Note: Descriptions are shown in the official language in which they were submitted.
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ORAL PRODUCT WITH MULTIPLE FLAVORS HAVING DIFFERENT RELEASE PROFILES
FIELD OF THE DISCLOSURE
The present disclosure relates to flavored products intended for human use.
The products are
configured for oral use and deliver substances such as flavors and/or active
ingredients during use. Such
products may include tobacco or a product derived from tobacco, or may be
tobacco-free alternatives.
BACKGROUND
Tobacco may be enjoyed in a so-called "smokeless" form. Particularly popular
smokeless tobacco
products are employed by inserting some form of processed tobacco or tobacco-
containing formulation into
the mouth of the user. Conventional formats for such smokeless tobacco
products include moist snuff, snus,
and chewing tobacco, which are typically formed almost entirely of
particulate, granular, or shredded tobacco,
and which are either portioned by the user or presented to the user in
individual portions, such as in single-use
pouches or sachets. Other traditional fonus 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
Stoty 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 al.; 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 al.; 2008/0173317 to
Robinson et al.;
2008/0209586 to Neilsen et al.; 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 Mita 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
organoleptic characteristics.
BRIEF SUMMARY
The present disclosure generally provides products and compositions configured
for oral use. The
products may be configured to impart a taste when used orally and,
additionally or alternatively, may deliver
active ingredients to a consumer, such as nicotine. The products and methods
of the present disclosure in
particular may be adapted or configured to provide one or more materials to a
consumer at a controlled release
rate, such as a sustained release.
In a first aspect is provided an oral composition comprising: a first content
of a flavor component; and
a second content of a flavor component; wherein the first content of the
flavor component is configured for
release from the oral composition according to a first release rate and the
second content of the flavor
component is configured for release from the oral composition according to a
second release rate that is
different from the first release rate.
In some embodiments, the first content of the flavor component and the second
content of the flavor
component each comprise the same flavor component. In some embodiments, the
first content of the flavor
component and the second content of the flavor component each comprise a
different flavor component.
In some embodiments, the composition further comprises one or more active
ingredients.
In some embodiments, the one or more active ingredients are selected from a
group consisting of a
nicotine component, botanicals, stimulants, amino acids, vitamins,
cannabinoids, cannabimimetics, terpenes,
nutraceuticals, and a combination thereof.
In some embodiments, the first content of the flavor component and the second
content of the flavor
component independently comprise a compound having a carbon-carbon double
bond, a carbon-oxygen
double bond, or both.
In some embodiments, the first content of the flavor component and the second
content of the flavor
component independently comprise one or more of ethyl vanillin, ci nna ma
ldehyde, sabi ne ne, linionene,
gamma-terpinene, beta-famesene, and citral.
In some embodiments, at least a portion of the first content of the flavor
component is in the form of
spray -dried particles. In some embodiments, the spray-dried particles are in
admixture with a content of a
filler. In some embodiments, the filler comprises a long-chain carbohydrate.
In some embodiments, the long-
chain carbohydrate is a starch.
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In some embodiments, the first content of the flavor component comprises the
flavor component on a
first carrier component that is substantially insoluble in saliva, and the
second content of the flavor component
comprises the flavor component on a second carrier component that is
substantially soluble in saliva.
In some embodiments, the first content of the flavor component comprises a
flavor component that is
soluble in an aqueous solvent. In some embodiments, the second content of the
flavor component comprises
a flavor component that is soluble in an alcohol-based solvent.
In some embodiments, the first content of the flavor component is at least
partially present in the oral
composition in a liquid form, and wherein the second content of the flavor
component is at least partially
present in the oral composition in the form of spray-dried particles.
In some embodiments, at least a portion of the first content of the flavor
component is absorbed or
adsorbed on a carrier component.
In some embodiments, the second content of the flavor component is at least
partially present in the
oral composition in the form of spray-dried particles.
In some embodiments, one of the first release rate and the second release rate
is defined by at least
75% of the respective content of the flavor component being released from the
oral composition within 10
minutes of insertion of the oral composition into an oral cavity of a
consumer, and wherein the other of the
first release rate and the second release is defined by less than 25% of the
respective content of the flavor
component being release from the oral composition within 10 minutes of
insertion of the oral composition into
the oral cavity of the consumer, said percentage being by weight based on the
total weight of the oral
composition.
In some embodiments, the oral composition further comprises one or more salts,
one or more
sweeteners, one or more binding agents, one or more humectants, one or more
gums, a tobacco material, or
combinations thereof.
In another aspect is provided a method of preparing a composition for oral
use, the method comprising:
spray-drying a liquid flavor component to form particles of the liquid flavor
component; and mixing the
particles of the liquid flavor component with a long-chain carbohydrate.
In some embodiments, the long-chain carbohydrate comprises a starch.
In some embodiments, the method further comprises adding the particles of the
liquid flavor
component mixed with the long-chain carbohydrate to a fleece.
In still another aspect is provided a method of preparing a composition for
oral use, the method
comprising combining a content of a first flavor component, a content of a
second flavor component, and a
filler to form the composition in a form suitable for insertion into an oral
cavity of a consumer; wherein the
first content of the flavor component is configured for release from the
composition in the oral cavity of the
consumer according to a first release rate and the second content of the
flavor component is configured for
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release from the oral composition in the oral cavity of the consumer according
to a second release rate that is
different from the first release rate.
In some embodiments, prior to the combining, the first content of the flavor
component is prepared
by adsorbing or absorbing the flavor component in or on a carrier component
that is substantially insoluble in
the oral cavity of the consumer.
In some embodiments, prior to the combining, the second content of the flavor
component is prepared
by adsorbing or absorbing the flavor component in or on a carrier component
that is substantially soluble in
the oral cavity of the consumer.
In some embodiments, prior to the combining, the first content of the flavor
component is prepared
by dissolving the flavor component in a first solvent, and the second content
of the flavor component is
prepared by dissolving the flavor component in a second, different solvent.
In some embodiments, one of the first solvent and the second solvent is an
aqueous solvent, and the
other of the first solvent and the second solvent is an alcohol-based solvent.
In some embodiments, prior to the combining, the first content of the flavor
component is provided in
a liquid form, and the second content of the flavor component is provided in
the form of spray-dried particles.
The di scl o sure includes, without limitations, the foll ow i ng embodiments.
Embodiment 1: An oral composition comprising a first content of a flavor
component and a second
content of a flavor component, wherein the first content of the flavor
component can be configured for release
from the oral composition according to a first release rate and the second
content of the flavor component can
be configured for release from the oral composition according to a second
release rate that is different from
the first release rate.
Embodiment 2: The oral composition of embodiment 1, wherein the first content
of the flavor
component and the second content of the flavor component each can comprise the
same flavor component.
Embodiment 3: The oral composition of any of embodiments 1 to 2, wherein the
first content of the
flavor component and the second content of the flavor component each can
comprise a different flavor
component.
Embodiment 4: The oral composition of any of embodiments 1 to 3, wherein the
composition may
further comprise one or more active ingredients.
Embodiment 5: The oral composition of any of embodiments 1 to 4, wherein the
one or more active
ingredients may be selected from a group consisting of a nicotine component,
botanicals, stimulants, amino
acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and
a combination thereof.
Embodiment 6: The oral composition of any of embodiments 1 to 5, wherein the
first content of the
flavor component and the second content of the flavor component independently
may comprise a compound
havina a carbon-carbon double bond. a carbon-oxyaen double bond, or both.
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Embodiment 7: The oral composition of any of embodiments 1 to 6, wherein the
first content of the
flavor component and the second content of the flavor component independently
may comprise one or more
of ethyl vanillin, cinnamaldehyde, sabinenc, limoncne, gamma-terpinene, beta-
farnesenc, and citral.
Embodiment 8: The oral composition of any of embodiments 1 to 7, wherein at
least a portion of the
first content of the flavor component can be in the form of spray-dried
particles.
Embodiment 9: The oral composition of any of embodiments 1 to 8, wherein the
spray-dried particles
may be in admixture with a content of a filler.
Embodiment 10: The oral composition of any of embodiment 1 to 9, wherein the
filler may comprise
a long-chain carbohydrate.
Embodiment 11: The oral composition of any of embodiment 1 to 10, wherein the
long-chain
carbohydrate may be a starch.
Embodiment 12: The oral composition of any of embodiment 1 to 11, wherein the
first content of the
flavor component may comprise the flavor component on a first carrier
component that is substantially
insoluble in saliva, and the second content of the flavor component may
comprise the flavor component on a
second carrier component that is substantially soluble in saliva.
Embodiment 13: The oral composition of any of embodiments 1 to 12, wherein the
first content of
the flavor component comprises a flavor component that is soluble in an
aqueous solvent.
Embodiment 14: The oral composition of any of embodiments Ito 13, wherein the
second content
of the flavor component may comprise a flavor component that is soluble in an
alcohol-based solvent.
Embodiment 15: The oral composition of any of embodiments 1 to 14, wherein the
first content of
the flavor component may be at least partially present in the oral composition
in a liquid form, and wherein
the second content of the flavor component may be at least partially present
in the oral composition in the
form of spray-dried particles.
Embodiment 16: The oral composition of any of embodiments 1 to 15, at least a
portion of the first
content of the flavor component can be absorbed or adsorbed on a carrier
component.
