Oral Products Having Dissolvable Components

Abstract

Provided herein is a pouch product adapted for release of a water-soluble component therefrom. The pouch product can include an outer water-permeable pouch defining a cavity containing a composition including a water-soluble component releasable through the water-permeable pouch, wherein at least one of the outer water-permeable pouch and the composition is dissolvable in the mouth.

Description

[Technical field]

[0001] The present disclosure relates to flavored products intended for human use. The products are designed for oral use and to deliver substances such as flavors and / or active ingredients during use. Such products may include tobacco or tobacco-derived products or may be tobacco-free alternatives. [Background technology]

[0002] Tobacco can be enjoyed in so-called "smokeless" forms. Particularly popular smokeless tobacco products are utilized by inserting some form of processed tobacco or tobacco-containing formulation into the user's mouth. Traditional formats for such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed almost entirely of granular, granular, or cut tobacco and are either divided by the user or presented to the user in individual portions, such as disposable pouches or sachets. Other traditional forms of smokeless products include compressed or agglomerated forms, such as plugs, tablets, or pellets. Alternative product formats are also known, such as tobacco-containing gums and mixtures of tobacco with other plant materials.See, for example, 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. 4,987,907 to Sprinkle, III et al., each of which is incorporated herein by reference. No. 5,092,352 to White 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.; U.S. Patent Publication No. 2004 / 0020503 to Williams; U.S. Patent Publication No. 2005 / 0115580 to Inter et al.; U.S. Patent Publication No. 2006 / 0191548 to Strickland et al.; U.S. Patent Publication No. 2007 / 0062549 to Holton, Jr. et al.; U.S. Patent Publication No. 2007 / 0186941 to Holton, Jr. et al.; U.S. Patent Publication No. 2007 / 0186942 to Strickland et al.; U.S. Patent Publication No. 2008 / 0029110 to Dube et al.; Robinson et al. See the types of smokeless tobacco formulations, ingredients and processing methods described in U.S. Patent Publication No. 2008 / 0029116; U.S. Patent Publication No. 2008 / 0173317 to Robinson et al.; U.S. Patent Publication No. 2008 / 0209586 to Neilsen et al.; U.S. Patent Publication No. 2009 / 0065013 to Essen et al.; and U.S. Patent Publication No. 2010 / 0282267 to Atchley, as well as WO 2004 / 095959 to Arnarp et al.

[0003] The construction of smokeless tobacco products that combine tobacco materials with a variety of binders and fillers has recently been proposed, with exemplary product formats including lozenges, pastilles, gels, extruded forms, and the like. See, for example, U.S. Patent Application Publication No. 2008 / 0196730 to Engstrom et al.; U.S. Patent Application Publication No. 2008 / 0305216 to Crawford et al.; U.S. Patent Application Publication No. 2009 / 0293889 to Kumar et al.; U.S. Patent Application Publication No. 2010 / 0291245 to Gao et al.; U.S. Patent Application Publication No. 2011 / 0139164 to Mua et al.; U.S. Patent Application Publication No. 2012 / 0037175 to Cantrell et al.; U.S. Patent Application Publication No. 2012 / 0055494 to Hunt et al.; U.S. Patent Application Publication No. 2012 / 0138073 to Cantrell et al.; See the types of products described in U.S. Patent Application Publication No. 2012 / 0138074 to Rell et al.; U.S. Patent Application Publication No. 2013 / 0074855 to Holton, Jr.; U.S. Patent Application Publication No. 2013 / 0074856 to Holton, Jr.; U.S. Patent Application Publication No. 2013 / 0152953 to Mua et al.; U.S. Patent Application Publication No. 2013 / 0274296 to Jackson et al.; U.S. Patent Application Publication No. 2015 / 0068545 to Moldoveanu et al.; U.S. Patent Application Publication No. 2015 / 0101627 to Marshall et al.; and U.S. Patent Application Publication No. 2015 / 0230515 to Lampe et al.

[0004] Certain types of pouches or sachets have been utilized to contain compositions adapted for oral use. See, for example, the representative smokeless tobacco types and various smokeless tobacco formulations, ingredients, and processing methods referenced in the background art of Brinkley et al., U.S. Patent Publication No. 2011 / 0303511 and Duggins et al., U.S. Patent Publication No. 2013 / 0206150, both of which are incorporated herein by reference. During use, these pouches or sachets are inserted into the mouth of the user, and the water-soluble ingredients contained therein are released as a result of interaction with saliva.

[0005] Certain commercially available smokeless tobacco products, such as those commonly referred to as "snus", comprise milled tobacco material incorporated into a sealed pouch. Representative types of snus products are manufactured in Europe, particularly in Sweden, by or through companies such as Swedish Match AB (e.g., under brands such as General, Ettan, Goteborgs Rape and Grovsnus); Fiedler & Lundgren AB (e.g., under brands such as Lucky Strike, Granit, Krekt and Mocca); JTI Sweden AB (e.g., under brands such as Gustavus) and Rocker Production AB (e.g., under brands such as Rocker). Other types of snus products are commercially available in the United States through companies such as Philip Morris USA, Inc. (e.g., under brands such as Marlboro Snus); US Smokeless Tobacco Company (e.g., under brands such as SKOAL Snus) and RJ Reynolds Tobacco Company (e.g., under brands such as CAMEL Snus). See also, e.g., Bryzgalov et al., 1N1800 Life Cycle Assessment, Comparative Life Cycle Assessment of General Loose and Portion Snus (2005), incorporated herein by reference.

[0006] Various types of snus products and methods for processing components for and associated with these products have been proposed, see, for example, U.S. Patent No. 8,067,046 to Schleef et al. and U.S. Patent No. 7,861,728 to Holton, Jr. et al., U.S. Patent Publication No. 2004 / 0118422 to Lundin et al., U.S. Patent Publication No. 2008 / 0202536 to Torrence et al., U.S. Patent Publication No. 2009 / 0025738 to Mua et al., U.S. Patent Publication No. 2011 / 0180087 to Gee et al., U.S. Patent Publication No. 2010 / 0218779 to Zhuang et al., U.S. Patent Publication No. 2010 / 0294291 to Robinson et al., U.S. Patent Publication No. 2010 / 0294291 to Zimmermann et al., which are incorporated herein by reference. See US Patent Publication No. 2010 / 0300465; US Patent Publication No. 2011 / 0061666 to Dube et al.; US Patent Publication No. 2011 / 0303232 to Williams et al.; US Patent Publication No. 2012 / 0067362 to Mola et al.; US Patent Publication No. 2012 / 0085360 to Kawata et al.; US Patent Publication No. 2012 / 0103353 to Sebastian et al. and US Patent Publication No. 2012 / 0247492 to Kobal et al.; and PCT Publication No. WO05 / 063060 to Atchley et al. and PCT Publication No. WO08 / 56135 to Onno. In addition, certain quality standards related to snus production have been established as the so-called GothiaTek standards. Furthermore, various methods and methods useful for the production of snus-type products have been proposed.See, for example, U.S. Patent Nos. 4,607,479 to Linden and 4,631,899 to Nielsen, which are incorporated herein by reference; and U.S. Patent Publication Nos. 2008 / 0156338 to Winterson et al.; 2010 / 0018539 to Brinkley et al.; 2010 / 0059069 to Boldrini; 2010 / 0071711 to Boldrini; 2010 / 006062 to Boldrini; 2010 / 0059069 to Boldrini; 2010 / 0071711 to Boldrini; 2010 / 0071722 to Boldrini; 2010 / 0071731 to Boldrini; 2010 / 0071741 to Boldrini; 2010 / 0071751 to Boldrini; 2010 / 0071761 to Boldrini; 2010 / 0071771 to Boldrini; 2010 / 0071781 to Boldrini; 2010 / 0071791 to Boldrini; 2010 / 0071792 to Boldrini; 2010 / 0071793 to Boldrini; 2010 / 0071794 to Boldrini; 2010 / 0071795 to Boldrini; 2010 / 0071796 to Boldrini; 2010 / 0071797 to Boldrini; 2010 / 00717981 to Boldrini; 2010 / 00717996 to Boldrini; 2010 / 00717 No. 101189; U.S. Patent Publication No. 2010 / 0101588 to Boldrini; U.S. Patent Publication No. 2010 / 0199601 to Boldrini; U.S. Patent Publication No. 2010 / 0200005 to Fallon; U.S. Patent Publication No. 2010 / 0252056 to Gruss et al.; U.S. Patent Publication No. 2011 / 0284016 to Gunter et al.; U.S. Patent Publication No. 2011 / 0239591 to Gruss et al.; U.S. Patent Publication No. 2011 / 0303511 to Brinkley et al.; Novak See U.S. Patent Publication Nos. 2012 / 0055493 to III et al. and 2012 / 0103349 to Hansson et al.; and PCT Publication Nos. WO2008 / 081341 to Winterson et al. and WO2008 / 146160 to Cecil et al. Additionally, snus products can be manufactured using equipment available, for example, from Merz Verpackungmaschinen GmBH as SB 51-1 / T, SBL 50, and SB 53-2 / T.

