Note: Descriptions are shown in the official language in which they were submitted.
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ORAL PRODUCT AND METHOD OF MANUFACTURE
FIELD OF THE DISCLOSURE
The present disclosure relates to products intended for human consumption. 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 component 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 al.; 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 al.; 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 al.; 2007/0186942 to Strickland et al.; 2008/0029110 to Dube et
al.; 2008/0029116 to
Robinson et at.; 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 Arnarp et al.,
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 al.;
2010/0291245 to Gao et al; 2011/0139164 to Mua et al.; 2012/0037175 to
Cantrell et al.; 2012/0055494 to
Hunt et al.; 2012/0138073 to Cantrell et al.; 2012/0138074 to Cantrell et al.;
2013/0074855 to Holton, Jr.;
2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et al.; 2013/0274296 to
Jackson et al.; 2015/0068545 to
Moldoveanu et al.; 2015/0101627 to Marshall et al.; and 2015/0230515 to Lampe
et al., 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. Products of this type may suffer from certain drawbacks,
such as poor product stability
that could lead to discoloration of the product and/or undesirable
organolepfic characteristics. Accordingly,
it would be desirable in the art to provide products configured for oral use
with enhanced stability to provide
a more enjoyable user experience.
BRIEF SUMMARY
The present disclosure generally provides products configured for oral use and
methods of making
such products. The products are intended to impart a taste when used orally,
and typically also deliver one or
more active ingredients to the consumer, such as nicotine.
The disclosure includes, without limitations, the following embodiments. Where
a method refers to
an intermediate composition as optionally fitrther including one or more
components selected from a list,
such a reference includes compositions that include a single member from a
single classification of
components from the list (e.g., a single alginate), or two or more members
from a single classification of
components from the list (e.g., two sweeteners), or combinations of one or
more members from each of two
or more classifications of components from the list (e.g., a sweetener and an
alginate).
Embodiment 1: A method of preparing an oral product, comprising:
combining a filler and a salt to fonn a thy mix, the dry mix optionally
further including one or more
of an alginate, a bleached tobacco, a sweetener, a carbonate salt, and a
natural gum;
forming an aqueous solution of a flavoring agent or an active ingredient or
both a flavoring agent
and an active ingredient (meaning the solution may include a single flavoring
agent, multiple
flavoring agents, a single active ingredient, multiple active ingredients, or
both one or more
flavoring agents and one or more active ingredients), the solution optionally
further including one or
more of a pH adjuster, a preservative, a humectant, and a sweetener,
adding the aqueous solution to the dry mix to form a mixture; and
optionally encasing the mixture within a pouch.
Embodiment 2; The method of any preceding embodiment, further comprising
forming a second aqueous
solution of a sugar alcohol, a pH adjuster, and an optional preservative; and
adding the second solution to the
mixture prior to encasing the mixture within a pouch.
Embodiment 3; The method of any preceding embodiment, wherein the dry mix does
not include an
alginate, further comprising adding an aqueous solution of an alginate and a
sugar alcohol to the thy mix.
Embodiment 4: The method of any preceding embodiment, wherein the dry mix does
not include a
carbonate salt, further comprising adding an aqueous solution of a carbonate
salt to the dry mix.
Embodiment 5; The method of any preceding embodiment, comprising:
combining a filler, an alginate, and a salt to form a dry mix;
adding an aqueous solution of a carbonate salt to the dry mix;
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forming an aqueous solution of both a flavoring agent and an active ingredient
(meaning a solution
containing one or more flavoring agents and one or more active ingredients),
the solution further including a
sugar alcohol, a pH adjuster, a preservative, a humectant, and a sweetener;
adding the aqueous solution to the dry mix to form a mixture;
forming a second aqueous solution of a sugar alcohol, a pH adjuster, a
sweetener, and an optional
preservative; and adding the second aqueous solution to the mixture to form a
second mixture; and
optionally encasing the second mixture within a pouch.
Embodiment 6: The method of any preceding embodiment, comprising:
combining a filler, an alginate, a bleached tobacco, and a salt to form a dry
mix;
adding an aqueous solution of a carbonate salt to the dry mix;
forming an aqueous solution of both a flavoring agent and an active
ingredient, the solution further
including a sugar alcohol, a pH adjuster, a preservative, and a sweetener;
adding the aqueous solution to the dry mix to form a mixture;
forming a second aqueous solution of a sugar alcohol, a pH adjuster, a
sweetener, and an optional
preservative; and adding the second aqueous solution to the mixture to form a
second mixture; and
optionally encasing the second mixture within a pouch.
Embodiment 7: The method of any preceding embodiment, comprising:
combining a filler, an alginate, a bleached tobacco, a natural gum, and a salt
to form a dry mix;
adding an aqueous solution of a carbonate salt to the dry mix;
forming an aqueous solution of both a flavoring agent and an active
ingredient, the solution further
including a sugar alcohol, a pH adjuster, a preservative, and a sweetener;
adding the aqueous solution to the dry mix to form a mixture; and
optionally encasing the mixture within a pouch.
Embodiment 8: The method any preceding embodiment, comprising:
combining a filler, a bleached tobacco, a natural gum, a sweetener, a
carbonate salt, a preservative,
and a salt to form a dry mix;
adding an aqueous solution of an alginate and a sugar alcohol to the dry mix
to form a mixture;
forming a second aqueous solution of both a flavoring agent and an active
ingredient;
adding the second aqueous solution to the mixture; and
optionally encasing the mixture within a pouch.
Embodiment 9: The method of any preceding embodiment, wherein the temperature
of each aqueous
solution is between about 30 to about 100 C.
Embodiment 10: The method of any preceding embodiment, wherein:
the filler is a cellulose material; or
the salt is sodium chloride; or
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the alginate is sodium alginate, calcium alginate, potassium alginate,
magnesium alginate,
ammonium alginate, or a mixture of two or more of the foregoing; or
the sugar alcohol is xylitol; or
the pH adjuster is ammonium chloride; or
the carbonate salt is sodium bicarbonate; or
the active ingredient is selected from the group consisting of a nicotine
component, botanicals,
stimulants, amino acids, vitamins, and camiabinoids; or
the natural gum is guar gum; or
the preservative is potassium sorbate; or
the sweetener is sucralose or acesulfame K; or
a combination of one or more of the above.
Embodiment 11: A method of preparing an oral product, comprising:
combining a filler and a salt to form a dry mix, the dry mix optionally
further including one or more
of an alginate, a bleached tobacco, a sweetener, a carbonate salt, and a
natural gum;
adding a flavoring agent and an active ingredient to the thy mix to form a
mixture, wherein the
active ingredient is applied either before, after, or simultaneously with the
flavoring agent;
thereafter, applying water to the mixture to form a second mixture, wherein at
least 50% by weight
of the water content of the second mixture is added after adding the active
ingredient (such as at least
about 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90%); and
optionally encasing the second mixture within a pouch.
Embodiment 12: The method of any preceding embodiment, further comprising
introducing one or more
capsules into the oral product, the one or more capsules comprising an outer
shell and an inner payload, the
inner payload comprising at least one flavoring agent, and wherein the one or
more capsules optionally
include a water-resistant outer coating.
Embodiment 13: A product configured for oral use, the product prepared by the
method of any preceding
embodiment.
Embodiment 14: A method of preparing an oral product containing nicotine,
comprising premixing a
nicotine component with a humectant to form a premix, thereafter combining the
premix with a filler.
Embodiment 15: The method of any preceding embodiment, wherein the humectant
is propylene glycol or
olive oil.
Embodiment 16: A composition, comprising:
a filler in an amount of at least 40% percent by weight, based on total weight
of the composition (e.g.,
from about 40% to about 60% by weight of the composition or about 40% to about
50%);
a sugar alcohol (e.g., from about 1% to about 10% by weight of the composition
or about 2% to about
6%);
a salt (e.g., from about 1% to about 10% by weight of the composition or about
2% to about 6%);
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an alginate (e.g., from about 0.1% to about 10% by weight of the composition
or about 0.5% to about
1.5%);
a sweetener such as an artificial sweetener (e.g., from about 0.1% to about
10% by weight of the
composition or about 0.5% to about 1.5%);
at least one flavoring agent or at least one active ingredient or at least one
of both a flavoring agent and
an active ingredient (e.g., a flavoring agent or active ingredient from about
0.1% to about 10% by weight of
the composition or about 0.5% to about 1.5%);
an optional natural gum (e.g., present in an amount of from about 0.1% to
about 15% by weight of the
composition or about 1% to about 10% or about 2% to about 6%);
and a moisture content of at least about 40% by weight (e.g., from about 40%
to about 60% by weight of
the composition or about 40% to about 55%).
Embodiment 17: The composition of any preceding embodiment, further comprising
a humectant (e.g.,
from about 0.01% to about 10% by weight of the composition or about 0.5% to
about 6%).
Embodiment 18: The composition of any preceding embodiment, wherein the
humectant is propylene
glycol or olive oil.
Embodiment 19: The composition of any preceding embodiment, comprising from
about 0.001 to about
10% by weight of a nicotine component, calculated as the free base and based
on the total weight of the
composition (e.g., about 0.5% to about 1.5%).
Embodiment 20: The composition of any preceding embodiment, wherein the
composition is substantially
free of tobacco material, excluding any nicotine component present, based on
the total weight of the
composition.
