U.S. patent application number 17/836661 was filed with the patent office on 2022-09-29 for oral product and method of manufacture.
The applicant listed for this patent is NICOVENTURES TRADING LIMITED. Invention is credited to John E. Bunch, Anthony Richard Gerardi, Darrell Eugene Holton, JR., Ronald K. Hutchens, Luis Monsalud, John Paul Mua, Thomas H. Poole, Frank Kelley St. Charles.
Application Number | 20220304364 17/836661 |
Document ID | / |
Family ID | 1000006451986 |
Filed Date | 2022-09-29 |
United States Patent
Application |
20220304364 |
Kind Code |
A1 |
Mua; John Paul ; et
al. |
September 29, 2022 |
ORAL PRODUCT AND METHOD OF MANUFACTURE
Abstract
A composition is provided, the composition including a binder
system in an amount of at least about 5% by weight, based on the
total weight of the composition, and at least one active ingredient
and/or flavoring agent. The binder system includes at least one
thermoplastic binding material and at least one plasticizer. The
composition is typically substantially free of unbleached tobacco
material, excluding any nicotine component present.
Inventors: |
Mua; John Paul; (Advance,
NC) ; Bunch; John E.; (Cary, NC) ; Gerardi;
Anthony Richard; (Winston-Salem, NC) ; Holton, JR.;
Darrell Eugene; (Clemmons, NC) ; Hutchens; Ronald
K.; (East Bend, NC) ; Monsalud; Luis;
(Kernersville, NC) ; Poole; Thomas H.;
(Winston-Salem, NC) ; St. Charles; Frank Kelley;
(Bowling Green, KY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
NICOVENTURES TRADING LIMITED |
London |
|
GB |
|
|
Family ID: |
1000006451986 |
Appl. No.: |
17/836661 |
Filed: |
June 9, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/IB2020/061616 |
Dec 8, 2020 |
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17836661 |
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16707580 |
Dec 9, 2019 |
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PCT/IB2020/061616 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A24B 15/303 20130101;
A24B 15/403 20130101; A24B 15/16 20130101; A24B 15/308
20130101 |
International
Class: |
A24B 15/16 20060101
A24B015/16; A24B 15/30 20060101 A24B015/30; A24B 15/40 20060101
A24B015/40 |
Claims
1. A composition, comprising: a thermoplastic binder system in an
amount of at least about 5% percent by weight, based on total dry
weight of the composition; and at least one of a flavoring agent
and an active ingredient; wherein the thermoplastic binder system
comprises at least one thermoplastic polymer and at least one
plasticizer; wherein the composition is substantially free of
unbleached tobacco material, excluding any nicotine component
present.
2. The composition of claim 1, wherein the at least one
thermoplastic polymer is selected from the group consisting of
cellulose ethers, polyvinyl alcohol, polyvinyl acetate, aliphatic
polyester, polyvinyl polypyrrolidone, maltodextrin, pullulan,
polyethylene oxide, natural gums, and blends thereof.
3. The composition of claim 1, wherein the at least one
thermoplastic polymer is a cellulose ether selected from the group
consisting of hydroxypropyl cellulose, ethylcellulose,
hydroxypropyl methylcellulose, and blends thereof.
4. The composition of claim 1, wherein the at least one
thermoplastic polymer exhibits thermoplastic behavior at
temperatures less than about 100.degree. C.
5. The composition of claim 1, wherein the thermoplastic binder
system comprises at least one of pullulan, gum arabic, and xanthan
gum.
6. The composition of claim 1, wherein the at least one plasticizer
comprises a plasticizer selected from the group consisting of
glycerin, propylene glycol, polypropylene glycol, polyethylene
glycol, sorbitol, maltitol, polyglycitol, erythritol, isomalt,
xylitol, mannitol, and blends thereof.
7. The composition of claim 1, wherein the at least one plasticizer
is in the form of a plasticizer blend comprising: at least one of
sorbitol, maltitol, and polyglycitol; at least one of erythritol,
isomalt, xylitol, and mannitol; and at least one of glycerin,
propylene glycol, polypropylene glycol, and polyethylene
glycol.
8. The composition of claim 1, wherein the at least one
thermoplastic polymer has a softening temperature, and wherein the
at least one plasticizer is capable of lowering the softening
temperature by about 20.degree. C. or more.
9. The composition of claim 1, wherein the active ingredient is
selected from the group consisting of a nicotine component,
botanicals, nutraceuticals, stimulants, amino acids, vitamins,
cannabinoids cannabimimetics, terpenes, and combinations
thereof.
10. The composition of claim 1, comprising from about 0.001 to
about 10% by weight of a nicotine component, calculated as the free
base and based on the total dry weight of the composition.
11. The composition of claim 1, wherein the composition is
substantially free of tobacco material, excluding any nicotine
component present.
12. The composition of claim 1, wherein the thermoplastic binder
system is present in an amount of at least about 20% percent by
weight, based on total dry weight of the composition.
13. The composition of claim 1, comprising: about 5 to about 50% by
dry weight thermoplastic binding system; about 5 to about 75% by
dry weight of filler; about 0.1 to about 5% by dry weight of
sweetener; about 0.5 to about 7.5% by dry weight of salt; and about
1 to about 10% by dry weight of one or more active ingredients,
flavoring agents, or combinations thereof.
14. A method of forming a composition, comprising: contacting a
thermoplastic binder system with at least one of an active
ingredient and a flavorant to provide a mixture; subjecting the
mixture to an elevated temperature; forming the mixture into a
desired shape of an oral product; and cooling the oral product;
wherein the thermoplastic binder system comprises at least one
thermoplastic polymer and at least one plasticizer; wherein the
composition is substantially free of unbleached tobacco material,
excluding any nicotine component present.
15. The method of claim 14, wherein the at least one thermoplastic
polymer is selected from the group consisting of cellulose ethers,
polyvinyl alcohol, polyvinyl acetate, aliphatic polyester,
polyvinyl polypyrrolidone, maltodextrin, pullulan, polyethylene
oxide, natural gums, and blends thereof.
16. The method of claim 14, wherein the at least one thermoplastic
polymer exhibits thermoplastic behavior at temperatures less than
about 100.degree. C.
17. The method of claim 14, wherein the at least one plasticizer
comprises a plasticizer selected from the group consisting of
glycerin, propylene glycol, polypropylene glycol, polyethylene
glycol, sorbitol, maltitol, polyglycitol, erythritol, isomalt,
xylitol, mannitol, and blends thereof.
18. The method of claim 14, wherein the active ingredient is
selected from the group consisting of a nicotine component,
botanicals, nutraceuticals, stimulants, amino acids, vitamins,
cannabinoids, cannabimimetics, terpenes, and combinations
thereof.
19. The method of claim 14, wherein the composition is
substantially free of tobacco material, excluding any nicotine
component present.
20. The method of claim 14, wherein the thermoplastic binder system
is present in an amount of at least about 10% percent by weight,
based on total dry weight of the composition.
Description
FIELD OF THE DISCLOSURE
[0001] 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
[0002] Tobacco may be enjoyed in a so-called "smokeless" form.
Particularly popular smokeless tobacco products are employed by
inserting some form of processed tobacco or tobacco-containing
formulation into the mouth of the user. Conventional formats for
such smokeless tobacco products include moist snuff, snus, and
chewing tobacco, which are typically formed almost entirely of
particulate, granular, or shredded tobacco, and which are either
portioned by the user or presented to the user in individual
portions, such as in single-use pouches or sachets. Other
traditional forms of smokeless products include compressed or
agglomerated forms, such as plugs, tablets, or pellets. Alternative
product formats, such as tobacco-containing gums and mixtures of
tobacco with other plant materials, are also known. See for
example, the types of smokeless tobacco formulations, ingredients,
and processing methodologies set forth in U.S. Pat. Nos. 1,376,586
to Schwartz; U.S. Pat. No. 4,513,756 to Pittman et al.; U.S. Pat.
No. 4,528,993 to Sensabaugh, Jr. et al.; U.S. Pat. No. 4,624,269 to
Story et al.; U.S. Pat. No. 4,991,599 to Tibbetts; U.S. Pat. No.
4,987,907 to Townsend; U.S. Pat. No. 5,092,352 to Sprinkle, III et
al.; U.S. Pat. No. 5,387,416 to White et al.; U.S. Pat. No.
6,668,839 to Williams; U.S. Pat. No. 6,834,654 to Williams; U.S.
Pat. No. 6,953,040 to Atchley et al.; U.S. Pat. No. 7,032,601 to
Atchley et al.; and U.S. Pat. No. 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 WO2004/095959 to Arnarp et al., each of which
is incorporated herein by reference. It is noted that certain types
of oral products that contain tobacco substitutes (or combinations
of tobacco and tobacco substitutes) also have been proposed.
Certain types of oral products have been employed to contain
nicotine, such as those used for nicotine replacement therapy (NRT)
types of products (e.g., a pharmaceutical product distributed under
the tradename ZONNIC.RTM. by Niconovum AB).
[0003] Smokeless tobacco product configurations that combine
tobacco material with various binders and fillers have been
proposed more recently, with example product formats including
lozenges, pastilles, gels, extruded forms, and the like. See, for
example, the types of products described in US Patent App. Pub.
Nos. 2008/0196730 to Engstrom et al.; 2008/0305216 to Crawford et
al.; 2009/0293889 to Kumar et al.; 2010/0291245 to Gao et al;
2011/0139164 to Mua et al.; 2012/0037175 to Cantrell et al.;
2012/0055494 to Hunt et al.; 2012/0138073 to Cantrell et al.;
2012/0138074 to Cantrell et al.; 2013/0074855 to Holton, Jr.;
2013/0074856 to Holton, Jr.; 2013/0152953 to Mua et al.;
2013/0274296 to Jackson et al.; 2015/0068545 to Moldoveanu et al.;
2015/0101627 to Marshall et al.; and 2015/0230515 to Lampe et al.,
each of which is incorporated herein by reference.
[0004] Certain types of pouches or sachets have been employed to
contain compositions adapted for oral use. See for example, the
types of representative smokeless tobacco products, as well as the
various smokeless tobacco formulations, ingredients and processing
methodologies, referenced in the background art set forth in U.S.
Pat. Pub. Nos. 2011/0303511 to Brinkley et al. and 2013/0206150 to
Duggins et al.; which are incorporated herein by reference. During
use, those pouches or sachets are inserted into the mouth of the
user, and water soluble components contained within those pouches
or sachets are released as a result of interaction with saliva.