[0007] Certain types of products utilizing pouches or sachets containing tobacco substitutes (or a combination of tobacco and tobacco substitutes) have also been proposed, see, for example, U.S. Patent No. 5,167,244 to Kjerstad and U.S. Patent No. 7,950,399 to Winterson et al., and U.S. Patent No. 2005 / 0061339 to Hansson et al., 2011 / 0041860 to Essen et al., and 2011 / 0247640 to Beeson et al., which are incorporated herein by reference.

[0008] Certain types of pouch or sachet-based products have been used to contain nicotine, such as in nicotine replacement therapy (NRT) type products (e.g., pharmaceutical products distributed by Niconovum AB under the trade name ZONNIC®). See also, for example, U.S. Pat. No. 4,907,605 to Ray et al., U.S. Pat. Publication Nos. 2009 / 0293895 to Axelsson et al. and 2011 / 0268809 to Brinkley et al., and the types of pouch materials and nicotine-containing formulations described in PCT Publication Nos. WO 2010 / 031552 to Axelsson et al. and WO 2012 / 134380 to Nilsson, which are incorporated herein by reference.

[0009] To produce the above-mentioned types of pouch products, the pouch must be sealed after being filled with the desired material. As described in U.S. Patent Publication No. 2014 / 0026912 to Rushforth et al., such sealing is typically achieved by application of a binder material to the fiber network, which allows the pouch to be sealed by application of heat. However, traditional binders applied to such fiber pouches, such as acrylic polymers, are expensive to apply to the pouch and inhibit the biodegradability of the discarded pouch.

[0010] All-white snus portions are becoming increasingly popular and offer a distinct, aesthetically pleasing and pleasant-tasting alternative to traditional snus. These modern "white" pouch products may contain bleached tobacco or may be tobacco-free. [Prior art documents] [Patent documents]

[0011] [Patent Document 1] U.S. Pat. No. 1,376,586 [Patent Document 2] U.S. Pat. No. 4,513,756 [Patent Document 3] U.S. Pat. No. 4,528,993 [Patent Document 4] U.S. Pat. No. 4,624,269 [Patent Document 5] U.S. Pat. No. 4,991,599 [Patent Document 6] U.S. Pat. No. 4,987,907 [Patent Document 7] U.S. Patent No. 5,092,352 [Patent Document 8] U.S. Pat. No. 5,387,416 [Patent Document 9] U.S. Pat. No. 6,668,839 [Patent Document 10] U.S. Patent No. 6,834,654 [Patent Document 11] U.S. Patent No. 6,953,040 [Patent Document 12] U.S. Patent No. 7,032,601 [Patent Document 13] U.S. Pat. No. 7,694,686 [Patent Document 14] US Patent Application Publication No. 2004 / 0020503 [Patent Document 15] US Patent Application Publication No. 2005 / 0115580 [Patent Document 16] US Patent Application Publication No. 2006 / 0191548 [Patent Document 17] US Patent Application Publication No. 2007 / 0062549 [Patent Document 18] US Patent Application Publication No. 2007 / 0186941 [Patent Document 19] US Patent Application Publication No. 2007 / 0186942 [Patent Document 20] US Patent Application Publication No. 2008 / 0029110 [Patent Document 21] US Patent Application Publication No. 2008 / 0029116 [Patent Document 22] US Patent Application Publication No. 2008 / 0173317 [Patent Document 23] US Patent Application Publication No. 2008 / 0209586 [Patent Document 24] US Patent Application Publication No. 2009 / 0065013 [Patent Document 25] US Patent Application Publication No. 2010 / 0282267 [Patent Document 26] International Publication No. 2004 / 095959 [Patent Document 27] US Patent Application Publication No. 2008 / 0196730 [Patent Document 28] US Patent Application Publication No. 2008 / 0305216 [Patent Document 29] US Patent Application Publication No. 2009 / 0293889 [Patent Document 30] US Patent Application Publication No. 2010 / 0291245 [Patent Document 31] US Patent Application Publication No. 2011 / 0139164 [Patent Document 32] US Patent Application Publication No. 2012 / 0037175 [Patent Document 33] US Patent Application Publication No. 2012 / 0055494 [Patent Document 34] US Patent Application Publication No. 2012 / 0138073 [Patent Document 35] US Patent Application Publication No. 2012 / 0138074 [Patent Document 36] US Patent Application Publication No. 2013 / 0074855 [Patent Document 37] US Patent Application Publication No. 2013 / 0074856 [Patent Document 38] US Patent Application Publication No. 2013 / 0152953 [Patent Document 39] US Patent Application Publication No. 2013 / 0274296 [Patent Document 40] US Patent Application Publication No. 2015 / 0068545 [Patent Document 41] US Patent Application Publication No. 2015 / 0101627 [Patent Document 42] US Patent Application Publication No. 2015 / 0230515 [Patent Document 43] US Patent Application Publication No. 2011 / 0303511 [Patent Document 44] US Patent Application Publication No. 2013 / 0206150 [Patent Document 45] U.S. Patent No. 8,067,046 [Patent Document 46] U.S. Patent No. 7,861,728 [Patent Document 47] US Patent Application Publication No. 2004 / 0118422 [Patent Document 48] US Patent Application Publication No. 2008 / 0202536 [Patent Document 49] US Patent Application Publication No. 2009 / 0025738 [Patent Document 50] US Patent Application Publication No. 2011 / 0180087 [Patent Document 51] US Patent Application Publication No. 2010 / 0218779 [Patent Document 52] US Patent Application Publication No. 2010 / 0294291 [Patent Document 53] US Patent Application Publication No. 2010 / 0300465 [Patent Document 54] US Patent Application Publication No. 2011 / 0061666 [Patent Document 55] US Patent Application Publication No. 2011 / 0303232 [Patent Document 56] US Patent Application Publication No. 2012 / 0067362 [Patent Document 57] US Patent Application Publication No. 2012 / 0085360 [Patent Document 58] US Patent Application Publication No. 2012 / 0103353 [Patent Document 59] US Patent Application Publication No. 2012 / 0247492 [Patent Document 60] International Publication No. 2005 / 063060 [Patent Document 61] WO 2008 / 56135 [Patent Document 62] U.S. Pat. No. 4,607,479 [Patent Document 63] U.S. Pat. No. 4,631,899 [Patent Document 64] US Patent Application Publication No. 2008 / 0156338 [Patent Document 65] US Patent Application Publication No. 2010 / 0018539 [Patent Document 66] US Patent Application Publication No. 2010 / 0059069 [Patent Document 67] US Patent Application Publication No. 2010 / 0071711 [Patent Document 68] US Patent Application Publication No. 2010 / 0101189 [Patent Document 69] US Patent Application Publication No. 2010 / 0101588 [Patent Document 70] US Patent Application Publication No. 2010 / 0199601 [Patent Document 71] US Patent Application Publication No. 2010 / 0200005 [Patent Document 72] US Patent Application Publication No. 2010 / 0252056 [Patent Document 73] US Patent Application Publication No. 2011 / 0284016 [Patent Document 74] US Patent Application Publication No. 2011 / 0239591 [Patent Document 75] US Patent Application Publication No. 2012 / 0055493 [Patent Document 76] US Patent Application Publication No. 2012 / 0103349 [Patent Document 77] International Publication No. 2008 / 081341 [Patent Document 78] International Publication No. 2008 / 146160 [Patent Document 79] U.S. Patent No. 5,167,244 [Patent Document 80] U.S. Patent No. 7,950,399 [Patent Document 81] US Patent Application No. 2005 / 0061339 [Patent Document 82] US Patent Application No. 2011 / 0041860 [Patent Document 83] US Patent Application No. 2011 / 0247640 [Patent Document 84] U.S. Pat. No. 4,907,605 [Patent Document 85] US Patent Application Publication No. 2009 / 0293895 [Patent Document 86] US Patent Application Publication No. 2011 / 0268809 [Patent Document 87] International Publication No. 2010 / 031552 [Patent Document 88] International Publication No. 2012 / 134380 [Patent Document 89] US Patent Application Publication No. 2014 / 0026912 [Non-patent literature]