Embodiment 17: The oral composition of any of embodiments 1 to 16, wherein the
second content
of the flavor component can be at least partially present in the oral
composition in the form of spray-dried
particles.
Embodiment 18: The oral composition of any of embodiments 1 to 17, wherein one
of the first release
rate and the second release rate may be defined by at least 75% of the
respective content of the flavor
component being released from the oral composition within 10 minutes of
insertion of the oral composition
into an oral cavity of a consumer, and wherein the other of the first release
rate and the second release may be
defined by less than 25% of the respective content of the flavor component
being release from the oral
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composition within 10 minutes of insertion of the oral composition into the
oral cavity of the consumer, said
percentage being by weight based on the total weight of the oral composition.
Embodiment 19: The oral composition of any of embodiments 1 to 18, wherein the
oral composition
may further comprise one or more salts, one or more sweeteners, one or more
binding agents, one or more
humectants, one or more gums, a tobacco material, or combinations thereof.
Embodiment 20: A method of preparing a composition for oral use, the method
comprising spray-
drying a liquid flavor component to form particles of the liquid flavor
component; and mixing the particles of
the liquid flavor component with a long-chain carbohydrate.
Embodiment 21: The method of embodiment 20, wherein the long-chain
carbohydrate may comprise
a starch.
Embodiment 22: The method of any of embodiments 20 to 21, wherein the method
may further
comprise adding the particles of the liquid flavor component mixed with the
long-chain cathohydrate to a
fleece.
Embodiment 23: A method of preparing a composition for oral use, the method
comprising combining
a content of a first flavor component, a content of a second flavor component,
and a filler to form the
composition in a form suitable for insertion into an oral cavity of a
consumer; wherein the first content of the
flavor component is configured for release from the composition in the oral
cavity of the consumer according
to a first release rate and the second content of the flavor component is
configured for release from the oral
composition in the oral cavity of the consumer according to a second release
rate that is different from the first
release rate.
Embodiment 24: The method of embodiment 23, wherein prior to the combining,
the first content of
the flavor component can be prepared by adsorbing or absorbing the flavor
component in or on a carrier
component that is substantially insoluble in the oral cavity of the consumer.
Embodiment 25: The method of any of embodiments 23 to 24, wherein prior to the
combining, the
second content of the flavor component can be prepared by adsorbing or
absorbing the flavor component in
or on a carrier component that is substantially soluble in the oral cavity of
the consumer.
Embodiment 26: The method of any of embodiments 23 to 25, wherein prior to the
combining, the
first content of the flavor component can be prepared by dissolving the flavor
component in a first solvent,
and the second content of the flavor component can be prepared by dissolving
the flavor component in a
second, different solvent.
Embodiment 27: The method of any of embodiments 23 to 26, wherein one of the
first solvent and
the second solvent can be all aqueous solvent, and the other of the first
solvent and the second solvent can be
an alcohol-based solvent.
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Embodiment 28: The method of any of embodiments 23 to 27, wherein prior to the
combining, the
first content of the flavor component can be provided in a liquid form, and
the second content of the flavor
component can be provided in the form of spray-dried particles.
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 drawing,
which is 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 DRAWING
Having thus described aspects of the disclosure in the foregoing general
terms, reference will now be
made to the accompanying drawing, which is not necessarily drawn to scale. The
drawing is exemplary only,
and should not be construed as limiting the disclosure.
FIG. 1 is a perspective view of a pouched product according to an example
embodiment of the present
disclosure including a pouch or fleece at least partially filled with a
composition for oral use.
DETAILED DESCRIPTION
The present disclosure provides compositions and products formed therefrom,
the compositions and
products particularly being configured for oral usc. The compositions and
products may incorporate one or
more components that are effective for retaining a releasable component and
then releasing the releasable
component at a desired time, such as when in contact with an oral cavity. The
components for retaining the
releasable component can be adapted to or configured to provide for release
according to one or more release
profiles in some embodiments. The releasable component may be a flavor in
particular, but may likewise
include an active ingredient.
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 arc provided so that this disclosure will
satisfy applicable legal
requirements. As used in this specification and the claims, the singular forms
"a," "an,'' and "the" include
plural referents unless the context clearly dictates otherwise. Reference to
"dry weight percent" or "dry weight
basis" refers to weight on the basis of dry ingredients (i.e., all ingredients
except water). Reference to "wet
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weight" refers to the weight of the mixture including water. Unless otherwise
indicated, reference to "weight
percent" of a mixture reflects the total wet weight of the mixture (i.e.,
including water).
The present disclosure provides compositions and products that can include the
compositions. More
particularly, the disclosure provides for oral compositions including a first
content of a flavor component and
a second content of the same flavor component or a different flavor component,
and the first content of the
flavor component may be configured for release according to a first release
rate while the second content of
the flavor component may be configured for release according to a second
release rate that is different from
the first release rate. As described, the compositions may be provided in a
variety of forms and, as further
described herein, specifically, may be provided in a substantially solid form,
such as a collection of particles,
fibers, or the like. Accordingly, a product may include the composition
itself, or the composition positioned
within a unitizing stmeture, such as a pouch, a fleece, or the like. In sonic
embodiments, the products as
described herein comprise a mixture of components, typically including at
least one carrier and/or 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. In particular, one or more
components of the composition may be combined in a manner such that a first
content of a flavor material is
adapted to or configured to be released according to a first release profile
and a second content of a flavor
material is adapted to or configured to be released according to a second
release profile when the composition
is positioned in an oral cavity of a consumer. The example individual
components of the composition are
described herein below.
Carrier/Filler Component
Compositions as described herein include at least one component that may be
characterized as being
a carrier component and/or a filler component. In some embodiments, the
compositions may include both of
a carrier and a filler, and various materials may fulfill the function of both
a carrier and a filler. A carrier
component according to the present disclosure preferably may be adapted to or
configured to retain at least a
flavor component as described herein and may, in some embodiments, retain
substantially all of the further
components of the composition. A filler component 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 filler components are porous particulate
materials. In some embodiments,
the present compositions may comprise a carrier. In further embodiments, the
present compositions may
comprise a carrier and a filler.
In some embodiments, a carrier component and/or a filler component may be
cellulose-based. For
example, suitable particulate components are any non-tobacco plant material or
derivative thereof, including
cellulose materials derived from such sources. Examples of cellulosic non-
tobacco plant material include
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cereal grains (e.g., maize, oat, barley, rye, buckwheat, and the like), sugar
beet (e.g., FIBREX 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 filler components
include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose,
mannitol, xylitol, and sorbitol.
Combinations of materials can also be used.
"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 mixture
based on the ability of the starch material to impart a specific organolcptic
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, a rracacha, bana nas, 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, qpinoa, rye, tapioca, taro, 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. Sonic starches have been developed
by genetic modifications, and
are considered to be "genetically modified" starches. Other starches are
obtained and subsequently modified
by chemical, enzymatic, or physical means. 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,
tmnsglycosylation and depolymerization
(e.g., dextrinization in the presence of a catalyst), cross-linking,
acetylation, hydroxypropylation, and/or
partial hydrolysis. Enzymatic treatment includes subjecting native starches to
enzyme isolates or concentrates,
microbial enzymes, and/or enzymes native to plant materials, e.g., amylase
present in corn kernels to modify
corn starch. Other starches are modified by heat treatments, such as pregelati
nization, dextri ni zat ion, and/or
cold water swelling processes. Certain modified starches include monostarch
phosphate, distarch glycerol,
distarch phosphate esterified with sodium trimetaphosphate, phosphate distarch
phosphate, acetylatcd 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, a carrier component and/or a filler component may be a
cellulose material or
cellulose derivative. One particularly suitable material for use in the
products described herein is
microciystalline 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,
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12, 20 and EMOCEL grades 50M and 90M, and the like, and mixtures thereof. In
one embodiment, a
composition as described herein may comprise MCC as a particulate filler
component and/or as a carrier
component. The quantity of MCC present in the compositions as described herein
may vary according to the
desired properties. In some embodiments, a cellulose derivative or a
combination of such derivatives in
particular may be used in combination with a different carrier component, and
this particularly can include
cellulose derivatives, such as 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"),
hydrovethyl 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.
The total amount of carrier component(s) and filler component(s) present in
the composition 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 ra nge of total carrier and/or filler component w ithin
the co nip s it i o n 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 total amount of
carrier/filler component 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.
In one or more embodiments, a carrier component may bc adapted to or
configured to substantially
surround or envelop further components of the composition. For example, the
carrier may be configured as a
packet, a pouch, a fleece, or the like, and such structures are further
described herein. The term -fleece" may
particularly be used herein as a common term for such structures and should
not be viewed as limiting the
nature of the structure.
A suitable fleece, for example, may be formed of a plurality of fibers. The
term "fiber" as used herein
includes both fibers of finite length, such as conventional staple fibers and
nanofibers, as well as substantially
continuous structures, such as continuous filaments, unless otherwise
indicated. The fibers can have a
substantially round or circular cross section or non-circular cross sections
(for example, oval, rectangular,
multi-lobed, and the like). The fibers can be provided in a variety of
configurations, and the fibers particularly
can include multicomponcnt fibers.
