U.S. patent application number 16/707808 was filed with the patent office on 2021-06-10 for methods of manufacturing an oral composition.
The applicant listed for this patent is NICOVENTURES TRADING LIMITED. Invention is credited to Dwayne William Beeson, Darrell Eugene Holton, JR., Ronald K. Hutchens, Christopher Keller, Thomas H. Poole, Frank Kelley St. Charles.
Application Number | 20210169130 16/707808 |
Document ID | / |
Family ID | 1000004546318 |
Filed Date | 2021-06-10 |
United States Patent
Application |
20210169130 |
Kind Code |
A1 |
Holton, JR.; Darrell Eugene ;
et al. |
June 10, 2021 |
METHODS OF MANUFACTURING AN ORAL COMPOSITION
Abstract
The disclosure provides for oral compositions comprising a
clarified tobacco extract and one or more filler components. In
another aspect, the disclosure provides methods of preparing a
clarified tobacco extract. Such methods can comprise processing a
tobacco extract through at least one ultrafiltration step to
provide a filtered tobacco extract and passing the filtered tobacco
extract through a solution comprising one or more non-molecularly
imprinted polymer (NIP) to provide the clarified tobacco
extract.
Inventors: |
Holton, JR.; Darrell Eugene;
(Clemmons, NC) ; Beeson; Dwayne William;
(Kernersville, NC) ; Hutchens; Ronald K.; (East
Bend, NC) ; Keller; Christopher; (Advance, 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: |
1000004546318 |
Appl. No.: |
16/707808 |
Filed: |
December 9, 2019 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A24B 15/243 20130101;
A24B 13/00 20130101 |
International
Class: |
A24B 15/24 20060101
A24B015/24; A24B 13/00 20060101 A24B013/00 |
Claims
1. A method for preparing a clarified tobacco extract, the method
comprising: processing a tobacco extract through at least one
ultrafiltration step to provide a filtered tobacco extract; and
passing the filtered tobacco extract through a solution comprising
one or more non-molecularly imprinted polymer (NIP) to provide the
clarified tobacco extract.
2. The method of claim 1, further comprising providing the tobacco
extract by extracting a tobacco material with an aqueous
solution.
3. The method of claim 2, wherein the tobacco material comprises
lamina and stems.
4. The method of claim 1, wherein the processing the tobacco
extract through at least one ultrafiltration comprises processing
through a first ultrafiltration membrane having a nominal molecular
weight cut off (NMWCO) of about 50 kda.
5. The method of claim 4, wherein the processing the tobacco
extract through at least one ultrafiltration further comprises
processing through a second ultrafiltration membrane having a NMWCO
of about 5 kda.
6. The method of claim 1, wherein the clarified tobacco extract
comprises nicotine in an amount of about 5% to about 50% by weight
based on the total weight of the clarified tobacco extract.
7. The method of claim 1, wherein the one or more NIP comprises at
least one NIP that is specific for tobacco-specific nitrosamines
(TSNAs).
8. An oral composition comprising: a clarified tobacco extract
prepared according to the method of claim 1, or a derivative of
said clarified tobacco extract; and one or more filler
components.
9. The oral composition of claim 8, wherein the clarified tobacco
extract comprises nicotine.
10. The oral composition of claim 8, wherein the oral composition
is positioned within a pouch.
11. The oral composition of claim 8, wherein the oral composition
is in the form of a lozenge.
12. The oral composition of claim 8, wherein the clarified tobacco
extract is substantially translucent.
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. No. 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.
[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] All-white snus portions are growing in popularity, and offer
a discrete and aesthetically pleasing alternative to traditional
snus. Such modern "white" pouched products may include a bleached
tobacco or may be tobacco-free. Products of this type may suffer
from certain drawbacks, such as poor product stability that could
lead to discoloration of the product and/or undesirable
organoleptic characteristics.
BRIEF SUMMARY
[0005] The present disclosure generally provides products
configured for oral use. The products may be configured to impart a
taste when used orally and, additionally or alternatively, may
deliver active ingredients to a consumer, such as nicotine. The
products and methods of the present disclosure in particular may be
adapted or configured to provide one or more materials to a
consumer.
[0006] In one or more embodiments, the present disclosure can
provide methods for preparing clarified tobacco extracts. For
example, such methods can comprise processing a tobacco extract
through at least one ultrafiltration step to provide a filtered
tobacco extract and passing the filtered tobacco extract through a
solution comprising one or more non-molecularly imprinted polymer
(NIP) to provide the clarified tobacco extract.
[0007] The disclosure includes, without limitations, the following
embodiments.
[0008] Embodiment 1: A method for preparing a clarified tobacco
extract, the method comprising processing a tobacco extract through
at least one ultrafiltration step to provide a filtered tobacco
extract, and passing the filtered tobacco extract through a
solution comprising one or more non-molecularly imprinted polymer
(NIP) to provide the clarified tobacco extract.
[0009] Embodiment 2: The method of embodiment 1, wherein the method
further can comprise providing the tobacco extract by extracting a
tobacco material with an aqueous solution.
[0010] Embodiment 3: The method of any one of embodiments 1 to 2,
wherein the tobacco material can comprise lamina and stems.
[0011] Embodiment 4: The method of any one of embodiments 1 to 3,
wherein the processing the tobacco extract through at least one
ultrafiltration can comprise processing through a first
ultrafiltration membrane having a nominal molecular weight cut off
(NMWCO) of about 50 kda.
[0012] Embodiment 5: The method of any one of embodiments 1 to 4,
wherein the processing the tobacco extract through at least one
ultrafiltration further can comprise processing through a second
ultrafiltration membrane having a NMWCO of about 5 kda.
[0013] Embodiment 6: The method of any one of embodiments 1 to 6,
wherein the clarified tobacco extract can comprise nicotine in an
amount of about 5% to about 50% by weight based on the total weight
of the clarified tobacco extract.
[0014] Embodiment 7: The method of any one of embodiments 1 to 6,
wherein the one or more NIP can comprise at least one NIP that is
specific for tobacco-specific nitrosamines (TSNAs).
[0015] Embodiment 8: An oral composition comprising a clarified
tobacco extract prepared according to the method of any one of
embodiments 1 to 7, or a derivative of the clarified tobacco
extract, and one or more filler components.
[0016] Embodiment 9: The oral composition of embodiment 8, wherein
the clarified tobacco extract can comprise nicotine.
[0017] Embodiment 10: The oral composition of any one of
embodiments 8 to 9, wherein the oral composition can be positioned
within a pouch.
[0018] Embodiment 11: The oral composition of any one of
embodiments 8 to 10, wherein the oral composition can be in the
form of a lozenge.