[0012] [Non-Patent Document 1] Bryzgalov et al., 1N1800 Life Cycle Assessment, Comparative Life Cycle Assessment of General Loose and Portion Snus (2005) Summary of the Invention [Problem to be solved by the invention]

[0013] (Brief summary) The present disclosure relates to a pouch product adapted for the release of water-soluble components therefrom, which may include an outer water-permeable pouch that defines a cavity containing an oral composition that optionally includes a water-soluble component that can be released through the water-permeable pouch. In some embodiments, the pouch material itself may be dissolvable or degradable so that the pouch and the substrate material can be ingested by the user. The preferred pouch material is water-dispersible or dissolvable, but can be designed and manufactured such that under normal use conditions, a significant amount of the contents of the substrate material will permeate through the pouch material before the pouch loses its physical integrity. In certain embodiments, the composition within the pouch material may be dissolvable.

[0014] In certain embodiments, the composition in the cavity of the pouch can contain a tobacco-derived product, such as a particulate tobacco material, a particulate non-tobacco material (e.g., microcrystalline cellulose) that has been processed to contain nicotine, nicotine and / or flavorings, or a fibrous plant material (e.g., beet pulp fiber) that has been processed to contain a tobacco extract. In various embodiments, the composition in the cavity of the pouch is a smokeless tobacco product or a nicotine replacement therapy product. In some embodiments, the composition in the cavity of the pouch can be a particulate material adapted for steeping or extraction (i.e., configured for liquid extraction), such as a tea or coffee material. Thus, in certain embodiments, the composition in the cavity of the pouch can include a particulate or fibrous plant material, such as found in various teas or tea variants. In some embodiments, the composition in the cavity can include flavoring ingredients such that flavors are added to a liquid (e.g., water).

[0015] The present invention includes, without limitation, the following embodiments.

[0016] Embodiment 1: A pouch product comprising an outer water-permeable pouch defining a cavity, and an oral composition located within the cavity, wherein at least one of the outer water-permeable pouch and the composition is dissolvable in the mouth.

[0017] Embodiment 2: The pouch product of embodiment 1, wherein the composition may comprise at least one of an active ingredient and a flavoring agent in an amount of at least about 3% by weight, a sugar substitute in an amount of at least about 80% by weight, and a sugar alcohol syrup.

[0018] Embodiment 3: A pouch product according to any of embodiments 1-2, wherein the sugar substitute can be a non-hygroscopic sugar alcohol capable of forming a glassy matrix.

[0019] Embodiment 4: A pouch product according to any one of embodiments 1 to 3, wherein the sugar substitute can be isomalt.

[0020] Embodiment 5: A pouch product according to any of embodiments 1 to 4, wherein the sugar substitute may be present in an amount of at least about 85% by weight.

[0021] Embodiment 6: A pouch product according to any of embodiments 1 to 5, wherein the sugar substitute may be present in an amount of at least about 90% by weight.

[0022] Embodiment 7: The pouch product of any of embodiments 1 to 6, wherein the sugar alcohol syrup can be maltitol syrup.

[0023] Embodiment 8: The pouch product of any of embodiments 1-7, wherein the composition can comprise an active ingredient selected from the group consisting of nicotine components, botanicals, stimulants, nutraceuticals, amino acids, vitamins, cannabinoids, cannabis analogs, terpenes, and combinations thereof.

[0024] Embodiment 9: A pouch product according to any one of embodiments 1 to 8, wherein the composition can be in the form of a granular material having a size ranging from 0.1 mm to about 5 mm.

[0025] Embodiment 10: A pouch product according to any of embodiments 1 to 9, wherein the outer water-permeable pouch can be dissolvable in the mouth and the composition can be dissolvable in the mouth.

[0026] Embodiment 11: A pouch product according to any one of embodiments 1 to 10, wherein the composition may comprise a filler selected from the group consisting of polyols, glucose, maltodextrin, and combinations thereof.

[0027] Embodiment 12: The pouch product of any of embodiments 1 to 11, wherein the composition may comprise at least one flavoring agent.

[0028] Embodiment 13: The pouch product of any of embodiments 1 to 12, wherein the amount of flavoring agent can be from about 0.1 to about 0.5 weight percent of the composition.

[0029] Embodiment 14: The pouch product of any of embodiments 1-13, wherein the composition can be substantially free of tobacco materials.

[0030] Embodiment 15: A pouch product according to any one of embodiments 1 to 14, wherein the oral composition comprises a water-soluble component constructed to be released through the water-permeable pouch.

[0031] Embodiment 16: A pouch product according to any one of embodiments 1 to 15, wherein the outer water-permeable pouch is dissolvable in the mouth.

[0032] Embodiment 17: A pouch product according to any one of embodiments 1 to 16, wherein the outer water-permeable pouch comprises a fibrous material, such as a nonwoven material.

[0033] Embodiment 18: A pouch product according to any one of embodiments 1 to 17, wherein the outer water-permeable pouch comprises at least one hydrophilic polymer, such as a hydrophilic polymer in the form of a fiber.

[0034] Embodiment 19: The pouch product of any one of embodiments 1 to 18, wherein the outer water-permeable pouch comprises polyvinylpyrrolidone, polyvinyl alcohol, alginate, gluten, carrageenan, or a combination thereof.

[0035] Embodiment 20: A method of forming a pouch product comprising the steps of providing a continuous supply of pouch material; engaging side edges of the pouch material so as to form a longitudinally extending seam; sealing the longitudinally extending seam so as to form a continuous tubular member from the continuous supply of pouch material; inserting a composition adapted for oral use into the continuous tubular member; subdividing the continuous tubular member into separate pouch portions so that each pouch portion comprises a fill material of the composition; and sealing leading and trailing ends of each separate pouch portion so as to form an outer water permeable pouch enclosing the fill material of the composition, wherein at least one of the pouch material and the composition is dissolvable in the mouth.

[0036] Embodiment 21: The method of embodiment 20, wherein the outer water-permeable pouch can be dissolvable in the mouth, and the composition is dissolvable in the mouth.

[0037] Embodiment 22: The method of any of embodiments 20-21, wherein the composition may comprise at least one of an active ingredient and a flavoring agent in an amount of at least about 3% by weight, a sugar substitute in an amount of at least about 80% by weight, and a sugar alcohol syrup.

[0038] Embodiment 23: The method of any of embodiments 20 to 22, which may further comprise the steps of: (i) mixing at least one active ingredient and / or flavoring agent with a non-hygroscopic sugar alcohol capable of forming a glassy matrix in the molten state to form a mixture; (ii) cooling the mixture to room temperature to form a solid, mouth-dissolvable product; and (iii) milling the solid, mouth-dissolvable product to form a composition in the form of a granular material.

[0039] Embodiment 24: A pouch product prepared according to the method of any one of embodiments 20 to 23.

[0040] These and other features, aspects and advantages of the present disclosure will become apparent upon reading the following detailed description in conjunction with the accompanying figures, which are briefly described below. The present invention includes any combination of two, three, four or more of the above-described embodiments, as well as any combination of two, three, four or more features or elements described in this disclosure, regardless of whether such features or elements are explicitly combined in the description of a particular embodiment herein. Because this disclosure is intended to be read as a whole, it should be considered that any separable features or elements of the disclosed invention are intended to be combinable in any of its various aspects and embodiments, unless the context clearly dictates otherwise.

