be colorless, and will have some discernible brown/black coloring.
Following ultrafiltration, the extract
can be stored in the refrigerator or freezer or the extract can be freeze
dried or spray dried prior to use in the
products of the invention. In certain embodiments, it is provided in syrup
form.
Although in some embodiments, the tobacco extract is used directly, it may be
desirable to heat neat
the extract. This thermal treatment can be conducted before the
ultrafiltration, after the ultrafiltration, or
both before and after the ultrafiltration. For example, a tobacco material can
be thermally processed by
mixing the tobacco material, water, and an additive selected from the group
consisting of lysine, glycine,
histidine, alanine, methionine, glutamic acid, aspartic acid, praline,
phenylalanine, valine, arginine, di- and
trivalent cations, asparaginase, saccharides, phenolic compounds, reducing
agents, compounds having a free
thiol group, oxidizing agents (e.g., hydrogen peroxide), oxidation catalysts,
plant extracts, and combinations
thereof, to form a moist tobacco mixture; and heating the moist tobacco
mixture at a temperature of at least
about 60 C to form a heat-treated tobacco mixture. In one embodiment, the
treated tobacco extract is heat
treated in the presence of water, NaOH, and an additive (e.g., lysine) at
about 88 C for about 60 minutes.
Such heat treatment can help prevent acrylamide production resulting from
reaction of asparagine with
reducing sugars in tobacco materials and can provide some degree of
pasteurization. See, for example, US
Pat. Pub. No. 201010300463 to Chen et al., which is incorporated herein by
reference. In certain
embodiments wherein a heat-treated tobacco extract is used in a smokeless
tobacco product of the present
invention, the product can be characterized by very low acrylarnide content.
For example, in some
embodiments, the smokeless tobacco product is characterized by an acrylamide
content of less than about
500 ppb (ng/g), less than about 400 ppb, less than about 300 ppb, less than
about 200 ppb, or less than about
100 ppb.
Accordingly, "treated tobacco extract" as used herein refers to a tobacco
extract that has been treated
in some way to remove high molecular weight components and thereby improve
clarity (e.g., an ultrafiltered
extract). The "treated tobacco extract" may or may not be heat-treated as
described herein.
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It should be noted that inclusion of a tobacco material into the compositions
and products described
herein is meant to be optional and is not required. In some embodiments, oral
products as described herein
can generally be characterized as being tobacco free-alternatives. For
example, in some embodiments, oral
products of the present disclosure may be said to be completely free or
substantially flee of tobacco material
(other than purified nicotine as an active ingredient). Oral products that are
referred to as "completely free
of' or "substantially free of' a tobacco material herein are meant to refer to
oral products that can be
characterized as having less than about 1.0% by weight, less than about 0.5%
by weight, less than about
0.1% by weight of tobacco material, or 0% by weight of tobacco material.
Buffering agent and/or pH adjuster
In some embodiments, the products of the present disclosure may further
comprise one or more
buffering agents and/or pH adjusteis (i.e., acids or bases). In such
embodiments, the one or more buffering
agents and/or pH adjusters are added to the mixture to ensure that the final
oral product has a pH within a
desirable range. Example pH ranges for oral products as described herein are
generally from about 5 to
about 7. In such embodiments, the amount of buffering agent and/or pH adjuster
added to the product
mixture is simply that amount required to bring the formulation to or keep the
formulation at the desired pH.
The amount of buffering agent and/or pH adjuster added to any given
formulation can be readily calculated
by one skilled in the art based on the desired pH and may comprise, for
example, about 0.5% to about 1% by
weight of the mixture. In some embodiments, the quantity of p14 adjuster
present may vary based on the
acidity and basicity of other components which may be present in the
composition (e.g., nicotine, salts,
buffers, and the like). Accordingly, the buffering agent and/or pH adjuster is
provided in a quantity sufficient
to provide a pH of the composition of from about 5.0 to about 7.0, for
example, from about 5.0, about 5.5, or
about 6.0, to about 6.5, or about 7Ø In some embodiments, the organic acid
is provided in a quantity
sufficient to provide a pH of the composition of from about 5.5 to about 6.5,
for example, from about 5.5,
about 5.6, about 5.7, about 5.8, about 5.9, or about 6.0, to about 6.1, about
6.2, about 6.3, about 6.4, or about
6.5.
It should be noted that the pfl level of the oral products may be varied to
alter certain characteristics
of the product, for example, the release profile of the active ingredient
contained within the product. For
example, in some embodiments, an amount of buffering agent (e.g., such as a
citric acid) may be
incorporated into the product so as to alter the overall pH of that product to
be between about 5.0 and 7.0, as
noted above. Preferably, in some embodiments, the pH may be adjusted to a pH
of approximately 5.5.
Advantageously, it was discovered that adding citric acid to adjust the pH of
the products described herein to
a pH of around 5.5 generally reduced the nicotine loss in those products when
compared to products having
higher pH values, such as those commonly employed in traditional smokeless
tobacco products (e.g., in the
range of about? to about 11, or preferably about 8 to about 10). In some
embodiments, the citric acid may
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be used as a processing aid which is added to the composition or product to
reduce nicotine loss during the
production thereof The use of citric acid in the products disclosed herein is
not meant to be limiting and it
should be noted that any buffering agent and/or pH adjuster may be suitable
for altering the pH of the overall
product. Such buffering agents and/or pH adjusters may be added singularly, or
in the form of a combination
of one or more compounds.
Additionally, various food-grade buffering agents are known and can be used to
adjust the pH of the
products as described herein. Suitable buffering agents may include those
selected from the group
consisting of acetates, glycinates, phosphates, glycerophosphates, citrates
such as citrates of alkaline metals,
carbonates, hydrogen carbonates, and borates, and mixtures thereof. In certain
embodiments, the buffering
agent is an amino acid, as taught for example, in US Pat. Pub. No.