[0005] Certain commercially available smokeless tobacco products,
such as products commonly referred to as "snus," comprise ground
tobacco materials incorporated within sealed pouches.
Representative types of snus products have been manufactured in
Europe, particularly in Sweden, by or through companies such as
Swedish Match AB (e.g., for brands such as General, Ettan,
Goteborgs Rape and Grovsnus); Fiedler & Lundgren AB (e.g., for
brands such as Lucky Strike, Granit, Krekt and Mocca); JTI Sweden
AB (e.g., for brands such as Gustavus) and Rocker Production AB
(e.g., for brands such as Rocker). Other types of snus products
have been commercially available in the U.S.A. through companies
such as Philip Morris USA, Inc. (e.g., for brands such as Marlboro
Snus); U.S. Smokeless Tobacco Company (e.g., for brands such as
SKOAL Snus) and R. J. Reynolds Tobacco Company (e.g., for brands
such as CAMEL Snus). See also, for example, Bryzgalov et al.,
1N1800 Life Cycle Assessment, Comparative Life Cycle Assessment of
General Loose and Portion Snus (2005); which is incorporated herein
by reference.
[0006] Various types of snus products, as well as components for
those products and methods for processing components associated
with those products, have been proposed. See, for example, U.S.
Pat. No. 8,067,046 to Schleef et al. and U.S. Pat. No. 7,861,728 to
Holton, Jr. et al.; US Pat. Pub. Nos. 2004/0118422 to Lundin et
al.; 2008/0202536 to Torrence et al.; 2009/0025738 to Mua et al.;
2011/0180087 to Gee et al.; 2010/0218779 to Zhuang et al.;
2010/0294291 to Robinson et al.; 2010/0300465 to Zimmermann;
2011/0061666 to Dube et al.; 2011/0303232 to Williams et al.;
2012/0067362 to Mola et al.; 2012/0085360 to Kawata et al.;
2012/0103353 to Sebastian et al. and 2012/0247492 to Kobal et al.;
and PCT Pub. Nos. WO 05/063060 to Atchley et al. and WO 08/56135 to
Onno; which are incorporated herein by reference. In addition,
certain quality standards associated with snus manufacture have
been assembled as a so-called GothiaTek standard. Furthermore,
various manners and methods useful for the production of snus types
of products have been proposed. See, for example, U.S. Pat. No.
4,607,479 to Linden and U.S. Pat. No. 4,631,899 to Nielsen; and US
Pat. Pub. Nos. 2008/0156338 to Winterson et al.; 2010/0018539 to
Brinkley et al.; 2010/0059069 to Boldrini; 2010/0071711 to
Boldrini; 2010/0101189 to Boldrini; 2010/0101588 to Boldrini;
2010/0199601 to Boldrini; 2010/0200005 to Fallon; 2010/0252056 to
Gruss et al.; 2011/0284016 to Gunter et al.; 2011/0239591 to Gruss
et al.; 2011/0303511 to Brinkley et al.; 2012/0055493 to Novak III
et al. and 2012/0103349 to Hansson et al.; and PCT Pub. Nos. WO
2008/081341 to Winterson et al. and WO 2008/146160 to Cecil et al.;
which are incorporated herein by reference. Additionally, snus
products can be manufactured using equipment such as that available
as SB 51-1/T, SBL 50 and SB 53-2/T from Merz Verpackungmaschinen
GmBH.
BRIEF SUMMARY
[0007] The present disclosure relates to an oral product adapted
for release of a water-soluble component therefrom. The oral
products described herein can incorporate binder systems, wherein
the binder system possesses or exhibits thermoplastic properties,
characteristics or behaviors. For example, the binder system can
incorporate at least one type of binding agent that exhibits
thermoplastic properties, characteristics or behaviors (e.g., the
binding agent can be composed of at least one thermoplastic
polymeric material). Additionally, the binder system can
incorporate ingredients or materials so as to provide a binding
agent that exhibits thermoplastic characteristics (e.g., the
binding agent can be composed of at least one thermoplastic binding
material in combination with a plasticizer). In various
embodiments, the thermoplastic binder system can comprise at least
one thermoplastic polymer, at least one additional binding
material, and at least one plasticizer.
[0008] In certain embodiments, the oral product composition can
contain a tobacco-derived product, such as a particulate tobacco
material, nicotine, particulate non-tobacco material (e.g.,
microcrystalline cellulose) that has been treated to contain
nicotine and/or flavoring agents, or fibrous plant material (e.g.,
beet pulp fiber) treated to contain a tobacco extract. In various
embodiments, the oral product is a smokeless tobacco product or
nicotine replacement therapy product.
[0009] The invention includes, without limitation, the following
embodiments.
[0010] Embodiment 1: A composition, comprising: a thermoplastic
binder system in an amount of at least about 5% percent by weight,
based on total dry weight of the composition; and at least one of a
flavoring agent and an active ingredient; wherein the thermoplastic
binder system comprises at least one thermoplastic polymer and at
least one plasticizer; wherein the composition is substantially
free of unbleached tobacco material, excluding any nicotine
component present.
[0011] Embodiment 2: A composition according to embodiment 1,
wherein the at least one thermoplastic polymer is selected from the
group consisting of cellulose ethers, polyvinyl alcohol, polyvinyl
acetate, aliphatic polyester, polyvinyl polypyrrolidone,
maltodextrin, pullulan, polyethylene oxide, natural gums, and
blends thereof.
[0012] Embodiment 3: A composition according to any of embodiments
1-2, wherein the at least one thermoplastic polymer is a cellulose
ether selected from the group consisting of hydroxypropyl
cellulose, ethylcellulose, hydroxypropyl methylcellulose, and
blends thereof.
[0013] Embodiment 4: A composition according to any of embodiments
1-3, wherein the at least one thermoplastic polymer exhibits
thermoplastic behavior at temperatures less than about 100.degree.
C.
[0014] Embodiment 5: A composition according to any of embodiments
1-4, wherein the thermoplastic binder system comprises at least one
of pullulan, gum arabic, and xanthan gum.
[0015] Embodiment 6: A composition according to any of embodiments
1-5, wherein the at least one plasticizer comprises a plasticizer
selected from the group consisting of glycerin, propylene glycol,
polypropylene glycol, polyethylene glycol, sorbitol, maltitol,
polyglycitol, erythritol, isomalt, xylitol, mannitol, and blends
thereof.
[0016] Embodiment 7: A composition according to any of embodiments
1-6, wherein the at least one plasticizer is in the form of a
plasticizer blend comprising: at least one of sorbitol, maltitol,
and polyglycitol; at least one of erythritol, isomalt, xylitol, and
mannitol; and at least one of glycerin, propylene glycol,
polypropylene glycol, and polyethylene glycol.
[0017] Embodiment 8: A composition according to any of embodiments
1-7, wherein the at least one thermoplastic polymer has a softening
temperature, and wherein the at least one plasticizer is capable of
lowering the softening temperature by about 20.degree. C. or
more.
[0018] Embodiment 9: A composition according to any of embodiments
1-8, wherein the active ingredient is selected from the group
consisting of a nicotine component, botanicals, nutraceuticals,
stimulants, amino acids, vitamins, cannabinoids cannabimimetics,
terpenes, and combinations thereof.
[0019] Embodiment 10: A composition according to any of embodiments
1-9, comprising from about 0.001 to about 10% by weight of a
nicotine component, calculated as the free base and based on the
total dry weight of the composition.
[0020] Embodiment 11: A composition according to any of embodiments
1-10, wherein the composition is substantially free of tobacco
material, excluding any nicotine component present.
[0021] Embodiment 12: A composition according to any of embodiments
1-11, wherein the thermoplastic binder system is present in an
amount of at least about 20% percent by weight, based on total dry
weight of the composition.
[0022] Embodiment 13: A composition according to any of embodiments
1-12, comprising: about 5 to about 50% by dry weight thermoplastic
binding system; about 5 to about 75% by dry weight of filler; about
0.1 to about 5% by dry weight of sweetener; about 0.5 to about 7.5%
by dry weight of salt; and about 1 to about 10% by dry weight of
one or more active ingredients, flavoring agents, or combinations
thereof.
[0023] Embodiment 14: A method of forming a composition,
comprising: contacting a thermoplastic binder system with at least
one of an active ingredient and a flavorant to provide a mixture;
subjecting the mixture to an elevated temperature; forming the
mixture into a desired shape of an oral product; and cooling the
oral product; wherein the thermoplastic binder system comprises at
least one thermoplastic polymer and at least one plasticizer;
wherein the composition is substantially free of unbleached tobacco
material, excluding any nicotine component present.
[0024] Embodiment 15: A method according to embodiment 14, wherein
the at least one thermoplastic polymer is selected from the group
consisting of cellulose ethers, polyvinyl alcohol, polyvinyl
acetate, aliphatic polyester, polyvinyl polypyrrolidone,
maltodextrin, pullulan, polyethylene oxide, natural gums, and
blends thereof.
[0025] Embodiment 16: A method according to any of embodiments
14-15, wherein the at least one thermoplastic polymer exhibits
thermoplastic behavior at temperatures less than about 100.degree.
C.
[0026] Embodiment 17: A method according to any of embodiments
14-16, wherein the at least one plasticizer comprises a plasticizer
selected from the group consisting of glycerin, propylene glycol,
polypropylene glycol, polyethylene glycol, sorbitol, maltitol,
polyglycitol, erythritol, isomalt, xylitol, mannitol, and blends
thereof.
[0027] Embodiment 18: A method according to any of embodiments
14-17, wherein the active ingredient is selected from the group
consisting of a nicotine component, botanicals, nutraceuticals,
stimulants, amino acids, vitamins, cannabinoids cannabimimetics,
terpenes, and combinations thereof.
[0028] Embodiment 19: A method according to any of embodiments
14-18, wherein the composition is substantially free of tobacco
material, excluding any nicotine component present.
[0029] Embodiment 20: A method according to any of embodiments
14-19, wherein the thermoplastic binder system is present in an
amount of at least about 10% percent by weight, based on total dry
weight of the composition.
[0030] Embodiment 21: An oral product prepared according to the
method of any of embodiments 14-20.
[0031] These and other features, aspects, and advantages of the
disclosure will be apparent from a reading of the following
detailed description. The invention includes any combination of
two, three, four, or more of the above-noted embodiments as well as
combinations of any two, three, four, or more features or elements
set forth in this disclosure, regardless of whether such features
or elements are expressly combined in a specific embodiment
description herein. This disclosure is intended to be read
holistically such that any separable features or elements of the
disclosed invention, in any of its various aspects and embodiments,
should be viewed as intended to be combinable unless the context
clearly dictates otherwise.