[0041] Having thus described aspects of the present disclosure in general terms above, reference is now made to the accompanying drawings, which are not necessarily drawn to scale and are merely examples and should not be construed as limiting the present disclosure. [Brief description of the drawings]

[0042] [Figure 1] FIG. 1 is a front perspective view illustrating a pouch product according to an embodiment of the present disclosure; [Diagram 2] 1 is a flow chart illustrating the general steps for manufacturing a pouch product according to certain embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0043] The present invention will now be described more fully hereinafter. However, the present invention may be embodied in many different forms and should not be construed as being limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0044] The present disclosure generally provides products that are structured for oral use. The term "structured for oral use" as used herein means that the product is provided in a form such that one or more components of the mixture (e.g., flavoring agent and / or nicotine) are carried into the user's mouth by the user's oral saliva during use. In certain embodiments, the product is adapted to deliver a component to the user through the user's oral mucosa, and in some cases, the component is an active ingredient (e.g., including but not limited to, nicotine) that can be absorbed through the oral mucosa when the product is used.

[0045] In particular, the present disclosure provides products in the form of a mixture of one or more components disposed within a moisture-permeable container (e.g., a water-permeable pouch). Such mixtures in a water-permeable pouch format are typically used by placing the pouch containing the mixture in the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's oral cavity, e.g., under the lips, in the same manner that moist snuff products are typically used. Preferably, the pouch is not chewed or swallowed. Exposure to saliva then causes some of the components of the mixture therein (e.g., flavoring agents and / or nicotine) to pass through, e.g., the water-permeable pouch, providing flavor and satisfaction to the user, without the user having to expectorate any part of the mixture. After about 10 minutes to about 60 minutes, typically about 15 minutes to about 45 minutes of use / enjoyment, a substantial amount of the mixture is ingested by the human subject and the pouch can be removed from the consumer's mouth for disposal. Preferred pouch materials for the products described herein can be designed and manufactured such that, under normal conditions of use, a significant amount of the contents of the formulation within the pouch will permeate through the pouch material prior to the point at which the pouch loses its physical integrity.

[0046] For example, as illustrated in Figure 1, an exemplary pouch product 10 can include an outer water-permeable container 20 in the form of a pouch containing a particulate mixture 15 adapted for oral use. The orientation, size and type of the outer water-permeable pouch and the type and nature of the composition adapted for oral use illustrated herein should not be construed as limiting the present invention.

[0047] In various embodiments, a moisture-permeable packet or pouch acts as a container for using the composition. For example, the pouch provides a type of liquid-permeable container that may be considered similar in nature to the mesh-type materials used in the construction of tea bags. If desired, flavoring ingredients, disintegration aids, and other desired components may be incorporated into or applied to the pouch material. The composition / structure of such a packet or pouch, such as the container pouch 20 of the embodiment illustrated in FIG. 1, may vary as described herein. For example, suitable packets, pouches, or containers of the type used in the manufacture of smokeless tobacco products may be modified according to the present disclosure and are available under the trade names CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare. Pouch-type products of similar shape and form to the various embodiments of the pouch products described herein are commercially available as ZONNIC (distributed by Niconovum AB).Furthermore, the pouch-type products are generally similar in shape and form to the various embodiments of the pouch products described as snuff bag compositions E-J in Example 1 of PCT WO2007 / 104573 to Axelsson et al., which are incorporated herein by reference, and which are produced using excipient ingredients and processing conditions that can be used to manufacture the pouch products described herein.

[0048] Pouch Material The pouches of the present disclosure can be formed from fleece materials, such as fibrous nonwoven webs. As used herein, the term "fiber" is defined as the basic element of a textile. Fibers are often in the form of rope-like or thread-like elements. As used herein, the term "fiber" is intended to include fibers, filaments, continuous filaments, staple fibers, and the like. The term "multicomponent fiber" refers to a fiber that contains two or more components with different physical or chemical properties, including bicomponent fibers. Specifically, the term "multicomponent fiber" includes staple and continuous fibers prepared from two or more polymers that exist in separate structured domains within the fiber, as opposed to blends, where the domains tend to be dispersed, random, or unstructured.

[0049] "Fleece material," as used herein, can be formed from various types of fibers, as described in more detail herein below, and can form a conventional fleece fabric or other conventional pouch material. For example, the fleece material can be provided in the form of a woven or nonwoven fabric. Suitable types of fleece materials are described, for example, in U.S. Patent No. 8,931,493 to Sebastian et al.; and U.S. Patent Application Publication No. 2015 / 0128978 to Sebastian et al., U.S. Patent Application Publication No. 2016 / 0000140 to Sebastian et al., and U.S. Patent Application Publication No. 2016 / 0073689 to Sebastian et al., all of which are incorporated herein by reference.

[0050] The term "nonwoven" is used herein in reference to a fibrous material, web, mat, batt, or sheet in which the fibers are aligned in an undefined or random direction. Nonwoven fibers are initially presented as unbonded fibers or filaments. A key step in the manufacture of nonwovens involves bonding the various fibers or filaments together. The manner in which the fibers or filaments are bonded may vary and include thermal, mechanical, and chemical techniques that are selected in part based on the desired characteristics of the final product, as discussed in more detail herein below.

[0051] In various embodiments, the pouch material can be dissolvable (i.e., ingestible for oral use) such that the pouch material dissolves under conditions of normal use (i.e., upon contact with saliva in the mouth of the user). Preferably, the pouch material dissolves after a significant amount of the dissolving components of the composition within the pouch (e.g., active ingredient(s) and / or flavoring agent(s)) have permeated through the pouch material into the mouth of the user. For example, the pouch material can be constructed to dissolve at a rate such that the pouch material holds the composition together for a period of time sufficient to allow release of substantially all of the water-soluble components. As described in more detail below, in certain embodiments, the composition within the pouch material can also be dissolvable. In such embodiments, the pouch material can be constructed to dissolve at a rate similar to that at which the composition dissolves. In certain embodiments, the pouch material can be adapted or constructed to at least partially dissolve or completely dissolve in about 5 minutes or more, about 15 minutes or more, about 30 minutes or more, or about 1 hour or more. In certain embodiments, the pouch material can be adapted or constructed to at least partially dissolve or completely dissolve in 30 minutes or more, 45 minutes or more, or 1 hour or more. In some embodiments, the pouch material can be adapted or constructed to at least partially dissolve or completely dissolve in a time period of about 30 seconds to about 30 minutes, about 1 minute to about 25 minutes, about 5 minutes to about 20 minutes, or about 5 minutes to about 15 minutes. Without being limited by theory, pouch products that include dissolvable pouch materials can provide environmental benefits.

[0052] In various embodiments, the dissolvable pouch material may include, but is not limited to, spun or nonwoven alginate fibers, gluten fibers, perforated mini flat sheets derived from alginate, carrageenan and other polymeric binders, and combinations thereof. Without being limited by theory, the dissolution rate of the pouch material may be controlled by using, for example, alginate or pectin cross-linking techniques with calcium salts. In certain embodiments, the dissolvable pouch material may include fast dissolving fibers formed using an electrospinning process (e.g., solution-based electrospinning) with hydrophilic polymers. See, for example, the techniques and fibers disclosed in Asawahame, Chawalinee et al., Formation of Orally Fast Dissolving Fibers Containing Propolis by Electrospinning Technique, Chiang Mai J.Sci., 2015, Vol. 42(2), pp. 469-480, which is incorporated herein by reference in its entirety.

[0053] In some embodiments, the fibers in the fleece material can include a polymer selected from the group consisting of, but not limited to, polyglycolic acid, polylactic acid, polyhydroxyalkanoate, polycaprolactone, polybutylene succinate, polybutylene succinate adipate, and copolymers thereof. In some embodiments, the fibers in the fleece material can be selected from the group consisting of wool, cotton, fibers made of cellulosic materials, such as regenerated cellulose, cellulose acetate, cellulose triacetate, cellulose nitrate, ethyl cellulose, cellulose acetate propionate, cellulose acetate butyrate, hydroxypropyl cellulose, methylhydroxypropyl cellulose, protein fibers, and the like. See also the types of fibers described in U.S. Patent Application Publication No. 2014 / 0083438 to Sebastian et al., which is incorporated herein by reference. In various embodiments, the pouch material can include a polymer selected from the group consisting of polyvinylpyrrolidone, polyvinyl alcohol, and combinations thereof.