2008/0286341 to Andeisson et al. and
PCT Appl. No. W02008/040371 to Andersson et al., which are both incorporated
herein by reference. As
noted therein, various amino acids and salts thereof are useful for this
purpose, including, but not limited to,
arginine, asparagine, glutamic acid, glutamine, glycine, histidine,
isoleucine, leucine, lysine, methionine,
phenylalanine, serine, threonine, valine, cysteic acid, N-glycylglycine, and
omithine. In certain
embodiments, N-glycylglycine or L-lysine is added as a buffering agent. In
some embodiments, an amino
acid buffering agent is used in combination with another amino acid buffering
agent and/or in combination
with one or more non-amino acid buffering agents. In certain embodiments, the
optional pH adjusting agent
is a base (e.g., NaOH). In certain embodiments, L-lysine and NaOH are added to
the compositions of the
present invention.
Emulsifier
In certain embodiments, an emulsifier may be added. In certain embodiments,
lecithin can be added
to the composition to provide smoother textural properties of the composition
and to improve flowability and
mixing of the lipid with the remaining components of the composition. Lecithin
can be used in an amount of
about 0.01 to about 5% by thy weight of the composition, such as about 0.1 to
about 2.5% or about 0.1 to
about 1.0%.
Further additives
In addition to the components provided in the lozenge and pastille
compositions as noted above,
such compositions may further comprise one or more additives. For example,
lozenge and pastille
compositions accoiding to the present disclosure may further comprise one or
more of a flavoring agent, one
or more sweeteners, one or more additional binders, disintegration aids,
humectants, salts, and mixtures
thereof.
As used herein, a "flavorant" or "flavoring agent" is any flavorful or
aromatic substance capable of
altering the sensory characteristics associated with the oral products of the
present disclosure. Example
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sensory characteristics that can be modified by the flavorant include, taste,
mouthfeel, moistness,
coolness/heat, and/or fragrance/aroma. Non-limiting examples of flavoring
agents that may be included
within the present compositions and/or products can include vanilla, coffee,
chocolate/cocoa, cream, mint,
spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom,
nutmeg, cinnamon, clove,
cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon,
orange, apple, peach, lime,
cherry, strawberry, trigeminal sensates, terpenes, and any combinations
thereof See also, Leffingwell et al.,
Tobacco Flavoring for Smoking Products, R. J. Reynolds Tobacco Company (1972),
which is incorporated
herein by reference. Flavoring agents may comprise components such as
terpenes, terpenoids, aldehydes,
ketones, esters, and the like. In some embodiments, the flavoring agent is a
trigeminal sensate. As used
herein, "trigeminal sensate" refers to a flavoring agent which has an effect
on the trigeminal nerve,
producing sensations including heating, cooling, tingling, and the like. Non-
limiting examples of trigeminal
sensate flavoring agents include capsaicin, citric acid, menthol, Sichuan
buttons, erythritol, and cubebol.
Flavorings also may include components that are considered moistening, cooling
or smoothening agents,
such as eucalyptus. These flavors may be provided neat (i.e., alone) or in a
composite, and may be
employed as concentrates or flavor packages (e.g., spearmint and menthol,
orange and cinnamon; lime,
pineapple, and the like). Representative types of components also are set
forth in US Pat. No. 5,387,416 to
White et al.; US Pat. App. Pub. No. 2005/0244521 to Strickland et al.; and PCT
Application Pub. No. WO
05/041699 to Quinter et al., each of which is incorporated herein by
reference. In some instances, the
flavoring agent may be provided in a spray-dried form or a liquid form.
The flavoring agent generally comprises at least one volatile flavor
component. As used herein,
"volatile" refers to a chemical substance that forms a vapor readily at
ambient temperatures (i.e., a chemical
substance that has a high vapor pressure at a given temperature relative to a
nonvolatile substance).
Typically, a volatile flavor component has a molecular weight below about 400
Da, and often include at
least one carbon-carbon double bond, carbon-oxygen double bond, or both. In
one embodiment, the at least
one volatile flavor component comprises one or more alcohols, aldehydes,
aromatic hydrocarbons, ketones,
esters, terpenes, terpenoids, or a combination thereof. Non-limiting examples
of aldehydes include vanillin,
ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde,
curninaldehyde, benzaldehyde, and
citronella'. Non-limiting examples of ketones include 1-hydroxy-2-propanone
and 2-hydroxy-3-methyl-2-
cyclopentenone-1-one. Non-limiting examples of esters include ally' hexanoate,
ethyl heptanoate, ethyl
hexanoate, isoamyl acetate, and 3-methylbutyl acetate. Non-limiting examples
of terpenes include sabinene,
limonene, gamma-terpinene, beta-famesene, nerolidol, thnjone, myrcene,
geraniol, nerol, citronellol,
linalool, and eucalyptol. In one embodiment, the at least one volatile flavor
component comprises one or
more of ethyl vanillin, cimiarnaldehyde, sabinene, limonene, gamma-teipinene,
beta-farnesene, or citral. In
one embodiment, the at least one volatile flavor component comprises ethyl
vanillin. Flavorants are typically
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present in an amount of about 0.5 to about 10 weight percent, often about 1 to
about 6 weight percent, and
most often about 2 to about 5 weight percent, based on the total weight of the
composition.