DETAILED DESCRIPTION
[0032] The present invention now will be described more fully
hereinafter. This invention may, however, be embodied in many
different forms and should not be construed as limited to the
embodiments set forth herein; rather, these embodiments are
provided so that this disclosure will be thorough and complete, and
will fully convey the scope of the invention to those skilled in
the art. As used in this specification and the claims, the singular
forms "a," "an," and "the" include plural referents unless the
context clearly dictates otherwise.
[0033] The disclosure generally provides products 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 components to a user through mucous membranes in
the user's mouth and, in some instances, said component is an
active ingredient (including, but not limited to, for example,
nicotine) that can be absorbed through the mucous membranes in the
mouth when the product is used.
[0034] In particular, the disclosure provides products in the form
of a mixture of one or more components, including at least one
active agent and/or at least one flavorant and a binder system. The
active agent(s) and/or flavorant(s), as well as any other suitable
ingredients, are processed in the presence of a binder system
during production or assembly of the oral product. In certain
preferred embodiments, the binder system possesses or exhibits
thermoplastic properties, characteristics or behaviors. See, e.g.,
the oral products and binder systems described in U.S. Pat. Pub.
No. 2011/0220130 to Mua et al., which is herein incorporated by
reference in its entirety.
Oral Product Composition
[0035] The oral products described herein generally comprise a
mixture that is capable of being processed, extruded, and/or molded
into a final shape.
Binding agents
[0036] The composition incorporates a binder system. The binder
system may be employed in certain embodiments, in amounts
sufficient to provide the desired physical attributes and physical
integrity to the mixture. Binders also often function as thickening
or gelling agents. The binder systems disclosed herein include at
least one type of binding agent that exhibits thermoplastic
properties, characteristics, or behaviors (e.g., the binding agent
can include at least one thermoplastic polymer, at least one
thermoplastic binding material, and/or at least one plasticizing
agent). In some embodiments, the binder system includes ingredients
or materials which in combination provide a binding agent that
exhibits thermoplastic characteristics. The amount of thermoplastic
binder system material employed within embodiments of the oral
products described herein typically is at least about 5 percent, at
least about 10 percent, and often at least about 20 percent, of the
final formed product, on a dry weight basis. The amount of
thermoplastic binder system material employed within the mixtures
described herein generally is less than about 50 percent, and can
be less than about 35 percent, less than about 30 percent, or less
than about 25 percent of the final formed product, on a dry weight
basis. In some embodiments, the amount of binder system in the
mixture can be present in an amount of about 5 to about 50 weight
percent, about 10 to about 45 weight percent, or about 20 to about
40 weight percent, based on the total dry weight of the
mixture.
[0037] The ingredient materials of the thermoplastic binder system
can vary. The thermoplastic binder systems described herein include
at least one thermoplastic polymer. The term thermoplastic as used
herein refers to a property of an ingredient (e.g., a polymeric
material) where upon heating, the ingredient softens or melts into
a liquid that when cooled, hardens or forms a gel. For example, a
polymeric material that comprises thermoplastic properties,
characteristics or behaviors softens or melts when exposed to heat,
and then returns to its original physical type of condition when
cooled (e.g., to about ambient temperature). As such, a
thermoplastic binding agent can be contacted with an active
agent(s) and/or flavorant(s) and various other ingredients, mixed
so as to provide physical contact of the binding agent with those
ingredients, heated so as to soften or liquefy the polymeric
material of the thermoplastic binder system, and then cooled so as
to harden the softened thermoplastic polymeric material (and hence
result in an oral product that is formed from the ingredients and
that has a desirable physical integrity). For purposes of the
present disclosure, desirable thermoplastic polymeric materials
useful in the binder systems and oral products described herein
generally soften or melt (and hence exhibit thermoplastic
characteristics) at temperatures of about 50.degree. C. or greater,
about 60.degree. C. or greater, about 70.degree. C. or greater,
about 100.degree. C. or greater, about 120.degree. C. or greater,
about 150.degree. C. or greater, or about 180.degree. C. or
greater. In various embodiments, the thermoplastic polymer can have
a melting point of about 200.degree. C. or less, about 300.degree.
C. or less, 250.degree. C. or less, about 200.degree. C. or less,
about 160.degree. C. or less, about 150.degree. C. or less, about
140.degree. C. or less, about 120.degree. C. or less, about
100.degree. C. or less, or about 90.degree. C. or less. In some
embodiments, the thermoplastic polymer can have a melting point in
the range of about 100.degree. C. to about 350.degree. C., or about
200.degree. C. to about 300.degree. C.
[0038] Example thermoplastic polymers include various polyolefin
and polyester materials. In certain embodiments, the thermoplastic
polymer of the binder system can be a biodegradable polymer, such
as an aliphatic polyester. Example aliphatic polyesters include
polyglycolic acid (PGA), polylactic acid (PLA) (e.g., poly(L-lactic
acid) or poly(DL-lactic acid)), polyhydroxyalkanoates (PHAs) such
as polyhydroxypropionate, polyhydroxyvalerate, polyhydroxybutyrate,
polyhydroxyhexanoate, and polyhydroxyoctanoate, polycaprolactone
(PCL), polybutylene succinate, polybutylene succinate adipate, and
copolymers thereof (e.g., polyhydroxybutyrate-co-hydroxyvalerate
(PHBV)). In some embodiments, the thermoplastic polymer can include
polyethylene oxide, certain cellulose ethers (e.g., hydroxypropyl
cellulose, ethylcellulose and hydroxypropyl methylcellulose),
polyvinyl alcohol and polyvinyl acetate.
[0039] In certain embodiments, the binder system can include a
thermoplastic polymer selected from the group consisting of
polyvinyl polypyrrolidone, methylcellulose, maltodextrin, pullulan,
certain modified starches and high molecular weight propylene
glycols (e.g., propylene glycols having molecular weights above
about 4000 Da), and combinations thereof. In certain embodiments,
the binder system 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.
[0040] In various embodiments of the oral products described
herein, a thermoplastic polymer can be present in an amount of at
least about 5 percent, at least about 10 percent, or at least about
15 percent of the final formed product, on a dry weight basis. In
some embodiments, the amount of thermoplastic polymeric material
employed within a representative oral product generally is less
than about 30 percent, less than about 25 percent, less than about
20 percent, or less than about 15 percent of the final formed
product, on a dry weight basis.
[0041] The amount of thermoplastic binding materials employed
within a representative processed oral product of the present
disclosure can be at least about 5 percent, at least about 10
percent, or at least about 15 percent of the final formed product,
on a dry weight basis. The amount of thermoplastic binding material
employed within a representative processed oral product of the
present disclosure generally can be about 40 percent or less, about
30 percent or less, about 25 percent or less, about 20 percent or
less, or about 15 percent or less of the final formed product, on a
dry weight basis.
[0042] The binder system can incorporate a compound that can be
characterized as a plasticizer. For example, the aforementioned
thermoplastic binding materials can be combined with, and processed
in combination with, at least one plasticizer. In some oral
products, a binder system can be employed with a plasticizer blend.
In some embodiments, the plasticizer blend can be pre-mixed
separate from the mixing with a binder system or other
ingredients.
[0043] In various embodiments, the plasticizer can be organic
non-polymeric materials. For example, the plasticizer can include
glycerin, propylene glycol, polyethylene glycol, polypropylene
glycol, and combinations thereof. In certain embodiments, the
plasticizer can comprise a medium and/or high molecular weight
polyol-type compounds. Some example representative polyols include
maltitol, sorbitol, isomalt, erythritol, xylitol, mannitol,
polyglycitol, and combinations thereof.
[0044] In some embodiments, the binder system can include a
plasticizer blend. The plasticizer blend can comprise various
polyols, such as maltitol, sorbitol, isomalt, erythritol, xylitol,
mannitol, and polyglycitol;
[0045] glycerin; propylene glycol; polyethylene glycol;
polypropylene glycol; and combinations thereof. In some plasticizer
blends, a syrup or liquid form of a polyol can be employed, for
example, maltitol syrup or sorbitol liquid. The syrup or liquid
form of the polyol can include at least 20 percent solids, at least
35 percent solids, at least 50 percent solids, at least 60 percent
solids, at least 70 percent solids, or at least 75 percent
solids.
[0046] The amount of plasticizer utilized within the oral product
can vary. When employed, the amount of plasticizer present within a
representative oral product can be at least about 1 percent, at
least about 2 percent, at least about 3 percent, at least about 5
percent, at least about 10 percent, or at least about 15 percent of
the final formed product, on a dry weight basis. When employed, the
amount of plasticizer employed within a representative processed
oral product typically is about 50 percent or less, about 35
percent or less, about 25 percent or less, 15 percent or less,
about 10 percent or less, or about 5 percent or less, of the final
formed product, on a dry weight basis.
[0047] In some embodiments, the plasticizer (including blends
thereof) can be prepared separately and then added to a premixed
oral product mixture including a binder system as described herein.
The plasticizer can be prepared by mixing its granular components
with water. The plasticizer can be heated for a period of time and
stirred until the plasticizer blend exhibits clear, viscous liquid
properties. In some embodiments, the plasticizer can be prepared
without the mixing of its granular components with water. By mixing
and heating the plasticizer separate from the oral product mixture
and binding system, the plasticizer can be heated to a higher
temperature without concern of charring and/or scalding the other
components of the oral product composition. Upon subjecting the
plasticizer to a higher temperature, the plasticizer blend can
exhibit plastic-type or visco-elastic properties. The viscosity of
such a plasticizer at about 25.degree. C. is typically less than
about 25,000 centipoise (cp), and often less than about 15,000 cp.
When employed in an oral product, the viscosity of the plasticizer
at about 25.degree. C. is about 100 cp or greater, or about 1500 cp
or greater. Without being limited by theory, an oral product
incorporating a plasticizer having such plastic-like or
visco-elastic properties can provide a chewable tobacco product
that does not crumble or fall apart in a user's mouth upon light to
moderate chewing. Such a chewable tobacco product can change shape
in the mouth when lightly to moderately chewed without
disintegrating into small particles.