In some embodiments, the fleece can be in the form of a non-woven material.
The term "nonwoven"
is used herein in reference to fibrous materials, webs, mats, batts, or sheets
in which fibers are aligned in an
undefined or random orientation. In some embodiments, the plurality- of fibers
used in forming a fleece may
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include heat sealable and/or meltable binder fibers. Further aspects of a
suitable pouch or fleece are further
described below.
Active Ingredients
In some embodiments, the present compositions and products may comprise an
active ingredient. For
example, the compositions and products may include a single active ingredient
or a plurality of active
ingredients. If desired, one or more active ingredients may be retained on a
portion of a filler/carrier, and one
or more active ingredients may be otherwise retained in the compositions
and/or products, such as being bound
to a further filler or being present in a unitary form (e.g., pelletized
active ingredients).
As used herein, an "active ingredient" refers to one or more substances
belonging to any of the
following categories: API (active pharmaceutical substances), food additives,
natural medicaments, and
naturally occurring substances that can have an effect on humans. Example
active ingredients include any
ingredient known to impact one or more biological functions within the body,
such as ingredients that furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of
disease, or which affect the structure or any function of the body of humans
(e.g., provide a stimulating action
on the central nervous system, have an energizing effect, an antipyretic or
analgesic action, or an otherwise
useful effect on the body). In some embodiments, the active ingredient may be
of the type generally referred
to as dietary supplements, nutraceuticals, "phytochemicals" or "functional
foods''. These types of additives are
sometimes defined in the art as encompassing substances typically available
from naturally-occurring sources
(e.g., botanical materials) that provide one or more advantageous biological
effects (e.g., health promotion,
disease prevention, or other medicinal properties), but are not classified or
regulated as drugs.
Non-limiting examples of active ingredients include those falling in the
categories of botanical
ingredients (e.g., hemp, lavender, peppermint, eucalyptus, rooibos, fennel,
cloves, chamomile, basil, rosemary,
clove, citrus, ginger, cannabis, ginseng, maca, and tisanes), stimulants
(e.g., caffeine or guarana), amino acids
(e.g., taurine, theanine, phenylalanine, tyrosine, and tryptophan), vitamins
(B6, B12, and C), antioxidants,
nicotine components, pharmaceutical ingredients (e.g., nutraceutical and
medicinal ingredients), cannabinoids
(e.g., tetrahydrocannabinol (THC) or cannabidiol (CBD)) and/or melatonin..
Each of these categories is further
described herein below. The particular choice of active ingredients will vary
depending upon the desired
flavor, texture, and desired characteristics of the particular product.
The particular percentages of active ingredients present will vary depending
upon the desired
characteristics of the particular product. Typically, an active ingredient or
combination thereof is present in a
total concentration of at least about 0.001% by weight of the composition,
such as in a range from about
0.001% to about 20%. In some embodiments, the active ingredient or combination
of active ingredients is
present in a concentration from about 0.1% w/w to about 10% by weight, such
as, e.g., from about 0.5% w/w
to about 10%, from about 1% to about 10%, from about 1% to about 5% by weight,
based on the total weight
of the composition. In some embodiments, the active ingredient or combination
of active ingredients is present
in a concentration of from about 0.001%, about 0.01%, about 0.1%, or about 1%,
up to about 20% by weight,
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such as, e.g., from about 0.001%, about 0.002%, about 0.003%, about 0.004%,
about 0.005%, about 0.006%,
about 0.007%, about 0.008%, about 0.009%, about 0.01%, about 0.02%, about
0.03%, about 0.04%, about
0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1%, about
0.2%, about 0.3%, about
0.4%, 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 7%, about 8%, about 9%, about 10%, about
11%, about 12%, about
13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, or
about 20% by weight, based
on the total weight of the composition. Further suitable ranges for specific
active ingredients are provided
herein below.
Botanical
In some embodiments, the active ingredient comprises a botanical ingredient.
As used herein, the term
"botanical ingredient" or "botanical" refers to any plant material or fungal-
derived material, including plant
material in its natural form and plant material derived from natural plant
materials, such as extracts or isolates
from plant materials or treated plant materials (e.g., plant materials
subjected to heat treatment, fermentation,
bleaching, or other treatment processes capable of altering the physical
and/or chemical nature of the material).
For the purposes of the present disclosure, a "botanical" includes, but is not
limited to, "herbal materials,"
which refer to seed-producing plants that do not develop persistent woody
tissue and are often valued for their
medicinal or sensory characteristics (e.g., teas or tisanes). Reference to
botanical material as "non-tobacco"
is intended to exclude tobacco materials (i.e., does not include any Nicotiana
species).
When present, a botanical is typically at a concentration of from about 0.01%
w/w to about 10% by
weight, such as, e.g., from about 0.01% vi/w, about 0.05%, about 0.1%, or
about 0.5%, to about 1%, about
2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or
about 10%, about 11%,
about 12%, about 13%, about 14%, or about 15% by weight, based on the total
weight of the composition.
The botanical materials useful in the present disclosure may comprise, without
limitation, any of the
compounds and sources set forth herein, including mixtures thereof. Certain
botanical materials of this type
are sometimes referred to as dietary supplements, nutraceuticals,
"phytochemicals" or "functional foods."
Certain botanicals, as the plant material or an extract thereof, have found
use in traditional herbal medicine,
and are described further herein. Non-limiting examples of botanicals or
botanical-derived materials include
hemp, eucalyptus, rooibos, fennel, citrus, cloves, lavender, peppermint,
chamomile, basil, rosemary, ginger,
turmeric, green tea, white mulberry, cannabis, cocoa, ashwagandha, baobab,
chlorophyll, cordyceps, damiana,
ginseng, guarana, and maca. In some embodiments, the composition comprises
green tea, turmeric, and white
mulbe rry
Ashwagandha (Withania somnifera) is a plant in the ,S'olanaceae (nightshade)
family. As an herb,
Ashwagandha has found use in the Indian Ayurvedic system of medicine, where it
is also known as "Indian
Winter cherry" or "Indian Ginseng."
In some embodiments, the active ingredient comprises ashwagandlia.
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Baobab is the common name of a family of deciduous trees of the genus
Adansonia. The fruit pulp
and seeds of the Baobab are consumed, generally after drying, as a food or
nutritional supplement. In some
embodiments, the active ingredient comprises baobab.
Chlorophyll is any of several related green pigments found in the mesosomes of
cyanobacteria, as
well as in the chloroplasts of algae and plants. Chlorophyll has been used as
a food additive (colorant) and a
nutritional supplement. Chlorophyll may be provided either from native plant
materials (e.g., botanicals) or in
an extract or dried powder form. In some embodiments, the active ingredient
comprises chlorophyll.
Cordyceps is a diverse genus of ascomycete (sac) fungi which are abundant in
humid temperate and
tropical forests. Members of the cordyceps family are used extensively in
traditional Chinese medicine. In
some embodiments, the active ingredient comprises cordyceps.
Damiana is a small, woody shrub of the family Passifloraceae. It is native to
southern Texas, Central
America, Mexico, South America, and the Caribbean. Damiana produces small,
aromatic flowers, followed
by fruits that taste similar to figs. The extract from damiana has been found
to suppress aromatase activity,
including the isolated compounds pinocembrin and acacetin In sonic
embodiments, the active ingredient
comprises damiana.
Guarana is a climbing plant in the family Sapindaceae, native to the Amazon
basin. The seeds from
its fruit, which are about the size of a coffee bean, have a high
concentration of caffeine and, consequently,
stimulant activity. In some embodiments, the active ingredient comprises
guarana. In some embodiments, the
active i ngre di e nt co mp ri se s gua ra no, honey, a nd a shw a ga ndha .
Ginseng is the root of plants of the genus Panax, which are characterized by
the presence of unique
steroid saponin phytochemicals (ginsenosides) and gintonin. Ginseng finds use
as a dietary supplement in energy
drinks or herbal teas, and in traditional medicine. Cultivated species include
Korean ginseng (P. ginseng), South
China ginseng (P. notoginseng), and American ginseng (P. quinquefolius).
American ginseng and Korean ginseng
vary in the type and quantity of various ginsenosides present. In some
embodiments, the active ingredient
comprises ginseng. In some embodiments, the ginseng is American ginseng or
Korean ginseng. in specific
embodiments, the active ingredient comprises Korean ginseng.
Maca is a plant that grows in central Peru in the high plateaus of the Andes
Mountains. It is a relative of
the radish, and has an odor similar to butterscotch. Maca has been used in
traditional (e.g., Chinese) medicine. in
some embodiments, the active ingredient comprises maca.
Stimulants
Iii sonic embodiments, the active ingredient comprises one or more stimulants.
As used herein, the
term "stimulant" refers to a material that increases activity of the central
nervous system and/or the body, for
example, enhancing focus, cognition, vigor, mood, alertness, and the like. Non-
limiting examples of stimulants
include caffeine, theacrine, theobromine, and theophylline. Theaerine (1,3,7,9-
tetiameillyluric acid) is a parine
alkaloid which is structurally related to caffeine, and possesses stimulant,
analgesic, and anti-inflornmatcny
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effects. Present stimulants may be natural, naturally derived, or wholly
synthetic. For example, certain
botanical materials (guarana, tea, coffee, cocoa, and the like) may possess a
stimulant effect by virtue of the
presence of e.g., caffeine or related alkaloids, and accordingly arc "natural"
stimulants. By "naturally derived"
is meant the stimulant (e.g., caffeine, theacrine) is in a purified form,
outside its natural (e.g., botanical) matrix.