[0054] Regenerated cellulose fibers can be particularly advantageous, and are typically prepared by extracting non-cellulosic compounds from wood, contacting the extracted wood with caustic soda, followed by carbon disulfide, then sodium hydroxide to obtain a viscous solution. The solution is then extruded through a spinneret head to produce a viscous thread of regenerated fiber. Exemplary methods for the preparation of regenerated cellulose are provided in U.S. Patent No. 4,237,274 to Leoni, U.S. Patent No. 4,268,666 to Baldini et al., U.S. Patent No. 4,252,766 to Baldini et al., U.S. Patent No. 4,388,256 to Ishida et al., U.S. Patent No. 4,535,028 to Yokogi et al., U.S. Patent No. 5,441,689 to Laity, U.S. Patent No. 5,997,790 to Vos et al., and U.S. Patent No. 8,177,938 to Sumnicht, which are incorporated herein by reference. The manner in which regenerated cellulose is made is not limited and can include, for example, both the rayon process and the TENCEL process. Various manufacturers of regenerated cellulose are known, including Lenzing (Austria), Cordenka (Germany), Aditya Birla (India), and Daicel (Japan).

[0055] The morphology of the fibers used in the nonwoven webs according to the present disclosure may vary and may include fibers having any type of cross-section, including, but not limited to, circular, rectangular, square, elliptical, triangular, and multilobal. In certain embodiments, the fibers may have one or more void spaces, and the void spaces may have, for example, circular, rectangular, square, elliptical, triangular, or multilobal cross-sections. As previously described, the fibers may be selected from a variety of monocomponent (i.e., uniform in composition throughout the fiber) or multicomponent fibers, including, but not limited to, fibers having a sheath / core structure or an islands-in-the-sea structure, as well as fibers having side-by-side, segmented pie, segmented cross, segmented ribbon, or multilobal cross-sections with tips.

[0056] The physical parameters of the fibers present in the nonwoven web may vary. For example, the fibers used in the nonwoven web may have different size (e.g., length, denier per filament (dpf)) and crimp characteristics. In some embodiments, the fibers used in the nonwoven web may be nanofibers, submicron fibers, and / or micron-sized fibers. In certain embodiments, the fibers of the nonwoven webs useful herein may measure from about 1.5 dpf to about 2.0 dpf, or from about 1.6 dpf to about 1.90 dpf. In various embodiments, each fiber may measure from about 4 to 10 crimps per cm, or from about 5 to 8 crimps per cm. In some embodiments, each fiber may be a continuous filament fiber. In certain embodiments, each fiber may be a staple fiber. Each fiber length may measure, for example, from about 35 mm to about 60 mm, or from about 38 mm to about 55 mm. To ensure a preferred blend and orientation of the fibers in the nonwoven web, it can be advantageous for all of the fibers in the nonwoven web to have similar fiber size and crimp characteristics.

[0057] The fibrous web can have different thicknesses, porosities, and other parameters. The nonwoven web can be formed to retain the composition adapted for oral use enclosed within the outer water permeable pouch, and still allow the consumer to enjoy the flavor of the composition, depending on the fiber orientation and porosity of the pouch product formed from the nonwoven web. For example, in some embodiments, the fibrous web can have a basis weight of about 20 gsm to about 35 gsm, or about 25 gsm to about 30 gsm. In a preferred embodiment, the fibrous web can have a basis weight of about 28 gsm. The basis weight of the woven fabric can be measured, for example, using ASTM D3776 / D3776M-09a(2013) (Standard Test Methods for Mass Per Unit Area(Weight) of Fabric). In various embodiments, the fibrous web can have a thickness of about 0.1 mm to about 0.15 mm (e.g., about 0.11 mm). The fibrous web can have an elongation of about 70% to about 80%, e.g., about 78%. In some embodiments, the fibrous web can have a peak load of about 4 lbs. to about 8 lbs., e.g., about 5.5 lbs. The elongation and breaking strength of textile fabrics can be measured, for example, using ASTM D5034-09(2013) (Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)). In various embodiments, the fibrous web can have a Tensile Energy Absorption (TEA) of about 35 to about 40, e.g., about 37. In one particular embodiment, the fibrous web can have a Tensile Energy Absorption (TEA) of about 10,000 ml / min / cm. 2The porosity of a textile fabric can be measured, for example, as the force required to break the sample under a tensile load applied per side area of ​​the sample. The porosity, or air permeability, of a textile fabric can be measured, for example, using ASTM D737-04(2012) (Standard Test method for Air Permeability of Textile Fabrics).

[0058] In various embodiments of the pouch products described herein, the outer water-permeable pouch is made from a nonwoven web as described above. In some embodiments, the pouch is constructed of a single layer of the nonwoven web. In various embodiments, the pouch material comprises a multi-layer composite made from two or more nonwoven layers, each layer being orally ingestible. Each nonwoven layer can be formed by the process discussed below. In the multi-layer structure, the first layer can be relatively hydrophilic and the second layer can be relatively hydrophobic (relative to each other). In some embodiments, the outer water-permeable pouch can comprise an outer hydrophilic layer and an inner hydrophobic layer that can contact the composition adapted for oral use. Thus, the hydrophobic layer can retain any moisture in the composition adapted for oral use so that the flavoring in the composition is not lost due to moisture loss during storage of the pouch product. However, the capillaries in the hydrophobic layer can allow moisture to escape to the mouth of the user so that the flavoring is released into the oral cavity upon use. In this way, the pouch material can enhance storage stability without significantly compromising the end user's enjoyment of the product. In a less preferred embodiment, a relatively hydrophilic layer can also be located inside the multi-layer structure. The two layers can be bonded together using any means known in the art, for example, using adhesives or stitching to form a multi-layer composite nonwoven material. The hydrophobicity of the woven material can be evaluated as known in the art, for example, by measuring the contact angle between a liquid droplet and the surface of the woven material.

[0059] In certain embodiments, the pouch material can include a flavoring ingredient (e.g., any of the flavoring ingredients noted herein), which can be applied to the nonwoven layer in any conventional manner, for example, by coating, printing, etc. In some embodiments of the pouch products described herein, the flavoring in the outer pouch material can be different from the flavoring contained in the internal composition adapted for oral use. For example, in certain embodiments, the pouch material can have a first flavoring ingredient, and after the pouch material is dissolved, more moisture can reach the composition in the pouch material, and the flavoring ingredient in the composition can be enhanced. In this way, the product can be designed to provide multiple, different sensory experiences, where a first sensory experience is where the flavoring in the outer pouch material migrates into the user's mouth, and a second sensory experience, which typically occurs at a later time, is where the flavoring of the internal composition migrates into the user's mouth.

[0060] In some embodiments, a heat-sealable binder coating or binder material (e.g., a coating or other additive) can be added to the fibers before, during, or after forming the fleece material. As used herein, "heat-sealable binder coating" refers to a coating material, e.g., an acrylic polymer composition, that is applied to a substrate (e.g., a nonwoven web or fleece material) that allows for sealing of individual pouch seams upon heating. In some embodiments, the binder material can be added to the web fibers before or during lamination of the fibrous webs (i.e., before the fibrous webs are bonded to form the fleece material). In certain embodiments, the binder material can be added to the fleece material after it is formed. In various embodiments, the binder material is in the form of a liquid coating. In certain embodiments, a binder powder can be applied to the fleece material. For example, powdered polyethylene can be used as the binder material. A liquid or powder coating can be applied between the fibrous layers, for example, in cross lamination, air lamination, or after processing. A brief exposure in an oven is sufficient to melt and fuse the binder material.

[0061] Method for producing free pouch material The means of producing the free pouch material may vary. Web formation can be accomplished by any means known in the art. Nonwoven web formation typically includes a carding step, which involves depositing fibers on a surface followed by longitudinal alignment / blending of the fibers. The fibrous web is then typically subjected to some type of bonding / entanglement, including but not limited to thermal melting or bonding, mechanical entanglement, chemical adhesion, or combinations thereof. In one embodiment, the fibrous web is thermally bonded using a calendar (which can provide flat or point bonding), steam jet bonding, or a ventilated oven. Additional bonding methods include ultrasonic bonding and crimping. In some embodiments, needle punching is utilized, which uses needles to obtain physical entanglement between the fibers. In one embodiment, the web is entangled using a hydroentanglement method, which is a process used to entangle and bond the fibers using hydrodynamic forces. As mentioned above, a binder material can be applied to the fibers of the fibrous web before laminating the fibrous web, during the formation of the fibrous web, and / or after the fibrous web is bonded to form the fleece material. After the fleece material is formed, heat can be applied to the fleece material to activate / at least partially melt the binder material to further bond the fleece material, thus further enhancing the mechanical integrity of the fleece material.