[0048] The selection and amount of plasticizer(s) or plasticizer
blend can be such that the softening temperature of the
thermoplastic binding material is lowered. For example, HPC
(KLUCEL) a thermoplastic material, has a melting point of about
370.degree. C., which is lowered to less than 250.degree. C. in the
presence of either the plasticizer propylene glycol (PG) or
glycerol. HPMC (BENECEL E4M) has a melting point of about
200.degree. C., which is lowered to less than 150.degree. C. in the
presence of PG or glycerol. The above involve the inclusion of
glycerol or PG at about 10-20% by weight. Without being limited by
theory, the plasticizer can act to facilitate hydration, and hence
facilitate liquification of the thermoplastic binding material. As
such, formation of the oral product at relatively low temperatures
can be facilitated (e.g., at a temperature lower than the normal
melting point of the thermoplastic binding material). In this way,
the binder system within an oral formulation of the present
disclosure can lower the operating temperature at which the oral
formulation is formed, thereby reducing and/or avoiding the
scalding and/or charring of the other materials in the mixture. In
addition, the plasticizer can reduce the need for large amounts of
moisture, or other liquid carrier materials, that in tum need to be
boiled off through drying stages after formation of the oral
product.
[0049] Thermoplastic polymeric materials, plasticizers, and
mixtures of these materials can be processed at the processing and
operating conditions described in more detail below. Such
thermoplastic polymeric materials and plasticizers typically
exhibit thermoplastic characteristics at temperatures below about
140.degree. C., below about 120.degree. C., or below about
100.degree. C.
Active ingredient
[0050] The composition as disclosed herein includes one or more
active ingredients. As used herein, an "active ingredient" refers
to one or more substances belonging to any of the following
categories: API (active pharmaceutical ingredient), food additives,
natural medicaments, and naturally occurring substances that can
have an effect on humans. Example active ingredients include any
ingredient known to impact one or more biological functions within
the body, such as ingredients that furnish pharmacological activity
or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease, or which affect the structure
or any function of the body of humans (e.g., provide a stimulating
action on the central nervous system, have an energizing effect, an
antipyretic or analgesic action, or an otherwise useful effect on
the body). In some embodiments, the active ingredient may be of the
type generally referred to as dietary supplements, nutraceuticals,
"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.
[0051] Non-limiting examples of active ingredients include those
falling in the categories of botanical ingredients, stimulants,
amino acids, nicotine components, and/or pharmaceutical,
nutraceutical, and medicinal ingredients (e.g., vitamins, such as
A, B3, B6, B12, and C, and/or cannabinoids, such as
tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these
categories is further described herein below. The particular choice
of active ingredients will vary depending upon the desired flavor,
texture, and desired characteristics of the particular product.
[0052] 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.
[0053] 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, 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
[0054] In some embodiments, the active ingredient comprises a
botanical ingredient. As used herein, the term "botanical
ingredient" or "botanical" refers to any plant material or
fungal-derived material, including plant material in its natural
form and plant material derived from natural plant materials, such
as extracts or isolates from plant materials or treated plant
materials (e.g., plant materials subjected to heat treatment,
fermentation, bleaching, or other treatment processes capable of
altering the physical and/or chemical nature of the material). For
the purposes of the present disclosure, a "botanical" includes, but
is not limited to, "herbal materials," which refer to
seed-producing plants that do not develop persistent woody tissue
and are often valued for their medicinal or sensory characteristics
(e.g., teas or tisanes). Reference to botanical material as
"non-tobacco" is intended to exclude tobacco materials (i.e., does
not include any Nicotiana species). In some embodiments, the
compositions as disclosed herein can be characterized as free of
any tobacco material (e.g., any embodiment as disclosed herein may
be completely or substantially free of any tobacco material). By
"substantially free" is meant that no tobacco material has been
intentionally added. For example, certain embodiments can be
characterized as having less than 0.001% by weight of tobacco, or
less than 0.0001%, or even 0% by weight of tobacco.
[0055] When present, a botanical is typically at a concentration of
from about 0.01% w/w to about 10% by weight, such as, e.g., from
about 0.01% w/w, about 0.05%, about 0.1%, or about 0.5%, to about
1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%,
about 8%, about 9%, or about 10%, about 11%, about 12%, about 13%,
about 14%, or about 15% by weight, based on the total weight of the
composition.
[0056] 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 ashwagandha, Bacopa monniera,
baobab, basil, Centella asiatica, Chai-hu, chamomile, cherry
blossom, chlorophyll, cinnamon, citrus, cloves, cocoa, cordyceps,
curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential
oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba,
ginseng (e.g., Panax ginseng), green tea, Griffonia simplicifolia,
guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai
ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein,
maca, matcha, Nardostachys chinensis, oil-based extract of Viola
odorata, peppermint, quercetin, resveratrol, Rhizoma gastrodiae,
Rhodiola, rooibos, rose essential oil, rosemary, Sceletium
tortuosum, Schisandra, Skullcap, spearmint extract, Spikenard,
terpenes, tisanes, turmeric, Turnera aphrodisiaca, valerian, white
mulberry, and Yerba mate.
[0057] In some embodiments, the active ingredient comprises lemon
balm. Lemon balm (Melissa officinalis) is a mildly lemon-scented
herb from the same family as mint (Lamiaceae). The herb is native
to Europe, North Africa, and West Asia. The tea of lemon balm, as
well as the essential oil and the extract, are used in traditional
and alternative medicine. In some embodiments, the active
ingredient comprises lemon balm extract. In some embodiments, the
lemon balm extract is present in an amount of from about 1 to about
4% by weight, based on the total weight of the composition.
[0058] In some embodiments, the active ingredient comprises
ginseng. 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 ginseng is American ginseng or Korean
ginseng. In specific embodiments, the active ingredient comprises
Korean ginseng. In some embodiments, ginseng is present in an
amount of from about 0.4 to about 0.6% by weight, based on the
total weight of the composition.
Stimulants
[0059] In some embodiments, the active ingredient comprises one or
more stimulants. As used herein, the term "stimulant" refers to a
material that increases activity of the central nervous system
and/or the body, for example, enhancing focus, cognition, vigor,
mood, alertness, and the like. Non-limiting examples of stimulants
include caffeine, theacrine, theobromine, and theophylline.
Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid which
is structurally related to caffeine, and possesses stimulant,
analgesic, and anti-inflammatory 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 are "natural"
stimulants. By "naturally derived" is meant the stimulant (e.g.,
caffeine, theacrine) is in a purified form, outside its natural
(e.g., botanical) matrix. For example, caffeine can be obtained by
extraction and purification from botanical sources (e.g., tea). By
"wholly synthetic", it is meant that the stimulant has been
obtained by chemical synthesis. In some embodiments, the active
ingredient comprises caffeine. In some embodiments, the caffeine is
present in an encapsulated form. On example of an encapsulated
caffeine is Vitashure.RTM., available from Balchem Corp., 52
Sunrise Park Road, New Hampton, N.Y., 10958.
[0060] 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 composition
comprises caffeine in an amount of from about 1.5 to about 6% by
weight, based on the total weight of the composition;
Amino Acids
[0061] In some embodiments, the active ingredient comprises an
amino acid. As used herein, the term "amino acid" refers to an
organic compound that contains amine (--NH2) and carboxyl (--COOH)
or sulfonic acid (SO.sub.3H) 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), theanine
(L-.gamma.-glutamylethylamide), hydroxyproline, and beta-alanine.
In some embodiments, the active ingredient comprises theanine. In
some embodiments, the active ingredient comprises GABA. In some
embodiments, the active ingredient comprises a combination of
theanine and GABA. In some embodiments, the active ingredient is a
combination of theanine, GABA, and lemon balm.
[0062] In some embodiments, the active ingredient is a combination
of caffeine, theanine, and ginseng. In some embodiments, the active
ingredient comprises taurine. In some embodiments, the active
ingredient is a combination of caffeine and taurine.
[0063] When present, an amino acid or combination of amino acids
(e.g., theanine, GABA, 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.
Vitamins
[0064] 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-retinol-esters, as well as
all-trans-beta-carotene and other provitamin A carotenoids),
vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3
(niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine),
vitamin 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).
In some embodiments, the active ingredient comprises vitamin C In
some embodiments, the active ingredient is a combination of vitamin
C, caffeine, and taurine.
[0065] 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 6% 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%, about 1%, about 2%, about 3%, about 4%, about 5%, or
about 6% by weight, based on the total weight of the
composition.
Antioxidants
[0066] In some embodiments, the active ingredient comprises one or
more antioxidants. As used herein, the term "antioxidant" refers to
a substance which prevents or suppresses oxidation by terminating
free radical reactions, and may delay or prevent 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.
[0067] Examples of botanical materials which are associated with
antioxidant characteristics include without limitation acai berry,
alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild
bergamot, black pepper, blueberries, borage seed oil, bugleweed,
cacao, calamus 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, jiaogulan, kava, lavender, licorice,
marjoram, milk thistle, mints (menthe), oolong tea, beet root,
orange, oregano, papaya, pennyroyal, peppermint, red clover,
rooibos (red or green), rosehip, 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, yacon root, yellow dock, yerba 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.
[0068] Non-limiting examples of other suitable antioxidants include
citric acid, Vitamin E or a derivative thereof, a tocopherol,
epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic
acid, sodium erythorbate, 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.
[0069] When present, an antioxidant is typically at a concentration
of from about 0.001% w/w to about 10% by weight, such as, e.g.,
from about 0.001%, about 0.005%, about 0.01% w/w, about 0.05%,
about 0.1%, or about 0.5%, to about 1%, about 2%, about 3%, about
4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%,
based on the total weight of the composition.
Nicotine Component
[0070] In certain embodiments, the products of the present
disclosure can include a nicotinic compound. Various nicotinic
compounds, and methods for their administration, are set forth in
US Pat. Pub. No. 2011/0274628 to Borschke, which is incorporated
herein by reference. As used herein, "nicotinic compound" or
"source of nicotine" often refers to naturally-occurring or
synthetic nicotinic compound unbound from a plant material, meaning
the compound is at least partially purified and not contained
within a plant structure, such as a tobacco leaf. Most preferably,
nicotine is naturally-occurring and obtained as an extract from a
Nicotiana species (e.g., tobacco). The nicotine can have the
enantiomeric form S(-)-nicotine,
[0071] R(+)-nicotine, or a mixture of S(-)-nicotine and
R(+)-nicotine. Most preferably, the nicotine is in the form of
S(-)-nicotine (e.g., in a form that is virtually all S(-)-nicotine)
or a racemic mixture composed primarily or predominantly of
S(-)-nicotine (e.g., a mixture composed of about 95 weight parts
S(-)-nicotine and about 5 weight parts R(+)-nicotine). Most
preferably, the nicotine is employed in virtually pure form or in
an essentially pure form. Highly preferred nicotine that is
employed has a purity of greater than about 95 percent, more
preferably greater than about 98 percent, and most preferably
greater than about 99 percent, on a weight basis.