Embodiment 21: The composition of any preceding embodiment, wherein:
the filler is a cellulose material; or
the salt is sodium chloride; or
the alginate is sodium alginate, calcium alginate, potassium alginate,
magnesium alginate,
ammonium alginate, or a mixture of two or more of the foregoing; or
the sugar alcohol is xylitol; or
the active ingredient is selected from the group consisting of a nicotine
component, botanicals,
stimulants, amino acids, vitamins, and cannabinoids; or
the natural gum is guar gum; or
a combination of one or more of the above.
Embodiment 22: The composition of any preceding embodiment, further comprising
one or more capsules
comprising an outer shell and an inner payload, the inner payload comprising
at least one flavoring agent.
Embodiment 23: The composition of any preceding embodiment, wherein the one or
more capsules include
a water-resistant outer coating.
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Embodiment 24: The composition of any preceding embodiment, wherein the filler
comprises a cellulose
material.
Embodiment 25: The composition of any preceding embodiment, wherein the
cellulose material comprises
microcrystalline cellulose.
Embodiment 26: The composition of any preceding embodiment, comprising from
about 10 to about 50% of
the one or more particulate filler components; and from about 5 to about 60%
by weight of the water, based
on the total weight of the composition.
Embodiment 27: The composition of any preceding embodiment, wherein the
composition comprises no
more than about 10% by weight of a tobacco material (e.g., from about 0.01% to
about 10% by weight of the
composition or about 0.5% to about 5%), excluding any nicotine component
present, based on the total
weight of the composition.
Embodiment 28: The composition of any preceding embodiment, wherein the
composition is in a free-
flowing particulate form.
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.
BRIEF DESCRIPTION OF THE DRAWINGS
Having thus described aspects of the disclosure in the foregoing general
terms, reference will now
be made to the accompanying drawings, which are not necessarily drawn to
scale. The drawings are
exemplary only, and should not be construed as limiting the disclosure.
Fig. 1 is a cross-sectional view of a pouched product embodiment, taken across
the width of the
product, showing an outer pouch filled with a composition of the present
disclosure;
Fig. 2 is a bar graph illustrating subjective overall irritation associated
with an embodiment of a
pouched product of the disclosure; and
Fig. 3 is a schematic view of an active ingredient dosing system according to
one embodiment of the
present disclosure.
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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 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 "thy
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 composition including water. Unless
otherwise indicated, reference
to "weight percent" of a composition reflects the total wet weight of the
composition (i.e., including water).
The products as described herein comprise a mixture of components, typically
including at least one
filler and at least one flavoring agent and/or active ingredient. In some
embodiments, the composition
further comprises one or more salts, one or more sweeteners, one or more
binding agents, one or more
humectants, one or more gums, an organic acid, a tobacco material, a tobacco-
derived material, or a
combination thereof The relative amounts of the various components within the
composition may vary, and
typically are selected so as to provide the desired sensory and performance
characteristics to the oral
product. The example individual components of the composition are described
herein below.
Filler Component
Compositions as described herein generally include at least one filler
component. Such fillers may
fulfill multiple functions, such as enhancing certain organoleptic properties
such as texture and mouthfeel,
enhancing cohesiveness or compressibility of the product, and the like.
Generally, the fillers are porous
particulate materials and are cellulose-based. For example, suitable
particulate fillers are any non-tobacco
plant material or derivative thereof, including cellulose materials derived
from such sources. Examples of
cellulosic non-tobacco plant material include cereal grains (e.g., maize, oat,
barley, rye, buckwheat, and the
like), sugar beet (e.g., FIBREX1) brand filler available from International
Fiber Corporation), bran fiber, and
mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant
material include starches (e.g.,
from potato, wheat, rice, corn), natural cellulose, and modified cellulosic
materials. Additional examples of
potential particulate fillers include maltodextrin, dextrose, calcium
carbonate, calcium phosphate, lactose,
mannitol, xylitol, and sorbitol. Combinations of fillers can also be wed.
"Starch" as used herein may refer to pure starch from any source, modified
starch, or starch
derivatives. Starch is present, typically in granular form, in almost all
green plants and in various types of
plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers,
shoots, fruits, grains, and stems). Starch
can vary in composition, as well as in granular shape and size. Often, starch
from different sources has
different chemical and physical characteristics. A specific starch can be
selected for inclusion in the
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composition based on the ability of the starch material to impart a specific
organoleptic property to
composition. Starches derived from various sources can be used. For example,
major sources of starch
include cereal grains (e.g., rice, wheat, and maize) and root vegetables
(e.g., potatoes and cassava). Other
examples of sources of starch include acorns, arrowroot, arracacha, bananas,
barley, beans (e.g., favas,
lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna,
chestnuts, colacasia, katakuri, kudzu,
malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potato,
quinoa, rye, tapioca, tam,
tobacco, water chestnuts, and yams. Certain starches are modified starches. A
modified starch has
undergone one or more structural modifications, often designed to alter its
high heat properties. Some
starches have been developed by genetic modifications, and are considered to
be "modified" starches. Other
starches are obtained and subsequently modified. For example, modified
starches can be starches that have
been subjected to chemical reactions, such as esterification, etherification,
oxidation, depolymerization
(thinning) by acid catalysis or oxidation in the presence of base, bleaching,
transglycosylation and
depolymerization (e.g., dextrinization in the presence of a catalyst), cross-
linking, enzyme treatment,
acetylation, hydroxypropylation, and/or partial hydrolysis. Other starches are
modified by heat treatments,
such as pregelatinization, dextrinization, and/or cold water swelling
processes. Certain modified starches
include monostarch phosphate, distarch glycerol, distarch phosphate esterified
with sodium
trimetaphosphate, phosphate distarch phosphate, acetylated distarch phosphate,
starch acetate esterified with
acetic anhydride, starch acetate esterified with vinyl acetate, acetylated
distarch adipate, acetylated distarch
glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, starch sodium
octenyl succinate.
In some embodiments, the particulate filler is a cellulose material or
cellulose derivative. One
particularly suitable particulate filler for use in the products described
herein is microcrystalline cellulose
("mcc"). The mcc may be synthetic or semi-synthetic, or it may be obtained
entirely from natural celluloses.
The mcc may be selected from the group consisting of AVICEL grades PH-100, PH-
102, PH-103, PH-105,
PH-112, PH-113, PH-200, PH-300, PH-302, VIVACEL grades 101, 102, 12, 20 and
EMOCEL grades
50M and 90M, and the like, and mixtures thereof. In one embodiment, the
composition comprises mcc as
the particulate filler component. The quantity of mcc present in the
composition as described herein may
vary according to the desired properties.
The amount of filler can vary, but is typically up to about 75 percent of the
composition by weight,
based on the total weight of the composition. A typical range of particulate
filler (e.g., mcc) within the
composition can be from about 10 to about 75 percent by total weight of the
composition, for example, from
about 10, about 15, about 20, about 25, or about 30, to about 35, about 40,
about 45, or about 50 weight
percent (e.g., about 20 to about 50 weight percent or about 25 to about 45
weight percent). In certain
embodiments, the amount of particulate filler material is at least about 10
percent by weight, such as at least
about 20 percent, or at least about 25 percent, or at least about 30 percent,
or at least about 35 percent, or at
least about 40 percent, based on the total weight of the composition.
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In one embodiment, the particulate filler further comprises a cellulose
derivative or a combination of
such derivatives. In some embodiments, the composition comprises from about 1
to about 10% of the
cellulose derivative by weight, based on the total weight of the composition,
with certain embodiments
comprising about 1 to about 5% by weight of cellulose derivative. In certain
embodiments, the cellulose
derivative is a cellulose ether (including carboxyalkyl ethers), meaning a
cellulose polymer with the
hydrogen of one or more hydroxyl groups in the cellulose structure replaced
with an alkyl, hydroxyalkyl, or
aryl group. Non-limiting examples of such cellulose
derivatives include methylcellulose,
hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"),
hydroxyethyl cellulose, and
carboxymethylcellulose ("CMC"). In one embodiment, the cellulose derivative is
one or more of
methylcellulose, HPC, HPMC, hydroxyethyl cellulose, and CMC. In one
embodiment, the cellulose
derivative is HPC. In some embodiments, the composition comprises from about 1
to about 3% HPC by
weight, based on the total weight of the composition.
Water
The water content of the composition, prior to use by a consumer of the
product, may vary
according to the desired properties. Typically, the composition, as present
within the product prior to
insertion into the mouth of the user, is less than about 60 percent by weight
of water, and generally is from
about 1 to about 60% by weight of water, for example, from about 5 to about
55, about 10 to about 50, about
to about 45, or about 25 to about 40 percent water by weight, including water
amounts of at least about
5% by weight, at least about 10% by weight, at least about 15% by weight, and
at least about 20% by
20 weight.
Organic acid
As used herein, the term "organic acid" refers to an organic (i.e., carbon-
based) compound that is
characterized by acidic properties. Typically, organic acids are relatively
weak acids (i.e., they do not
dissociate completely in the presence of water), such as carboxylic acids (-
CO2H) or sulfonic acids (-
S020H). As used herein, reference to organic acid means an organic acid that
is intentionally added. In this
regard, an organic acid may be intentionally added as a specific composition
ingredient as opposed to merely
being inherently present as a component of another composition ingredient
(e.g., the small amount of
organic acid which may inherently be present in a composition ingredient such
as a tobacco material). In
some embodiments, the one or more organic acids are added neat (i.e., in their
free acid, native solid or
liquid form) or as a solution in, e.g., water. In some embodiments, the one or
more organic acids are added
in the form of a salt, as described herein below.