[0019] Embodiment 12: The oral composition of any one of
embodiments 8 to 11, wherein the clarified tobacco extract can be
substantially translucent.
[0020] Embodiment 13: Use of clarification procedures for preparing
a powdered nicotine from a tobacco material.
[0021] Embodiment 14: Use of embodiment 13, wherein the
clarification procedures include processing a tobacco extract
through at least one ultrafiltration step to provide a filtered
tobacco extract.
[0022] Embodiment 15: Use of any one of embodiments 13 to 14,
wherein the clarification procedures further include passing the
filtered tobacco extract through a solution comprising one or more
non-molecularly imprinted polymer (NIP) to provide a clarified
tobacco extract.
[0023] Embodiment 16: Use of any one of embodiments 13 to 15,
further comprising one or both of concentrating the clarified
tobacco extract and spray-drying the clarified tobacco extract.
[0024] These and other features, aspects, and advantages of the
disclosure will be apparent from a reading of the following
detailed description together with the accompanying drawings, which
are briefly described below. The invention includes any combination
of two, three, four, or more of the above-noted embodiments as well
as combinations of any two, three, four, or more features or
elements set forth in this disclosure, regardless of whether such
features or elements are expressly combined in a specific
embodiment description herein. This disclosure is intended to be
read holistically such that any separable features or elements of
the disclosed invention, in any of its various aspects and
embodiments, should be viewed as intended to be combinable unless
the context clearly dictates otherwise.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Having thus described aspects of the disclosure in the
foregoing general terms, reference will now be made to the
accompanying drawing, which is not necessarily drawn to scale. The
drawing is exemplary only, and should not be construed as limiting
the disclosure.
[0026] The FIGURE is a perspective view of a pouched product
according to an example embodiment of the present disclosure
including a pouch or fleece at least partially filled with a
composition for oral use.
DETAILED DESCRIPTION
[0027] The present disclosure provides compositions and products
formed therefrom, the compositions and products particularly being
configured for oral use. The compositions and products may
incorporate one or more components that are effective for retaining
a releasable component and then releasing the releasable component
at a desired time, such as when in contact with an oral cavity. The
present disclosure further discloses methods for preparing
materials useful in compositions and products configured for oral
use. In particular, the methods can be adapted to or configured to
prepare clarified tobacco extracts.
[0028] The present disclosure will now be described more fully
hereinafter with reference to example embodiments thereof. These
example embodiments are described so that this disclosure will be
thorough and complete, and will fully convey the scope of the
disclosure to those skilled in the art. Indeed, the disclosure may
be embodied in many different forms and should not be construed as
limited to the embodiments set forth herein; rather, these
embodiments are provided so that this disclosure will satisfy
applicable legal requirements. As used in this specification and
the claims, the singular forms "a," "an," and "the" include plural
referents unless the context clearly dictates otherwise. Reference
to "dry weight percent" or "dry weight basis" refers to weight on
the basis of dry ingredients (i.e., all ingredients except water).
Reference to "wet weight" refers to the weight of the mixture
including water. Unless otherwise indicated, reference to "weight
percent" of a mixture reflects the total wet weight of the mixture
(i.e., including water).
[0029] The present disclosure provides methods for preparing
clarified tobacco extracts as well as compositions and products
that can include the clarified tobacco extracts. More particularly,
the product may include a clarified tobacco extract with one or
more filler components. The clarified tobacco extract may be
prepared by processing a tobacco extract through at least one
ultrafiltration step to provide a filtered tobacco extract followed
by passing the filtered tobacco extract through a solution
comprising one or more non-molecularly imprinted polymers (NIPs) to
provide a clarified tobacco extract. As described, the compositions
may be provided in a variety of forms and, as further described
herein, specifically, may be provided in a substantially solid
form, such as lozenges, or the like. In further embodiments, the
clarified tobacco extract may be combined with a content of a
filler material so as to provide a collection of particles, fibers,
or the like, which in turn may be positioned within a unitizing
structure, such as a pouch, a fleece, or the like. In some
embodiments, the products as described herein comprise a mixture of
components, typically including at least a clarified tobacco
extract, and optionally one or more of a carrier and/or filler, at
least one flavoring agent and/or active ingredient, one or more
salts, one or more sweeteners, one or more binding agents, one or
more humectants, one or more gums, an organic acid, a tobacco
material, or a combination thereof. The relative amounts of the
various components within the composition may vary, and typically
are selected so as to provide the desired sensory and performance
characteristics to the oral product. In particular, one or more
components of the composition may be combined in a manner such that
a releasable material is adapted to or configured to be released in
a controlled and/or sustained manner when the composition is
positioned in an oral cavity of a consumer.
Preparation of Clarified Tobacco Extracts
[0030] In one or more embodiments, the present disclosure can
provide methods of preparing a clarified tobacco extract. As
further described herein, a clarified tobacco extract may include
in individual, isolated component, such as nicotine extracted from
tobacco, or may comprise a plurality of components that may be
isolated from a tobacco material as a mixture of components.
[0031] In example embodiments, a method for preparing a clarified
tobacco extract can include processing a tobacco extract through at
least one ultrafiltration step to provide a filtered tobacco
extract. The tobacco extract may be obtained from a further
process. Alternatively, the present process may include a step of
forming a tobacco extract that is then processed through at least
one ultrafiltration step. Ultrafiltration can be adapted to or
configured to remove one or more high molecular weight components
that may be present in the tobacco extract. For example, in certain
ultrafiltration processes, the tobacco extract to be filtered is
brought into contact with a semipermeable membrane. The membrane
can be of any type, such as plate-and-frame (having a stack of
membranes and support plates), spiral-wound (having consecutive
layers of membrane and support material rolled up around a tube),
tubular (having a membrane-defined core through which the feed
flows and an outer, tubular housing where permeate is collected),
or hollow fiber (having several small diameter tubes or fibers
wherein the permeate is collected in the cartridge area surrounding
the fibers). The membrane can be constructed of various materials.
For example, polysulfone, polyethersulfone, polypropylene,
polyvinylidenefluoride, and cellulose acetate membranes are
commonly used, although other materials can be used without
departing from the invention described herein.
[0032] In one or more embodiments, the ultrafiltration may be
carried out utilizing one or a plurality of membranes. In
particular, when a plurality of membranes are used (e.g., at least
a first membrane and a second membrane), the membranes may be
adapted to or configured to filter up to specific molecular weight
cut-offs. For example, a substantially high molecular weight
cut-off may be utilized and/or a substantially low molecular weight
cut-off may be utilized. For example, a substantially high
molecular weight cut-off may be nominal molecular weight cut-off
(NMWCO) of about 100 kilodaltons (kda), about 80 kda, about 50 kda,
or about 25 kda. As a further example, a substantially low
molecular weight cut-off may be a NMWCO of about 15 kda, about 10
kda, about 5 kda, or about 2 kda. The tobacco extract may be
sequentially passed through a plurality of ultrafiltration
membranes of decreasing NMWCO. Specifically, the tobacco extract
may be passed through a first ultrafiltration membrane to provide a
first permeate that then can be passed through a second
ultrafiltration membrane to provide a second permeate, and such may
continue until providing a final permeate that then may be subject
to further processing as described herein.