[0072] In certain embodiments, a nicotine component may be included
in the mixture in free base form, salt form, as a complex, or as a
solvate. By "nicotine component" is meant any suitable form of
nicotine (e.g., free base or salt) for providing oral absorption of
at least a portion of the nicotine present. Typically, the nicotine
component is selected from the group consisting of nicotine free
base and a nicotine salt. In some embodiments, nicotine is in its
free base form, which easily can be adsorbed in for example, a
microcrystalline cellulose material to form a microcrystalline
cellulose-nicotine carrier complex. See, for example, the
discussion of nicotine in free base form in US Pat. Pub. No.
2004/0191322 to Hansson, which is incorporated herein by
reference.
[0073] 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 one or more organic
acids.
[0074] 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, U.S. 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 polyacrylic complex.
[0075] 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.
[0076] In some embodiments, the products or compositions of the
disclosure can be characterized as free of any nicotine component
(e.g., any embodiment as disclosed herein may be completely or
substantially free of any nicotine component). By "substantially
free" is meant that no nicotine has been intentionally added,
beyond trace amounts that may be naturally present in e.g., a
botanical material. For example, certain embodiments can be
characterized as having less than 0.001% by weight of nicotine, or
less than 0.0001%, or even 0% by weight of nicotine, calculated as
the free base.
[0077] In some embodiments, the active ingredient comprises a
nicotine component (e.g., any product or composition of the
disclosure, in addition to comprising any active ingredient or
combination of active ingredients as disclosed herein, may further
comprise a nicotine component).
Cannabinoids
[0078] 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), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL),
cannabivarin (CBV), 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
(tumeric), catechin, quercetin, salvinorin A, N-acylethanolamines,
and N-alkylamide lipids.
[0079] 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
[0080] 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
(C.sub.5H.sub.8).sub.n and include monoterpenes, sesquiterpenes,
and diterpenes. Terpenes can be acyclic, monocyclic or bicyclic in
structure. Some terpenes provide an entourage effect when used in
combination with cannabinoids or cannabimimetics. Examples include
beta-caryophyllene, linalool, limonene, beta-citronellol, linalyl
acetate, pinene (alpha or beta), geraniol, carvone, eucalyptol,
menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, and
germacrene, which may be used singly or in combination.
Pharmaceutical Ingredients
[0081] In some embodiments, the active ingredient comprises an
active pharmaceutical ingredient (API). The API can be any known
agent adapted for therapeutic, prophylactic, or diagnostic use.
These can include, for example, synthetic organic compounds,
proteins and peptides, polysaccharides and other sugars, lipids,
phospholipids, inorganic compounds (e.g., magnesium, selenium,
zinc, nitrate), neurotransmitters or precursors thereof (e.g.,
serotonin, 5-hydroxytryptophan, oxitriptan, acetylcholine,
dopamine, melatonin), and nucleic acid sequences, having
therapeutic, prophylactic, or diagnostic activity. Non-limiting
examples of APIs include analgesics and antipyretics (e.g.,
acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic
acid), phosphatidylserine, myoinositol, docosahexaenoic acid (DHA,
Omega-3), arachidonic acid (AA, Omega-6), S-adenosylmethionine
(SAM), beta-hydroxy-beta-methylbutyrate (HMB), citicoline
(cytidine-5'-diphosphate-choline), and cotinine. In some
embodiments, the active ingredient comprises citicoline. In some
embodiments, the active ingredient is a combination of citicoline,
caffeine, theanine, and ginseng. In some embodiments, the active
ingredient comprises sunflower lecithin. In some embodiments, the
active ingredient is a combination of sunflower lecithin, caffeine,
theanine, and ginseng.
[0082] The amount of API may vary. For example, when present, an
API is typically at a concentration of from about 0.001% w/w to
about 10% by weight, such as, e.g., from about 0.01%, about 0.02%,
about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%,
about 0.08%, about 0.09%, about 0.1% w/w, about 0.2%, about 0.3%,
about 0.4%, about 0.5% about 0.6%, about 0.7%, about 0.8%, about
0.9%, or about 1%, to about 2%, about 3%, about 4%, about 5%, about
6%, about 7%, about 8%, about 9%, or about 10% by weight, based on
the total weight of the composition.
[0083] In some embodiments, the composition is substantially free
of any API. By "substantially free of any API" means that the
composition does not contain, and specifically excludes, the
presence of any API as defined herein, such as any Food and Drug
Administration (FDA) approved therapeutic agent intended to treat
any medical condition.
Tobacco Material
[0084] In some embodiments, the mixture may include a tobacco
material. The tobacco material can vary in species, type, and form.
Generally, the tobacco material is obtained from for a harvested
plant of the Nicotiana species. Example Nicotiana species include
N. tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N.
forgetiana, N. 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); U.S. Pat. No.
4,660,577 to Sensabaugh, Jr. et al.; U.S. Pat. No. 5,387,416 to
White et al., U.S. Pat. No. 7,025,066 to Lawson et al.; U.S. Pat.
No. 7,798,153 to Lawrence, Jr. and U.S. Pat. No. 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.
[0085] 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 U.S. Pat. No.
5,539,093 to Fitzmaurice et al.; U.S. Pat. No. 5,668,295 to Wahab
et al.; U.S. Pat. No. 5,705,624 to Fitzmaurice et al.; U.S. Pat.
No. 5,844,119 to Weigl; U.S. Pat. No. 6,730,832 to Dominguez et
al.; U.S. Pat. No. 7,173,170 to Liu et al.; U.S. Pat. No. 7,208,659
to Colliver et al. and U.S. Pat. No. 7,230,160 to Benning et al.;
US Patent Appl. Pub. No. 2006/0236434 to Conkling et al.; and PCT
WO2008/103935 to Nielsen et al. See, also, the types of tobaccos
that are set forth in U.S. Pat. No. 4,660,577 to Sensabaugh, Jr. et
al.; U.S. Pat. No. 5,387,416 to White et al.; and U.S. Pat. No.
6,730,832 to Dominguez et al., each of which is incorporated herein
by reference.
[0086] The Nicotiana species can, in some embodiments, be selected
for the content of various compounds that are present therein. For
example, plants can be selected on the basis that those plants
produce relatively high quantities of one or more of the compounds
desired to be isolated therefrom. In certain embodiments, plants of
the Nicotiana species (e.g., Galpao commun tobacco) are
specifically grown for their abundance of leaf surface compounds.
Tobacco plants can be grown in greenhouses, growth chambers, or
outdoors in fields, or grown hydroponically.
[0087] 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).
[0088] 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 U.S. Pat. No. 4,340,073 to de la Burde et al.; U.S. Pat.
No. 5,259,403 to Guy et al.; and U.S. Pat. No. 5,908,032 to
Poindexter, et al.; and U.S. Pat. No. 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 WO2005/063060 to Atchley et al., which is incorporated herein
by reference.
[0089] 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 hammer mills, cutter heads, air control mills, or the like.
For example, tobacco parts or pieces may be ground or milled when
the moisture content thereof is less than about 15 weight percent
or less than about 5 weight percent. Most preferably, the tobacco
material is employed in the form of parts or pieces that have an
average particle size between 1.4 millimeters and 250 microns. In
some instances, the tobacco particles may be sized to pass through
a screen mesh to obtain the particle size range required. If
desired, air classification equipment may be used to ensure that
small sized tobacco particles of the desired sizes, or range of
sizes, may be collected. If desired, differently sized pieces of
granulated tobacco may be mixed together.
[0090] 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.
[0091] 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 U.S. 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 U.S. Pat. No. 7,650,892 to Groves et al.; Roton et
al., Beitrage Tabakforsch. Int., 21, 305-320 (2005) and Staaf et
al., Beitrage Tabakforsch. Int., 21, 321-330 (2005), which are
incorporated herein by reference. Certain types of tobaccos can be
subjected to alternative types of curing processes, such as fire
curing or sun curing.
[0092] 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, Xanthi and Yambol tobaccos), Maryland,
dark, dark-fired, dark air cured (e.g., Madole, Passanda,
[0093] 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.
[0094] 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.
[0095] 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 U.S. Pat.
No. 8,061,362 to Mua et al., which is incorporated herein by
reference. In certain embodiments, tobacco materials can be treated
with water and an additive capable of inhibiting reaction of
asparagine to form acrylamide upon heating of the tobacco material
(e.g., an additive selected from the group consisting of lysine,
glycine, histidine, alanine, methionine, cysteine, glutamic acid,
aspartic acid, proline, phenylalanine, valine, arginine,
compositions incorporating di- and trivalent cations, asparaginase,
certain non-reducing saccharides, certain reducing agents, phenolic
compounds, certain compounds having at least one free thiol group
or functionality, oxidizing agents, oxidation catalysts, natural
plant extracts (e.g., rosemary extract), and combinations thereof.
See, for example, the types of treatment processes described in
U.S. Pat. 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.
[0096] 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). In certain embodiments, the oral products described
herein are substantially free of unbleached tobacco material.
Tobacco pulp can be whitened in certain embodiments according to
any means known in the art. For example, bleached tobacco material
produced by various whitening methods using various bleaching or
oxidizing agents and oxidation catalysts can be used. Example
oxidizing agents include peroxides (e.g., hydrogen peroxide),
chlorite salts, chlorate salts, perchlorate salts, hypochlorite
salts, ozone, ammonia, potassium permanganate, and combinations
thereof. Example oxidation catalysts are titanium dioxide,
manganese dioxide, and combinations thereof. Processes for treating
tobacco with bleaching agents are discussed, for example, in U.S.
Pat. No. 787,611 to Daniels, Jr.; U.S. Pat. No. 1,086,306 to
Oelenheinz; U.S. Pat. No. 1,437,095 to Delling; U.S. Pat. No.
1,757,477 to Rosenhoch; U.S. Pat. No. 2,122,421 to Hawkinson; U.S.
Pat. No. 2,148,147 to Baier; U.S. Pat. No. 2,170,107 to Baier; U.S.