For example, caffeine can be obtained by extraction and purification from
botanical sources (e.g., tea). By
"wholly synthetic", it is meant that the stimulant has been obtained by
chemical synthesis.
When present, a stimulant or combination of stimulants (e.g., caffeine,
theacrine, and combinations
thereof) is typically at a concentration of from about 0.1% w/w to about 15%
by weight, such as, e.g., from
about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,
about 0.7%, about 0.8%, or
about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,
about 7%, about 8%, about
9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by
weight, based on the total
weight of the composition.
In some embodiments, the active ingredient comprises caffeine, in some
embodiments, the active
ingredient comprises theacrine. In some embodiments, the active ingredient
comprises a combination of
caffeine and theacrine.
Amino acids
In some embodiments, the active ingredient comprises an amino acid. As used
herein, the term "amino
acid" refers to an organic compound that contains amine (-N112) and carboxyl (-
COOH) or sulfonic acid
(SO3H) functional groups, along with a side chain (R group), which is specific
to each amino acid. Amino
acids may be proteinogenic or non-proteinogenic. By "proteinogenic" is meant
that the amino acid is one of
the twenty naturally occurring amino acids found in proteins. The
proteinogenic amino acids include alanine,
arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid,
glycine, histidine, isoleucine, leucine,
lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan,
tyrosine, and valine. By "non-
proteinogenic" is meant that either the amino acid is not found naturally in
protein, or is not directly produced
by cellular machinery (e.g., is the product of post-tranlational
modification). Non-limiting examples of non-
proteinogenic amino acids include gamma-aminobutyric acid (GABA), taurine (2-
aminoethanesulfonic acid),
',hemline (1, -'y -gin a] tly 1c:thy 'Amid e), hydroxy proline, and be ta-
alanine.
When present, an amino acid or combination of amino acids (e.g., taurine,
theanine, and combinations
thereof) is typically at a concentration of from about 0.1% w/w to about 15%
by weight, such as, e.g., from
about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5% about 0.6%,
about 0.7%, about 0.8%, or
about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,
about 7%, about 8%, about
9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by
weight, based on the total
weight of the composition.
In some embodiments, the amino acid is taurine, theanine, phenylalanine,
tyrosine, tryptophan, or a
combination thereof. In some embodiments, the amino acid is taurine. In some
embodiments, the active
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ingredient comprises a combination of taurine and caffeine. In some
embodiments, the active ingredient
comprises a combination of taurine, caffeine, and guarana. In some
embodiments, the active ingredient
comprises a combination of taurinc, maca, and cordyceps. In some embodiments,
the active ingredient
comprises a combination of theanine and caffeine.
Vitamins
In some embodiments, the active ingredient comprises a vitamin or combination
of vitamins. As used
herein, the term "vitamin" refers to an organic molecule (or related set of
molecules) that is an essential
micronutrient needed for the proper functioning of metabolism in a mammal.
There are thirteen vitamins
required by human metabolism, which are: vitamin A (as all-trans-retinol, all-
trans-retinyl-esters, as well as
all-trans-beta-carotene and other provitamin A carotenoids), vitamin B1
(thiamine), vitamin B2 (riboflavin),
vitamin B3 (niacin), vitamin BS (pantothenic acid), vitamin B6 (pyridoxine),
vitamin B7 (biotin), vitamin B9
(folic acid or folate), vitamin B12 (cobalamins), vitamin C (ascorbic acid),
vitamin D (calciferols), vitamin E
(tocopherols and tocotrienols), and vitamin K (quinones).
When present, a vitamin or combination of vitamins (e.g., vitamin B6, vitamin
B12, vitamin E,
vitamin C, or a combination thereof) is typically at a concentration of from
about 0.01% w/w to about 1% by
weight, such as, e.g., from about 0.01%, about 0.02%, about 0.03%, about
0.04%, about 0.05%, about 0.06%,
about 0.07%, about 0.08%, about 0.09%, or about 0.1% w/w, to about 0.2%, about
0.3%, about 0.4%, about
0.5% about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1% by weight,
based on the total weight of
the composition.
In some embodiments, the vitamin is vitamin B6, vitamin B12, vitamin E,
vitamin C, or a combination
thereof. In some embodiments, the active ingredient comprises a combination of
vitamin B6, caffeine, and
theanine. In some embodiments, the active ingredient comprises vitamin B6,
vitamin B12, and taurine. In some
embodiments, the active ingredient comprises a combination of vitamin B6,
vitamin B12, ginseng, and
theanine. In some embodiments, the active ingredient comprises a combination
of vitamin C, baobab, and
chlorophyll.
In certain embodiments, the active ingredient is selected from the group
consisting of caffeine, taurine,
GABA, theanine, vitamin C, lemon balm extract, ginseng, citicoline, sunflower
lecithin, and combinations
thereof. For example, the active ingredient can include a combination of
caffeine, theanine, and optionally
ginseng. In another embodiment, the active ingredient includes a combination
of theanine, gamma-amino
butyric acid (GABA), and lemon balm extract. In a further embodiment, the
active ingredient includes
theanine, theanine and tryptophan, or theanine and one or more B vitamins
(e.g., vitamin B6 or B12). In a
still further embodiment, the active ingredient includes a combination of
caffeine, taurine, and vitamin C.
Antioxidants
In some embodiments, the active ingredient comprises one or more antioxidants.
As used herein, the
term "antioxidant" refers to a substance which prevents or suppresses
oxidation by terminating free radical
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reactions, and may delay or prevent some types of cellular damage.
Antioxidants may be naturally occurring
or synthetic. Naturally occurring antioxidants include those found in foods
and botanical materials. Non-
limiting examples of antioxidants include certain botanical materials,
vitamins, polyphenols, and phenol
derivatives.
Examples of botanical materials which are associated with antioxidant
characteristics include without
limitation acai berry, alfalfa, allspice, annatto seed, apricot oil, basil,
bee balm, wild bergamot, black pepper,
blueberries, borage seed oil, buglevveed, cacao, calamus root, catnip,
catuaba, cayenne pepper, chaga
mushroom, chervil, cinnamon, dark chocolate, potato peel, grape seed, ginseng,
gingko biloba, Saint John's
Wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile,
cloves, cocoa powder, cranberry,
dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose,
feverfew, ginger, goldenseal,
hawthorn, hibiscus flower, j a gala n, kava, lavender, licorice, marjoram,
milk thistle, mints (menthe), oolong
tea, beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover,
rooibos (red or green), roschip,
rosemary, sage, clary sage, savory, spearmint, spirulina, slippery elm bark,
sorghum bran hi-tannin, sorghum
grain hi-tannin, sumac bran, comfrey- leaf and root, goji berries, gutu kola,
thyme, turmeric, uva ursi, valerian,
wild yam root, wintergreen, y-acon root, yellow dock, yeiba mate, yerba santa,
bacopa monniera, withania
somnifera, Lion's mane, and silybum marianum. Such botanical materials may be
provided in fresh or dry
form, essential oils, or may be in the form of an extracts. The botanical
materials (as well as their extracts)
often include compounds from various classes known to provide antioxidant
effects, such as minerals,
vitamins, isoflavones, phytoesterols, allyl sulfides, dithiolthiones,
isothiocyanates, indoles, lignans,
flavonoids, polyphenols, and carotenoids. Examples of compounds found in
botanical extracts or oils include
ascorbic acid, peanut endocarb, resveratrol, sulforaphane, beta-carotene,
lycopene, lutein, co-enzyme Q,
carnitine, quercetin, kaempferol, and the like. See, e.g., Santhosh et al.,
Phytomedicine, 12(2005) 216-220,
which is incorporated herein by reference.
Non-limiting examples of other suitable antioxidants include citric acid,
Vitamin E or a derivative
thereof, a tocopherol, epicatechol, epigallocatechol, epigallocatechol
gallate, elythorbic acid, sodium
elythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B,
theaflavin digallate, phenolic acids,
glycosides, quercitrin, isoquercitrin, hyperoside, polyphenols, catechols,
resveratrols, oleuropein, butylated
hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tertiary
butylhydroquinone (TBHQ), and
combinations thereof. In some embodiments, the antioxidant is Vitamin E or a
derivative thereof, a flavonoid,
a polyphenol, a carotenoid, or a combination thereof.
When present, an antioxidant is typically at a concentration of from about
0.001% w/w to about 10%
by weight, such as, e.g., from about 0.001%, about 0.005%, about 0.01% w/w,
about 0.05%, about 0.1%, or
about 0.5%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,
about 7%, about 8%, about
9%, or about 10%, based on the total weight of the composition.
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Nicotine component
In certain embodiments, a nicotine component may be included in the mixture.
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 microclystalline cellulose-
nicotine carrier complex. See, for example, the discussion of nicotine in free
base form in US Pat. Pub. No.
2004/0191322 to Hansson, which is incorporated herein by reference.