[0033] Alternatively, or additionally, the clarification can
comprise a distillation process, comprising contacting the tobacco
material with a solvent, for example water, and subjecting the
mixture to a distillation process for a time and at a temperature
sufficient to cause the distillation of one or more components of
the tobacco material and to provide a clarified tobacco extract, or
distillate.
[0034] The tobacco extract can also be subjected to further
treatment, which can be used in the place of, or in addition to,
the distillation and/or filtration described above. For example, in
the present disclosure, the extract can be brought into contact
with one or more non-molecularly imprinted polymers. Example
embodiments of NIPs suitable for use according to the present
disclosure are described in US Pat. Pub. Nos. 2007/0186940 to
Bhattacharyya et al; 2011/0041859 to Rees et al.; and 2011/0159160
to Jonsson et al; and U.S. patent application Ser. No. 13/111,330
to Byrd et al., filed May 19, 2011; and U.S. Pat. No. 9,243,096 to
Karlsson, et.al. the disclosures of which are incorporated herein
by reference. While not wishing to be bound by theory, the use of a
copolymer derived from monomers in which there is a difference in
hydrophobicity gives a pattern of regions or domains that
preferentially bind non-polar portions of the relevant small
molecules and regions or domains where polar regions of the
relevant small molecules can more readily bind and possibly form
hydrogen bonds, these regions or domains giving rise to the
observed difference in adsorption without the need for molecular
imprinting.
[0035] Treatment with a non-molecularly imprinted polymer can be
used to remove certain components of the extract, such as tobacco
specific nitrosamines (TSNAs) such as N'-nitrosonornicotine (NNN),
(4-methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK),
N'-nitrosoanatabine (NAT), and N'-nitrosoanabasine (NAB);
polyaromatic hydrocarbons (PAHs), including benz[a]anthracene,
polyaromatic hydrocarbons (PAHs), including benz[a]anthracene,
benzo[a]pyrene, benzo[b]fluoranthene, benzo[k] fluoranthene,
chrysene, dibenz[a,h]anthracene, and indeno[1,2,3-cd]pyrene; or
other Hoffmann analytes. Preferred NIPs exhibit selectivity,
relative to nicotine for, for example, compounds such as
nitrosamines. For example, useful NIPs may include at least one NIP
that is specific for tobacco-specific nitrosamines (TSNAs).
[0036] In one or more embodiments, the clarified tobacco extract
may contain nicotine. For example, a clarified tobacco extract may
be passed through a solution comprising an NIP comprising a
non-acidic monomer and a cross-linker having polar functionality,
one of which is hydrophilic, the other of which is hydrophobic that
is selective towards a tobacco specific nitrosamine relative to
nicotine, which may produce a clarified tobacco extract having
nicotine for delivery to a user. In certain embodiments the
clarified tobacco extract comprises nicotine in an amount of about
5% to about 50% by weight based on the total weight of the
clarified tobacco extract. In some embodiments, the clarified
tobacco extract can comprise nicotine in an amount of about 5% to
about 40%, about 6% to about 35%, about 8% to about 30%, or about
10% to about 20% by weight based on the total weight of the
clarified tobacco extract.
[0037] The clarified tobacco extract (which can be provided, for
example, directly from removal of the tobacco extract from the
tobacco pulp by filtration and/or distillation, or via filtration
or distillation of a separated tobacco extract) generally comprises
fewer high molecular weight components than tobacco extract that
has not been treated in this way. In certain embodiments, the
clarified tobacco extract can be characterized as translucent
and/or transparent. As used herein, "translucent" or "translucency"
refers to the ability to allow some level of light to travel
therethrough diffusely. In certain embodiments, the clarified
extract can have such a high degree of clarity that it can be
classified as "transparent" or exhibiting "transparency," which is
defined as a material allowing light to pass freely through without
significant diffusion. The clarity of the clarified extract is
generally such that there is some level of translucency as opposed
to opacity (which refers to materials that are impenetrable by
light).
[0038] In one or more embodiments, the clarified tobacco extract
may be subject to additional processing to provide an end product.
For example, the clarified tobacco extract may be concentrated,
such as through one or more distillation processes and/or through
use of an evaporating solvent. The clarified tobacco extract
alternatively, or additionally, may be spray-dried to form a
powdered product. In some embodiments, the powdered product may
comprise nicotine in an amount of about 20% or less, about 15% or
less, or about 10% or less by weight, such as about 1% to about
20%, about 2% to about 15%, about 3% to about 10%, or about 5% to
about 8% by weight, based on the total weight of the powdered
product.
[0039] A tobacco extract that is subject to clarifying as describe
above may refer 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;
[0040] 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. The
present disclosure thus may include extraction as described in the
foregoing or may start with a previously prepared tobacco extract
that is then clarified as described herein.
[0041] A clarified tobacco extract prepared according to the
present disclosure may be utilized in forming a composition or
product for oral use. The clarified tobacco extract may be
incorporated into a variety of product forms. For example, in some
embodiments, the clarified tobacco extract may be included in a
lozenge, a pastille, or other solid, unitary form. In further
embodiments, the clarified tobacco extract may be combined with a
filler and/or carrier material to provide a product that is
substantially in a particulate or fiber form, and the particles
and/or fibers may be included within a pouch or fleece as otherwise
described herein. In some embodiments, a derivative of the
clarified tobacco extract may be used in preparing a composition or
product of oral use. For example, as noted above, the clarified
tobacco extract may be concentrated and/or spray dried, and a
resulting concentrate or particulate product, respectively, may be
a useful derivative of the clarified tobacco extract. Other
processing may similarly be utilized to provide one or more
derivatives of the clarified tobacco extract for use in forming an
oral composition or oral product. Regardless of the final form, the
clarified tobacco extract (or derivative thereof) may be combined
with one or more further materials described below to achieve the
final composition or product form.
Carrier/Filler Component
[0042] Compositions as described herein can include at least one
component that may be characterized as being a carrier component
and/or a filler component. In some embodiments, the compositions
may include both of a carrier and a filler, and various materials
may fulfill the function of both a carrier and a filler. A carrier
component according to the present disclosure preferably may be
adapted to or configured to retain at least a releasable material
as described herein and may, in some embodiments, retain
substantially all of the further components of the composition. A
filler component may fulfill multiple functions, such as enhancing
certain organoleptic properties such as texture and mouthfeel,
enhancing cohesiveness or compressibility of the product, and the
like. Generally, the filler components are porous particulate
materials. In some embodiments, the present compositions may
comprise a carrier. In further embodiments, the present
compositions may comprise a carrier and a filler. In other
embodiments, the present composition may comprise one or more
filler components.