[0062] Methods for forming nonwoven webs containing natural and synthetic fibers can include dry-laid, airlaid and wet-laid methods. In some embodiments, nonwoven fabrics can be formed using spunlaid or spunmelt processes, which include both spunbond and meltblowing processes, and such processes are generally considered to involve melting, extruding, collecting and combining thermoplastic polymeric materials to form fibrous nonwoven webs. Meltblowing technology is known in the art and is discussed in various patents, such as U.S. Patent No. 3,849,241 to Butin, U.S. Patent No. 3,987,185 to Buntin et al., U.S. Patent No. 3,972,759 to Buntin, and U.S. Patent No. 4,622,259 to McAmish et al., each of which is incorporated herein by reference in its entirety. General spunbond processes are described, for example, in U.S. Pat. No. 4,340,563 to Appel et al., U.S. Pat. No. 3,692,618 to Dorschner et al., U.S. Pat. No. 3,802,817 to Matsuki et al., U.S. Pat. Nos. 3,338,992 and 3,341,394 to Kinney et al., U.S. Pat. No. 3,502,763 to Hartmann, and U.S. Pat. No. 303,542,615 to Dobo et al., all of which are incorporated herein by reference.

[0063] In various embodiments, nonwoven webs are made by preparing a dry-laid or spunlaid web of fibers and then needle-punching the web to bond the dry-laid or spunlaid web. A barbed needle is forced through the fibrous web, and the needle-punched fleece material is created when the barbed needle pushes some fibers up or down through the web. When the needle is withdrawn, the fibers punched through the web remain in their new position. This needle-punching process interlocks the fibers, and inter-fiber frictional forces caused by the compression of the web hold the structure together, thereby bonding the web. By moving a sufficient number of fibers within the web, the web is converted into a nonwoven fabric.

[0064] In certain embodiments, the nonwoven web is made by a free carding process with point bonding. Point bonding (e.g., using a calendar) should be limited to a relatively small portion of the surface area of ​​the nonwoven web to maintain good porosity within the web for the migration of water-soluble components through the web during oral use. In certain embodiments, the point bonding is limited to less than about 60% of the surface area of ​​the nonwoven web (or the resulting pouch), such as less than about 50%, less than about 30%, or less than about 20% (e.g., about 1% to about 50%, about 5% to about 40%, or about 10% to about 30%). The advantage of point bonding is the ability to control porosity, flexibility, and fabric strength.

[0065] In other embodiments, the nonwoven web can be subjected to hydroentanglement. The term "hydroentangled" or "spunlaced" as applied to the nonwoven fabrics herein is defined as the web being subjected to impingement by a curtain of high-velocity fine water jets, usually emanating from a nozzle jet strip housed in a pressure vessel, often referred to as a manifold or injector. The hydroentangled fabric can be characterized as reoriented, twisted, rotated, and entangled fibers. For example, the fibers can be hydroentangled by exposing the nonwoven web to hydraulic pressure from one or more hydroentanglement manifolds, at hydraulic pressures ranging from about 10 bar to about 1000 bar. In certain embodiments, compared to point bonding, spunlace technology has a lower impact on the porosity of the web, thereby enhancing the migration of flavorants through the nonwoven pouch material.

[0066] In various embodiments, the nonwoven web can be subjected to a second bonding method to reduce the elongation rate of the web during processing. In certain embodiments, the nonwoven web of the present disclosure can exhibit significant elongation rate during high speed processing on a pouching device. Excessive elongation rate of the nonwoven web can cause the web to shrink during processing, resulting in an end product that is not of the proper size. Thus, for example, it may be necessary to modify the processing equipment to fit a wider roll of fleece to compensate for any shrinkage of the end product due to elongation rate.

[0067] To avoid or at least reduce such elongation problems, in various embodiments, the nonwoven web can be point bonded after the first bonding (e.g., hydroentanglement) is completed. The second bonding process can increase the tensile strength and reduce the elongation characteristics of the nonwoven web. In particular, the point bonding process can bond the nonwoven web by partially or completely melting the web at discrete points (e.g., heat sealable binder material). For example, in some embodiments, the nonwoven web can be subjected to ultrasonic bonding after the initial bonding of the web. Any ultrasonic bonding system known in the art for nonwoven materials can be used to ultrasonically bond the nonwoven web. See, for example, the apparatus and devices disclosed in U.S. Pat. No. 8,096,339 to Aust and U.S. Pat. No. 8,557,071 to Weiler, which are incorporated herein by reference. In some embodiments, the nonwoven web can be subjected to point bonding via embossed and / or engraved calendar rolls, which are typically heated. See, for example, the point bonding methods incorporating the use of very high calendar pressures and embossing techniques discussed in U.S. Patent Publication No. 2008 / 0249492 to Schmidt, which is incorporated by reference herein in its entirety. Point bonding processes are typically limited to less than about 60% of the surface area of ​​the nonwoven web, as discussed above.

[0068] In certain embodiments, the processing techniques used to blend, entangle, and bond the nonwoven web can also impart a desired texture to the fibrous nonwoven web material. For example, point bonding or hydroentanglement can impart a desired texture (e.g., a desired pattern) to the nonwoven web. The texture pattern can include product identifying information. In some embodiments, the product identifying information is selected from the group consisting of product brand, company name, company logo, company brand, marketing message, product strength, active ingredients, product manufacturing date, product expiration date, product flavor, product release profile, weight, product code (e.g., batch code), identification marking with other products, and combinations thereof.

[0069] Composition in the pouch A pouch product generally comprises a mixture within a pouch that typically includes one or more active ingredients and / or one or more flavoring agents, as well as various other optional ingredients, in addition to the exterior of a pouch base. In various embodiments, the composition can be dissolvable in the mouth. The composition can be constructed to provide a sustained release of the active ingredient(s) and / or flavoring agent(s) upon contact with saliva in the mouth of the user. After use, the entire composition, and in certain embodiments, the entire pouch material that originally contained the composition, is dissolved and can be ingested by the user for oral use, leaving no pouch product to be removed from the mouth of the user. In various embodiments where both the pouch material and the composition within the pouch material are constructed to be dissolvable, the composition can be constructed such that at least about 85%, at least about 90%, or at least about 95% of the composition is dissolved before the dissolution of the pouch material is complete. In certain embodiments, the composition can be constructed such that the release profile of the water-soluble component contained therein is constant over a desired period of use (e.g., if the desired period of use is 20 minutes, then 25% of the water-soluble component can be released every 5 minutes).

[0070] In various embodiments, the composition can be adapted or constructed to at least partially dissolve or completely dissolve in about 5 minutes or more, about 15 minutes or more, about 30 minutes or more, or about 1 hour or more. In certain embodiments, the composition can be constructed to at least partially dissolve or completely dissolve in 30 minutes or more, 45 minutes or more, or 1 hour or more. In some embodiments, the composition can be constructed to at least partially dissolve or completely dissolve in about 30 seconds to about 30 minutes, about 1 minute to about 25 minutes, about 5 minutes to about 20 minutes, or about 5 minutes to about 15 minutes.

[0071] The composition of the material in the pouch provided herein is not particularly limited and can include any fill composition, including those contained in conventional pouch products. Such compositions are generally mixtures of two or more components, and thus the compositions are sometimes referred to herein below as "mixtures". Certain components that can be advantageously included in the mixture in certain embodiments of the pouch provided herein are generally outlined below. However, it should be understood that the following discussion is not intended to limit the components that can be incorporated into the disclosed pouch. In certain embodiments, the composition includes only saliva-soluble materials.

[0072] Filler Ingredients The material in the pouch described herein can include at least one particulate filler component. Such particulate filler components can fulfill multiple functions, such as enhancing certain sensory properties, such as texture and mouthfeel, enhancing the cohesiveness or compressibility of the product, etc. Typically, the filler component is a particulate material and is cellulose-based. For example, suitable particulate filler components are any non-tobacco plant material or derivatives thereof, including cellulose materials from such sources. Examples of cellulosic non-tobacco plant materials include grains (e.g., corn, oats, barley, rye, buckwheat, etc.), sugar beet (e.g., FIBREX® brand filler available from International fiber Corporation), bran fiber, and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starches (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulosic materials. Additional examples of potential particulate filler components include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol and sorbitol. Combinations of fillers may also be used.