In some embodiments, the organic acid is an alkyl carboxylic acid. Non-
limiting examples of alkyl
carboxylic acids include formic acid, acetic acid, propionic acid, octanoic
acid, nonanoic acid, decanoic acid,
tmdecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid,
linolenic acid, and the like. In some
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embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples
of alkyl sulfonic acids
include propanesulfonic acid and octanesulfonic acid.
In some embodiments, the organic acid is citric acid, malic acid, tartaric
acid, octanoic acid, benzoic
acid, a toluic acid, salicylic acid, or a combination thereof In some
embodiments, the organic acid is benzoic
acid. In some embodiments, the organic acid is citric acid.
In alternative embodiments, a portion, or even all, of the organic acid may be
added in the form of a
salt with an alkaline component, which may include, but is not limited to,
nicotine. Non-limiting examples
of suitable salts, e.g., for nicotine, include fonnate, acetate, propionate,
isobutyrate, butyrate, alpha-
methylbutyate, isovalerate, beta-methylvalerate, caproate, 2-furoate,
phenylacetate, heptanoate, octanoate,
nonanoate, oxalate, malonate, glycolate, benzoate, tartrate, levulinate,
ascorbate, fiunarate, citrate, ntalate,
lactate, aspantate, saficylate, tosylate, succinate, pyruvate, and the like.
In some embodiments, the organic
acid or a portion thereof may be added in the form of a salt with an alkali
metal such as sodium, potassium,
and the like. In organic acids having more than one acidic group (such as a di-
or-tri-carboxylic acid), in
some instances, one or more of these acid groups may be in the form of such a
salt. Suitable non-limiting
examples include monosodium citrate, disodium citrate, and the like. In some
embodiments, the organic acid
is a salt of citric acid, malic acid, tartaric acid, octanoic acid, benzoic
acid, a toluic acid, salicylic acid, or a
combination thereof. In some embodiments, the organic acid is a mono or di-
ester of a di- or tri-carboxylic
acid, respectively, such as a monomethyl ester of citric acid, malic acid, or
tartaric acid, or a dimethyl ester
of citric acid.
The amount of organic acid present in the composition may vary. Generally, the
composition
comprises from about 0.1 to about 10% by weight of organic acid, present as
one or more organic acids,
based on the total weight of the composition. In some embodiments, the
composition comprises about 0.1%,
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%, about 6%, about 70/0, about 8%,
about 9%, or about 10%
organic acid by weight, based on the total weight of the composition. In some
embodiments, the composition
comprises from about 0.1 to about 0.5% by weight of organic acid, for example,
about 0.1, about 0.15, about
0.2, about 0.25, about 0.3, about 0.35, about 0.4, about 0.45, or about 0.5%
by weight, based on the total
weight of the composition. In some embodiments, the composition comprises from
about 0.25 to about
0.35% by weight of organic acid, for example, from about 0.25, about 0.26,
about 0.27, about 0.28, about
0.29, or about 0.3, to about 0.31, about 0.32, about 0.33, about 0.34, or
about 0.35% by weight, based on the
total weight of the composition. In the case where a salt of an organic acid
is added, the percent by weight is
calculated based on the weight of the free acid, not including any counter-ion
which may be present.
The quantity of acid present will 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 organic acid
is provided in a quantity sufficient to provide a pH of 7.0 or below,
(typically about 6.8 or below, about 6.6
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or below, or about 6.5 or below) of the composition. In certain embodiments
the acid inclusion is sufficient
to provide a composition pH of from about 4.0 to about 7.0; for example, from
about 4.5, 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.
Flavoring agent
As used herein, a "flavoring agent" or "flavorant" is any flavorful or
aromatic substance capable of
altering the sensory characteristics associated with the oral product.
Examples of sensory characteristics that
can be modified by the flavoring agent include taste, mouthed, moistness,
coolness/heat, and/or
fragrance/aroma. Flavoring agents may be natural or synthetic, and the
character of the flavors imparted
thereby may be described, without limitation, as fresh, sweet, herbal,
confectionary, floral, fruity, or spicy.
Specific types of flavors include, but are not limited to, vanilla, coffee,
chocolate/cocoa, cream, mint,
spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamon,
nutmeg, cinnamon, clove,
cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon,
orange, apple, peach, lime,
cherry, strawberry, 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.
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 Quintet 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,
cinninaldehyde, benzaldehyde, and
citronella]. Non-limiting examples of ketones include 1-hydroxy-2-propanone
and 2-hydroxy-3-methy1-2-
cyclopentenone-l-one. Non-limiting examples of esters include allyl hexanoate,
ethyl heptanoate, ethyl
hexanoate, isoarnyl acetate, and 3-rnethylbutyl acetate. Non-limiting examples
of terpenes include sabiutene,
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limonene, gamma-terpinene, beta-famesene, nerolidol, thujone, myrcene,
geraniol, nerol, citronellol,
linalool, and eucalyptol. In one embodiment, the at least one volatile flavor
component comprises one or
more of ethyl vanillin, cinnamaldehyde, sabinene, litnonene, gamma-terpinene,
beta-farnesene, or citral. In
one embodiment, the at least one volatile flavor component comprises ethyl
vanillin.
The amount of flavoring agent utilized in the composition can vary, but is
typically up to about 10
weight percent, and certain embodiments are characterized by a flavoring agent
content of at least about 0.1
weight percent, such as about 0.5 to about 10 weight percent, about 1 to about
6 weight percent, or about 2
to about 5 weight percent, based on the total weight of the composition.
Salts
In some embodiments, the composition may further comprise a salt (e.g., alkali
metal salts),
typically employed in an amount sufficient to provide desired sensory
attributes to the composition. Non-
limiting examples of suitable salts include sodium chloride, potassium
chloride, ammonium chloride, flour
salt, and the like. When present, a representative amount of salt is about 0.5
percent by weight or more,
about 1.0 percent by weight or more, or at about 1.5 percent by weight or
more, but will typically make up
about 10 percent or less of the total weight of the composition, or about 7.5
percent or less or about 5 percent
or less (e.g., about 0.5 to about 5 percent by weight).
Sweeteners
The composition typically further comprises one or more sweeteners. The
sweeteners can be any
sweetener or combination of sweeteners, in natural or artificial form, or as a
combination of natural and
artificial sweeteners. Examples of natural sweeteners include fructose,
sucrose, glucose, maltose, mamiose,
galactose, lactose, stevia, honey, and the like. Examples of artificial
sweeteners include sucra1ose,
isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame and
the like. In some
embodiments, the sweetener comprises one or more sugar alcohols. Sugar
alcohols are polyols derived from
monosaccharides or disaccharides that have a partially or fully hydrogenated
form. Sugar alcohols have, for
example, about 4 to about 20 carbon atoms and include erythritol, arabitol,
ribitol, isomalt, maltitol, dulcitol,
ichtol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g.,
hydrogenated starch hydroly sates).
When present, a representative amount of sweetener may make up from about 0.1
to about 20 percent or
more of the of the composition by weight, for example, from about 0.1 to about
1%, from about 1 to about
5%, from about 5 to about 10%, or from about 10 to about 20% of the
composition on a weight basis, based
on the total weight of the composition.
Binding agents
A 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 composition. 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, A
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binder may be employed in amounts sufficient to provide the desired physical
attributes and physical
integrity to the composition. The amount of binder utilized in the composition
can vary, but is typically up
to about Si) 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 certain embodiments, the binder includes a gum, for example, a natural gum.
As used herein, a
natural gum refers to polysaccharide materials of natural origin that have
binding properties, and which are
also useful as a thickening or gelling agents. Representative natural gums
derived from plants, which are
typically water soluble to some degree, include xanthan gum, guar gum, gum
arabic, ghatti gwn, gum
tragacanth, karaya gum, locust bean gum, gellan gum, and combinations thereof.
When present, natural gum
binder materials are typically present in an amount of up to about 5% by
weight, for example, from about
0.1, 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, or about 5% by weight, based on the total weight of
the composition.
Humectants
In certain embodiments, one or more humectants may be employed in the
composition. Examples
of humectants include, but are not limited to, glycerin, propylene glycol, and
the like. Other examples
include plant-based oils, such as olive oil, almond oil, avocado seed oil,
coconut oil, corn oil, cottonseed oil,
flax seed oil, grapeseed oil, hemp oil, palm kernel oil, peanut oil, pumpkin
seed oil, rice bran oil, safflower
seed oil, sesame seed oil, sunflower seed oil, soybean oil, or walnut oil.
Where included, the humectant is typically provided in an amount sufficient to
provide desired
moisture attributes to the composition. Further, in some instances, the
humectant may impart desirable flow
characteristics to the composition for depositing in a mold.
When present, a humectant will typically make up about 5% or less of the
weight of the composition
(e.g., from about 0.5 to about 5% by weight). When present, a representative
amount of humectant is about
0,1% to about 1% by weight, or about 1% to about 5% by weight, based on the
total weight of the
composition.