[0043] In some embodiments, a carrier component and/or a filler
component may be cellulose-based. For example, suitable particulate
components are any non-tobacco plant material or derivative
thereof, including cellulose materials derived from such sources.
Examples of cellulosic non-tobacco plant material include 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 starches (e.g., from potato, wheat, rice, corn), natural
cellulose, and modified cellulosic materials. Additional examples
of potential particulate carrier and/or filler components include
maltodextrin, dextrose, calcium carbonate, calcium phosphate,
lactose, mannitol, xylitol, and sorbitol. Combinations of materials
can also be used.
[0044] "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 "modified" starches. Other starches are obtained
and subsequently modified. For example, modified starches can be
starches that have been subjected to chemical reactions, such as
esterification, etherification, oxidation, depolymerization
(thinning) by acid catalysis or oxidation in the presence of base,
bleaching, transglycosylation and depolymerization (e.g.,
dextrinization in the presence of a catalyst), cross-linking,
enzyme treatment, acetylation, hydroxypropylation, and/or partial
hydrolysis. Other starches are modified by heat treatments, such as
pregelatinization, dextrinization, and/or cold water swelling
processes. Certain modified starches include monostarch phosphate,
distarch glycerol, distarch phosphate esterified with sodium
trimetaphosphate, phosphate distarch phosphate, acetylated distarch
phosphate, starch acetate esterified with acetic anhydride, starch
acetate esterified with vinyl acetate, acetylated distarch adipate,
acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl
distarch glycerol, starch sodium octenyl succinate.
[0045] In some embodiments, a carrier component and/or a filler
component may be a cellulose material or cellulose derivative. One
particularly suitable material for use in the products described
herein is 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, a composition as described
herein may comprise mcc as a particulate filler component and/or as
a carrier component. The quantity of mcc present in the
compositions as described herein may vary according to the desired
properties. In some embodiments, a cellulose derivative or a
combination of such derivatives in particular may be used in
combination with a different carrier component, and this
particularly can include cellulose derivatives, such as a cellulose
ether (including carboxyalkyl ethers), meaning a cellulose polymer
with the hydrogen of one or more hydroxyl groups in the cellulose
structure replaced with an alkyl, hydroxyalkyl, or aryl group.
Non-limiting examples of such cellulose derivatives include
methylcellulose, hydroxypropylcellulose ("HPC"),
hydroxypropylmethylcellulose ("HPMC"), 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.
[0046] The total amount of carrier component(s) and filler
component(s) present in the composition can vary, but is typically
up to about 75 percent of the composition by weight, based on the
total weight of the composition. A typical range of total carrier
and/or filler component within the composition can be from about 10
to about 75 percent by total weight of the composition, for
example, from about 10, about 15, about 20, about 25, or about 30,
to about 35, about 40, about 45, or about 50 weight percent (e.g.,
about 20 to about 50 weight percent or about 25 to about 45 weight
percent). In certain embodiments, the total amount of
carrier/filler component is at least about 10 percent by weight,
such as at least about 20 percent, or at least about 25 percent, or
at least about 30 percent, or at least about 35 percent, or at
least about 40 percent, based on the total weight of the
composition.
[0047] In one or more embodiments, a carrier component may be
adapted to or configured to substantially surround or envelop
further components of the composition. For example, the carrier may
be configured as a packet, a pouch, a fleece, or the like, and such
structures are further described herein. The term "fleece" may
particularly be used herein as a common term for such structures
and should not be viewed as limiting the nature of the
structure.
[0048] A suitable fleece, for example, may be formed of a plurality
of fibers. The term "fiber" as used herein includes both fibers of
finite length, such as conventional staple fibers and nanofibers,
as well as substantially continuous structures, such as continuous
filaments, unless otherwise indicated. The fibers can have a
substantially round or circular cross section or non-circular cross
sections (for example, oval, rectangular, multi-lobed, and the
like). The fibers can be provided in a variety of configurations,
and the fibers particularly can include multicomponent fibers.
[0049] In some embodiments, the fleece can be in the form of a
non-woven material. The term "nonwoven" is used herein in reference
to fibrous materials, webs, mats, batts, or sheets in which fibers
are aligned in an undefined or random orientation. In some
embodiments, the plurality of fibers used in forming a fleece may
include heat sealable and/or meltable binder fibers.
Active Ingredients
[0050] In some embodiments, a composition or product as described
herein may include one or more active ingredients. For example, the
releasable material may include a single active ingredient or a
plurality of active ingredients. If desired, one or more active
ingredients may be retained on a portion of a filler, and one or
more active ingredients may be otherwise retained in the
compositions and/or products, such as being bound to a further
filler or being present in a unitary form (e.g., pelletized active
ingredients).
[0051] Non-limiting examples of active ingredients that may be used
as a releasable material herein and/or be otherwise included within
the present compositions and/or products can include a nicotine
component, nutraceuticals, botanical ingredients (e.g., lavender,
peppermint, chamomile, basil, rosemary, ginger, hemp, cannabis,
eucalyptus, rooibos, fennel, citrus, cloves, ginseng, maca, and
tisanes), stimulants (e.g., caffeine and guarana), amino acids
(e.g., taurine, theanine, phenylalanine, tyrosine, and tryptophan)
and/or pharmaceutical, nutraceutical, and medicinal ingredients
(e.g., vitamins, such as B6, B12, and C, and/or cannabinoids, such
as tetrahydrocannabinol (THC) and cannabidiol (CBD)). The
particular percentages and choice of ingredients can vary depending
upon the desired flavor, texture, and other characteristics.
Example active ingredients would include any ingredient known to
impact one or more biological functions within the body, such as
ingredients that furnish pharmacological activity or other direct
effect in the diagnosis, cure, mitigation, treatment, or prevention
of disease, or which affect the structure or any function of the
body of humans or other animals (e.g., provide a stimulating action
on the central nervous system, have an energizing effect, an
antipyretic or analgesic action, or an otherwise useful effect on
the body).
[0052] In certain embodiments, a nicotine component may be included
in the mixture. By "nicotine component" is meant any suitable form
of nicotine (e.g., free base or salt) for providing oral absorption
of at least a portion of the nicotine present. Typically, the
nicotine component is selected from the group consisting of
nicotine free base and a nicotine salt. In some embodiments,
nicotine is in its free base form, which easily can be adsorbed in
for example, a microcrystalline cellulose material to form a
microcrystalline cellulose-nicotine carrier complex. See, for
example, the discussion of nicotine in free base form in US Pat.