In some embodiments, at least a portion of the nicotine 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 K&K
Laboratories, Division of ICN Biochemicals, Inc. Typically, the nicotine
component is selected from the
group consisting of nicotine free base, a nicotine salt such as hydrochloride,
dihydrochloride, monotartrate,
bitartrate, sulfate, salicylate, and nicotine zinc chloride. In some
embodiments, the nicotine component or a
portion 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-polyacrylic carbomer complex, such as with Carbopol
974P. In some embodiments,
nicotine may be present in the form of a nicotine polyactylic 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 mixture, such as in a range from about
0.001% to about 10%. In some
embodiments, the nicotine component is present in a concentration from about
0.1% w/w to about 10% by
weight, such as, e.g., from about 0.1% w/w, about 0.2%, about 0.3%, about
0.4%, about 0.5% about 0.6%,
about 0.7%, about 0.8%, or about 0.9%, to about 1%, about 2%, about 3%, about
4%, about 5%, about 6%,
about 7%, about 8%, about 9%, or about 10% by weight, calculated as the free
base and based on the total
weight of the mixture. In some embodiments, the nicotine component is present
in a concentration from about
0.1% w/w to about 3% by weight, such as, e.g., from about 0.1% w/w to about
2.5%, from about 0.1% 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 mixture. These ranges can also apply
to other active ingredients noted
herein.
In some embodiments, the oral composition of the disclosure can be
characterized as completely free
or substantially free of nicotine components. By "substantially free of
nicotine components" is meant that no
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nicotine has been intentionally added, beyond trace amounts that may be
naturally present in e.g., a botanical
material. For example, certain embodiments can be characterized as having less
than 0.001% by weight of
nicotine, or less than 0.0001%, or even 0% by weight of nicotine, calculated
as the free base.
Cannabinoids
In some embodiments, the active ingredient comprises one or more cannabinoids.
As used herein, the
term "cannabinoid" refers to a class of diverse chemical compounds that acts
on cannabinoid receptors, also
known as the endocannabinoid system, in cells that alter neurotransmitter
release in the brain. Ligands for
these receptor proteins include the endocannabinoids produced naturally in the
body by animals;
phytocannabinoids, found in cannabis; and synthetic cannabinoids, manufactured
artificially. Cannabinoids
found in cannabis include, without limitation: cannabigerol (CBG),
cannabichromene (CBC), cannabidiol
(CBD), tetrahydrocannabinol (THC), caimabinol (CBN), cannabinodiol (CBDL),
cannabicyclol (CBL),
cannabivarin (CB V). tetrahydrocannabivarin (THCV), cannabidivarin (CBDV),
cannabichromevarin
(CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM),
cannabinerolic acid,
cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol
(CBO), tetrahydrocannabinolic
acid (THCA), and tetrahydrocannabivarinic acid (THCV A). In certain
embodiments, the cannabinoid is
selected from tetrahydrocannabinol (THC), the primary psychoactive compound in
cannabis, and cannabidiol
(CBD) another major constituent of the plant, but which is devoid of
psychoactivity. All of the above
compounds can be used in the form of an isolate from plant material or
synthetically derived.
Alternatively, the active ingredient can be a cannabimimetic, which is a class
of compounds derived
from plants other than cannabis that have biological effects on the
endocannabinoid system similar to
cannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin (also
classified as terpenes),
cyanidin, curcumin (lumeric), catcchin, quercctin, salvinorin A, N-
acylahanolamincs, and N-alkylamidc
lipids.
When present, a cannabinoid (e.g., CBD) or cannabimimetic is typically in a
concentration of at least
about 0.1% by weight of the composition, such as in a range from about 0.1% to
about 30%, such as, e.g.,
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%, or
about 0.9%, to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%,
about 7%, about 8%, about
9%, about 10%, about 15%, about 20%, or about 30% by weight, based on the
total weight of the composition.
Terpenes
Active ingredients suitable for use in the present disclosure can also be
classified as terpenes, many
of which are associated with biological effects, such as calming effects.
Terpenes are understood to have the
general formula of (C5H8)11 and include monoterpenes, sesquiterpenes, and
diterpenes. Terpenes can be
acyclic, monocyclic or bicyclic in structure. Some terpenes provide an
entourage effect when used in
combination with camiabinoids or cannabimimetics. Examples include beta-
caryophyllene, linalool,
limonene, beta-citronellol, linalyl acetate, pinene (alpha or beta), geraniol,
carvone, eucalyptol, menthone, iso-
menthone, piperitone, myrecne, beta-bourbonene, and germacrenc, which may be
used singly or in
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combination.
Pharinaceutical ingredients
The pharmaceutical ingredient can be any known agent adapted for therapeutic,
prophylactic, or
diagnostic use. These can include, for example, synthetic organic compounds,
proteins and peptides,
polysaccharides and other sugars, lipids, inorganic compounds, and nucleic
acid sequences, having
therapeutic, prophylactic, or diagnostic activity. Non-limiting examples of
pharmaceutical ingredients include
analgesics and antipyretics (e.g., acetylsalicylic acid, acetaminophen, 3-(4-
isobutylphenyl)propanoic acid).
Flavoring Agents
In some embodiments, the present compositions and products may comprise one or
more 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, mouthfeel, 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. In
some embodiments, the compositions and products may include a single flavoring
agent or a plurality of
flavoring agents. if desired, one or more flavoring agents may be retained on
a portion of a carrier or filler,
and one or more flavoring agents may be otherwise retained in the compositions
and/or products, such as being
bound to a further carrier or filler.
Non-limiting exa mpl es of flavoring agents that may be used herein and/or be
otherwise included
within the present compositions and/or products can include vanilla, coffee,
chocolate/cocoa, cream, mint,
spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom,
nutmeg, cinnamon, clove,
cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon,
orange, apple, peach, lime, cherry,
strawberry, trigeminal sensates, fernenes, 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. As used herein, "trigeminal sensate" refers to a flavoring agent
which has an effect on the trigeminal
nerve, producing sensations including heating, cooling, tingling, and the
like. Non-limiting examples of
trigeminal sensate flavoring agents include capsaicin, citric acid, menthol,
Sichuan buttons, erythritol, and
cubebol. Flavorings also may include components that are considered
moistening, cooling or smoothening
agents, such as eucalyptus. These flavors may be provided neat (i.e., alone)
or in a composite, and may be
employed as concentrates or flavor packages (e.g., spearmint and menthol,
orange and cinnamon; lime,
pineapple, and the like). Representative types of components also are set
forth in US Pat. No. 5,3R7,416 to
White et al.; US Pat. App. Pub. No. 2005/0244521 to Strickland et al.; and PCT
Application Pub. No. WO
05/041699 to Quinter etal., 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
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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, cuminaldehyde,
benzaldehyde, and citronellal. Non-
limiting examples of ketones include 1-hydroxy-2-propanone and 2-hydroxy-3-
methy1-2-eyelopentenone-1-
one. Non-limiting examples of esters include allyl hexanoate, ethyl
heptanoate, ethyl hexanoate, isoamyl
acetate, and 3-methylbutyl acetate. Non-limiting examples of terpenes include
sabinene, limonene, gamma-
terpinene, beta-farnesene, 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, limonene, gamma-terpinene, beta-farnesene, or
citral. In one embodiment, the at
least one volatile flavor component comprises ethyl vanillin.
In one or more embodiments of the present disclosure, the oral compositions
and products can
comprise at least two flavor components that are adapted to or configured to
be released according to
independent release profiles (e.g., a fast release or immediate release
profile and/o a slow release or delayed
release profile and/or a sustained release profile). The two flavor components
may be the same material or
different materials, and the independent release profiles may relate at least
in part to the chemical nature of
the flavor component and/or the manner in which the flavor component is
incorporated into the composition.
The flavor components thus may be referenced herein in relation to a first
content of a flavor component and
a second content of a flavor component. This therefore may reference a first
amount of a first flavor
component and a second amount of the same, first flavor component.
Alternatively, this may reference a first
amount of a first flavor component and a second amount of a second, different
flavor component. The fist
content or amount and the second content or amount may be different or may be
substantially the same.
Accordingly, in some embodiments, the present disclosure can provide
compositions and products comprising
a first content of a flavor component and a second content of a flavor
component wherein the first content of
the flavor component is configured for release from the composition according
to a first release rate and the
second content if the flavor component is configured for release from the oral
composition according to a
second release rate that is different from the first release rate. In one
embodiments, the first content of the
flavor component and the second content of the flavor component each comprise
the same flavor component.
In other embodiments, the first content of the flavor component and the second
content of the flavor
component each comprise a different flavor component.
Flavor release as used herein can indicate a process of transferring a flavor
from one environment to
another environment. For example, at least a portion of one or more flavor
component can be released from
the present compositions and products (e.g., from a carrier material with
which the flavor material may be
combined) into the mouth of a user where it interacts with saliva. The
solubility of a flavor component in
saliva can be a factor in the perception of the flavor by the user. Since some
flavor compounds may have
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limited solubility in water, it can be useful to provide such flavors in the
present compositions in a manner
that can improve the ability to impart the desired flavor to the user.
Further, various methods as described
herein may be utilized to provide the compositions and products in a state
that achieves the desired release
profiles of the flavor(s).