Pat. No. 2,274,649 to Baier; U.S. Pat. No. 2,770,239 to Prats et
al.; U.S. Pat. No. 3,612,065 to Rosen; U.S. Pat. No. 3,851,653 to
Rosen; U.S. Pat. No. 3,889,689 to Rosen; U.S. Pat. No. 3,943,940 to
Minami; U.S. Pat. No. 3,943,945 to Rosen; U.S. Pat. No. 4,143,666
to Rainer; U.S. Pat. No. 4,194,514 to Campbell; U.S. Pat. Nos.
4,366,823, 4,366,824, and 4,388,933 to Rainer et al.; U.S. Pat. No.
4,641,667 to Schmekel et al.; U.S. Pat. No. 5,713,376 to Berger;
U.S. Pat. No. 9,339,058 to Byrd Jr. et al.; U.S. Pat. No. 9,420,825
to Beeson et al.; and U.S. Pat. No. 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.
WO1996/031255 to Giolvas and WO2018/083114 to Bjorkholm, all of
which are incorporated herein by reference. See also, e.g., U.S.
patent application Ser. No. 16/226,742 to Mclanahan et al., filed
Dec. 20, 2018, which is herein incorporated by reference in its
entirety.
[0097] In some embodiments, the whitened tobacco material can have
an ISO brightness of at least about 50%, at least about 60%, at
least about 65%, at least about 70%, at least about 75%, or at
least about 80%. In some embodiments, the whitened tobacco material
can have an ISO brightness in the range of about 50% to about 90%,
about 55% to about 75%, or about 60% to about 70%. ISO brightness
can be measured according to ISO 3688:1999 or ISO 2470-1:2016.
[0098] 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.
[0099] In various embodiments, the tobacco material can be treated
to extract a soluble component of the tobacco material therefrom.
"Tobacco extract" as used herein refers to the isolated components
of a tobacco material that are extracted from solid tobacco pulp by
a solvent that is brought into contact with the tobacco material in
an extraction process. Various extraction techniques of tobacco
materials can be used to provide a tobacco extract and tobacco
solid material. See, for example, the extraction processes
described in US Pat. Appl. Pub. No. 2011/0247640 to Beeson et al.,
which is incorporated herein by reference. Other example techniques
for extracting components of tobacco are described in U.S. Pat. No.
4,144,895 to Fiore; U.S. Pat. No. 4,150,677 to Osborne, Jr. et al.;
U.S. Pat. No. 4,267,847 to Reid; U.S. Pat. No. 4,289,147 to Wildman
et al.; U.S. Pat. No. 4,351,346 to Brummer et al.; U.S. Pat. No.
4,359,059 to Brummer et al.; U.S. Pat. No. 4,506,682 to Muller;
U.S. Pat. No. 4,589,428 to Keritsis; U.S. Pat. No. 4,605,016 to
Soga et al.; U.S. Pat. No. 4,716,911 to Poulose et al.; U.S. Pat.
No. 4,727,889 to Niven, Jr. et al.; U.S. Pat. No. 4,887,618 to
Bernasek et al.; U.S. Pat. No. 4,941,484 to Clapp et al.; U.S. Pat.
No. 4,967,771 to Fagg et al.; U.S. Pat. No. 4,986,286 to Roberts et
al.; U.S. Pat. No. 5,005,593 to Fagg et al.; U.S. Pat. No.
5,018,540 to Grubbs et al.; U.S. Pat. No. 5,060,669 to White et
al.; U.S. Pat. No. 5,065,775 to Fagg; U.S. Pat. No. 5,074,319 to
White et al.; U.S. Pat. No. 5,099,862 to White et al.; U.S. Pat.
No. 5,121,757 to White et al.; U.S. Pat. No. 5,131,414 to Fagg;
U.S. Pat. No. 5,131,415 to Munoz et al.; U.S. Pat. No. 5,148,819 to
Fagg; U.S. Pat. No. 5,197,494 to Kramer; U.S. Pat. No. 5,230,354 to
Smith et al.; U.S. Pat. No. 5,234,008 to Fagg; U.S. Pat. No.
5,243,999 to Smith; U.S. Pat. No. 5,301,694 to Raymond et al.; U.S.
Pat. No. 5,318,050 to Gonzalez-Parra et al.; U.S. Pat. No.
5,343,879 to Teague; U.S. Pat. No. 5,360,022 to Newton; U.S. Pat.
No. 5,435,325 to Clapp et al.; U.S. Pat. No. 5,445,169 to Brinkley
et al.; U.S. Pat. No. 6,131,584 to Lauterbach; U.S. Pat. No.
6,298,859 to Kierulff et al.; U.S. Pat. No. 6,772,767 to Mua et
al.; and U.S. Pat. No. 7,337,782 to Thompson, all of which are
incorporated by reference herein.
[0100] 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).
[0101] 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.
Flavoring Agent
[0102] 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. Specific types of flavors include, but are not
limited to, vanilla, coffee, chocolate/cocoa, cream, mint,
spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender,
cardamon, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey,
jasmine, ginger, anise, sage, licorice, lemon, orange, apple,
peach, lime, cherry, strawberry, trigeminal sensates, and any
combinations thereof. See also, Leffingwell et al., Tobacco
Flavoring for Smoking Products, R. J. Reynolds Tobacco Company
(1972), which is incorporated herein by reference. Flavorings also
may include components that are considered moistening, cooling or
smoothening agents, such as eucalyptus. These flavors may be
provided neat (i.e., alone) or in a composite, and may be employed
as concentrates or flavor packages (e.g., spearmint and menthol,
orange and cinnamon; lime, pineapple, and the like). Representative
types of components also are set forth in U.S. Pat. No. 5,387,416
to White et al.; US Pat. App. Pub. No. 2005/0244521 to Strickland
et al.; and PCT Application Pub. No. WO 05/041699 to Quinter et
al., each of which is incorporated herein by reference. In some
instances, the flavoring agent may be provided in a spray-dried
form or a liquid form.
[0103] The flavoring agent generally comprises at least one
volatile flavor component. As used herein, "volatile" refers to a
chemical substance that forms a vapor readily at ambient
temperatures (i.e., a chemical substance that has a high vapor
pressure at a given temperature relative to a nonvolatile
substance). Typically, a volatile flavor component has a molecular
weight below about 400 Da, and often include at least one
carbon-carbon double bond, carbon-oxygen double bond, or both. In
one embodiment, the at least one volatile flavor component
comprises one or more alcohols, aldehydes, aromatic hydrocarbons,
ketones, esters, terpenes, terpenoids, or a combination thereof.
Non-limiting examples of aldehydes include vanillin, ethyl
vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde,
cuminaldehyde, benzaldehyde, and citronellal. Non-limiting examples
of ketones include 1-hydroxy-2-propanone and
2-hydroxy-3-methyl-2-cyclopentenone-1-one. Non-limiting examples of
esters include 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
[0104] 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 5 weight percent, based on the total dry weight of the
composition.
Salts
[0105] In some embodiments, the composition may further comprise a
salt (e.g., alkali metal salts), typically employed in an amount
sufficient to provide desired sensory attributes to the
composition. Non-limiting examples of suitable salts include sodium
chloride, potassium chloride, ammonium chloride, flour salt, and
the like. When present, a representative amount of salt is about
0.5 percent by weight or more, about 1.0 percent by weight or more,
or at about 1.5 percent by weight or more, but will typically make
up about 10 percent or less of the total dry weight of the
composition, or about 7.5 percent or less or about 5 percent or
less (e.g., about 0.5 to about 5 percent by weight).
Sweeteners
[0106] The composition typically further comprises one or more
sweeteners. The sweeteners can be any sweetener or combination of
sweeteners, in natural or artificial form, or as a combination of
natural and artificial sweeteners. Examples of natural sweeteners
include isomaltulose, fructose, sucrose, glucose, maltose, 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 erythritol,
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 on a
dry weight basis, based on the total weight of the composition.
Filler Component
[0107] The composition typically includes at least one filler,
which is optionally in particulate form. Such particulate fillers
may fulfill multiple functions, such as enhancing certain
organoleptic properties such as texture and mouthfeel, enhancing
cohesiveness or compressibility of the product, and the like.
Generally, the fillers are particulate materials and are
cellulose-based. For example, suitable particulate fillers are any
non-tobacco plant material or derivative thereof, including
cellulose materials derived from such sources. Examples of
cellulosic non-tobacco plant material include cereal grains (e.g.,
maize, oat, barley, rye, buckwheat, and the like), sugar beet
(e.g., FIBREX.RTM. brand filler available from International Fiber
Corporation), bran fiber, and mixtures thereof. Non-limiting
examples of derivatives of non-tobacco plant material include rice
flour or other grain flour, 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, and sorbitol. Xylitol in liquid form
can also be used as a filler material. Combinations of fillers can
also be used.
[0108] "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 organoleptic property to composition.
Starches derived from various sources can be used. For example,
major sources of starch include cereal grains (e.g., rice, wheat,
and maize) and root vegetables (e.g., potatoes and cassava). Other
examples of sources of starch include acorns, arrowroot, arracacha,
bananas, barley, beans (e.g., favas, lentils, mung beans, peas,
chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia,
katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot,
sago, sorghum, sweet potato, quinoa, rye, tapioca, 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.
Some starches have been developed by genetic modifications, and are
considered to be "genetically modified" starches. Other starches
are obtained and subsequently physically (e.g., heat, cool water
swelling, etc.), chemically, or enzymatically modified. For
example, modified starches can be starches that have been subjected
to chemical reactions, such as esterification, etherification,
oxidation, depolymerization (thinning) by acid catalysis or
oxidation in the presence of base, bleaching, transglycosylation
and depolymerization (e.g., dextrinization in the presence of a
catalyst), cross-linking, 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 pregelatinization, dextrinization, and/or
cold water swelling processes. Certain modified starches include
monostarch phosphate, distarch glycerol, distarch phosphate
esterified with sodium trimetaphosphate, phosphate distarch
phosphate, acetylated distarch phosphate, starch acetate esterified
with acetic anhydride, starch acetate esterified with vinyl
acetate, acetylated distarch adipate, acetylated distarch glycerol,
hydroxypropyl starch, hydroxypropyl distarch glycerol, starch
sodium octenyl succinate.