Pub. No. 2004/0191322 to Hansson, which is incorporated herein by
reference. In some embodiments, at least a portion of the nicotine
used as an active ingredient may be provided in the clarified
tobacco extract prepared as described above.
[0053] 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
U.S. Pat. No. 2,033,909 to Cox et al. and Perfetti, Beitrage
Tabakforschung Int., 12: 43-54 (1983), which are incorporated
herein by reference. Additionally, salts of nicotine are available
from sources such as Pfaltz and Bauer, Inc. and K&K
Laboratories, Division of ICN Biochemicals, Inc. Typically, the
nicotine component is selected from the group consisting of
nicotine free base, a nicotine salt such as hydrochloride,
dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and
nicotine zinc chloride. In some embodiments, the nicotine component
or a portion thereof is a nicotine salt with at least a portion of
the one or more organic acids as disclosed herein above.
[0054] 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.
[0055] 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 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 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.
Flavoring Agents
[0056] In some embodiments, a composition or product as described
herein may include one or more flavoring agent. As used herein, a
"flavoring agent" or "flavorant" is any flavorful or aromatic
substance capable of altering the sensory characteristics
associated with the oral product. Examples of sensory
characteristics that can be modified by the flavoring agent include
taste, mouthfeel, moistness, coolness/heat, and/or fragrance/aroma.
Flavoring agents may be natural or synthetic, and the character of
the flavors imparted thereby may be described, without limitation,
as fresh, sweet, herbal, confectionary, floral, fruity, or spicy.
In some embodiments, the releasable material may include a single
flavoring agent or a plurality of flavoring agents. If desired, one
or more flavoring agents may be retained on a portion of a carrier
or filler, and one or more flavoring agents may be otherwise
retained in the compositions and/or products, such as being bound
to a further carrier or filler.
[0057] Non-limiting examples of flavoring agents that may be used
as a releasable material herein and/or be otherwise included within
the present compositions and/or products (e.g., when not retained
by the porous alumina) can include vanilla, coffee,
chocolate/cocoa, cream, mint, spearmint, menthol, peppermint,
wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon,
clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage,
licorice, lemon, orange, apple, peach, lime, cherry, strawberry,
trigeminal sensates, terpenes, and any combinations thereof. See
also, Leffingwell et al., Tobacco Flavoring for Smoking Products,
R. J. Reynolds Tobacco Company (1972), which is incorporated herein
by reference. Flavoring agents may comprise components such as
terpenes, terpenoids, aldehydes, ketones, esters, and the like. In
some embodiments, the flavoring agent is a trigeminal sensate. As
used herein, "trigeminal sensate" refers to a flavoring agent which
has an effect on the trigeminal nerve, producing sensations
including heating, cooling, tingling, and the like. Non-limiting
examples of trigeminal sensate flavoring agents include capsaicin,
citric acid, menthol, Sichuan buttons, erythritol, and cubebol.
Flavorings also may include components that are considered
moistening, cooling or smoothening agents, such as eucalyptus.
These flavors may be provided neat (i.e., alone) or in a composite,
and may be employed as concentrates or flavor packages (e.g.,
spearmint and menthol, orange and cinnamon; lime, pineapple, and
the like). Representative types of components also are set forth in
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.
[0058] 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.
[0059] 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 weight of the
mixture.
[0060] Tobacco Material
[0061] In some embodiments, the present compositions and/or
products may include a tobacco material. The tobacco material can
vary in species, type, and form. Generally, the tobacco material is
obtained from for a harvested 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.
[0062] 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.
[0063] 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.
[0064] 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).
[0065] 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.
[0066] 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.
[0067] 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.
[0068] 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.
[0069] 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, 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.
[0070] 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.
[0071] 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.
[0072] In some embodiments, the type of tobacco material is
selected such that it is initially visually lighter in color than
other tobacco materials to some degree (e.g., whitened or
bleached). Tobacco pulp can be whitened in certain embodiments
according to any means known in the art. For example, bleached
tobacco material produced by various whitening methods using
various bleaching or oxidizing agents and oxidation catalysts can
be used. Example oxidizing agents include peroxides (e.g., hydrogen
peroxide), chlorite salts, chlorate salts, perchlorate salts,
hypochlorite salts, ozone, ammonia, potassium permanganate, and
combinations thereof. Example oxidation catalysts are titanium
dioxide, manganese dioxide, and combinations thereof. Processes for
treating tobacco with bleaching agents are discussed, for example,
in 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.
[0073] 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.
[0074] 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.
[0075] In various embodiments, the tobacco material can be treated
to extract a soluble component of the tobacco material therefrom. A
tobacco extract thus may be incorporated into the presently
disclosed compositions and products. More particularly, a tobacco
extract that has been clarified according to methods as described
herein may be utilized.
[0076] Typical inclusion ranges for tobacco materials can vary
depending on the nature and type of the tobacco material, and the
intended effect on the final mixture, with an example range of up
to about 30% by weight (or up to about 20% by weight or up to about
10% by weight or up to about 5% by weight), based on total weight
of the mixture (e.g., about 0.1 to about 15% by weight). In some
embodiments, the products of the disclosure can be characterized as
completely free or substantially free of tobacco material (other
than purified nicotine as an active ingredient). For example,
certain embodiments can be characterized as having less than 1% by
weight, or less than 0.5% by weight, or less than 0.1% by weight of
tobacco material, or 0% by weight of tobacco material. In some
embodiments, a composition or product according to the present
disclosure may comprise no more than about 10% by weight of a
tobacco material, excluding any nicotine component present, based
on the total weight of the mixture.
[0077] Further Additives
[0078] In some embodiments, one or more further additives can be
included in the disclosed compositions and/or products. For
example, the compositions can be processed, blended, formulated,
combined and/or mixed with other materials or ingredients. The
additives can be artificial, or can be obtained or derived from
herbal or biological sources. Specific types of further additives
that may be included are further described below.
[0079] In some embodiments, the compositions and products may
include a content of water. The water content of the composition
within the product, prior to use by a consumer of the product, may
vary according to the desired properties. Typically, the
composition, as present within the product prior to insertion into
the mouth of the user, can comprise less than 60%, less than 50%,
less than 40%, less than 30%, less than 20%, less than 10%, or less
than 5% by weight of water. For example, total water content in the
composition and/or product may be in the range of about 0.1% to
about 60%, about 1% to about 50%, about 1.5% to about 40%, or about
2% to about 25% by weight of water. In some embodiments, the
compositions and products may include at least 1%, at least 2%, at
least 5%, at least 10%, or at least 20% by weight water.