Bufferitte agents
In certain embodiments, the composition of the present disclosure can comprise
pH adjusters or
buffering agents. Examples of pH adjusters and buffering agents that can be
used include, but are not
limited to, metal hydroxides (e.g., alkali metal hydroxides such as sodium
hydroxide and potassium
hydroxide), and other alkali metal buffers such as metal carbonates (e.g.,
potassium carbonate or sodium
carbonate), or metal bicarbonates such as sodium bicarbonate, and the like.
Where present, the buffering
agent is typically present in an amount less than about 5 percent based on the
weight of the composition, for
example, from about 0.5% to about 5%, such as, e.g.. from about 0.75% to about
4%, from about 0.75% to
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about 3%, or about 0.5% to about 1.5%, or from about 1% to about 2% by weight,
based on the total weight
of the composition. Non-limiting examples of suitable buffers include alkali
metals acetates, glycinates,
phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates,
borates, or mixtures thereof
Colorants
A colorant may be employed in amounts sufficient to provide the desired
physical attributes to the
composition. Examples of colorants include various dyes and pigments, such as
caramel coloring and
titanium dioxide. The amount of colorant utilized in the composition 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%, to about 3% by weight,
based on the total weight of the composition.
Active ingredient
The composition may additionally include one or more active ingredients
including, but not limited
to, a nicotine component, botanical ingredients (e.g., lavender, peppermint,
chamomile, basil, rosemary,
ginger, cannabis, ginseng, maca, and tisanes), stimulants (e.g., caffeine and
guarana), amino acids (e.g.,
taurine, theartine, phenylalaitiute, tyrosine, and tryptophan) and/or
pharmaceutical, nutraceutical, and
medicinal ingredients (e.g., vitamins, such as B6, B12, and C, and/or
cannabinoids, such as
tetrahydrocannabinol (THC) and cannabidiol (CBD)). The particular percentages
and choice of ingredients
will vary depending upon the desired flavor, texture, and other
characteristics. Example active ingredients
would 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, Of which affect the structure or any
function of the body of humans or
other animals (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 certain embodiments, a nicotine component may be included in the
composition. 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,
nicotine is 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 fonn 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 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 are available from sources such as
Pfaltz and Bauer, Inc. and IC&K
Laboratories, Division of ICN Biochemicals, Inc. Typically, the nicotine
component is selected from the
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group consisting of nicotine free base, a nicotine salt such as hydrochloride,
dihydrochloride, monotarfrate,
bitartrate, sulfate, salicylate, and nicotine zinc chloride. In some
embodiments, the nicotine component or a
protion thereof is a nicotine salt with at least a portion of the one or more
organic acids as disclosed herein
above.
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 polymethacrilic acid, such as Amberlite IRP64,
Purolite C115HMR, or Doshion
P551. See, for example, US Pat. No. 3,901,248 to Lichtneckert et al., which is
incorporated herein by
reference. Another example is a nicotine-polyaciylic carbomer complex, such as
with Carbopol 974P. In
some embodiments, nicotine may be present in the form of a nicotine
polyacrylic 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 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 TA, 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 from about 0.1% w/w
to about 2.5%, from about 0.1% to about 2.0%, from about 0.1% to about 1.5%,
or from about 0.1% to about
1% by weight, calculated as the free base and based on the total weight of the
composition. These ranges can
also apply to other active ingredients noted herein.
Tobacco material
In some embodiments, the composition may include a tobacco material. The
tobacco material can
vary in species, type, and form. Generally, the tobacco material is obtained
from for a harvested plant of the
Nicotiana species. Example Nicotiana species include N. tabacum, N. rustica,
N. alata, N. arentsii, N.
excelsior, N. forgetiana, N. g,lauca, N. glutinosa, N. gossei, N. kawakarnii,
N. knightiana, N. langsdorffi, N.
otophora, 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. phunbaginifolia, N.
raimondii, N. rosulata, N. simulans, N.
stocktonii, N. suaveolens, N. urnbratica, N. velutina, N. wigandioides, N.
acaulis, N. actuninata, N.
attenuata, N. benthamiana, N. cavicola, N. clevelandii, N. cordifolia, N.
corymbosa, N. fragrans, N.
goodspeedii, N. linearis, N. miersii, N. nudicaulis, N. obtusifolia, N.
occidentalis subsp. Hersperis, N.
pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N.
solanifolia, and N. spegazzinii.
Various representative other types of plants from the Nicotiana species are
set forth in Goodspeed, The
Genus Nicotiana, (Chonica Botanica) (1954); US Pat. Nos. 4,660,577 to
Sensabaugh, Jr. et al.; 5,387,416 to
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White et al., 7,025,06610 Lawson et al.; 7,798,153 to Lawrence, Jr. and
8,186,360 to Marshall et al.; 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 Fitzmaurice et at.;
5,668,295 to Wahab et al.; 5,705,624 to Fitimaurice et al.; 5,844,119 to
Weigl; 6,730,832 to Dominguez et
al.; 7,173,170 to Liu et al.; 7,208,659 to Colliver et al_ 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., (alpao 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 a composition
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 composition disclosed herein can include processed
tobacco parts or pieces,
cured and aged tobacco in essentially natural lamina and/or stem form, a
tobacco extract, 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
composition 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 composition may have processed forms, such
as processed tobacco stems
(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 Burde et al.; 5,259,403
to Guy et al.; and 5,908,032 to
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Poindexter, et al.; and 7,556,047 to Poindexter, et al., all of which are
incorporated by reference. In
addition, the d composition 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., shredded,
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 fortn 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 finely divided or powder type
of form may vary.
Preferably, tobacco parts or pieces are comminuted, ground or pulverized into
a powder type of fonn 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 canying 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
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.
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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
composition 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,
Chemistry and Technology, Davis et al. (Eds.) (1999). Examples of techniques
and conditions for curing
flue-cured tobacco are set forth in Nestor et al., Beitrage Tabakforsch. mt.,
20, 467-475 (2003) and US Pat.
No. 6,895,974 to Peele, 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 at.,
Beitrage Tabakforsch. Int, 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.,
1(326), burley, sun-cured (e.g., Indian Kurnool and Oriental tobaccos,
including Katerini, Prelip, Komotini,
Xanthi and Yambol tobaccos), Maryland, dark, dark-fired, dark air cured (e.g.,
Madole, Passanda, Cubano,
Jatin and Bezuki tobaccos), light air cured (e.g., North Wisconsin and Galpao
tobaccos), Indian air cured,
Red Russian and Rust/ca tobaccos, as well as various other rare or specially
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 lamina and stem), and about 30 to about 70 parts
flue cured tobacco (e.g., stem,
lamina, or lamina and stem) on a dry 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 dry 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 dry 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
otherwise subjected to controlled heat treatment. Such treatment processes are
detailed, for example, in US
Pat. No. 8,061,362 to Mua et al., 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, histidime, alanine, methionine, cysteine, glutamic acid,
aspartie acid, proline, phenylalanine,
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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, 8,944,072, and 8,991,403 to Chen et al., 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.
In some embodiments, the type of tobacco material is selected such that it is
initially visually lighter
in color than other tobacco materials to some degree (e.g., whitened or
bleached). Tobacco pulp can be
whitened in certain embodiments according to any means known in the art. For
example, bleached tobacco
material produced by various whitening methods using various bleaching or
oxidizing agents and oxidation
catalysts can be used. Example oxidizing agents include peroxides (e.g.,
hydrogen peroxide), chlorite salts,
chlorate salts, perchlorate salts, hypochlorite salts, ozone, ammonia,
potassium permanganate, and
combinations thereof Example oxidation catalysts are titanium dioxide,
manganese dioxide, and
combinations thereof Processes for treating tobacco with bleaching agents are
discussed, for example, in
US Patent Nos. 787,611 to Daniels, Jr.; 1,086,306 to Oelenheinz; 1,437,095 to
Delling; 1,757,477 to
Rosenhoch; 2,122,421 to Hawkinson; 2,148,147 to Baiter; 2,170,107 to Baier;
2,274,649 to Baler; 2,770,239
to Prats et al.; 3,612,065 to Rosen; 3,851,653 to Rosen; 3,889,689 to Rosen;
3,943,940 to Minami; 3,943,945
to Rosen; 4,143,666 to Rainer; 4,194,514 to Campbell; 4,366,823, 4,366,824,
and 4,388,933 to Rainer et al.;
4,641,667 to Sclunekel et al.; 5,713,376 to Berger; 9,339,058 to Byrd Jr. et
al.; 9,420,825 to Beeson et al.;
and 9,950,858 to Byrd Jr. et al.; as well as in US Pat. App. Pub, Nos.
2012/0067361 to Bjorkholm et al.;
2016/0073686 to Crooks; 2017/0020183 to Bjorkholm; and 2017/0112183 to
Bjorkhohn, and in PCT Publ.
Appl. Nos. W01996/031255 to Giolvas and W02018/083114 to Bjorkhohn, all of
which are incorporated
herein by reference.
In some embodiments, the whitened tobacco material can have an ISO brightness
of at least about
50%, at least about 60%, at least about 65%, at least about 70%, at least
about 75%, or at least about 80%.