[0073] "Starch" as used herein can refer to pure starch, modified starch, or starch derivatives from any source. Starch is usually present 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 may vary in composition and granule shape and size. Starches from different sources often have different chemical and physical characteristics. A particular starch can be selected for inclusion in a mixture based on the ability of the starch material to impart a particular organoleptic property to the composition. Starch from various sources can be used. For example, major sources of starch include cereals (e.g., rice, wheat, and corn) and root vegetables (e.g., potato and cassava). Other examples of starch sources include acorn, arrowroot, arracachá, banana, barley, legumes (e.g., broad bean, lentil, mung bean, pea, chickpea), breadfruit, buckwheat, canna, chestnut, colocasia, dogtooth violet, kudzu, malanga, millet, oat, oka, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches have undergone one or more structural changes, often designed to alter their high thermal properties. Some starches have been developed by genetic engineering and are considered "genetically modified" starches. Other starches are obtained and subsequently modified physically (e.g., by heating, cold water swelling, etc.), chemically, or enzymatically. For example, modified starch may be starch that has been subjected to chemical reactions such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of a base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, acetylation, hydroxypropylation and / or partial hydrolysis. Enzymatic treatments include exposing native starch to enzyme isolates or concentrates, microbial enzymes and / or enzymes derived from plant material, e.g., exposing corn starch to amylases present in corn kernels to modify corn starch.Other starches are modified by heat treatment, e.g., pregelatinization, dextrinization and / or cold water swelling processes. Certain modified starches include phosphated starch, glycerol crosslinked starch, phosphated crosslinked starch esterified with sodium trimetaphosphate, phosphated phosphated crosslinked starch, acetylated phosphated crosslinked starch, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated adipate crosslinked starch, acetylated glycerol crosslinked starch, hydroxypropylated starch, hydroxypropylated glycerol crosslinked starch, and sodium starch octenylsuccinate.

[0074] In some embodiments, the particulate filler component is a cellulose material or a cellulose derivative. One particularly suitable particulate filler component for use in the products described herein is microcrystalline cellulose ("MCC"). MCC can be synthetic, semi-synthetic, or derived entirely from natural cellulose. MCC can be selected from the group consisting of AVICEL® grades PH-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-302, VIVACEL® grades 101, 102, 12, 20, and EMOCEL® grades 50M and 90M, and the like, and mixtures thereof. In one embodiment, the mixture includes MCC as a particulate filler component. The amount of MCC present in the mixtures described herein can vary depending on the desired properties.

[0075] The amount of particulate filler component may vary, but is typically up to about 75 weight percent (based on the total weight of the mixture) of the material (i.e., the mixture) contained in the pouch. A typical range of particulate filler material (e.g., MCC) in the mixture can be from about 10 to about 75 weight percent, e.g., about 10 weight percent, about 15 weight percent, about 20 weight percent, about 25 weight percent, or about 30 weight percent, to about 35 weight percent, about 40 weight percent, about 45 weight percent, or about 50 weight percent (e.g., about 20 to about 50 weight percent or about 25 to about 45 weight percent) of the total weight of the mixture. In certain embodiments, the amount of particulate filler material is at least about 10 weight percent, e.g., at least about 20 weight percent, or at least about 25 weight percent, or at least about 30 weight percent, or at least about 35 weight percent, or at least about 40 weight percent, based on the total weight of the mixture.

[0076] In one embodiment, the particulate filler component further comprises a cellulose derivative or a combination of such derivatives. In some embodiments, the mixture comprises about 1 to about 10 wt. % of the cellulose derivative, and in certain embodiments, about 1 to about 5 wt. % of the cellulose derivative, based on the total weight of the mixture. In certain embodiments, the cellulose derivative is a cellulose ether (including a carboxyalkyl ether), which refers to a cellulose polymer in which the hydrogen of one or more hydroxyl groups in the cellulose structure is replaced with an alkyl, hydroxyalkyl, or aryl group. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethylcellulose, and carboxymethylcellulose ("CMC"). In one embodiment, the cellulose derivative is one or more of methylcellulose, HPC, HPMC, hydroxyethylcellulose, and CMC. In one embodiment, the cellulose derivative is HPC. In some embodiments, the mixture comprises about 1 to about 3 wt. % of HPC, based on the total weight of the mixture. In certain embodiments, the composition comprises a filler selected from the group consisting of polyols, glucose, maltodextrin, and combinations thereof. In some embodiments, the composition comprises a filler selected from the group consisting of sugar alcohol(s) (e.g., sorbitol, maltitol, xylitol, isomalt, erythritol, and combinations thereof), glucose, maltose, maltotriose, maltodextrin, modified starch, and combinations thereof.

[0077] water The water content of the mixture in the pouch products described herein prior to consumer use of the product may vary depending on the desired properties. Typically, the mixture present in the product prior to insertion into the user's mouth contains less than about 60 weight percent water, typically about 1 to about 60 weight percent water, such as about 5 to about 55 weight percent water, about 10 to about 50 weight percent water, about 20 to about 45 weight percent water, or about 25 to about 40 weight percent water, including amounts of water of at least about 5 weight percent water, at least about 10 weight percent water, at least about 15 weight percent water, and at least about 20 weight percent water.

[0078] Flavoring Agent As used herein, a "flavoring agent" or "flavoring agent" is any flavorful or fragrant substance capable of modifying the sensory characteristics associated with an oral product. Examples of sensory characteristics that can be modified with a flavoring agent include taste, mouthfeel, moistness, cooling / heating, and / or flavor / aroma. Flavoring agents can be natural or synthetic, and the resulting flavor characteristics can be described as fresh, sweet, herbal, confectionery, floral, fruity, or spicy, without limitation. Specific types of flavors include, but are not limited to, 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 combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, RJ Reynolds Tobacco Company (1972), incorporated herein by reference. Flavoring agents may include components such as terpenes, terpenoids, aldehydes, ketones, esters, etc. In some embodiments, the flavoring agent is a trigeminal sensate agent. As used herein, "trigeminal sensate agent" refers to a flavoring agent that has an effect on the trigeminal nerve and produces sensations including heating, cooling, tingling, etc. Non-limiting examples of trigeminal sensate flavoring agents include capsaicin, citric acid, menthol, Sichuan button, erythritol, and cubebol. Flavoring agents may also include components that are considered to be humectants, cooling agents, or smoothing agents, such as eucalyptus. These flavors may be provided pure (ie, alone) or complexed and may be utilized as concentrates or flavor packages (eg, spearmint and menthol, orange and cinnamon; lime, pineapple, etc.).Representative types of components are also described in U.S. Patent No. 5,387,416 to White et al., U.S. Patent Application Publication No. 2005 / 0244521 to Strickland et al., and PCT Application WO 05 / 041699 to Quinter et al., each of which is incorporated herein by reference. In some cases, the flavoring agent may be provided in a spray-dried or liquid form.

[0079] Flavoring agents generally include at least one volatile flavor ingredient. As used herein, "volatile" refers to a chemical that readily forms vapor at ambient temperature (i.e., a chemical that has a high vapor pressure at a given temperature compared to non-volatile substances). Typically, volatile flavor ingredients have a molecular weight of less than about 400 Da and often contain at least one carbon-carbon double bond, carbon-oxygen double bond, or both. In one embodiment, the at least one volatile flavor ingredient includes one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or combinations 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, cinnamic aldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, or citral. In one embodiment, the at least one volatile flavor component comprises ethyl vanillin.

[0080] The amount of flavoring utilized in the mixture may vary, but is typically up to about 10 weight percent, with certain embodiments characterized as having a flavoring content of at least about 0.1 weight percent, e.g., from about 0.5 to about 10 weight percent, from about 1 to about 6 weight percent, or from about 2 to about 5 weight percent, based on the total weight of the mixture.

[0081] The amount of flavoring agent present in the mixture may vary over a period of time (e.g., during the storage period after preparation of the mixture). For example, certain volatile components present in the mixture may undergo evaporation or chemical transformation, which results in a decrease in the concentration of one or more volatile flavoring components. In one embodiment, the concentration of one or more of the at least one volatile flavoring components present is higher than the concentration of one or more volatile flavoring components present in a control pouch product that does not contain one or more organic acids after the same period of time. Without wishing to be bound by theory, it is believed that the same mechanism responsible for the loss of whiteness leads to a slow decrease in certain volatile components in the flavoring fraction (e.g., aldehydes, ketones, terpenes). Thus, it can be expected that the decrease in the presence of these volatile components that lead to discoloration over time will reduce the sensory satisfaction associated with products that are exposed to such degradation processes.