In some embodiments according to the present disclosure, flavor release
profile may be at least
partially controlled in reference to a filler/carrier material on which a
respective content of a flavor is carried.
This may include, for example, utilizing a carrier/filler that exhibits low
solubility or is substantially insoluble
in saliva, and utilizing a carrier/filler that exhibits high solubility or is
substantially completely soluble in
saliva. Thus, in some embodiments, an oral composition or product may be
configured with a first content of
a flavor component on a first carrier that exhibits low solubility or is
substantially insoluble in saliva, and a
second content of a flavor component on a second carrier component that is
exhibits high solubility or is
substantially soluble in saliva. Thus, release rate of the respective contents
of the flavor component(s) may
be relatively quicker for the content of the flavor that is present on the
substantially soluble carrier and may
be relatively slower for the content of the flavor that is present on the
substantially insoluble carrier.
In some embodiments, flavor release profile may be at least partially
controlled in reference to a
solubility characteristic of the flavor material(s). Different flavor
materials may exhibit varying degrees of
solubility in different solvents, and such degrees of solubility may be a
factor in providing a composition or
product with desired release profiles for the contents of the flavor
material(s). In some embodiments, it may
thus be desirable to utilize a first flavor component that has a first level
of solubility in a first solvent and a
second, different flavor component that has a second, different level of
solubility in the same, first solvent. In
other embodiments, it may be desirable to utilize a first flavor component
that is substantially soluble or
completely soluble in a first solvent and a second, different flavor component
that is substantially soluble or
completely soluble in a second, different solvent. In example embodiments, a
suitable composition may
include a first flavor component that is substantially soluble or complete
soluble in an aqueous solvent and a
second flavor component that is substantially soluble in an alcohol-based
solvent. In some embodiments, non-
limiting examples of suitable solvents can include propylene glycol, glycerin
(e.g., vegetable glycerin),
medium chain triglycerides (MCT's), and the like.
In some embodiments, the physical form of a flavor component may be a factor
in the release profile
of the flavor component in the composition or product. For example, in some
embodiments, at least a portion
of a flavor component can be in the form of spray-dried particles. The
substantially small size of the spray-
dried particles can provide for an increased surface area, which may provide
for a substantially rapid release
of the flavor component. If desired, at least a portion of the spray-dried
particles may be provided in admixture
with a content of a carrier/filler. Any suitable material as described herein
may be used as the carrier/filler for
admixture with the spray-dried particles. In example embodiments, the
carrier/filler may be a long chain
carbohydrate and, more particularly, may include a starch material.
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In some embodiments, the first content of a flavor component and the second
content of the flavor
component may be present in the composition/product in different physical
forms. For example, one of the
first content and the second content may be present in the form of spray-dried
particles, and the other of the
first content and the second content may be present in a different form. More
particularly, in certain
embodiments, the first content of the flavor component may be present in the
oral composition in liquid form,
while the second content of the flavor component may be partially present as
spray-dried particles. In further
embodiments, the first content of the flavor component and the second content
of the flavor component may
both be at least partially present in the oral composition in the form of
spray-dried particles. Such particles
may be provided in different sizes to provide for different release profiles
or may be provided with different
carriers/fillers to provide for different release profiles.
Compositions and products according to the present disclosure may be adapted
to or configured to
provide a desired release profile in relation a flavor component. The
foregoing discussion thus provides non-
limiting examples of configurations that can provide for desired release
profiles, including one or more of:
fast release or rapid release; slow release or sustained release; delayed
release; and the like. The release profile
may be at least partially controlled by any one or more of the chemical nature
of the flavor component, the
physical state of the flavor component in the composition/product, a
carrier/filler with which the flavor
component is combined (e.g., absorbed or adsorbed thereon), and solubility of
the flavor component. In certain
embodiments, the first content of the flavor component and the second content
of the flavor component can
be adapted to or configured to have overlapping release profiles, and such
overlapping may include providing
a relatively fast release of one content of the flavor component and providing
a relatively slow release of one
content of the flavor component. In this manner, a prolonged, overall flavor
profile may be provided and/or
it may be possible to provide different flavor sensations at different times
of use of the composition/product.
In example embodiments, a first content of a flavor component may be defined
by a first release rate,
and a second content of a flavor component may be defined by a second,
different release rate. Accordingly,
one of the first release rate and the second release rate may be defined by at
least 75% of the respective content
of the flavor component being released from the oral composition within about
10 minutes of insertion of the
oral composition into an oral cavity of a consumer, and the other of the first
release rate and the second release
can be defined by less than 25% of the respective content of the flavor
component being released from the
oral composition within 10 minutes of insertion of the oral composition into
the oral cavity of the consumer,
with the percentages described as being by weight based on the total weight of
the oral composition. In some
embodiments, one of the first release rate and the second release rate may be
defined by about 25% to about
50% of the respective content of the flavor component being released from the
oral composition within about
10 minutes of insertion of the oral composition into an oral cavity of a
consumer, and the other of the first
release rate and the second release can be defined by about 50% to about 75%
of the respective content of the
flavor component being released from the oral composition within 10 minutes of
insertion of the oral
composition into the oral cavity of the consumer, with the percentages
described as being by weight based on
the total weight of the oral composition.
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The amount of flavoring agent utilized in the mixture 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
weight percent, based on the total weight of the mixture. The foregoing ranges
may define a total amount of
5 flavor component present in the compositions/products, encompassing the
sum of the first content of flavor
material and the second content of flavor material. In other embodiments, the
foregoing ranges may define
the first content of flavor material and the second content of flavor material
independent from each other. As
such, it is understood that the first content and the second content may be
substantially equal (e.g., present in
a substantial 1 to 1 ratio). In some embodiments, the first content or the
second content may be a greater
relative amount. Likewise, a content of flavor material adapted to or
configured to provide for fast or quick
release may be greater than a content of flavor material adapted to or
configured to provide for slow or
sustained release. In other embodiments, the reverse situation may apply. The
ratio of a content of a fast
release flavor material to a content of a slow release flavor material may be
in the range of about 10 to 1 to
about 1 to 10, about 5 to 1 to about 1 to 5, about 3 to 1 to about 1 to 3, or
about 2 to 1 to about 1 to 2.
Tobacco material
In some embodiments, the present compositions and/or products 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 plain of the Nicotiana species. Example Nicotiana species include N.
tabacum, N. rustica, N. alata,
N. arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei,
N. kawakamii, 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. plumbaginifolia, N.
raimondii, N. rosulata, N. simulans,
N. stocktonii, N. suaveolens, N. umbratica, N. velutina, N. wigandioides, N.
acaulis, N. acuminata, 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 White
et al., 7.025,066 to 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 al.: 5,668,295 to Wahab
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et al.; 5,705,624 to Fitzmaurice etal.; 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 al.; US Patent
Appl. Pub. No. 2006/0236434 to
Conkling et al.; and PCT W02008/103935 to Nielsen et al. See, also, the types
of tobaccos that are set forth
in US Pat. Nos. 4,660,577 to Sensabaugh, Jr. et al.; 5,387,416 to White et
al.; and 6,730,832 to Dominguez et
al., each of which is incorporated herein by reference.
The Nicotiana species can, in some embodiments, be selected for the content of
various compounds
that are present therein. For example, plants can be selected on the basis
that those plants produce relatively
high quantities of one or more of the compounds desired to be isolated
therefrom. In certain embodiments,
plants of the Nicotiana species (e.g., Galpao comrnun 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 mixture 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 mixture 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 mixture most
preferably includes tobacco
lamina, or a tobacco lamina and stem mixture (of which at least a portion is
smoke-treated). Portions of the
tobaccos within the mixture may have processed forms, such as processed
tobacco stems (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 Burdc et al.; 5,259,403 to Guy et al.; and
5,908,032 to Poindexter, et al.; and
7,556,047 to Poindexter, et al., all of which are incorporated by reference.
In addition, the d mixture optionally
may incorporate tobacco that has been fermented. See, also, the types of
tobacco processing techniques set
forth in PCT W02005/063060 to Atchley et al., which is incorporated herein by
reference.
The tobacco material is typically used in a form that can be described as
particulate (i e , 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
comminuted, ground or pulverized into
a particulate form using equipment and techniques for grinding, milling, or
the like. Most preferably, the plant
material is relatively dry in form during grinding or milling, using equipment
such as ha mmer mills, cutter
heads, air control mills, or the like. For example, tobacco parts or pieces
may be ground or milled when the
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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 form using
equipment and techniques for grinding, milling, or the like. Most preferably,
the tobacco is relatively dry in
form during grinding or milling, using equipment such as hammer mills, cutter
heads, air control mills, or the
like. For example, tobacco parts or pieces may be ground or milled when the
moisture content thereof is less
than about 15 weight percent to less than about 5 weight percent. For example,
the tobacco plant or portion
thereof can be separated into individual parts or pieces (e.g., the leaves can
be removed from the stems, and/or
the stems and leaves can be removed from the stalk). The harvested plant or
individual parts or pieces can be
further subdivided into parts or pieces (e.g., the leaves can be shredded,
cut, comminuted, pulverized, milled
or ground into pieces or parts that can be characterized as filler-type
pieces, granules, particulates or fine
powders). The plant, or parts thereof, can be subjected to external forces or
pressure (e.g., by being pressed
or subjected to roll treatment). When carrying out such processing conditions,
the plant or portion thereof can
have a moisture content that approximates its natural moisture content (e.g.,
its moisture content immediately
upon harvest), a moisture content achieved by adding moisture to the plant or
portion thereof, or a moisture
content that results from the drying of the plant or portion thereof. For
example, powdered, pulverized, ground
or milled pieces of plants or portions thereof can have moisture contents of
less than about 25 weight percent,
often less than about 20 weight percent, and frequently less than about 15
weight percent.