Sweeteners can be used in natural or artificial form or as a combination of
artificial and natural
sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose,
maltose, mannose,
5 galactose, lactose, isomaltulose, stevia, honey, and the like. Examples
of artificial sweeteners include
sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame awl the
like. In one embodiment,
sucrose and sucralose are primary sweetener ingredients. When present, a
representative amount of
sweetener, whether an artificial sweetener and/or natural sugar, may make up
at least about 0.2 percent or at
least about 5 percent, of the total weight of the composition. Preferably, the
amount of sweetener within the
10 composition will not exceed about 40 percent, often will not exceed
about 35 percent, and frequently will
not exceed about 30 percent, of the total weight of the composition. Sucrose
can be particularly
advantageous in certain embodiments as an ingredient as it is believed to
contribute to the chewing
resistance or "bounce" of the final product. In addition, while granulated
sucrose provides far less
sweetening effect as compared to sucralose, the presence of sucrose can be
advantageous as an additional
15 filler component. When these two sweeteners are present together, the
sucralose is typically present in an
amount of at least about 0.25 weight percent, often at least about 0.5 weight
percent, and most often at least
about 1.0 weight percent (e.g., about 0.25 to about 2.0 weight percent), and
the sucrose is typically present in
an amount of at least about 2.0 weight percent, often at least about 3.0
weight percent, and most often at
least about 4.0 weight percent (e.g., about 1.0 to about 6.0 weight percent).
In further embodiments,
20 sucralose is present in an amount of about 0.01 to about 0.5 weight
percent (e.g., about 0.02 to about 0.1
weight percent).
A salt (e.g., sodium chloride, flour salt) may be employed in amounts
sufficient to provide desired
sensory attributes to the products of the present disclosure. Non-limiting
examples of suitable salts include
sodium chloride, potassium chloride, anunonium chloride, flour salt, and the
like. When present, a
25 representative amount of salt is at least about 0.5 weight percent or at
least about 1.0 weight percent or at
least about 1.5 weight percent, but will typically may make up less than about
5 percent of the total weight
of the composition (e.g., about 0.5 to about 4 weight percent).
A humectant (e.g., glycerin) may be employed in amounts sufficient to provide
desired moisture
attributes to the oral products described herein. Further, in some instances,
the humectant may impart
30 desirable flow characteristics to the smokeless tobacco composition for
depositing in a starch mold. When
present, a representative amount of humectant is at least about 0.5 weight
percent or at least about 1.0 weight
percent or at least about 1.5 weight percent, but will typically make up less
than about 5 percent of the total
weight of the composition (e.g., about 0.5 to about 4 weight percent).
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An additional binder (or combination of binders) may be employed in certain
embodiments, in
amounts sufficient to provide the desired physical attributes and physical
integrity to the mixture, and
binders also often function as thickening or gelling agents. Typical binders
can be organic or inorganic, or a
combination thereof. Representative binders include povidone, sodium alginate,
starch-based binders, pectin,
carrageenan, pullulan, zein, and the like, and combinations thereof. In some
embodiments, the binder
comprises pectin or carrageenan or combinations thereof. The amount of binder
utilized in the composition
can vary, but is typically up to about 30 weight percent, and certain
embodiments are characterized by a
binder content of at least about 0.1% by weight, such as about 1 to about 30%
by weight, or about 5 to about
10% by weight, based on the total weight of the composition.
In some embodiments, the lozenge and/or pastille products described herein may
include one or
more colorants. A colorant may be employed in amounts sufficient to provide
the desired physical attributes
to the composition or product. Examples of colorants include various dyes and
pigments, such as caramel
coloring and titanium dioxide. The amount of colorant utilized in the
compositions or products can vary, but
when present is typically up to about 3 weight percent, such as from about
0.1%, about 0.5%, or about 1 4
to about 3% by weight, based on the total weight of the composition.
Various other substances can be added to the compositions of the present
invention. For example,
excipients such as fillers or carriers for active ingredients (e.g., calcium
polycarbophil, microcrystalline
cellulose, hydroxypropylcellulose, sodium carboxymethylcellulose, cornstarch,
silicon dioxide, calcium
carbonate, lactose, and starches including potato starch, maize starch, etc.),
thickeners, film formers and
binders (e.g., hydroxypropyl cellulose, hydroxypropyl methylcellulose, acacia,
sodium alginate, xanthan
gum and gelatin), antiadherents (e.g., talc), glidants (e.g., colloidal
silica), humectants (e.g., glycerin),
preservatives and antioxidants (e.g., sodium benzoate and ascothyl palmitate),
surfactants (e.g., polysorbate
80), dyes or pigments (e.g., titanium dioxide or D&C Yellow No. 10), and
lubricants or processing aids
(e.g., calcium stearate or magnesium stearate) are added to the compositions
in certain embodiments.
Examples of even further types of additives that may be used in the present
compositions and products
include thickening or gelling agents (e.g., fish gelatin), emulsifiers, oral
care additives (e.g., thyme oil,
eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate and the
like), disintegration aids, zinc or
magnesium salts selected to be relatively water soluble for compositions with
greater water solubility (e.g.,
magnesium or zinc gluconate) or selected to be relatively water Soluble for
compositions with reduced
water solubility (e.g., magnesium or zinc oxide), or combinations thereof.
See, for example, those
representative components, combination of components, relative amounts of
those components, and manners
and methods for employing those components, set forth in US Pat. No. 9,237,769
to Mua et al., US Pat. No.
7,861,728 to Holton, Jr. et al., US Pat. App. Pub. No. 2010/0291245 to Gao et
al., and US Pat. App. Pub.
No. 2007/0062549 to Holton, Jr. et al., each of which is incorporated herein
by reference. Typical inclusion
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ranges for such additional additives can vary depending on the nature and
function of the additive and the
intended effect on the final mixture, with an example range of up to about 10%
by weight, based on total
weight of the mixture (e.g., about 0.1 to about 5% by weight).
ht some embodiments, the composition comprises a magnesium salt. A non-
limiting example of a
suitable magnesium salt is magnesium gluconate. In some embodiments, the
composition comprises
magnesium in an amount by weight from about 0.1% to about 2%, or from about
0.2 to about 1%, based on
elemental magnesium.
The aforementioned types of additives can be employed together (e.g., as
additive formulations) or
separately (e.g., individual additive components can be added at different
stages involved in the preparation
of the final oral product). The relative amounts of the various components
within the oral products may
vary, and typically are selected so as to provide the desired sensory and
performance characteristics to the
oral product Furthenrnore, the aforementioned types of additives may be
encapsulated as provided in the
final product or composition. Example encapsulated additives are described,
for example, in WO
2010/132444 A2 to Atchley, which has been previously incorporated by reference
herein.