[0080] In some embodiments, the compositions and products may
include a content of one or more organic acids. As used herein, the
term "organic acid" refers to an organic (i.e., carbon-based)
compound that is characterized by acidic properties. Typically,
organic acids are relatively weak acids (i.e., they do not
dissociate completely in the presence of water), such as carboxylic
acids (--CO.sub.2H) or sulfonic acids (--SO.sub.2OH). As used
herein, reference to organic acid means an organic acid that is
intentionally added. In this regard, an organic acid may be
intentionally added as a specific ingredient as opposed to merely
being inherently present as a component of another ingredient
(e.g., the small amount of organic acid which may inherently be
present in an ingredient such as a tobacco material). In some
embodiments, the one or more organic acids are added neat (i.e., in
their free acid, native solid or liquid form) or as a solution in,
e.g., water. In some embodiments, the one or more organic acids are
added in the form of a salt, as described herein below.
[0081] In some embodiments, the organic acid is an alkyl carboxylic
acid. Non-limiting examples of alkyl carboxylic acids include
formic acid, acetic acid, propionic acid, octanoic acid, nonanoic
acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic
acid, oleic acid, linoleic acid, linolenic acid, and the like. In
some embodiments, the organic acid is an alkyl sulfonic acid.
Non-limiting examples of alkyl sulfonic acids include
propanesulfonic acid and octanesulfonic acid. In some embodiments,
the alkyl carboxylic or sulfonic acid is substituted with one or
more hydroxyl groups. Non-limiting examples include glycolic acid,
4-hydroxybutyric acid, and lactic acid. In some embodiments, an
organic acid may include more than one carboxylic acid group or
more than one sulfonic acid group (e.g., two, three, or more
carboxylic acid groups). Non-limiting examples include oxalic acid,
fumaric acid, maleic acid, and glutaric acid. In organic acids
containing multiple carboxylic acids (e.g., from two to four
carboxylic acid groups), one or more of the carboxylic acid groups
may be esterified. Non-limiting examples include succinic acid
monoethyl ester, monomethyl fumarate, monomethyl or dimethyl
citrate, and the like.
[0082] In some embodiments, the organic acid may include more than
one carboxylic acid group and one or more hydroxyl groups.
Non-limiting examples of such acids include tartaric acid, citric
acid, and the like. In some embodiments, the organic acid is an
aryl carboxylic acid or an aryl sulfonic acid. Non-limiting
examples of aryl carboxylic and sulfonic acids include benzoic
acid, toluic acids, salicylic acid, benzenesulfonic acid, and
p-toluenesulfonic acid. In some embodiments, the organic acid is
citric acid, malic acid, tartaric acid, octanoic acid, benzoic
acid, a toluic acid, salicylic acid, or a combination thereof. In
some embodiments, the organic acid is benzoic acid. In some
embodiments, the organic acid is citric acid. In alternative
embodiments, a portion, or even all, of the organic acid may be
added in the form of a salt with an alkaline component, which may
include, but is not limited to, nicotine. Non-limiting examples of
suitable salts, e.g., for nicotine, include formate, acetate,
propionate, isobutyrate, butyrate, alpha-methylbutyate,
isovalerate, beta-methylvalerate, caproate, 2-furoate,
phenylacetate, heptanoate, octanoate, nonanoate, oxalate, malonate,
glycolate, benzoate, tartrate, levulinate, ascorbate, fumarate,
citrate, malate, lactate, aspartate, salicylate, tosylate,
succinate, pyruvate, and the like.
[0083] The amount of organic acid present in the compositions may
vary. Generally, the compositions can comprise from 0 to about 10%
by weight of organic acid, present as one or more organic acids,
based on the total weight of the mixture.
[0084] In some embodiments, the compositions may further comprise a
salt (e.g., alkali metal salts), typically employed in an amount
sufficient to provide desired sensory attributes to the
compositions and products. Non-limiting examples of suitable salts
include sodium chloride, potassium chloride, ammonium chloride,
flour salt, and the like. When present, a representative amount of
salt is about 0.5 percent by weight or more, about 1.0 percent by
weight or more, or at about 1.5 percent by weight or more, but will
typically make up about 10 percent or less of the total weight of
the composition or product, or about 7.5 percent or less or about 5
percent or less (e.g., about 0.5 to about 5 percent by weight).
[0085] The compositions and products also may include one or more
sweeteners. The sweeteners can be any sweetener or combination of
sweeteners, in natural or artificial form, or as a combination of
natural and artificial sweeteners. Examples of natural sweeteners
include fructose, sucrose, glucose, maltose, mannose, galactose,
lactose, stevia, honey, and the like. Examples of artificial
sweeteners include sucralose, isomaltulose, maltodextrin,
saccharin, aspartame, acesulfame K, neotame and the like. In some
embodiments, the sweetener comprises one or more sugar alcohols.
Sugar alcohols are polyols derived from monosaccharides or
disaccharides that have a partially or fully hydrogenated form.
Sugar alcohols have, for example, about 4 to about 20 carbon atoms
and include erythritol, arabitol, ribitol, isomalt, maltitol,
dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and
combinations thereof (e.g., hydrogenated starch hydrolysates). When
present, a representative amount of sweetener may make up from
about 0.1 to about 20 percent or more of the of the composition by
weight, for example, from about 0.1 to about 1%, from about 1 to
about 5%, from about 5 to about 10%, or from about 10 to about 20%
of the composition or product on a weight basis, based on the total
weight of the composition or product. Sweeteners in particular may
be useful in forming solid, unitary dosage forms including a
clarified tobacco extract, such as a lozenge form.
[0086] In some embodiments, the compositions and products may
include one or more binding agents. A binder (or combination of
binders) may be employed in certain embodiments, in amounts
sufficient to provide the desired physical attributes and physical
integrity to the composition. Typical binders can be organic or
inorganic, or a combination thereof. Representative binders include
povidone, sodium alginate, starch-based binders, pectin,
carrageenan, pullulan, zein, and the like, and combinations
thereof. A binder may be employed in amounts sufficient to provide
the desired physical attributes and physical integrity to the
composition. The amount of binder utilized can vary, but is
typically up to about 30 weight percent, and certain embodiments
are characterized by a binder content of at least about 0.1% by
weight, such as about 1 to about 30% by weight, or about 5 to about
10% by weight, based on the total weight of the composition or
product.
[0087] In certain embodiments, the binder includes a gum, for
example, a natural gum. As used herein, a natural gum refers to
polysaccharide materials of natural origin that have binding
properties, and which are also useful as a thickening or gelling
agents. Representative natural gums derived from plants, which are
typically water soluble to some degree, include xanthan gum, guar
gum, gum arabic, ghatti gum, gum tragacanth, karaya gum, locust
bean gum, gellan gum, and combinations thereof. When present,
natural gum binder materials are typically present in an amount of
up to about 5% by weight, for example, from about 0.1, about 0.2,
about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8,
about 0.9, or about 1%, to about 2, about 3, about 4, or about 5%
by weight, based on the total weight of the composition or
product.