For the preparation of oral products, it is typical for a harvested plant of
the Nicotiana species to be
subjected to a curing process. The tobacco materials incorporated within the
mixture 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. Int., 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 al.,
Beitrage Tabakforsch. mt., 21,
305-320 (2005) and Stanf et al., Beitrage inbakfarsch. Int , 21, 321-330
(2005), which are incorporated herein
by reference. Certain types of tobaccos can be subjected to alternative types
of curing processes, such as fire
curing or sun curing.
In certain embodiments, tobacco materials that can be employed include flue-
cured or Virginia (e.g.,
K326), burley, sun-cured (e.g., Indian Kurnool and Oriental tobaccos,
including Katerini, Prelip, Komotini,
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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 Rustica tobaccos, as well as various other rare or specialty
tobaccos and various blends of any of
the foregoing tobaccos.
The tobacco material may also have a so-called "blended" form. For example,
the tobacco material
may include a mixture of parts or pieces of flue-cured, burley (e.g., Malawi
burley tobacco) and Oriental
tobaccos (e.g., as tobacco composed of, or derived from, tobacco lamina, or a
mixture of tobacco lamina and
tobacco stem). For example, a representative blend may incorporate about 30 to
about 70 parts burley tobacco
(e.g., lamina, or 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 the tobacco material (e.g., an additive selected from
the group consisting of lysine,
glycine, histidine, alaninc, mcthioninc, cy steinc, glutamic acid, aspartic
acid, proline, phenylalanine, valine,
arginine, compositions incorporating di- and trivalent cations, asparaginase,
certain non-reducing saccharides,
certain reducing agents, phenolic compounds, certain compounds having at least
one free thiol group or
functionality, oxidizing agents, oxidation catalysts, natural plant extracts
(e.g., rosemary extract), and
combinations thereof. See, for example, the types of treatment processes
described in US Pat. Pub. Nos.
8,434,496, 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
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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 Barer; 2,170,107 to Baier; 2,274,649 to
Baicr; 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
Milian* 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 Schmekel 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 Bjorkholm, and in PCT
Publ. Appl. Nos.
W01996/031255 to Giolvas and W02018/083114 to Bjorkholm, all of which are
incorporated herein by
reference.
in sonic embodiments, the whitened tobacco material can have an iS0 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.
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 arc 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 arc 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 Brummer et al.; 4,359,059
to Brummer et al.; 4,506,682 to Muller; 4,589,428 to Keritsis; 4,605,016 to
Soga et al.; 4,716,911 to Poulose
et al.; 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 al.; 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 ct al.; 5,099,862 to White ct al.;
5,121,757 to White ct al.; 5,131,414
to Fagg; 5,131,415 to Munoz et al.; 5,148,819 to Fagg; 5,197,494 to Kramer;
5,230,354 to Smith et al.;
5,234,008 to Fagg; 5,243,999 to Smith; 5,301,694 to Raymond et al.; 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 al.; 6,131,584
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to Lauterbach; 6,298,859 to Kierulff et al.; 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 mixture, 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 mixture (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. In some embodiments, a composition or product
according to the present
disclosure may comprise no more than about 10% by weight of a tobacco
material, excluding any nicotine
component present, based on the total weight of the mixture.
Further Additives
In some embodiments, one or more further additives can be included in the
disclosed compositions
and/or products. For example, the compositions 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. Specific types of further additives that may be
included are further described
below.
in some embodiments, the compositions and products may include a content of
water. The water
content of the composition within the product, 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, can comprise less than 60%, less than 50%, less than 40%,
less than 30%, less than 20%,
less than 10%, or less than 5% by weight of water. For example, total water
content in the composition and/or
product may be in the range of about 0.1% to about 60%, about 1% to about 50%,
about 1.5% to about 40%,
or about 2% to about 25% by weight of water. In some embodiments, the
compositions and products may
include at least 1%, at least 2%, at least 5%, at least 10%, or at least 20%
by weight water.
In some embodiments, the compositions and products may include a content of
one or more organic
acids. 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 (-
0O21-1) 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 ingredient as opposed to
merely being inherently present
as a component of another ingredient (e.g., the small amount of organic acid
which may inherently be present
in an 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 arc added in the form of a salt, as described
herein below.
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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,
undecanoic acid, dodccanoic acid, stcaric acid, oleic acid, linolcic acid,
linolcnic acid, and the like. In some
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 alkyl
carboxylic or sulfonic acid is
substituted with one or more hydroxyl groups. Non-limiting examples include
glycolic acid, 4-hydroxybutyric
acid, and lactic acid. In some embodiments, an organic acid may include more
than one carboxylic acid group
or more than one sulfonic acid group (e.g., two, three, or more carboxylic
acid groups). Non-limiting examples
include oxalic acid, fumaric acid, maleic acid, and glutaric acid. In organic
acids containing multiple
carboxylic acids (e.g., from two to four carboxylic acid groups), one or more
of the carboxylic acid groups
may be esterified. Non-limiting examples include succinic acid monoethyl
ester, monomethyl fumarate,
monomethyl or dimethyl citrate, and the like.
In some embodiments, the organic acid may include more than one carboxylic
acid group and one or
more hydroxyl groups. Non-limiting examples of such acids include tartaric
acid, citric acid, and the like. In
some embodiments, the organic acid is an aryl carboxylic acid or an aryl
sulfonic acid. Non-limiting examples
of aryl carboxylic and sulfonic acids include benzoic acid, toluic acids,
salicylic acid, benzenesulfonic acid,
and p-toluenesulfonic 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. Tn 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
formate, acetate, propionate, isobutyrate, butyrate, alpha-methylbutyate,
isovalerate, beta-methylvalerate,
caproate, 2-furoate, phenylacetate, heptanoate, octanoate, nonanoate, oxalate,
malonate, glycolate, benzoate,
tartrate, levulinate, ascorbate, fumarate, citrate, malate, lactate,
aspartate, salicy-late, tosylate, succinate,
pyruvate, and the like.
The amount of organic acid present in the compositions may vary. Generally,
the compositions can
comprise from 0 to about 10% by weight of organic acid, present as one or more
organic acids, based on the
total weight of the mixture.
In some embodiments, the compositions may further comprise a salt (e.g.,
alkali metal salts), typically
employed in an amount sufficient to provide desired sensory attributes to the
compositions and products. 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 product, or about
7.5 percent or less or about 5 percent
or less (e.g., about 0.5 to about 5 percent by weight).
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The compositions and products also may include 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,
isomaltulose, mannose, galactose, lactose, stevia, honey, and the like.
Examples of artificial sweeteners
include sucralose, 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 ery-thritol, arabitol,
ribitol, isomalt, maltitol, dulcitol,
iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g.,
hydrogenated starch hydrolysates).
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 or
product on a weight basis, based
on the total weight of the composition or product.
In some embodiments, the compositions and products may include one or more
binding agents. A
binder (or co mbi nation of bi nders) may be e mployed in certain embodi me
nts, in a mounts sufficient to provide
the desired physical attributes and physical integrity to the composition, and
binders also often function as
thickening or gelling agents. Typical binders can be organic or inorganic, or
a combination thereof.
Representative binders include cellulose derivatives (e.g., cellulose ethers),
povidone, sodium alginate, starch-
based binders, pectin, gums, carrageenan, pul lul a n, ze n, and the like, and
combinations thereof. in so me
embodiments, the binder comprises pectin or carrageenan or combinations
thereof. The amount of binder
utilized can vary, but is typically up to about 30 weight percent, and certain
embodiments are characterized
by a binder content of at least about 0.1% by weight, such as about 1 to about
30% by weight, or about 5 to
about 10% by weight, based on the total weight of the composition or product.
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 gum, 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 or product.
In certain embodiments, one or more humectants may be employed in the
compositions. Examples
of humectants include, but are not limited to, glycerin, propylene glycol, and
the like. Where included, the
humectant is typically provided in an amount sufficient to provide desired
moisture attributes to the
compositions. 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
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the weight of the composition or product (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 or product.
In certain embodiments, the compositions 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 compositions
or products, 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 about 3%, or from
about 1% to about 2% by weight, based on the total weight of the compositions
or products. Non-limiting
examples of suitable buffers include alkali metals acetates, glycinates,
phosphates, glyccrophosphatcs, citrates,
carbonates, hydrogen carbonates, borates, or mixtures thereof.
In some embodiments, the compositions and products may include one or more
colorants. A colorant
may be employed in amounts sufficient to provide the desired physical
attributes to the composition or product.
Examples of colorants include various dyes and pigments, such as caramel
coloring and titanium dioxide. The
amount of colorant utilized in the compositions or products can vary, but when
present is typically up to about
3 weight percent, such as from about 0.1%, about 0.5%, or about 1%, to about
3% by weight, based on the
total weight of the composition or product.