[0109] In some embodiments, the particulate filler component is a
cellulose material or cellulose derivative. One particularly
suitable particulate filler component for use in the products
described herein is microcrystalline cellulose ("MCC"). The MCC may
be synthetic or semi-synthetic, or it may be obtained entirely from
natural celluloses. The MCC may be selected from the group
consisting of AVICEL.RTM. grades PH-100, PH-102, PH-103, PH-105,
PH-112, PH-113, PH-200, PH-300, PH-302, VIVACEL.RTM. grades 101,
102, 12, 20 and EMOCEL.RTM. grades 50M and 90M, and the like, and
mixtures thereof. In one embodiment, the composition comprises MCC
as the particulate filler component. The quantity of MCC present in
the composition as described herein may vary according to the
desired properties.
[0110] The amount of particulate filler component can vary, but is
typically up to about 75 percent of the material by weight, based
on the total dry weight of the composition. A typical range of
particulate filler material (e.g., MCC) within the composition can
be from about 10 to about 75 percent by total dry weight of the
composition, for example, from about 10, about 15, about 20, about
25, or about 30, to about 35, about 40, about 45, or about 50
weight percent (e.g., about 20 to about 50 weight percent or about
25 to about 45 weight percent). In certain embodiments, the amount
of particulate filler material is at least about 10 percent by
weight, such as at least about 20 percent, or at least about 25
percent, or at least about 30 percent, or at least about 35
percent, or at least about 40 percent, based on the total dry
weight of the composition.
[0111] In one embodiment, the particulate filler component further
comprises a cellulose derivative or a combination of such
derivatives. In some embodiments, the composition comprises from
about 1 to about 10% of the cellulose derivative by weight, based
on the total dry weight of the composition, with certain
embodiments comprising about 1 to about 5% by weight of cellulose
derivative. In certain embodiments, the cellulose derivative is a
cellulose ether (including carboxyalkyl ethers), meaning a
cellulose polymer with the hydrogen of one or more hydroxyl groups
in the cellulose structure replaced with an alkyl, hydroxyalkyl, or
aryl group. Non-limiting examples of such cellulose derivatives
include methylcellulose, hydroxypropylcellulose ("HPC"),
hydroxypropylmethylcellulose ("HPMC"), hydroxyethyl cellulose, and
carboxymethylcellulose ("CMC"). In one embodiment, the cellulose
derivative is one or more of methylcellulose, HPC, HPMC,
hydroxyethyl cellulose, and CMC. In one embodiment, the cellulose
derivative is HPC. In some embodiments, the composition comprises
from about 1 to about 3% HPC by weight, based on the total dry
weight of the composition.
Water
[0112] The water content of the composition described herein, prior
to use by a consumer of the product, may vary according to the
desired properties. Typically, the mixture, as present within the
product prior to insertion into the mouth of the user, is less than
about 60 percent by weight of water, and generally is from about 1
to about 60% by weight of water, for example, from about 5 to about
55, about 10 to about 50, about 20 to about 45, or about 25 to
about 40 percent water by weight, including water amounts of at
least about 5% by weight, at least about 10% by weight, at least
about 15% by weight, and at least about 20% by weight.
Humectants
[0113] In certain embodiments, one or more humectants may be
employed in the composition. Examples of humectants include, but
are not limited to, glycerin, propylene glycol, and the like. It is
noted that certain humectants can also function as plasticizers
useful in embodiments of the oral compositions described herein, as
described in more detail above. Where included, the humectant is
typically provided in an amount sufficient to provide desired
moisture attributes to the composition. Further, in some instances,
the humectant may impart desirable flow characteristics to the
composition for depositing in a mold. When present, a humectant
will typically make up about 5% or less of the dry weight of the
composition (e.g., from about 0.5 to about 5% by weight). When
present, a representative amount of humectant is about 0.1% to
about 1% by weight, or about 1% to about 5% by weight, based on the
total dry weight of the composition.
Buffering Agents
[0114] In certain embodiments, the composition of the present
disclosure can comprise pH adjusters or buffering agents. Examples
of pH adjusters and buffering agents that can be used include, but
are not limited to, metal hydroxides (e.g., alkali metal hydroxides
such as sodium hydroxide and potassium hydroxide), and other alkali
metal buffers such as metal carbonates (e.g., potassium carbonate
or sodium carbonate), or metal bicarbonates such as sodium
bicarbonate, and the like. Where present, the buffering agent is
typically present in an amount less than about 5 percent based on
the dry weight of the composition, for example, from about 0.1% 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 dry weight. Non-limiting examples of suitable buffers
include alkali metals acetates, glycinates, phosphates,
glycerophosphates, citrates, carbonates, hydrogen carbonates,
borates, or mixtures thereof.
Colorants
[0115] A colorant may be employed in amounts sufficient to provide
the desired physical attributes to the composition. Examples of
colorants include various dyes and pigments, such as caramel
coloring and titanium dioxide. The amount of colorant utilized in
the composition can vary, but when present is typically up to about
3 weight percent, such as from about 0.1%, about 0.5%, or about 1%,
to about 3% by weight, based on the total dry weight.
Other Additives
[0116] Other additives can be included in the disclosed
composition. For example, the composition can be processed,
blended, formulated, combined and/or mixed with other materials or
ingredients. The additives can be artificial, or can be obtained or
derived from herbal or biological sources. Examples of further
types of additives include thickening or gelling agents (e.g., fish
gelatin), emulsifiers, oral care additives (e.g., thyme oil,
eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate
and the like), 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), disintegration aids, or combinations
thereof. See, for example, those representative components,
combination of components, relative amounts of those components,
and manners and methods for employing those components, set forth
in U.S. Pat. No. 9,237,769 to Mua et al., U.S. 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 composition, with an example range of up to about 10%
by weight, based on total dry weight (e.g., about 0.1 to about 5%
by weight).
[0117] 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
product or mixture. Example encapsulated additives are described,
for example, in WO2010/132444 to Atchley, which has been previously
incorporated by reference herein.
[0118] 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.
[0119] The particle size of a particulate material may be measured
by sieve analysis. As the skilled person will readily appreciate,
sieve analysis (otherwise known as a gradation test) is a method
used to measure the particle size distribution of a particulate
material. Typically, sieve analysis involves a nested column of
sieves which comprise screens, preferably in the form of wire mesh
cloths. A pre-weighed sample may be introduced into the top or
uppermost sieve in the column, which has the largest screen
openings or mesh size (i.e. the largest pore diameter of the
sieve). Each lower sieve in the column has progressively smaller
screen openings or mesh sizes than the sieve above. Typically, at
the base of the column of sieves is a receiver portion to collect
any particles having a particle size smaller than the screen
opening size or mesh size of the bottom or lowermost sieve in the
column (which has the smallest screen opening or mesh size).
[0120] In some embodiments, the column of sieves may be placed on
or in a mechanical agitator. The agitator causes the vibration of
each of the sieves in the column The mechanical agitator may be
activated for a pre-determined period of time in order to ensure
that all particles are collected in the correct sieve. In some
embodiments, the column of sieves is agitated for a period of time
from 0.5 minutes to 10 minutes, such as from 1 minute to 10
minutes, such as from 1 minute to 5 minutes, such as for
approximately 3 minutes. Once the agitation of the sieves in the
column is complete, the material collected on each sieve is
weighed. The weight of each sample on each sieve may then be
divided by the total weight in order to obtain a percentage of the
mass retained on each sieve. As the skilled person will readily
appreciate, the screen opening sizes or mesh sizes for each sieve
in the column used for sieve analysis may be selected based on the
granularity or known maximum/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 some embodiments, the largest screen
opening or mesh sizes of the sieves used for sieve analysis may be
1000 .mu.m, such as 500 .mu.m, such as 400 .mu.m, such as 300
.mu.m.
[0121] 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 .mu.m, such as no greater than about 500
.mu.m, such as no greater than about 400 .mu.m, such as no greater
than about 350 .mu.m, such as no greater than about 300 .mu.m. 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 .mu.m,
such as no greater than about 500 .mu.m, such as no greater than
about 400 .mu.m, such as no greater than about 350 .mu.m, such as
no greater than about 300 .mu.m. 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 .mu.m, such as no greater than about 500
.mu.m, such as no greater than about 400 .mu.m, such as no greater
than about 350 .mu.m, such as no greater than about 300 .mu.m. 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 .mu.m,
such as no greater than about 500 .mu.m, such as no greater than
about 400 .mu.m, such as no greater than about 350 .mu.m, such as
no greater than about 300 .mu.m. 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 .mu.m, such as no greater than about 500
.mu.m, such as no greater than about 400 .mu.m, such as no greater
than about 350 .mu.m, such as no greater than about 300 .mu.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 .mu.m,
such as no greater than about 500 .mu.m, such as no greater than
about 400 .mu.m, such as no greater than about 350 .mu.m, such as
no greater than about 300 .mu.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 .mu.m, such as no greater than about 500
.mu.m, such as no greater than about 400 .mu.m, such as no greater
than about 350 .mu.m, such as no greater than about 300 .mu.m. 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 .mu.m,
such as no greater than about 500 .mu.m, such as no greater than
about 400 .mu.m, such as no greater than about 350 .mu.m, such as
no greater than about 300 .mu.m.
[0122] 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
.mu.m to about 1000 .mu.m, such as from about 0.05 .mu.m to about
750 .mu.m, such as from about 0.1 .mu.m to about 500 .mu.m, such as
from about 0.25 .mu.m to about 500 .mu.m. 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 .mu.m to about 400 .mu.m, such as from
about 50 .mu.m to about 350 gm, such as from about 100 .mu.m to
about 350 .mu.m, such as from about 200 .mu.m to about 300 .mu.m.
In certain embodiments, at least a portion of the particles have a
particle size as measured by sieve analysis of about 100 .mu.m or
less, about 50 .mu.m or less, or about 30 .mu.m or less.
Preparation of the Oral Product
[0123] The manner by which the various components of the
composition can be combined may vary. The various components of the
formulation may be contacted, combined, or mixed together in
conical-type blenders, mixing drums, ribbon blenders, or the like.
As such, the overall mixture of various components (i.e., the
active ingredient(s) and/or flavorant(s), the thermoplastic binder
system, and any other ingredients) may be relatively uniform in
nature. See also, for example, the types of methodologies set forth
in U.S. Pat. No. 4,148,325 to Solomon et al.; U.S. Pat. No.
6,510,855 to Korte et al.; and U.S. Pat. No. 6,834,654 to Williams,
each of which is incorporated herein by reference. The components
of the oral product formulation can be brought together in
admixture using any mixing technique or equipment known in the art.