In some embodiments, the whitened tobacco material can have an ISO brightness
in the range of about 50%
to about 90%, about 55% to about 75%, or about 60% to about 70%. ISO
brightness can be measured
according to ISO 3688:1999 or ISO 2470-1:2016.
In some embodiments, the whitened tobacco material can be characterized as
lightened in color
(e.g., "whitened") in comparison to an untreated tobacco material. White
colors are often defined with
reference to the International Commission on Illumination's (CIE's)
chromaticity diagram. The whitened
tobacco material can, in certain embodiments, be characterized as closer on
the chromaticity diagram to pure
white than an untreated tobacco material
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In various embodiments, the tobacco material can be treated to extract a
soluble component of the
tobacco material therefrom. "Tobacco extract" as used herein refers to the
isolated components of a tobacco
material that are extracted from solid tobacco pulp by a solvent that is
brought into contact with the tobacco
material in an extraction process. Various extraction techniques of tobacco
materials can be used to provide
a tobacco extract and tobacco solid material. See, for example, the extraction
processes described in US Pat
Appl. Pub. No. 2011/0247640 to Beeson et al., which is incorporated herein by
reference. Other example
techniques for extracting components of tobacco are described in US Pat. 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 at.;
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 Poulcvse et at.; 4,727,889 to Niven, Jr. et al.; 4,887,618 to Bernasek et
al.; 4,941,484 to Clapp et al.;
4,967,771 to Fagg et at.; 4,986,286 to Roberts et al.; 5,005,593 to Fagg et
al.; 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 at.; 5,148,819 to
Fagg; 5,197,494 to Kramer;
5,230,354 to Smith et al.; 5,234,008 to Fagg; 5,243,999 to Smith; 5,301,694 to
Raymond et at.; 5,318,050 to
Gonzalez-Parra et al.; 5,343,879 to Teague; 5,360,022 to Newton; 5,435,325 to
Clapp et al.; 5,445,169 to
Brinkley et at.; 6,131,58410 Lauterbach; 6,298,859 to Kierulff et at.;
6,772,767 to Mua et al.; and 7,337,782
to Thompson, all of which are incorporated by reference herein.
Typical inclusion ranges for tobacco materials can vary depending on the
nature and type of the
tobacco material, and the intended effect on the final composition, with an
example range of up to about
30% by weight (or up to about 20% by weight or up to about 10% by weight or up
to about 5% by weight),
based on total weight of the composition (e.g., about 0.1 to about 15% by
weight). In some embodiments,
the products of the disclosure can be characterized as completely free or
substantially free of tobacco
material (other than purified nicotine as an active ingredient). For example,
certain embodiments can be
characterized as having less than 1% by weight, or less than 0.5% by weight,
or less than 0.1% by weight of
tobacco material, or 0% by weight of tobacco material.
Other additives
Other additives can be included in the disclosed composition. For example, the
composition can be
processed, blended, formulated, combined and/or mixed with other materials or
ingredients. The additives
can be artificial, or can be obtained or derived from herbal or biological
sources. Examples of further types
of additives 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,
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 at., 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
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incorporated herein by reference. Typical inclusion ranges for such additional
additives can vary depending
on the nature and function of the additive and the intended effect on the
final composition, with an example
range of up to about 10% by weight, based on total weight of the composition
(e.g., about 0.1 to about 5%
by weight or about 0.5% to about 1.5%).
The aforementioned 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 composition). Furthermore, the aforementioned types of additives
may be encapsulated as
provided in the final product or composition. Exemplary encapsulated additives
are described, for example,
in W02010/132444 to Atchley, which has been previously incorporated by
reference herein.
In some embodiments, any one or more of a filler, a tobacco material, and the
overall oral product
described herein can be described as a particulate material. As used herein,
the term "particulate" refers to a
material in the form of a plurality of individual particles, some of which can
be in the form of an
agglomerate of multiple particles, wherein the particles have an average
length to width ratio less than 2:1,
such as less than 1.5:1, such as about 1:1. In various embodiments, the
particles of a particulate material can
be described as substantially spherical or granular.
The particle size of a particulate material may be measured by sieve analysis.
As the skilled person
will readily appreciate, sieve analysis (otherwise known as a gradation test)
is a method used to measure the
particle size distribution of a particulate material. Typically, sieve
analysis involves a nested column of
sieves which comprise screens, preferably in the form of wire mesh cloths. A
pre-weighed sample may be
introduced into the top or uppermost sieve in the column, which has the
largest screen openings or mesh size
(i.e. the largest pore diameter of the sieve). Each lower sieve in the column
has progressively smaller screen
openings or mesh sizes than the sieve above. Typically, at the base of the
column of sieves is a receiver
portion to collect any particles having a particle size smaller than the
screen opening size or mesh size of the
bottom or lowermost sieve in the column (which has the smallest screen opening
or mesh size).
In some embodiments, the column of sieves may be placed on or in a mechanical
agitator. The
agitator causes the vibration of each of the sieves in the column. The
mechanical agitator may be activated
for a pre-determined period of time in order to ensure that all particles are
collected in the correct sieve. In
some embodiments, the column of sieves is agitated for a period of time from
0.5 minutes to 10 minutes,
such as from 1 minute to 10 minutes, such as from 1 minute to 5 minutes, such
as for approximately 3
minutes. Once the agitation of the sieves in the column is complete, the
material collected on each sieve is
weighed. The weight of each sample on each sieve may then be divided by the
total weight in order to
obtain a percentage of the mass retained on each sieve. As the skilled person
will readily appreciate, the
screen opening sizes or mesh sizes for each sieve in the column used for sieve
analysis may be selected
based on the granularity or known maximum/minimtun particle sizes of the
sample to be analysed. In some
embodiments, a column of sieves may be used for sieve analysis, wherein the
column comprises from 2 to
20 sieves, such as from 5 to 15 sieves. In some embodiments, a column of
sieves may be used for sieve
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analysis, wherein the coluinn comprises 10 sieves. In some embodiments, the
largest screen opening or
mesh sizes of the sieves used for sieve analysis may be 1000 pin, such as 500
pm, such as 400 pm, such as
300 gm.
In some embodiments, any particulate material referenced herein (e.g., filler
component, tobacco
material, and the overall oral product) can be characterized as having at
least 50% by weight of particles
with a particle size as measured by sieve analysis of no greater than about
1000 pm, such as no greater than
about 500 gm, such as no greater than about 400 pm, such as no greater than
about 350 gm, such as no
greater than about 300 pm. In some embodiments, at least 60% by weight of the
particles of any particulate
material referenced herein have a particle size as measured by sieve analysis
of no greater than about 1000
pm, such as no greater than about 500 pm, such as no greater than about 400
pm, such as no greater than
about 350 pm, such as no greater than about 300 gm. In some embodiments, at
least 70% by weight of the
particles of any particulate material referenced herein have a particle size
as measured by sieve analysis of
no greater than about 1000 iun, such as no greater than about 500 pm, such as
no greater than about 400 iun,
such as no greater titan about 350 pm, such as no greater than about 300 pm.
In some embodiments, at least
80% by weight of the particles of any particulate material referenced herein
have a particle size as measured
by sieve analysis of no greater than about 1000 gm, such as no greater than
about 500 pm, such as no greater
than about 400 pm, such as no greater than about 350 gm, such as no greater
than about 300 gm. In some
embodiments, at least 90% by weight of the particles of any particulate
material referenced herein have a
particle size as measured by sieve analysis of no greater than about 1000 pm,
such as no greater than about
500 pm, such as no greater than about 400 pm, such as no greater than about
350 gm, such as no greater
than about 300 gm. In some embodiments, at least 95% by weight of the
particles of any particulate material
referenced herein have a particle size as measured by sieve analysis of no
greater than about 1000 gm, such
as no greater than about 500 pm, such as no greater than about 400 pm, such as
no greater than about 350
pm, such as no greater than about 300 pm. In some embodiments, at least 99% by
weight of the particles of
any particulate material referenced herein have a particle size as measured by
sieve analysis of no greater
than about 1000 fun, such as no greater than about 500 gm, such as no greater
than about 400 pm, such as
no greater than about 350 gm, such as no greater than about 300 pm. In some
embodiments, approximately
100% by weight of the particles of any particulate material referenced herein
have a particle size as
measured by sieve analysis of no greater than about 1000 pm, such as no
greater than about 500 inn, such as
no greater than about 400 pm, such as no greater than about 350 pm, such as no
greater than about 300 pm.
In some embodiments, at least 50% by weight, such as at least 60% by weight,
such as at least 70%
by weight, such as at least 80% by weight, such as at least 90% by weight,
such as at least 95% by weight
such as at least 99% by weight of the particles of any particulate material
referenced herein have a particle
size as measured by sieve analysis of from about 0.01 pm to about 1000 pm,
such as from about 0.05 pin to
about 750 pm, such as from about 0.1 pm to about 500 gm, such as from about
0.25 pm to about 500 pm. In
some embodiments, at least 50% by weight, such as at least 60% by weight, such
as at least 70% by weight,
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such as at least 80% by weight, such as at least 90% by weight, such as at
least 95% by weight, such as at
least 99% by weight of the particles of any particulate material referenced
herein have a particle size as
measured by sieve analysis of from about 10 gm to about 400 gm, such as from
about 50 gm to about 350
gm, such as from about 100 gm to about 350 gm, such as from about 200 gm to
about 300 tun.