Examples of even further types of additives that may be used in the present
compositions and products
include thickening or gelling agents (e.g., fish gelatin), emulsifiers, oral
care additives (e.g., thyme oil,
eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate and the
like), disintegration aids, zinc or
magnesium salts selected to be relatively water soluble for compositions with
greater water solubility (e.g.,
magnesium or zinc gluconate) or selected to be relatively water insoluble for
compositions with reduced water
solubility (e.g., magnesium or zinc oxide), or combinations thereof. See, for
example, those representative
components, combination of components, relative amounts of those components,
and manners and methods
for employing those components, set forth in US Pat. No. 9,237,769 to Mua et
al., US Pat. No. 7.861,728 to
Holton, Jr. et al., US Pat. App. Pub. No. 2010/0291245 to Gao et al., and US
Pat. App. Pub. No. 2007/0062549
to Holton, Jr. et al., each of which is incorporated herein by reference.
Typical inclusion ranges for such
additional additives can vary depending on the nature and function of the
additive and the intended effect on
the final mixture, with an example range of up to about 10% by weight, based
on total weight of the mixture
(e.g., about 0.1 to about 5% by weight).
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
mixture). Furthermore, the aforementioned types of additives may be
encapsulated as provided in the final
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product or mixture. Exemplary encapsulated additives are described, for
example, in W02010/132444 to
Atchley, which has been previously incorporated by reference herein.
Particles
In some embodiments, any one or more of a filler component, 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 colunm 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 sonic 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 colunui 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 analy sis may be
selected based on the granularity or
known maximum/minimum 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
analysis, wherein the column
comprises 10 sieves in sonic embodiments, the largest screen opening or mesh
sizes of the sieves used for
sieve analysis may be 1000 gm, such as 500 gm, such as 400 gm, 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
gm, such as no greater than about
500 gm, such as no greater than about 400 gm, such as no greater than about
350 um, such as no greater than
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about 300 gm. 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 gm, such
as no greater than about 500 gm, such as no greater than about 400 gm, such as
no greater than about 350 gm,
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 gm, such as no greater than about 500 gm, such as no greater than
about 400 gm, such as no
greater than about 350 gm, 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
gm, such as no greater than
about 400 gm, such as no greater than about 350 m, 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 gm,
such as no greater than about
500 gm, such as no greater than about 400 gm, such as no greater than about
350 gm, such as no greater than
about 300 p.m. 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 gm, such as no greater than about 400 gm, such as
no greater than about 350 um,
such as no greater than about 300 p.m. 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 gm, such as no greater than about 500 gm, such as no greater than
about 400 gm, such as no
greater than about 350 gm, such as no greater than about 300 gm. 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 gm, such as no greater than about
500 gm, such as no greater
than about 400 gm, such as no greater than about 350 gm, such as no greater
than about 300 gm.
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 gm to about 1000 gm,
such as from about 0.05 gm to
about 750 pm, such as from about 0.1 gm to about 500 gm, such as from about
0.25 gm to about 500 gm. 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 10 gm to about 400 gm, such as from about 50
p.m to about 350 gm, such as
from about 100 gm to about 350 pm, such as from about 200 pm to about 300 gm.
Preparation
The present disclosure may relate to one or more methods of preparing a
composition and/or product
that is adapted to or configured to be inserted into the oral cavity of a
user, and the manner by which the
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various components of the present compositions are combined may vary. As such,
an overall mixture of
various components with e.g., powdered mixture components may be relatively
uniform in nature. The
components noted above, which may be in liquid or dry solid form, can be
admixed in a pretreatment step
prior to mixture with any remaining components of the mixture, or simply mixed
together with all other liquid
or dry ingredients. The various components 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
also, for example, the types of methodologies set forth in US Pat. Nos.
4,148,325 to Solomon et al.; 6,510,855
to Korte et al.; and 6,834,654 to Williams, each of which is incorporated
herein by reference. In some
embodiments, the components forming the mixture are prepared such that the
mixture thereof may be used in
a starch molding process for forming the mixture. Manners and methods for
formulating mixtures will be
apparent to those skilled in the art. 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.
in example embodiments, a method of preparing a composition for oral use as
disclosed herein may
comprise spray-drying a liquid flavor component to form particles of the
liquid flavor component and mixing
the particles of the liquid flavor component with a long-chain carbohydrate.
For example, the long chain
carbohydrate may include a starch. Such method further may comprise adding the
particles of the liquid flavor
component mixed with the long-chain carbohydrate to a fleece.
In further example embodiments, a method of preparing a composition for oral
use as disclosed herein
can comprise combining a content of a first flavor component, a content of a
second flavor component, and a
filler to form the composition in a form suitable for insertion into an oral
cavity of a consumer. In particular,
the first content of the flavor component can be adapted to or configured to
be released from the composition
in the oral cavity of the consumer according to a first release rate, and the
second content of the flavor
component can be adapted to or configured to be released from the oral
composition in the oral cavity- of the
consumer according to a second release rate that is different from the first
release rate. In further embodiments,
prior to the combining, the first content of the flavor component may be
prepared by adsorbing or absorbing
the flavor component in or on a carrier component that is substantially
insoluble in the oral cavity of the
consumer. In other embodiments, prior to the combining, the second content of
the flavor component may be
prepared by adsorbing or absorbing the flavor component in or on a carrier
component that is substantially
soluble in the oral cavity of the consumer. In yet other embodiments, prior to
combining, the first content of
the flavor component may be prepared by dissolving the flavor component in a
first solvent, and the second
content of the flavor component may be prepared by dissolving the flavor
component in a second, different
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solvent. In still further embodiments, one of the first solvent and the second
solvent may be an aqueous
solvent, and the other of the first solvent and the second solvent may be an
alcohol-based solvent. In even
further embodiments, prior to the combining, the first content of the flavor
component may be provided in a
liquid form, and the second content of the flavor component may be provided in
the form of spray-dried
particles.
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 mixture (e.g., flavoring agents and/or
nicotine) to pass into the mouth of the
user. In certain embodiments, the product is adapted to deliver releasable
components (e.g., one or more
flavors and/or active ingredients) to a user through mucous membranes in the
user's mouth. In some instances,
said active ingredient can include but is not limited to, for example,
nicotine, and 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 mixture so that the final 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 mixtures of the present disclosure may be
dissolvable. As used herein,
the terms "dissolve," "dissolving," and "dissolvable" refer to mixtures 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 mixtures
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
seconds or less, about 30 seconds orless, or about 20 seconds or less)
Dissolution can occu r by any means,
such as melting, mechanical disruption (e.g., chewing), enzymatic or other
chemical degradation, or by
disruption of the interaction between the components of the mixture. In some
embodiments, the product can
be meltable as discussed, for example. in US Patent App. Pub. No. 2012/0037175
to Cantrell et al. In other
35 embodiments, the products do not dissolve during the product's residence
in the user's mouth.
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In one embodiment, the product comprising the composition of the present
disclosure is in the form
of a mixture disposed within a moisture-permeable container (e.g., a water-
permeable pouch). Such mixtures
in the water-permeable pouch format arc typically used by placing one pouch
containing the mixture 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 mixture therein (e.g.,
flavoring agents and/or active ingredients, such as 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
mixture. After about 10 minutes to about 60 minutes, typically about 15
minutes to about 45 minutes, of
use/enjoyment, substantial amounts of the mixture have been ingested by the
human subject, and the pouch
may be removed from the mouth of the human subject for disposal.
Accordingly, in certain embodiments, the mixture 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 mixture
to provide a pouched product configured for oral use. Certain embodiments of
the disclosure will be described
with reference to FIG. 1, and these described embodiments involve snus-type
products having an outer pouch
and containing a mixture 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 mixture/construction of such packets or
pouches, such as the container pouch
102 in the embodiment illustrated in FIG. 1, may be varied. Referring to FIG.
1, there is shown a first
embodiment of a pouched product 100. The pouched product 100 includes a
moisture-permeable container in
the form of a pouch 102, which contains a material 104 comprising a
composition as described herein. The
pouched product 100 may be an example of a product as described herein formed
at least in part from the
described compositions.
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 mixture 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
mixture readily diffuse through the
pouch and into the mouth of the user.
Non-limiting examples of suitable types of pouches arc 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
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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 mixture each may undergo complete dispersion
within the mouth of the user
during normal conditions of use, and hence the pouch and mixture both may be
ingested 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., fine 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 mixture
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 w ithi n, 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 mixture within each pouch is at least about 50
mg, for example, from about
50 mg to about 2 grams, from about 100 mg to about 1.5 grams, or from about
200 to about 700 mg. In some
smaller embodiments, the weight of the mixture 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 EF SA Journal (2004) 85, 1-32; which are
incorporated herein by reference.
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., D592,956 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
ct al.; 2009/0014450 to
Bjorkholm; 2009/0250360 to Bellamah et al.; 2009/0266837 to Gelardi et al.;
2009/0223989 to Gelardi;
2009/0230003 to Thiellier; 2010/0084424 to Gelardi; and 2010/0133140 to Bailey
et al; 2010/0264157 to
Bailey et al.; and 2011/0168712 to Bailey et al. which are incorporated herein
by reference.
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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.
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