Various components noted herein, 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 composition, or the mixture
components can be simply mixed all together. Any mixing method that
brings the oral composition ingredients into intimate contact can
be used. A mixing apparatus featuring an impeller or other
structure capable of agitation is typically used. Example mixing
equipment includes casing drums, conditioning cylinders or drums,
liquid spray apparatus, ribbon blenders, mixers available as
FKM130, FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day,
Inc., Plough Share types of mixer cylinders, and the like.
[0124] The manner that the oral product is formed can vary, and
various methods for forming processed oral products or for
producing processed oral products will be readily apparent to those
skilled in the art of oral product manufacture. For example,
suitably heated oral formulations incorporating thermoplastic
binder systems and having a pourable, formable or generally liquid
character can be cast into a sheet-like form and cooled to yield a
sheet-like oral product. As another example, suitably heated oral
product formulations incorporating thermoplastic binder systems can
be molded into a desired shape and cooled. Example shapes of formed
oral products include pill, tablet, sphere, sheet, film, coin,
cube, bead, ovoid, obloid, bean, cylinder, stick, and rod. As yet
another example, oral product formulations incorporating
thermoplastic binder systems can be extruded from heated extrusion
devices and cooled. As another example, oral product formulations
incorporating a binder system and a pre-mixed plasticizer blend can
be extruded from heated extrusion devices and cooled.
[0125] The oral product can be manufactured using hot melt
extrusion techniques. As such, processed oral product formulations
can be subjected to sufficient heat during formation of oral
product to eliminate the need for any additional heat treatment
steps. For example, flashing off the moisture from a processed oral
product formulation during a hot melt extrusion process can
eliminate any need for further heating, drying, or the like.
[0126] Processed oral product formulations, such as multi-layered
pellets, can be manufactured using a wide variety of extrusion
techniques. For example, multi-layered pellets can be manufactured
using co-extrusion techniques (e.g., using twin screw extruders).
In such a situation, successive wet or dry components or component
mixtures can be placed within separate extrusion hoppers. Steam,
gases (e.g., ammonia, air, carbon dioxide, and the like),
plasticizers (e.g., glycerin or propylene glycol), and a
plasticizer blend can be injected into the extruder barrel as each
dry mix is propelled, plasticized, and cooked. As such, the various
components are processed so as to be very well mixed, and hence,
come in complete contact with each other. For example, the contact
of components is such that individual components can be well
embedded in the extrusion matrix or extrudate. See, for example,
U.S. Pat. No. 4,821,749 to Toft et al., which is incorporated
herein by reference. Multilayered materials can have the general
form of films, and alternatively, multi-layered generally spherical
materials can possess various layers extending from the inside
outward.
[0127] Some shapes of oral products, such as rods or cubes, can be
formed by first extruding the material through a die having the
desired cross-section (e.g., round or square) and then optionally
cutting the extruded material into desired lengths. For example,
extruder equipment comprising single or multiple screw extruders
can by employed to form the shape of a product according to the
present disclosure. Some extruders can comprise twin screw
extruders which comprise co-rotating twin screw extruders. Various
screw configurations can be employed. For example, screws having
combinations of elements for feeding, mixing, pumping, shearing,
and the like, can be selected as desired for optimum results.
Screws having sections or elements which provide relatively large
output capacities, which have interrupted or nonconjugated flights,
or which are "counterflighted" or "reversing" also can be employed.
Typical screw elements as well as screws having combinations of
such elements are available from extruder manufacturers. An
extruder can provide a barrel for heating of the materials which
are introduced within the extruder. The extruder barrel can
comprise multiple barrel zones. The conditions of the extrusion
set-up can vary, for example, in modifying feed rate of dry blend
ingredients, feed rate of wet blend ingredients, screw RPM setting,
temperature conditions, aperture die dimensions, barrel zone entry
point for certain ingredients, as well as additional
parameters.
[0128] Techniques and equipment for extruding oral product
materials have been set forth in U.S. Pat. No. 3,098,492 to
Wursburg; U.S. Pat. No. 4,874,000 to Tamol et al.; U.S. Pat. No.
4,880,018 to Graves et al.; U.S. Pat. No. 4,989,620 to Keritsis et
al.; U.S. Pat. No. 5,072,744 to Luke et al.; U.S. Pat. No.
5,829,453 to White et al.; and U.S. Pat. No. 6,182,670 to White et
al.; each of which is incorporated herein by reference. Example
extrusion equipment suitable for use include industrial pasta
extruders such as Model TP 200/300 available from Emiliomiti, LLC
of Italy, and the ZSK model twin screw extruder from Coperion Corp,
Ramsey, N.J.
[0129] In some methods that can be used to produce oral products, a
portion of the ingredients can be mixed and fed into the extruder.
Additional ingredients can be introduced to the extruder at a
different point or barrel zone as compared to other ingredients.
For example, a pre-mixed subgroup of ingredients can be fed into a
first barrel zone of the extruder to contact a dry mix of other
ingredients. A hopper or plurality of hoppers can be employed to
facilitate the input of various ingredients into an extruder.
[0130] Processed sheet-like materials can be prepared by applying
the oral product composition onto a moving belt and passing the
moving belt through a nip formed by opposing rollers, followed by
cutting the sheet into desired lengths. Alternatively, the oral
product can be over-coated with powdered or liquid coating.
Furthermore, if desired, the surface of the oral product can be
embossed or printed.
EXAMPLES
[0131] The present invention can be more fully illustrated by the
following examples, which are set forth to illustrate some
embodiments of the present invention and are not to be construed as
limiting thereof. All weight percentages are expressed on a dry
weight basis, meaning water content is excluded, unless otherwise
indicated.
Example 1
Binder System Formulations
[0132] Tables A-M provide various embodiments of a binder system
that can be incorporated into a composition for use in an oral
product representative of the present disclosure. The binder system
prepared according to the recipes shown in Tables A-M can be used
within the oral product formulations found in the examples
described hereinafter.
[0133] Each batch of binder system is prepared by mixing the
components in a commercially available Kitchen Aid mixer for about
3 to 5 minutes.
TABLE-US-00001 TABLE A Batch 1 Ingredients wt % g hydroxypropyl
methylcellulose 70 350 Propylene Glycol 30 150 Total ingredients:
100% 500
TABLE-US-00002 TABLE B Batch 2 Ingredients wt % g hydroxypropyl
methylcellulose 42 210 Propylene Glycol 28 140 Water 30 150 Total
ingredients: 100% 500
TABLE-US-00003 TABLE C Batch 3 Ingredients wt % g Xanthan 42 210
Maltodextrin 28 140 Propylene Glycol 30 150 Total ingredients: 100%
500
TABLE-US-00004 TABLE D Batch 4 Ingredients wt % g Xanthan 29.4 147
Maltodextrin 19.6 98 Propylene Glycol 21 105 Water 30 150 Total
ingredients: 100% 500
TABLE-US-00005 TABLE E Batch 5 Ingredients wt % g Gum Arabic 42 210
Propylene Glycol 28 140 Water 30 150 Total ingredients: 100%
500
TABLE-US-00006 TABLE F Batch 6 Ingredients wt % g Xanthan gum 21.7
108.5 Gum Arabic 33.6 168 polyvinylpyrrolidone 14.7 73.5 Propylene
Glycol 30 150 Total ingredients: 100% 500
TABLE-US-00007 TABLE G Batch 7 Ingredients wt % g Gum Arabic 60 300
Maltodextrin 15 75 Propylene Glycol 25 125 Total ingredients: 100%
500
TABLE-US-00008 TABLE H Batch 8 Ingredients wt % g Maltodextrin 73
365 Propylene Glycol 27 135 Total ingredients: 100% 500
TABLE-US-00009 TABLE I Batch 9 Ingredients wt % g Modified Starch
75 375 Propylene Glycol 25 125 Total ingredients: 100% 500
TABLE-US-00010 TABLE J Batch 10 Ingredients wt % g Modified Starch
65 325 Maltodextrin 10 50 Propylene Glycol 25 125 Total
ingredients: 100% 500
TABLE-US-00011 TABLE K Batch 11 Ingredients wt % g Pullulan 42 210
Maltodextrin 28 140 Propylene Glycol 30 150 Total ingredients: 100%
500
TABLE-US-00012 TABLE L Batch 12 Ingredients wt % g Pullulan 29.4
147 Maltodextrin 19.6 98 Propylene Glycol 21 105 Water 30 150 Total
ingredients: 100% 500
TABLE-US-00013 TABLE M Batch 13 Ingredients wt % g Pullulan 21.7
108.5 Gum Arabic 33.6 168 polyvinylpyrrolidone 14.7 73.5 Propylene
Glycol 30 150 Total ingredients: 100% 500
Example 2
[0134] Oral product formulations for use as a stick type of an oral
product as set forth in Table 1 are provided in the following
manner
[0135] Except for glycerin, all dry ingredients, in powder form,
are added together with a batch formulation and thoroughly mixed.
Each batch formulation is prepared by mixing propylene glycol
and/or water with a binder in a Kitchen Aid mixer for about 5
minutes, before being mixed with other dry ingredients. The
nicotine can be added to the binder system before adding to the dry
ingredients. Each mixed formulation is then commuted into the
hopper of an extruder. The extruder is operated at a temperature of
about 65.degree. C. to 100.degree. C., and the screw speed is set
at 60 rpm. The formulation is fed through the extruder and 3 5 mm
long sticks are prepared.
TABLE-US-00014 TABLE 1 Ingredients Weight % Nicotine .sup. 1-5%
Salt .sup. 0.5-7.5 Buffer 0.1-5 Sweetener 0.1-5 Colorant 0.1-3
Filler 5-75 Flavorant 0.1-10 Other Additive(s) 0.1-20 Binder System
(One of Table A-M) .sup. 20-50 Total ingredients: 100
Example 3
[0136] Example 2 is generally repeated, but a sheet type product is
formed having the general formula of Table 1. All ingredients are
added together and thoroughly mixed before being commuted into an
extruder. The extruder is set at a screw speed of 45-60 rpm and the
barrel sections and die operated at temperatures of about
75-100.degree. C. A sheeting die is employed. The formulation is
extruded into a continuous sheet that is about 0.85 mm thick. The
sheet is extruded onto a conveyor belt and transferred through a
cooling tunnel.
[0137] The sheet is further reduced in thickness by passage through
pin rolls, and is flattened into a sheet having a thickness of less
than 0.4 mm. The sheet is finally cut into bite-size strip pieces
of various shapes (e.g., pieces of about 2 cm by 2 cm).
[0138] 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.
* * * * *