[0088] In certain embodiments, one or more humectants may be
employed in the compositions. Examples of humectants include, but
are not limited to, glycerin, propylene glycol, and the like. Where
included, the humectant is typically provided in an amount
sufficient to provide desired moisture attributes to the
compositions. Further, in some instances, the humectant may impart
desirable flow characteristics to the composition for depositing in
a mold. When present, a humectant will typically make up about 5%
or less of the weight of the composition or product (e.g., from
about 0.5 to about 5% by weight). When present, a representative
amount of humectant is about 0.1% to about 1% by weight, or about
1% to about 5% by weight, based on the total weight of the
composition or product.
[0089] In certain embodiments, the compositions of the present
disclosure can comprise pH adjusters or buffering agents. Examples
of pH adjusters and buffering agents that can be used include, but
are not limited to, metal hydroxides (e.g., alkali metal hydroxides
such as sodium hydroxide and potassium hydroxide), and other alkali
metal buffers such as metal carbonates (e.g., potassium carbonate
or sodium carbonate), or metal bicarbonates such as sodium
bicarbonate, and the like. Where present, the buffering agent is
typically present in an amount less than about 5 percent based on
the weight of the compositions or products, for example, from about
0.5% to about 5%, such as, e.g., from about 0.75% to about 4%, from
about 0.75% to about 3%, or from about 1% to about 2% by weight,
based on the total weight of the compositions or products.
Non-limiting examples of suitable buffers include alkali metals
acetates, glycinates, phosphates, glycerophosphates, citrates,
carbonates, hydrogen carbonates, borates, or mixtures thereof.
[0090] In some embodiments, the compositions and products may
include one or more colorants. A colorant may be employed in
amounts sufficient to provide the desired physical attributes to
the composition or product. Examples of colorants include various
dyes and pigments, such as caramel coloring and titanium dioxide.
The amount of colorant utilized in the compositions or products can
vary, but when present is typically up to about 3 weight percent,
such as from about 0.1%, about 0.5%, or about 1%, to about 3% by
weight, based on the total weight of the composition or
product.
[0091] Examples of even further types of additives that may be used
in the present compositions and products include thickening or
gelling agents (e.g., fish gelatin), emulsifiers, oral care
additives (e.g., thyme oil, eucalyptus oil, and zinc),
preservatives (e.g., potassium sorbate and the like),
disintegration aids, 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 mixture, with an
example range of up to about 10% by weight, based on total weight
of the mixture (e.g., about 0.1 to about 5% by weight).
[0092] 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. Exemplary encapsulated additives are described,
for example, in WO2010/132444 to Atchley, which has been previously
incorporated by reference herein.
Particles
[0093] 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.
[0094] 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).
[0095] 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.
[0096] 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.
[0097] 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 .mu.m, such as from about 100 .mu.m to
about 350 .mu.m, such as from about 200 .mu.m to about 300
.mu.m.
Preparation of Compositions and/or Products
[0098] The manner by which the various components of the present
compositions (including clarified tobacco extracts prepared as
described herein) are combined may vary. As such, an overall
mixture of various components with e.g., powdered mixture
components may be relatively uniform in nature. The components
noted above, which may be in liquid or dry solid form, can be
admixed in a pretreatment step prior to mixture with any remaining
components of the mixture, or simply mixed together with all other
liquid or dry ingredients. The various components may be contacted,
combined, or mixed together using any mixing technique or equipment
known in the art. Any mixing method that brings the mixture
ingredients into intimate contact can be used, such as a mixing
apparatus featuring an impeller or other structure capable of
agitation. Examples of mixing equipment include casing drums,
conditioning cylinders or drums, liquid spray apparatus,
conical-type blenders, ribbon blenders, mixers available as FKM130,
FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day, Inc.,
Plough Share types of mixer cylinders, Hobart mixers, and the like.
See also, for example, the types of methodologies set forth in 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. In some embodiments, the
components forming the mixture are prepared such that the mixture
thereof may be used in a starch molding process for forming the
mixture. Manners and methods for formulating mixtures will be
apparent to those skilled in the art. See, for example, the types
of methodologies set forth in 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, U.S. Pat. No. 4,725,440 to Ridgway et al.,
and U.S. Pat. No. 6,077,524 to Bolder et al., each of which is
incorporated herein by reference.
[0099] Configured for Oral Use
[0100] Provided herein is a product configured for oral use. The
term "configured for oral use" as used herein means that the
product is provided in a form such that during use, saliva in the
mouth of the user causes one or more of the components of the
mixture (e.g., flavoring agents and/or nicotine) to pass into the
mouth of the user. In certain embodiments, the product is adapted
to deliver releasable components to a user through mucous membranes
in the user's mouth and, in some instances, said releasable
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.
[0101] Products configured for oral use as described herein may
take various forms, including gels, pastilles, gums, lozenges,
powders, and pouches. Gels can be soft or hard. Certain products
configured for oral use are in the form of pastilles. As used
herein, the term "pastille" refers to a dissolvable oral product
made by solidifying a liquid or gel mixture so that the final
product is a somewhat hardened solid gel. The rigidity of the gel
is highly variable. Certain products of the disclosure are in the
form of solids. Certain products can exhibit, for example, one or
more of the following characteristics: crispy, granular, chewy,
syrupy, pasty, fluffy, smooth, and/or creamy. In certain
embodiments, the desired textural property can be selected from the
group consisting of adhesiveness, cohesiveness, density, dryness,
fracturability, graininess, gumminess, hardness, heaviness,
moisture absorption, moisture release, mouthcoating, roughness,
slipperiness, smoothness, viscosity, wetness, and combinations
thereof.
[0102] The products comprising the mixtures of the present
disclosure may be dissolvable. As used herein, the terms
"dissolve," "dissolving," and "dissolvable" refer to mixtures
having aqueous-soluble components that interact with moisture in
the oral cavity and enter into solution, thereby causing gradual
consumption of the product. According to one aspect, the
dissolvable product is capable of lasting in the user's mouth for a
given period of time until it completely dissolves. Dissolution
rates can vary over a wide range, from about 1 minute or less to
about 60 minutes. For example, fast release mixtures typically
dissolve and/or release the active substance in about 2 minutes or
less, often about 1 minute or less (e.g., about 50 seconds or less,
about 40 seconds or less, about 30 seconds or less, or about 20
seconds or less). Dissolution can occur by any means, such as
melting, mechanical disruption (e.g., chewing), enzymatic or other
chemical degradation, or by disruption of the interaction between
the components of the mixture. In some embodiments, the product can
be meltable as discussed, for example, in US Patent App. Pub. No.