The rammer by which the various components of the lozenge and pastille
compositions referenced
above are combined may vary. The various components of those compositions may
be contacted, combined,
or mixed together in conical-type blenders, mixing drums, ribbon blenders, or
the like, such as a Hobart
mixer. As such, the overall mixture of various components with the active
ingredient may be relatively
uniform in nature. See also, for example, the types of methodologies set forth
in U.S. Pat Nos. 4,148,325 to
Solomon et at.; 6,510,855 to Korte et al.; and 6,834,654 to Williams, each of
which is incorporated herein by
reference.
Methods of manufacturing pastille products
Representative pastille compositions and products may incorporate about 10
weight percent or less
of at least one active ingredient, about 0.01 to about 2 percent sweetener,
about 0.1 to about 5 percent
humectant, about 25 to about 45 percent of at least one sugar alcohol filler,
about 35 to about 55 percent of
at least one gum, about 0.1 to about 5 percent of at least one flavoring
agent, and about 0.1 to about 5
percent of a salt, based on the total weight of the product. The particular
percentages and choice of
ingredients will \Taw depending upon the desired flavor, texture, and other
characteristics.
The manners and methods used to formulate and manufacture a pastille product
as described herein
above can vary. For example, the compositions fomting the pastille products
are prepared such that the
mixture thereof may be used in a starch molding process for forming the
pastille product. Example pastille
production processes are set forth in US Pat. Nos. 4,725,440 to Ridgway et al
and 6,077,524 to Bolder et al.,
which are incorporated by reference herein. In some embodiments, the
compositions for forming the pastille
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products may be prepared such that the mixture thereof may be used in a
starchless molding process (e.g.,
not including a starch-based component in the molding process) for forming the
pastille product.
In one embodiment, the process comprises heating a gum, and optionally
hydrating that gum
component with water, and then stirring at least one active ingredient into
the heated gum component
Generally, the gum may be heated to a temperature in the range of about 60 C
to about 80 C for a period of
a few seconds to a few minutes. In some embodiments, the gum may be heated to
a temperature of about
71 C before stirring in the at least one active ingredient, to allow the at
least active ingredient to dissolve
therein. In some instances, an aqueous mixture is formed in a separate
container by mixing one or more
additives (e.g., such as salts, sweeteners, humectants, emillcifiers,
flavoring agents, and others) with water to
fonn the aqueous mixture. Then, the aqueous mixture may be admixed with the
heated gum (including the at
least one active ingredient that has been added therein) to form a mixture in
the form of a slurry.
hi some embodiments, the at least one sugar alcohol component may be added
separately to this
mixture, or, in other embodiments, the at least one sugar alcohol may be
combined with the gum and the
active ingredient prior to addition to the mixture. In some instances, the at
least one wan alcohol may be
heated in yet another separate container and added to the mixture separately_
For example, in some
embodiments, the at least one sugar alcohol (which may optionally include
isomalt/maltitollelythritol) may
be heated to a temperature in the range of about 160 C to about 190 C before
addition to the mixture. In
some embodiments, the at least one sugar alcohol may be heated to a
temperature of at least about 160 C, at
least about 170 C, at least about 180 C, or at least about 190 C. In some
instances, the heated sugar alcohol
may be allowed to cool to a temperature in the range of about 120 C to about
160 C prior to addition to the
mixture. In some embodiments, for example, the heated sugar alcohol may be
cooled to a temperature of
about 160 C or less, about 150 C or less, about 140 C or less, or about 130 C
or less prior to addition to the
mixture.
In some instances, the heated (and optionally cooled) suglar alcohol may be
combined with the
mixture (e.g., including the heated gum, the at least one active ingredient,
and the aqueous mixture) and
stirred using a high shear mixer or a Hobart mixing bowl with a whipping
attachment to provide a pastille
composition, which may also be in the form of a slurry. The pastille
composition may then be heated to an
elevated temperature for a period of time, for example, heated to between
about 40 C to about 80 C, and
typically heated to about 71 C, for a period of about 1 to about 3 minutes,
for example, to dissolve any dry
ingredient within the pastille composition. The heating step can be
characterized as heating at a temperature
of at least about 50 C, at least about 60 C, or at least about 70 C. The
pastille composition typically has a
moisture content of at least about 40 percent by weight water, based on the
total weight of the composition.
According to some aspects, the pastille composition, in the form of a shiny,
may optionally be put
through a deaerating step or process prior to being received in a mold or
being subjected to other processing
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steps, so as to reduce or eliminate air bubbles present in the slurry mixture.
Air bubbles entrapped within the
shiny may affect the final weight of the pastille product, which could lead to
a lack of weight uniformity
between units of the final product. As such, any deaerating methods and
systems may be employed for
removing such air bubbles from the slurry material. For example, the slurry
may be placed under reduced
pressure (i.e., below atmospheric pressure) to pull the air bubbles out of the
slurry mixture. In some
instances, a vacuum deaerating process may be employed in which the slurry
mixture is placed in a vacuum
deacrator for deaerating the slurry mixture using pressure reduction. In some
instances, the slurry mixture
may be under vacuum for about 1 to about 10 minutes, and typically for about 3
to about 5 minutes. The
deaerating step may be observed and adjusted accordingly in order to
controllably remove the gaseous
components from the slurry mixture.
The viscosity of the heated and deaerated shiny mixture may be measured using,
for example, a
Brookfield viscometer HA Series, 5C4 water jacket, 27/13R sample chamber and a
No. 27 spindle. The
pastille composition may have a viscosity of about 5.7 Pascal-seconds (Pa's)
to about 6.2 Pa's when heated
to a temperature of about 38 C, about 4.9 Pa = s to about 5.4 Pa-s when heated
to a temperature of about
43 C, and about 4.2 Pa-s to about 4.7 Pa -s when heated to a temperature of
about 50 C. In some instances,
extra water may be added to the pastille composition so as to provide a
desired viscosity thereof.