Preparation of the composition
The manner by which the various components of the composition are combined may
vary. In
certain embodiments, various combinations of dry ingredients, typically
including the filler component, will
be blended to form a dry mix. Thereafter, typically in multiple steps, the
remaining liquid ingredients are
added to the dry mix to prepare the fmal product mixture. In certain
embodiments, the active ingredient
(e.g., nicotine) is mixed with a humectant (e.g., propylene glycol or olive
oil) to form a premix before adding
to the remainder of the composition, such as the dry mix containing a filler.
The use of a mixture of certain
active ingredients, such as nicotine, with a humectant can reduce mouth or
throat irritation associated with
oral use of the resulting product. If one or more capsules are included in the
composition, the capsules can
be added at various stages, such as addition to the dry mix or addition to the
product composition
immediately before fmal packaging (e.g., pouching) or after placement of the
composition in a pouch (but
before pouch sealing).
In certain embodiments, mixing efficiency and/or uniformity of the product can
be enhanced by
using multiple, successive addition steps in the process to add liquid
components (e.g., aqueous solutions or
dispersions) to the dry mix. By separating the liquid components into multiple
addition steps, smaller
amounts of each liquid composition are intimately mixed with the dry
ingredients, which can result in
improved mixing characteristics. Improved mixing efficiency and/or product
uniformity can also be
provided, in certain embodiments, through use of aqueous compositions at
elevated temperature, such as
between about 50 to about 100 C, including about 55 to about 80 C or about 60
to about 70 C.
In some embodiments, aqueous compositions used in the process are maintained
at room
temperature or below, such as between about 10 to about 25 C, including about
20 to about 25 C (room
temperature). Surprisingly, in certain embodiments, use of lower aqueous
composition temperatures during
mixing does not cause significant loss in product uniformity or mixing
efficiency, and can reduce overall
process cost, particularly where room temperature water is used.
Still further, in certain embodiments, a large percentage of the total amount
of water used in the
product is added in a fmal water addition step, particularly after active
ingredients and/or flavoring agents
are added. This type of process is particularly well-suited for use with lower
temperature water as noted
above. Surprisingly, applying a large percentage of the total amount of water
after addition of all, or
virtually all, other ingredients does not cause significant loss in product
uniformity or mixing efficiency, and
can provide the added benefit of removing residual active ingredient and/or
flavoring agent from the pipes in
the mixing system without the need for a separate rinsing step that could lead
to an undesirable increase in
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water use or loss in process efficiency. In certain embodiments, the amount of
water added in the final water
addition step is at least about 50% by weight of the total water content of
the product mixture (such as at
least about 60% or at least about 65% or at least about 70% or at least about
75% or at least about 80% or at
least about 85% or at least about 90%).
The various components of the composition may be contacted, combined, or mixed
together using
any mixing technique or equipment known in the art. Any mixing method that
brings the mixture
ingredients into intimate contact can be used, such as a mixing apparatus
featuring an impeller or other
structure capable of agitation. Examples of mixing equipment include casing
drums, conditioning cylinders
or drums, liquid spray apparatus, conical-type blenders, ribbon blenders,
mixers available as FKM130,
FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day, Inc., Plough Share
types of mixer
cylinders, Hobart mixers, and the like. See, for example, the types of
methodologies set forth in US Pat. No.
4,148,325 to Solomon et al.; US Pat. No. 6,510,855 to Korte et al.; and US
Pat. No. 6,834,654 to Williams,
US Pat. Nos. 4,725,440 to Ridgway et al., and 6,077,524 to Bolder et al., each
of which is incorporated
herein by reference.
Certain active ingredients, such as nicotine, present safety and handling
challenges. Accordingly,
the present disclosure includes a dosing system that reduces the time spent
handling active ingredients. An
embodiment of the dosing system 20 is shown in Fig. 3. As shown, the system
includes a storage tank 22
for the active ingredient, the storage tank in fluid communication with a
dosing tank 30. In certain
embodiments, the storage tank 22 can also be in fluid communication with an
inert gas container 26
containing an inert gas such as nitrogen, which enables the creation of an
inert gas blanket 24 in the
headspace over the active ingredient stored in the storage tank 22.
A pump 28 is used to transport the liquid active ingredient from the storage
tank 22 to the dosing
tank 30. One or more additional storage tanks are advantageously in fluid
communication with the dosing
tank 30, such as a storage tank 32 for a flavoring agent and a storage tank 34
for a humectant. In this
manner, additional components of a composition can be premixed with the active
ingredient in the dosing
tank 30. From the dosing tank 30, the active ingredient (optionally premixed
with additional components)
can be transported to one or more mixing tanks 36, which contain additional
components of the desired
composition, such as a dry mix as described above.
Configured for oral use
Provided herein is a product configured for oral use. 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 composition (e.g., flavoring
agents and/or nicotine) to pass into
the mouth of the user. In certain embodiments, the product is adapted to
deliver components to a user
through mucous membranes in the user's mouth and, in some instances, said
component is an active
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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.
Products configured for oral use as described herein may take various forms,
including gels,
pastilles, gums, lozenges, powders, and pouches. Gels can be soft or hard.
Certain products configured for
oral use are in the form of pastilles. As used herein, the term "pastille"
refers to a dissolvable oral product
made by solidifying a liquid or gel composition so that the fmal product is a
somewhat hardened solid gel.
The rigidity of the gel is highly variable. Certain products of the disclosure
are in the form of solids.
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 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
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 compositions typically
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 composition.
In some embodiments, the product can be meltable as discussed, for example, in
US Patent App. Pub. No.
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 one embodiment, the product comprising the composition of the present
disclosure is in the form
of a composition disposed within a moisture-pertneable container (e.g., a
water-permeable pouch). Such
compositions in the water-permeable pouch format are typically used by placing
one pouch containing the
composition in the mouth of a human subject/user. Generally, the pouch is
placed somewhere in the oral
cavity of the user, for example under the lips, in the same way as moist snuff
products are generally used.
The pouch preferably is not chewed or swallowed. Exposure to saliva then
causes some of the components
of the composition therein (e.g., flavoring agents and/or nicotine) to pass
through e.g., the water-permeable
pouch and provide the user with flavor and satisfaction, and the user is not
required to spit out any portion of
the composition. After about 10 minutes to about 60 minutes, typically about
15 minutes to about 45
minutes, of use/enjoyment, substantial amounts of the composition have been
absorbed (via either gingival
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or buccal absorption) by the human subject, and the pouch may be removed from
the mouth of the human
subject for disposal.
Accordingly, in certain embodiments, the composition as disclosed herein and
any other components
noted above are combined within a moisture-permeable packet or pouch that acts
as a container for use of
the composition to provide a pouched product configured for oral use. Certain
embodiments of the
disclosure will be described with reference to Fig. 1 of the accompanying
drawings, and these described
embodiments involve snus-type products having an outer pouch and containing a
composition as described
herein. As explained in greater detail below, such embodiments are provided by
way of example only, and
the pouched products of the present disclosure can include the composition in
other forms.
The composition/construction of such packets or pouches, such as the container
pouch 12 in the
embodiment illustrated in Fig. 1, may be varied. Referring to Fig. 1, there is
shown a first embodiment of a
pouched product 10. The pouched product 10 includes a moisture-permeable
container in the form of a
pouch 12, which contains a composition 14 as described herein. The pouched
product 10 optionally includes
one or more capsules 16 dispersed within the composition 14, the capsules
containing an additive (e.g., a
flavoring agent) such as described in greater detail below.
Suitable packets, pouches or containers of the type used for the manufacture
of smokeless tobacco
products are available under the tradenames CatchDry, Ettan, General, Granit,
Goteborgs Rape, Grovsnus
White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks,
Probe, Prince, Skruf and
TreAnkrare. The composition may be contained in pouches and packaged, in a
manner and using the types
of components used for the manufacture of conventional snus types of products.
The pouch provides a
liquid-permeable container of a type that may be considered to be similar in
character to the mesh-like type
of material that is used for the construction of a tea bag. Components of the
composition readily diffuse
through the pouch and into the mouth of the user.
Non-limiting examples of suitable types of pouches are set forth in, for
example, US Pat. Nos.
5,167,244 to Kjerstad and 8,931,493 to Sebastian et al.; as well as US Patent
App. Pub. Nos. 2016/0000140
to Sebastian et al.; 2016/0073689 to Sebastian et al.; 2016/0157515 to Chapman
et al.; and 2016/0192703 to
Sebastian et al., each of which are incorporated herein by reference. Pouches
can be provided as individual
pouches, or a plurality of pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30
pouches) can be connected or linked
together (e.g., in an end-to-end manner) such that a single pouch or
individual portion can be readily
removed for use from a one-piece strand or matrix of pouches.