2012/0037175 to Cantrell et al. In other embodiments, the products
do not dissolve during the product's residence in the user's
mouth.
[0103] In one embodiment, the product comprising the composition of
the present disclosure is in the form of a mixture disposed within
a moisture-permeable container (e.g., a water-permeable pouch).
Such mixtures in the water-permeable pouch format are typically
used by placing one pouch containing the mixture in the mouth of a
human subject/user. Generally, the pouch is placed somewhere in the
oral cavity of the user, for example under the lips, in the same
way as moist snuff products are generally used. The pouch
preferably is not chewed or swallowed. Exposure to saliva then
causes some of the components of the mixture therein (e.g.,
flavoring agents and/or active ingredients, such as nicotine) to
pass through e.g., the water-permeable pouch and provide the user
with flavor and satisfaction, and the user is not required to spit
out any portion of the mixture. After about 10 minutes to about 60
minutes, typically about 15 minutes to about 45 minutes, of
use/enjoyment, substantial amounts of the mixture have been
ingested by the human subject, and the pouch may be removed from
the mouth of the human subject for disposal.
[0104] Accordingly, in certain embodiments, the mixture as
disclosed herein and any other components noted above are combined
within a moisture-permeable packet or pouch that acts as a
container for use of the mixture to provide a pouched product
configured for oral use. Certain embodiments of the disclosure will
be described with reference to the FIGURE, and these described
embodiments involve snus-type products having an outer pouch and
containing a mixture as described herein. As explained in greater
detail below, such embodiments are provided by way of example only,
and the pouched products of the present disclosure can include the
composition in other forms. The mixture/construction of such
packets or pouches, such as the container pouch 102 in the
embodiment illustrated in the FIGURE, may be varied. Referring to
the FIGURE, there is shown a first embodiment of a pouched product
100. The pouched product 100 includes a moisture-permeable
container in the form of a pouch 102, which contains a material 104
comprising a composition as described herein. The pouched product
100 may be an example of a product as described herein formed at
least in part from the described compositions.
[0105] Suitable packets, pouches or containers of the type used for
the manufacture of smokeless tobacco products are available under
the tradenames CatchDry, Ettan, General, Granit, Goteborgs Rape,
Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca
Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare. The
mixture may be contained in pouches and packaged, in a manner and
using the types of components used for the manufacture of
conventional snus types of products. The pouch provides a
liquid-permeable container of a type that may be considered to be
similar in character to the mesh-like type of material that is used
for the construction of a tea bag. Components of the mixture
readily diffuse through the pouch and into the mouth of the
user.
[0106] Non-limiting examples of suitable types of pouches are set
forth in, for example, U.S. Pat. No. 5,167,244 to Kjerstad and U.S.
Pat. No. 8,931,493 to Sebastian et al.; as well as US Patent App.
Pub. Nos. 2016/0000140 to Sebastian et al.; 2016/0073689 to
Sebastian et al.; 2016/0157515 to Chapman et al.; and 2016/0192703
to Sebastian et al., each of which are incorporated herein by
reference. Pouches can be provided as individual pouches, or a
plurality of pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30
pouches) can be connected or linked together (e.g., in an
end-to-end manner) such that a single pouch or individual portion
can be readily removed for use from a one-piece strand or matrix of
pouches.
[0107] An example pouch may be manufactured from materials, and in
such a manner, such that during use by the user, the pouch
undergoes a controlled dispersion or dissolution. Such pouch
materials may have the form of a mesh, screen, perforated paper,
permeable fabric, or the like.
[0108] For example, pouch material manufactured from a mesh-like
form of rice paper, or perforated rice paper, may dissolve in the
mouth of the user. As a result, the pouch and mixture each may
undergo complete dispersion within the mouth of the user during
normal conditions of use, and hence the pouch and mixture both may
be ingested by the user. Other examples of pouch materials may be
manufactured using water dispersible film forming materials (e.g.,
binding agents such as alginates, carboxymethylcellulose, xanthan
gum, pullulan, and the like), as well as those materials in
combination with materials such as ground cellulosics (e.g., fine
particle size wood pulp). Preferred pouch materials, though water
dispersible or dissolvable, may be designed and manufactured such
that under conditions of normal use, a significant amount of the
mixture contents permeate through the pouch material prior to the
time that the pouch undergoes loss of its physical integrity. If
desired, flavoring ingredients, disintegration aids, and other
desired components, may be incorporated within, or applied to, the
pouch material.
[0109] The amount of material contained within each product unit,
for example, a pouch, may vary. In some embodiments, the weight of
the mixture within each pouch is at least about 50 mg, for example,
from about 50 mg to about 1 gram, from about 100 to 800 about mg,
or from about 200 to about 700 mg. In some smaller embodiments, the
weight of the mixture within each pouch may be from about 100 to
about 300 mg. For a larger embodiment, the weight of the material
within each pouch may be from about 300 mg to about 700 mg. If
desired, other components can be contained within each pouch. For
example, at least one flavored strip, piece or sheet of flavored
water dispersible or water soluble material (e.g., a
breath-freshening edible film type of material) may be disposed
within each pouch along with or without at least one capsule. Such
strips or sheets may be folded or crumpled in order to be readily
incorporated within the pouch. See, for example, the types of
materials and technologies set forth in U.S. Pat. No. 6,887,307 to
Scott et al. and U.S. Pat. No. 6,923,981 to Leung et al.; and The
EFSA Journal (2004) 85, 1-32; which are incorporated herein by
reference.
[0110] A pouched product as described herein can be packaged within
any suitable inner packaging material and/or outer container. See
also, for example, the various types of containers for smokeless
types of products that are set forth in U.S. Pat. No. 7,014,039 to
Henson et al.; U.S. Pat. No. 7,537,110 to Kutsch et al.; U.S. Pat.
No. 7,584,843 to Kutsch et al.; U.S. Pat. No. 8,397,945 to Gelardi
et al., D592,956 to Thiellier; D594,154 to Patel et al.; and
D625,178 to Bailey et al.; US Pat. Pub. Nos. 2008/0173317 to
Robinson et al.; 2009/0014343 to Clark et al.; 2009/0014450 to
Bjorkholm; 2009/0250360 to Bellamah et al.; 2009/0266837 to Gelardi
et al.; 2009/0223989 to Gelardi; 2009/0230003 to Thiellier;
2010/0084424 to Gelardi; and 2010/0133140 to Bailey et al;
2010/0264157 to Bailey et al.; and 2011/0168712 to Bailey et al.
which are incorporated herein by reference.
[0111] 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.
* * * * *