Once the desired viscosity is achieved, the heated pastille composition may
then be deposited into a
mold, such as, for example, a starch mold. While the process as further
described herein is directed to
forming a pastille product using a starch mold, it is noted that other types
of molds may be used in the
process, such as, for example, starchless molds, pectin molds, plastic tray
molds, metallic tray molds,
neoprene tray molds, etc.
In instances involving the use of starch molds, the starch molds may be pre-
dried to remove
moisture content from the starch mold itself. That is, prior to receiving the
slurry or viscous pastille
composition, the starch mold may be subjected to an elevated temperature to
drive out moisture in the starch
mold. For example, in some instances, the starch mold may initially have a
moisture content of about 10-15
weight percent. Such levels of moisture could potentially have an effect on
the uniformity of the resultant
product In this regard, certain moisture levels in the starch mold could
potentially have a wrinkling or
pruning effect on the product such that the final product has a shriveled or
otherwise wrinkled appearance.
As such, the starch mold may be dried at an elevated temperature to reduce the
moisture content of the
starch mold to between about 4 and about 10 weight percent, and preferably
between about 6 and about 8
weight percent, based on the total weight of the starch mold. By taking such
steps, the product may, in some
instances, be more uniformly consistent in appearance. Furthermore, the starch
mold may be heated to an
elevated temperature prior to receiving the pastille composition such that the
starch mold itself is at an
elevated temperature when receiving the pastille composition.
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The pastille composition remains in the starch mold at an elevated temperature
such as, for example,
at between about 40 C to about 80 C (e.g., at least about 40 C or at least
about 50 C), and typically at about
60 C. The pastille composition may be held at the elevated temperature for a
predetermined duration of
time such as, for example, about 15 -48 hours, and typically about 24 hours,
so as to allow the pastille
5 composition to cure and solidify into pastille form, while driving the
moisture content of the pastille
composition to a desired final moisture level. As noted above, in some
embodiments, the desired final
moisture level of the pastille product may be within the range of about 5 to
about 25 weight percent, or about
8 to about 20 weight percent, or about 1010 about 15 weight percent, based on
the total weight of the
product unit. In this regard, curing generally refers to the solidification
process in which moisture loss
10 occurs, the viscosity of the composition is raised, and chemical and
physical changes begin to occur (e.g.,
crystallization, cross-linking, gelling, film forming, etc.). The pastille
composition is allowed to cool and
thereafter removed from the starch mold. In some instances, the pastille
composition may be allowed to
cool at refrigerated or below ambient temperatures. An air blower / shaker
device can be used to remove
starch remnants from the pastille composition after being removed from the
starch mold.
15 The pastille composition is then allowed to post-cure for a time
and at a temperature suitable to
allow the composition to become equilibrated to a desired moisture, shape and
form. The time and
temperature can vary without departing from the invention and depend in part
on the desired fmal
characteristics of the product. In one embodiment, the post-cure is conducted
at ambient temperature for at
least about 20 hours after being removed from the mold. The resultant pastille
product may be provided in
20 individual pieces weighing between about 0.5 grams to about 5 grams,
although aspects of the present
disclosure are not limited to such weights.
The curing times and temperatures of the pastille composition can be varied as
desired. In this
regard, such variables may affect the fmal visual appearance of the pastille
product. For example, extended
curing times and/or low curing temperatures may affect the final outer
configuration or contours of the
25 pastille product. That is, the rate of drying and/or curing of the
product can affect the final properties of the
product. In some instances, for example, lowering the curing temperature and
extending the curing time
may cause the pastille product to have a relatively smooth outer surface. In
contrast, curing at higher
temperatures for shorter period of times can lead to a roughened or wrinkled
appearance in the product.
According to other aspects of the present disclosure, rather than using molds
to prepare the pastille
30 product, an extrusion process may be employed in which the final
pastille product is extruded. In some
instances, the pastille composition in slurry form may be formed into a sheet
and allowed to dry to a
moisture content, for example, of about 15 percent to about 25 percent by
weight water to form a tacky or
otherwise pasty material, which is in a form capable of physical handling. The
material may then be
chopped or otherwise cut into smaller pieces using, for example, a mixer. The
chopped material may then
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be extruded through an extrusion device to any shape/size desired, including
shapes that may be difficult or
impossible to achieve with a mold. In some instances, the extruded product may
then be dried to achieve a
desired moisture content. A similar type process is described, for example, in
US. Pat No. 3,806,617 to
Smylie et al., which is incorporated herein by reference in its entirety.
Further, the pastille composition may
be subjected to a co-extrusion process with another composition.
Shapes such as, for example, rods and cubes can be formed by first extruding
the material through a
die having the desired cross-section (e.g., round or square) and then
optionally cutting the extruded material
into desired lengths. Techniques and equipment for extruding tobacco materials
are set forth in US Pat. Nos.
3,098,492 to Wursburg; 4,874,000 to Tamol et al.; 4,880,018 to Graves etal.;
4,989,620 to Keritsis et at;
5,072,744 to Luke et al.; 5,829,453 to White et al.; and 6,182,670 to White et
at; each of which is
incorporated herein by reference. Example extrusion equipment suitable for use
include food or gum
extruders, or industrial pasta extruders such as Model TP 200/300 available
from Emiliomiti, LLC of Italy.
In some instances, a single machine may be capable of achieving multiple steps
of the processes described
herein, such as, for example, kneader systems available from Buss AG.