An example pouch may be manufactured from materials, and in such a manner,
such that during use
by the user, the pouch undergoes a controlled dispersion or dissolution. Such
pouch materials may have the
form of a mesh, screen, perforated paper, permeable fabric, or the like. For
example, pouch material
manufactured from a mesh-like form of rice paper, or perforated rice paper,
may dissolve in the mouth of the
user. As a result, the pouch and composition each may undergo complete
dispersion within the mouth of the
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user during normal conditions of use, and hence the pouch and composition both
may be ingested or
absorbed by the user. Other examples of pouch materials may be manufactured
using water dispersible film
forming materials (e.g., binding agents such as alginates,
carboxymethylcellulose, xanthan gum, pullulan,
and the like), as well as those materials in combination with materials such
as ground cellulosics (e.g., fme
particle size wood pulp). Preferred pouch materials, though water dispersible
or dissolvable, may be
designed and manufactured such that under conditions of normal use, a
significant amount of the
composition contents permeate through the pouch material prior to the time
that the pouch undergoes loss of
its physical integrity. If desired, flavoring ingredients, disintegration
aids, and other desired components,
may be incorporated within, or applied to, the pouch material.
The amount of material contained within each product unit, for example, a
pouch, may vary. In
some embodiments, the weight of the composition within each pouch is at least
about 50 mg, for example,
from about 50 mg to about 1 gram, from about 100 to 800 about mg, or from
about 200 to about 700 mg. In
some smaller embodiments, the weight of the composition within each pouch may
be from about 100 to
about 300 mg. For a larger embodiment, the weight of the material within each
pouch may be from about
300 mg to about 700 mg.
If desired, other components can be contained within each pouch. For example,
at least one flavored
strip, piece or sheet of flavored water dispersible or water soluble material
(e.g., a breath-freshening edible
film type of material) may be disposed within each pouch along with or without
at least one capsule. Such
strips or sheets may be folded or crumpled in order to be readily incorporated
within the pouch. See, for
example, the types of materials and technologies set forth in US Pat. Nos.
6,887,307 to Scott et al. and
6,923,981 to Leung et al.; and The EFSA Journal (2004) 85, 1-32; which are
incorporated herein by
reference.
As noted above, in some embodiments, any of the types of composition
components described
above can be added in an encapsulated form (e.g., in the form of capsules
including microcapsules), the
encapsulated form including a wall or barrier structure defining an inner
region and isolating the inner region
permanently or temporarily from the remainder of the product composition. The
inner region includes a
payload of an additive either adapted for enhancing one or more sensory
characteristics of the product, such
as taste, mouthfeel, moistness, coolness/heat, and/or fragrance, or adapted
for adding an additional
functional quality to the product, such as addition of an antioxidant or
immune system enhancing function.
See, for example, the subject matter of US Pat. Appl. Pub, No. 2009/0025738 to
Mua et al., which is
incorporated herein by reference.
The use of a capsule physically separates or segregates, to a certain extent,
an additive from one or
more other components of the product. The functional advantage of such a
separation can vary, but typically
involves the minimization or elimination of chemical interaction between the
additive and other components
of the product during conditions of normal storage and/or use. Separation of
certain additives can thus
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enhance storage stability of the resulting product and/or preserve the
desirable sensory characteristics of the
product.
The outer shell of the capsule serves as a bather between the payload (i.e.,
the additive) and the
remainder of the composition of the product. The additive in the core region
of the capsule is released under
certain conditions of product use. For instance, the outer shell may undergo
some type of physical
destruction, breakage, or other loss of physical integrity (e.g., through
disintegration, softening, crushing,
application of pressure, or the like) in response to a trigger condition
associated with the product. Such a
release of the additive may alter or enhance the flavor or other sensory
characteristics of the product, extend
the period of time that a user may enjoy the product, or provide other
functional advantages. The trigger
conditions associated with release of the additive may vary, and can include
for example, a change in
temperature or pH of the product, contact with a digestive enzyme, or physical
rupture or breakage caused,
for example, by chewing action of the product user.
In some embodiments, contact of the capsule with the raised temperature of the
user's mouth (e.g.,
the user's saliva) may cause the capsule to soften, lose its physical
integrity, and release the additive within
the user's mouth (e.g., at a temperature of about 37 C or higher). In some
embodiments, the capsule is
configured to release the additive in response to a change in pH, such as a
capsule configured to release the
additive when the pH of the capsule is at or near (e.g., greater than) a pH
typical of a user's mouth (e.g.,
approximately 5.6 to 7.9). Still further, in certain embodiments, the capsule
is configured to release the
additive in response to a digestive enzyme typically found in the mouth of a
user (e.g., amylase).
The capsules may be uniform or varied in size, weight, and shape, and such
properties of the
capsules will depend upon the desired properties of the product. The capsules
may be of various shape,
including being generally spherical, rectilinear, oblong, elliptical, or oval.
The size of the capsules can vary,
and will include diameter ranges such as about 0.5 to about 5 mm, as well as
microcapsule size ranges such
as diameters of less than about 100 microns, such as diameters in the range of
about 1 to about 40 microns,
or about 1 micron to about 20 microns. The total weight of the capsules within
the product may vary, but is
typically between about 10 mg to about 200 mg, such as about 20 mg to about 50
mg.
The number of the capsules utilized in each product can vary, depending upon
factors such as the
size of the capsules, the character or nature of the additive in the payload,
the desired attributes of the
product, and the like. The number of capsules will typically range from 1 to
about 500, more typically about
5 to about 100.
The outer wall or shell material used to form the capsules can vary. Classes
of materials that are
typically used as wall or shell materials include proteins, polysaccharides,
starches, waxes, fats, natural and
synthetic polymers, and resins, Example materials include gelatin, natural
gums, polyvinyl acetate,
potassium or sodium alginate, carrageenan, dextrin, polyvinyl alcohol,
povidone, dimethylpolysiloxane,
paraffm wax, shellac, cellulose derivatives (e.g., ethylcellulose,
carboxymethylcellulose, hydroxypropyl
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cellulose, hydroxypropyhnethylcellulose, methylcellulose, methyl ethyl
cellulose), microaystalline wax,
terpene resin, tragacanth, polyethylene, and polyethylene glycol.
In certain embodiments, the capsule may include an additional outer coating on
the outer shell, such
as a coating adapted to increase water resistance. Example coating materials
include various polymer
materials, such as cellulose derivatives (e.g., HPMC), polyvinyl alcohol, and
aciylate or methacrylate
polymers.
A pouched product as described herein can be packaged within any suitable
inner packaging
material and/or outer container. See also, 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 al.; 7,584,843
to Kutsch et al.; 8,397,945 to Gelardi et al., 13592,956 to Thiellier;
D594,154 to Patel et al.; and D625,178 to
Bailey et al.; US Pat. Pub. Nos. 2008/0173317 to Robinson et al.; 2009/0014343
to Clark et al.;
2009/0014450 to Bjorkhohn; 2009/0250360 to Bellamah et al.; 2009/0266837 to
Gelardi et at.;
2009/0223989 to Gelardi; 2009/0230003 to Thiellier; 2010/0084424 to Gelardi;
and 2010/0133140 to Bailey
et al; 2010/0264157 to Bailey et al.; and 2011/0168712 to Bailey et al. which
are incorporated herein by
reference.
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, it is 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.
EXPERIMENTAL
Aspects of the present invention are more fidly illustrated by the following
examples, which are set
forth to illustrate certain aspects of the present invention and are not to be
construed as limiting thereof
Example 1
An oral composition comprising the ingredients set forth in Table 1 below is
prepared. The actual
ingredient percentages can be varied depending the desired final product.
Table 1
Ingredient
% by weight
range
Water
40-55
Microcrystalline cellulose (MCC)
40-50
Sodium chloride
2-6
Xy
2-6
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Ingredient
% by weight
range
Nicotine
0.5-1.5
Propylene glycol
0,5-6
Sodium alginate
0.5-1.5
Flavoring agent
0.5-1.5
Sodium bicarbonate
0.5-1.5
Artificial sweetener
0.5-1.5
Potassium sorbate
0.5-1.5
The composition is prepared using the following method:
1. The MCC, sodium alginate, and sodium chloride are put into a paddle blender
and blended to form a
dry mix.
2. In a separate container, sodium bicarbonate is mixed with about half of the
total water to be used in
the recipe (e.g., water at an elevated temperature of about 65 C). The
mixture is stirred until the
soditun bicarbonate fully dissolves to form an aqueous solution.
3. The sodium bicarbonate solution is then sprayed from a pressure vessel on
the dry mix in the
blender and the resulting mixture is blended for about 5 minutes.
4. In a separate container, xylitol, ammonium chloride as a pH adjuster,
potassium sorbate as a
preservative, and an artificial sweetener (e.g., sucralose or acesulfame K)
are mixed with about two-
thirds of the remaining water (e.g., water at an elevated temperature of about
65 C) and stirred until
dissolved to form an aqueous solution.
5. In a separate container, a flavoring agent, propylene glycol, and
nicotine are mixed together and then
added to the solution of Step 4.
6. The mixture of Step 5 is then sprayed from a pressure vessel on the mixture
from Step 3 in the
blender, and the resulting mixture is blended for about 10 minutes.
7. In a separate container, xylitol, ammonium chloride as a pH adjuster,
potassium sorbate as a
preservative, and an artificial sweetener (e.g., sucralose or acesulfame K)
are mixed with the
remaining one-third of water (e.g., water at an elevated temperature of about
65 C) and stirred until
dissolved to form an aqueous solution.
8. The mixture of Step 7 is then sprayed from a pressure vessel on the mixture
from Step 6 in the
blender, and the resulting mixture is blended for about 10 minutes.
9. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
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Example 2
An oral composition comprising the ingredients set forth in Table 2 below is
prepared. The actual
ingredient percentages can be varied depending the desired final product.