The pastille product can be provided in any suitable predetermined shape or
fern), and most
preferably is provided in the form having a general shape of a pill, pellet,
tablet, coin, bead, ovoid, obloid,
cube, or the like. The mouthfeel of the smokeless tobacco product preferably
has a slightly chewable and
dissolvable quality with a mild resilience or "bounce" upon chewing that
gradually leads to greater
malleability during use. According to one aspect, the pastille product is
preferably capable of lasting in the
user's mouth for about 10-15 minutes until it completely dissolves.
Preferably, the products do not, to any
substantial degree, leave any residue in the mouth of the user thereof, and do
not impart a slick, waxy, or
slimy sensation to the mouth of the user.
According to some embodiments, the pastille composition may be coated with a
coating substance
after being removed from the starch mold and prior to drying. For example, a
glazing or anti-sticking
coating substance, such as, for example, CAPOL 410 (available from Centerchem,
Inc.), may be applied to
the pastille composition to provide free-flowing properties. Outer coatings
can also help to improve storage
stability of the pastille products of the present disclosure as well as
improve the packaging process by
reducing friability and dusting. Devices for providing outer coating layers to
the products of the present
disclosure include pan coaters and splay coaters, and particularly include the
coating devices available as
CompuLab 24, CompuLab 36, Accela-Cota 48 and Accela-Cota 60 from Thomas
Engineering.
An example outer coating comprises a film-forming polymer, such as a
cellulosic polymer, an
optional plasticizer, and optional flavorants, colorants, salts, sweeteners or
other additives of the types set
forth herein, The coating compositions are usually aqueous in nature and can
be applied using any pellet or
tablet coating technique known in the an, such as pan coating. Example film-
forming polymers include
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cellulosic polymers such as methylcellulose, hydroxypropyl cellulose (I-IPC),
hydroxypropyl
methylcellulose (TWMC), hydroxyethyl cellulose, and carboxy methylcellulose.
Example plasticizers
include aqueous solutions or emulsions of glyceryl monostearate and triethyl
citrate.
hr one embodiment, the coating composition comprises up to about 75 weight
potent of a film-
forming polymer solution (e.g., about 40 to about 70 weight potent based on
total weight of the coating
formulation), up to about 5 weight percent of a plasticizer (e.g., about 0.5
to about 2 weight percent), up to
about 5 weight percent of a sweetener (e.g., about 0.5 to about 2 weight
percent), up to about 10 weight
percent of one or more colorants (e.g., about 1 to about 5 weight percent), up
to about 5 weight percent of
one or more flavorants (e.g., about 0.5 to about 3 weight percent), up to
about 2 weight percent of a salt such
as NaCl (e.g., about 0.1 to about 1 weight percent), and the balance water.
Example coating compositions
and methods of application are described in U.S. Application No. 12/876,785 to
Hunt et al.; filed September
7, 2010, and which is incorporated by reference herein.
Although the foregoing description focuses on compositions that are uniform
throughout each
product unit, products can also be formed with multiple different formulations
having different properties in
the same product unit. For example, two different compositions can be
deposited in a single mold to
produce a layered product. Still further, two different compositions could be
co-extruded to form a product
with different characteristics across its cross-section. Such a process could
be used to provide a product
with two different compositions featuring different dissolution rates such
that a first portion of the product
dissolves at a first rate (e.g., a faster rate) and a second portion dissolves
at a second, slower rate.
Products of the present disclosure may be packaged and stored in any suitable
packaging_ See, for
example, the various types of containers for smokeless types of products that
are set forth in US Pat. Nos.
7,014,039 to Henson et al.; 7,537,110 to Kutsch et at; 7,584,843 to Kutsch et
at; D592,956 to Thiellier and
1)594,154 to Patel et at.; US Pat. Pub. Nos. 2008/0173317 to Robinson et al.;
2009/0014343 to Clark et al.;
2009/0014450 to Bjorkholm; 2009/0250360 to Bellamah et al.; 2009/0266837 to
Gelardi et al.;
2009/0223989 to Gelardi; 2009/0230003 to Thiellier; 2010/0084424 to Gelardi;
and 2010/0133140 to Bailey
et al; and US Pat Appl. Serial Nos. 29/342,212, filed August 20, 2009, to
Bailey et al.; 12/425,180, filed
April 16, 2009, to Bailey et al.; 12/685,819, filed January 12, 2010, to
Bailey et al.; and 12/814,015, filed
June 11, 2010, to Gelardi et al., which are incorporated herein by reference.
Methods of manufacturing lozenge products
Representative lozenge compositions and products may incorporate about 10
weight percent or less
of at least one active ingredient, about 0.01 to about 2 percent artificial
sweetener, about 1 to about 5 percent
humectant, about 1 to about 5 percent natural sweetener, at least about 80
percent of a sugar substitute, about
0.1 to about 10 percent of a sugar alcohol syrup, one or more flavorants in an
amount of up to about 5
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percent, and salt in an amount up to about 3 percent, based on the total
weight of the product. The particular
percentages and choice of ingredients will vary depending upon the desired
flavor, texture, and other
characteristics.
The mamiers and methods used to formulate and manufacture a lozenge product as
described herein
above can vary. For example, the compositions can be prepared via any method
commonly used for the
preparation of hard boiled confections. Example methods for the preparation of
hard confections can be
found, for example, in LFRA Ingredients Handbook, Sweeteners, Janet M.
Dalzell, Ed., Leatherhead Food
RA (Dec.. 1996), pp. 21-44, which is incorporated herein by reference.
Typically, a first mixture of ingredients is prepared. The composition of the
first mixture of
ingredients can vary; however, it typically comprises a sugar substitute and
may contain various additional
substances (e.g., the sugar alcohol syrup, NaC1, preservatives, further
sweeteners, water, and/or flavorings).
In certain embodiments, it comprises the sugar substitute, salt, and vanillin.
In other embodiments, the first
mixture comprises the sugar substitute and the sugar alcohol syrup. Typically,
the first mixture of
ingredients does not contain the active ingredient; although, it some
embodiments, the active ingredient may
be incorporated into the first mixture of ingredients.
The first mixture of ingredients is heated until it melts; subsequently, the
mixture is heated to or past
the hard crack stage. In confectionary making, the hard crack stage is defined
as the temperature at which
threads of the heated mixture (obtained by pulling a sample of cooled syrup
between the thumb and
forefinger) are brittle or as the temperature at which trying to mold the
syrup results in cracking. According
to the present method, the temperature at which the hard crack stage is
achieved can vary, depending on the
specific makeup of the product mixture but generally is between about 145 C
and about 170 'C. Typically,
the mixture is not heated above about 171 C, which is the temperature at
which caramelization begins to
occur. In the processes of the present disclosure, the mixture is typically
heated to the hard crack stage
temperature or above and then allowed to cool. The heating can be conducted at
atmospheric pressure or
under vacuum_ Typically, the method of the present invention is conducted at
atmospheric pressure.
In one example embodiment, the first mixture of ingredients comprises a high
percentage of isornalt
and the mixture is heated to about 143 'C. Once all components are dissolved,
the temperature is raised past
the hard crack stage (e.g., to about 166 C). The mixture is heated to this
temperature and then removed
from the heat to allow the mixture to cool.
In certain embodiments, the active ingredients and, optionally, additional
components (e.g.,
additional sweeteners, fillets, flavorants, and water) as described above are
separately combined in a second
mixture. The second mixture is added to the first mixture of ingredients,
typically after the first mixture of
ingredients has been removed from the heat. The addition of the second mixture
may, in some
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embodiments, occur only after the heated first mixture of ingredients has
cooled to a predetermined
temperature (e.g., in certain embodiments, to about 132 C). In certain
embodiments, one or more flavorants
are added to the second mixture immediately prior to adding the mixture to the
first, heated mixture of
ingredients. Certain flavorants are volatile and am thus preferably added
after the mixture has cooled
somewhat.
The combined mixture is then formed into the desired shape. In certain
embodiments, the mixture
is poured directly into molds, formed (e.g., rolled or pressed) into the
desired shape, or extruded. If desired,
the mixture can be extruded or injection molded. In certain embodiments, the
mixture is formed or extruded
into a mold of desired shape in an enclosed system, which may require
decreased temperature and which
may limit evaporation of certain mixture components. For example, such a
system may limit the
evaporation of volatile components including, but not limited to, flavorants.
Other methods of producing
lozenges are also intended to be encompassed herein.
Typical conditions associated with manufacture of food grade lozenge products
such as described
herein include control of heat and temperature (i.e., the degree of heat to
which the various ingredients are
exposed during manufacture and the temperature of the manufacturing
environment), moisture content (e.g.,
the degree of moisture present within individual ingredients and within the
final composition), humidity
within the manufacturing environment, atmospheric control (e.g., nitrogen
atmosphere), airflow experienced
by the various ingredients during the manufacturing process, and other similar
types of factors.
Additionally, various process steps involved in product manufacture can
involve selection of certain solvents
and processing aids, use of heat and radiation, refrigeration and cryogenic
conditions, ingredient mixing
rates, and the like. The manufacturing conditions also can be controlled due
to selection of the form of
various ingredients (e.g., solid, liquid, or gas), particle size or
ciystalline nature of ingredients of solid fonn,
concentration of ingredients in liquid form, or the like. Ingredients can be
processed into the desired
composition by techniques such as extrusion, compression, spraying, and the
like.
In certain embodiments, the lozenge product may be transparent or translucent.
As used herein,
"translucent" or "translucency" refers to materials allowing some level of
light to travel therethrough
diffusely. In certain embodiments, lozenge products of the present disclosure
can have such a high degree of
clarity that the material can be classified as "transparent" or exhibiting
"transparency," which is defined as a
material allowing light to pass freely through without significant diffusion.
The clarity of the lozenge
product is such that there is some level of translucency as opposed to opacity
(which refers to materials that
are impenetrable by light). Transparency/translucency can be determined by any
means commonly used in
the art; however, it is conunonly measured by spectrophotometric light
transmission over a range of
wavelengths (e.g., from about 400-700 mu). Alternatively, optical methods such
as turbidimetry (or
nephelornetry) and colorimetry may be used to quantify the cloudiness (light
scattering) and the color (light
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absorption), respectively, of the lozenge products provided herein.
Translucency can also be confirmed by
visual inspection by simply holding the material (e.g., extract) or product up
to a light source and
determining if light travels through the product in a diffuse manner.
5 EXPERIMENTAL
The following examples are provided to illustrate further aspects associated
with the present
disclosure, but should not be construed as limiting the scope thereof. Unless
otherwise noted, all parts and
percentages are by dry weight.
Example 1
10 An oral product in the form of a pastille (referred to herein as
"Pastille A") and configured for oral
use is provided in the following manner.
An aqueous mixture is prepared. The aqueous mixture is formed by admixing
water, a salt, a
sweetener, a humectant, and a flavoring agent. Next, a gum is heated to a
temperature of about 71 C and
then, the at least one active ingredient is stirred into the heated gum
component. The heated gum (including
15 the at least one active ingredient therein) is then added to the aqueous
composition to form a mixture. Then,
at least one sugar alcohol is heated to a temperature of about 175 C and then
cooled to a temperature of
about 150 C. The cooled sugar alcohol is then added to the mixture and stirred
in a Hobart mixing bowl to
fonn a pastille composition.
The pastille composition is heated to about 71 C and then deposited into a
starch mold. The pastille
20 composition remains in the starch mold for about 24 hours at about 60 C.
The pastille composition is
allowed to cool and then removed from the starch mold. The oral composition is
then cured at ambient room
temperature for about 24 hours to provide the pastille product configured for
oral use. Table 1 below
illustrates the relative percentages of each individual component in the final
oral product prepared as
described herein.