Table 2
Ingredient
% by weight
range
Water
40-55
Microcrystalline cellulose (MCC)
40-50
Sodium chloride
2-6
Xylitol
2-6
Nicotine
0.5-1.5
Bleached tobacco
0.5-5
Sodium alginate
0.5-1.5
Flavoring agent
0.5-1.5
Sodium bicarbonate
0,5-1.5
Artificial sweetener
0.5-1.5
Potassium sorbate
0.5-1.5
The composition is prepared using the following method:
1. The MCC, sodium alginate, bleached tobacco, and sodium chloride are put
into a paddle blender and
blended to form a dry mix.
2. In a separate container, sodium bicarbonate is mixed with about half of the
total water to be used in
the recipe (e.g., water at an elevated temperature of about 65 C). The
mixture is stirred until the
sodium bicarbonate fully dissolves to form an aqueous solution.
3. The sodium bicarbonate solution is then sprayed from a pressure vessel on
the dry mix in the
blender and the resulting mixture is blended for about 5 minutes.
4. In a separate container, xylitol, ammonium chloride as a pH adjuster,
potassium sorbate as a
preservative, and an artificial sweetener (e.g., sucralose or acesulfame K)
are mixed with about two-
thirds of the remaining water (e.g., water at an elevated temperature of about
65 C) and stirred until
dissolved to form an aqueous solution.
5. A flavoring agent and nicotine are added to the
solution of Step 4.
6. The mixture of Step 5 is then sprayed from a pressure vessel on the mixture
from Step 3 in the
blender, and the resulting mixture is blended for about 10 minutes.
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7. In a separate container, xylitol, ammonium chloride as a pH adjuster,
potassium sorbate as a
preservative, and an artificial sweetener (e.g., sucralose or acesulfame K)
are mixed with the
remaining one-third of water (e.g., water at an elevated temperature of about
65 C) and stirred until
dissolved to form an aqueous solution.
8. The mixture of Step 7 is then sprayed from a pressure vessel on the mixture
from Step 6 in the
blender, and the resulting mixture is blended for about 10 minutes.
9. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
Example 3
An oral composition comprising the ingredients set forth in Table 3 below is
prepared. The actual
ingredient percentages can be varied depending the desired final product.
Table 3
Ingredient
% by weight
range
Water
40-55
Microcrystalline cellulose (MCC)
40-50
Sodium chloride
2-6
Xy litol
2-6
Guar gum
2-6
Nicotine
0.543
Bleached tobacco
0.5-5
Sodium alginate
0.5-1.5
Flavoring agent
0.5-1.5
Sodium bicarbonate
0.5-1.5
Artificial sweetener
0.5-1.5
Potassium sorbate
0.5-1.5
The composition is prepared using the following method:
1, The MCC, sodium alginate, bleached tobacco, guar gum, and sodium chloride
are put into a paddle
blender and blended to form a dry mix.
1 In a separate container, sodium bicarbonate is mixed
with about half of the total water to be used in
the recipe (e.g., water at an elevated temperature of about 65 C). The
mixture is stirred until the
sodium bicarbonate fully dissolves to form an aqueous solution.
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3. The sodium bicarbonate solution is then sprayed from a pressure vessel on
the thy mix in the
blender and the resulting mixture is blended for about 5 minutes.
4. In a separate container, xylitol, ammonium chloride as a pH adjuster,
potassium sorbate as a
preservative, and an artificial sweetener (e.g., sucralose or acesulfame K)
are mixed with the
remaining water (e.g., water at an elevated temperature of about 65 C) and
stirred until dissolved to
form an aqueous solution.
5. A flavoring agent and nicotine are added to the solution of Step 4.
6. The mixture of Step 5 is then sprayed from a pressure vessel on the mixture
from Step 3 in the
blender, and the resulting mixture is blended for about 10 minutes.
7. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
Example 4
An oral composition comprising the ingredients set forth in Table 4 below is
prepared. The actual
ingredient percentages can be varied depending the desired fmal product.
Table 4
Ingredient
% by weight
range
Water
40-55
Microcrystalline cellulose (MCC)
40-50
Sodium chloride
2-6
Xylitol
2-6
Cruar gum
2-6
Nicotine
0.5-1.5
Bleached tobacco
0.5-5
Sodium alginate
0.5-1.5
Flavoring agent
0.5-1.5
Sodium bicarbonate
0.5-1.5
Artificial sweetener
0.5-1.5
Potassium sorbate
0.5-1.5
The composition is prepared using the following method:
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1. The MCC, bleached tobacco, guar gum, artificial sweetener (e.g., sticralose
or acesulfame K),
sodium bicarbonate, potassium sorbate, and sodium chloride are put into a
paddle blender and
blended to form a dry mix.
2. In a separate container, sodium alginate is mixed with water (e.g., water
at an elevated temperature
of about 65 C). The mixture is stirred until the sodium alginate fully
dissolves to form an aqueous
solution. Xylitol is then added and mixed until dissolved.
3. The solution from Step 2 is then sprayed from a pressure vessel on the dry
mix in the blender and
the resulting mixture is blended for about 5 minutes.
4. In a separate container, a flavoring agent and nicotine are mixed.
5. The mixture of Step 4 is then sprayed from a pressure vessel on the mixture
from Step 3 in the
blender, and the resulting mixture is blended for about 10 minutes.
6. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
Example 5
An oral composition comprising the ingredients set forth in Example 1 is
prepared using the
following method:
1. The MCC, sodium chloride, xylitol, sodium alginate, sodium bicarbonate,
artificial sweetener, and
potassium sorbate are put into a paddle blender and blended to form a dry mix.
2. A nicotine solution is mixed with propylene glycol and then sprayed from a
pressure vessel on the
dry mix in the blender and the resulting mixture is blended for about 5
minutes.
3. A flavoring agent is then sprayed from a pressure vessel on the mixture in
the blender and the
resulting mixture is blended for about 5 minutes.
4. All water used in the composition is then sprayed from a pressure vessel on
the mixture in the
blender and the resulting mixture is blended for about 10 minutes. The water
is not heated, and is
typically at room temperature or below.
5. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
Example 6
An oral composition comprising the ingredients set forth in Example 2 is
prepared using the
following method:
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1. The MCC, sodium chloride, xylitol, bleached tobacco, sodium alginate,
sodium bicarbonate,
artificial sweetener, and potassium sorlbate are put into a paddle blender and
blended to form a dry
mix.
2. A nicotine solution is then sprayed from a pressure vessel on the dry mix
in the blender and the
resulting mixture is blended for about 5 minutes.
3. A flavoring agent is then sprayed from a pressure vessel on the mixture in
the blender and the
resulting mixture is blended for about 5 minutes.
4. All remaining water used in the composition is then sprayed from a pressure
vessel on the mixture in
the blender and the resulting mixture is blended for about 10 minutes. The
water is not heated, and
is typically at room temperature or below.
5. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
Example 7
An oral composition comprising the ingredients set forth in Example 3 is
prepared using the
following method:
1. The MCC, sodium chloride, xylitol, guar gum, bleached tobacco, sodium
alginate, sodium
bicarbonate, artificial sweetener, and potassium sorbate are put into a paddle
blender and blended to
form a dry mix.
2. A nicotine solution is then sprayed from a pressure vessel on the dry mix
in the blender and the
resulting mixture is blended for about 5 minutes.
3. A flavoring agent is then sprayed from a pressure vessel on the mixture in
the blender and the
resulting mixture is blended for about 5 minutes.
4. All remaining water used in the composition is then sprayed from a pressure
vessel on the mixture in
the blender and the resulting mixture is blended for about 10 minutes. The
water is not heated, and
is typically at room temperature or below.
5. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
Example 8
An oral composition comprising the ingredients set forth in Example 4 is
prepared using the
following method:
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1. The MCC, sodium chloride, xylitol, guar gum, bleached tobacco, sodium
alginate, sodium
bicarbonate, artificial sweetener, and potassium sorbate are put into a paddle
blender and blended to
fonn a dry mix.
2. A nicotine solution is mixed with propylene glycol and then sprayed from a
pressure vessel on the
dry mix in the blender and the resulting mixture is blended for about 5
minutes.
3. A flavoring agent is then sprayed from a pressure vessel on the mixture in
the blender and the
resulting mixture is blended for about 5 minutes.
4. All remaining water used in the composition is then sprayed from a pressure
vessel on the mixture in
the blender and the resulting mixture is blended for about 10 minutes. The
water is not heated, and
is typically at room temperature or below.
5. The resulting mixture is then removed from the blender and placed into
storage containers for future
pouching.
Example 9: Irritation Reduction
Pouched product samples were made containing the same amounts of
microaystalline cellulose,
sodium chloride, alginate, and acesulfame K. Three sets of samples were
prepared using this same base
formulation, including: (1) pouches with 4 mg nicotine and 4 mg propylene
glycol (PG) added; (2) pouches
with 4 mg nicotine and 4 mg olive oil added; and (3) pouches with 4 mg
nicotine only added (no propylene
glycol or olive oil).
The sensory evaluation was conducted by requesting panelists to choose the
most irritating and the
least irritating sample. The collected data was used to generate the data
presented in Fig. 2. The trend line
indicates that there is lower irritation level for the samples containing
either propylene glycol or olive oil.
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