25 Table 1 ¨ Pastille A
Sugar Alcohol
25% -45%
Gum
35% - 55%
Active Ingredient
1% - 10%
Humectant
0.1% - 5%
Salt
OA% - 5%
Flavoring Agent
0.1% -5%
Sweetener
0.01% - 1%
Water
5%- 10%
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Example 2
An oral product in the form of a pastille (referred to herein as "Pastille B")
and configured for oral
use is provided in the following manner.
An aqueous mixture is prepared. The aqueous mixture is formed by admixing
water, a salt, a
sweetener (sucralose), a humectant (glycerin), and a flavoring agent. Next, a
gum (gum arabic solution) is
heated to a temperature of about 71 C and then, the at least one active
ingredient (e.g., including caffeine,
taurine, and ascorbic acid) is stirred into the heated gum component. The
heated gum (including the at least
one active ingredient therein) is then added to the aqueous composition to
form a mixture. Then, the at least
one sugar alcohol (e.g., including isomalt, maltitol, and erythritol) is
heated to a temperature of about 175 C
and then cooled to a temperature of about 150 C. The cooled sugar alcohol is
then added to the mixture and
stirred in a Hobart mixing bowl to form a pastille composition and allowed to
cool.
The pastille composition is heated to about 71 C and then deposited into a
starch mold. The pastille
composition remains in the starch mold for about 24 hours at about 60 C. The
pastille composition is
allowed to cool and then removed from the starch mold. The oral composition is
then cured at ambient room
temperature for about 24 hours to provide the pastille product configured for
oral use. Table 2 below
illustrates the relative percentages of each individual component in the final
oral product prepared as
described herein.
Table 2¨ Pastille B
'soma&
20% - 35%
Maltitol
1% - 10%
Elythritol
0A% - 2%
Glycerin
01% - 2%
Water
5%- 15%
Salt
1% - 3%
Sucralose
0.01% - 1%
Caffeine
1% - 5%
Taurine
1% - 5%
Ascorbic Acid
0_1% -2%
Flavor
0.1% - 2%
Gum Arabic Solution
35% - 55%
Example 3
An oral product in the form of a pastille (referred to herein as "Pastille C")
and configured for oral
use is piovided in the following manner.
An aqueous mixture is prepared. The aqueous mixture is formed by admixing
water, a salt, a
sweetener (sucralose), a humectant (glycerin), and a flavoring agent. Next, a
gum (gum arable solution) is
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heated to a temperature of about 71 C and then, the at least one active
ingredient (e.g., including theanine,
GABA, and lemon balm) is stirred into the heated gum component. The heated gum
(including the at least
one active ingredient therein) is then added to the aqueous composition to
form a mixture. Then, the at least
one sugar alcohol (e.g., including isomalt, maltitol, and erythritol) is
heated to a temperature of about 175 C
and then cooled to a temperature of about 150 C. The cooled sugar alcohol is
then added to the mixture and
stirred in a Hobart mixing bowl to form a pastilk composition and allowed to
cool.
The pastille composition is heated to about 71 C and then deposited into a
starch mold. The pastille
composition remains in the starch mold for about 24 hours at about 60 C. The
pastille composition is
allowed to cool and then removed from the starch mold. The oral composition is
then cured at ambient room
temperature for about 24 hours to pmvide the pastille product configured for
oral use. Table 3 below
illustrates the relative percentages of each individual component in the final
oral product prepared as
described herein.
Table 3¨ Pastille C
Isomalt
20% -35%
Maltitol
1% - 10%
Erythritol
0.1% - 2%
Glycerin
0_1% - 2%
Water
5%- 15%
Salt
Sucralose
0.01% - 1%
Theanine
1% - 5%
GABA
1% - 5%
Lemon Balm
0.1% - 2%
Flavor
0_1% -2%
Gum Arabic Solution
35% - 55%
Example 4
An oral product in the form of a pastille (referred to herein as "Pastille D")
and configured for oral
use is provided in the following manner.
An aqueous mixture is prepared. The aqueous mixture is formed by admixing
water, a salt, a
sweetener (sucralose), a humectant (glycerin), and a flavoring agent. Next, a
gum (gum arabic solution) is
heated to a temperature of about 71 C and then, the at least one active
ingredient (e.g., including caffeine,
theanine, and ginseng) is stirred into the heated gum component. The heated
gum (including the at least one
active ingredient therein) is then added to the aqueous composition to form a
mixture. Then, the at least one
sugar alcohol (e.g., including isomalt, maltitol, and erythritol) is heated to
a temperature of about 175 C and
then cooled to a temperature of about 150 C. The cooled sugar alcohol is then
added to the mixture and
stirred in a Hobart mixing bowl to form a pastille composition and allowed to
cool.
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The pastille composition is heated to about 71 C and then deposited into a
starch mold. The pastille
composition remains in the starch mold for about 24 hours at about 60 C. The
pastille composition is
allowed to cool and then removed from the starch mold. The oral composition is
then cured at ambient room
temperature for about 24 hours to provide the pastille product configured for
oral use. Table 4 below
illustrates the relative percentages of each individual component in the final
oral product prepared as
described herein.
Table 4 - Pastille D
Isomalt 20% -35%
Maltitol 1% - 10%
thythritol
0.1% - 2%
Glycerin
0.1% - 2%
Water
5%- 15%
Salt
Sucralose
0.01% - 1%
Caffeine 1% - 5%
Theanine
Ginseng 0.1% - 2%
Flavor 0.1% - 2%
Gum Arabic Solution
35% - 55%
Many modifications and other embodiments of the invention will come to mind to
one skilled in the
art to which this invention pertains having the benefit of the teachings
presented in the foregoing description_
Therefore, ills to be understood that the invention is not to be limited to
the specific embodiments disclosed
and that modifications and other embodiments are intended to be included
within the scope of the appended
claims_ Although specific terms are employed herein, they are used in a
generic and descriptive sense only
and not for purposes of limitation_
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