[0082] salt In some embodiments, the mixture may further include a salt (e.g., an alkali metal salt), typically utilized in an amount sufficient to provide the mixture with the desired sensory attributes. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salts, and the like. When present, representative amounts of salt are about 0.5 weight percent or more, about 1.0 weight percent or more, or about 1.5 weight percent or more, but typically comprise about 10 weight percent or less, or about 7.5 weight percent or less, or about 5 weight percent or less (e.g., about 0.5 to about 5 weight percent) of the total weight of the mixture.

[0083] Sweetener The mixture typically further comprises one or more sweeteners. The sweetener can be any sweetener or combination of sweeteners, in natural or artificial form, or a combination of natural and artificial sweeteners. Examples of natural sweeteners include isomaltulose, fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, etc. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, etc. In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides, with partial or complete hydrogenation. Sugar alcohols, for example, have from 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 comprise from about 0.1 to about 20 weight percent or more of the mixture, on a weight basis, based on the total weight of the mixture, for example, from about 0.1 to about 1 weight percent, from about 1 to about 5 weight percent, from about 5 to about 10 weight percent, or from about 10 to about 20 weight percent of the mixture.

[0084] Binder In certain embodiments, the binder (or combination of binders) can be utilized in an amount sufficient to provide the mixture with the desired physical characteristics and physical integrity. Binders often also function as thickeners or gelling agents. Typical binders can be organic or inorganic, or combinations thereof. Representative binders include modified cellulose, povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof. The binder can be utilized in an amount sufficient to provide the mixture with the desired physical characteristics and physical integrity. In some embodiments, the binder comprises pectin or carrageenan, or combinations thereof.

[0085] The amount of binder utilized in the mixture can vary, but is typically up to about 30 weight percent, with certain embodiments characterized by a binder content of at least about 0.1 weight percent, for example, from about 1 to about 30 weight percent, or from about 5 to about 10 weight percent, based on the total weight of the mixture.

[0086] In certain embodiments, the binder comprises a gum, such as a natural gum. As used herein, natural gum refers to a polysaccharide material of natural origin that has binding properties and is also useful as a thickening or gelling agent. Representative natural gums derived from plants, which are usually water-soluble to some extent, include xanthan gum, guar gum, gum arabic, gum ghatti, gum tragacanth, gum karaya, locust bean gum, gellan gum, and combinations thereof. When present, the natural gum binder material is usually 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 mixture.

[0087] Moisturizer In certain embodiments, one or more humectants can be utilized in the mixture. Examples of humectants include, but are not limited to, glycerin, propylene glycol, and the like. When included, the humectant is typically provided in an amount sufficient to provide the mixture with the desired moisture characteristics. Additionally, in some cases, the humectant can impart desirable flow properties to the mixture for deposition into a mold. When present, the humectant typically comprises about 5% or less by weight of the mixture (e.g., about 0.5 to about 5% by weight). When present, a representative amount of the 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 mixture.

[0088] Buffer In certain embodiments, the mixture of the present disclosure may include a pH adjusting agent or buffering agent. Examples of pH adjusting agents and buffering agents that can be used include, but are not limited to, metal hydroxides (e.g., alkali metal hydroxides, e.g., sodium hydroxide and potassium hydroxide) and other alkali metal buffers, e.g., metal carbonates (e.g., potassium carbonate or sodium carbonate), or metal bicarbonates, e.g., sodium bicarbonate. When present, the buffering agent is typically present in an amount of less than about 5 percent by weight of the mixture, e.g., about 0.5% to about 5% by weight, e.g., about 0.75% to about 4% by weight, about 0.75% to about 3% by weight, or about 1% to about 2% by weight, based on the total weight of the mixture. Non-limiting examples of suitable buffers include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof.

[0089] Coloring agent Colorants can be utilized in an amount sufficient to provide the mixture with the desired physical characteristics. Examples of colorants include various dyes and pigments, such as caramel color and titanium dioxide. The amount of colorant utilized in the mixture can vary, but when present, is typically up to about 3 weight percent, for example, from about 0.1 weight percent, about 0.5 weight percent, or about 1 weight percent, to about 3 weight percent, based on the total weight of the mixture.

[0090] active ingredient The compositions disclosed herein include one or more active ingredients. As used herein, "active ingredient" refers to one or more substances that belong to any of the following categories: API (active pharmaceutical ingredient), food additive, natural drug, and naturally derived substances that may have an effect on humans. Exemplary active ingredients include any ingredient known to affect one or more biological functions in the body, such as ingredients that provide pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or that affect the structure or any function of the human body (e.g., provide a stimulating effect on the central nervous system, have an energizing effect, an antipyretic or analgesic effect, or have other effects that are beneficial to the body). In some embodiments, the active ingredient may be of the type commonly referred to as a dietary supplement, nutraceutical, "phytochemical agent," or "functional food." These types of additives may also be defined in the art to include substances that provide one or more beneficial biological effects (e.g., health promotion, disease prevention, or other pharmacological effects), but are not classified or regulated as drugs, and are normally available from naturally derived sources (e.g., botanical materials).

[0091] Non-limiting examples of active ingredients include those falling into the categories of botanical ingredients, stimulants, amino acids, nicotine ingredients, and / or pharmaceutical, nutraceutical and medicinal ingredients (e.g., vitamins such as A, B3, B6, B12, and C, and / or cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these categories is further described herein below. The particular choice of active ingredient will depend on the desired flavor, texture, and desired characteristics of a particular product.

[0092] In certain embodiments, the active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, vitamin C, vitamin B (e.g., vitamin B6 or B12), lemon balm extract, tryptophan, carrot, citicoline, sunflower lecithin, and combinations thereof. For example, the active ingredient can include a combination of caffeine, theanine, and optionally carrot. In another embodiment, the active ingredient includes a combination of theanine, gamma-aminobutyric acid (GABA), and lemon balm extract. In a further embodiment, the active ingredient includes theanine, theanine and tryptophan, or theanine and one or more vitamin B (e.g., vitamin B6 or B12). In yet a further embodiment, the active ingredient includes a combination of caffeine, taurine, and vitamin C.

[0093] The specific percentage of active ingredients present will vary depending on the desired characteristics of the particular product. Typically, the active ingredient or combination thereof is present at a total concentration of at least about 0.001% by weight of the composition, for example, in the range of about 0.001% to about 20% by weight. In some embodiments, the active ingredient or combination of active ingredients is present at a concentration of about 0.1% to about 10% w / w%, for example, about 0.5% to about 10% w / w%, about 1% to about 10 w / w%, about 1% to about 5 w / w%, based on the total weight of the composition. In some embodiments, the active ingredient or combination of active ingredients is present in an amount of from about 0.001%, about 0.01%, about 0.1%, or about 1% by weight, up to about 20% by weight, for example, about 0.001%, about 0.002%, about 0.003%, about 0.004%, about 0.005%, about 0.006%, about 0.007%, about 0.008%, about 0.009%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, or about 10% by weight, based on the total weight of the composition. The active ingredient is present in a concentration of about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, or about 0.9% by weight, up to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, or about 20% by weight. Further suitable ranges for particular active ingredients are provided herein below.

[0094] Botanical In some embodiments, the active ingredient comprises a botanical ingredient. As used herein, the term "botanical ingredient" or "botanical" refers to any plant material or fungus-derived material (including plant material in its natural form) and plant material derived from natural plant material, such as an extract or isolate from a plant material or a processed plant material (e.g., a plant material that has been subjected to a heat treatment, fermentation, bleaching, or other treatment process that can modify the physical and / or chemical properties of the material). For purposes of this disclosure, "botanical" includes, but is not limited to, "herbal materials," which refer to seed-producing plants that do not produce persistent woody tissue and are often valued for their medicinal or sensory properties (e.g., tea or herbal tea). Reference to a botanical material as "non-tobacco" is intended to exclude tobacco materials (i.e., does not include any Nicotiana species). In some embodiments, the compositions disclosed herein can be characterized as being free of any tobacco materials (e.g., any embodiment disclosed herein may be completely or substantially free of any tobacco materials). By "substantially free" it is meant that no tobacco material has been intentionally added. For example, certain embodiments may be characterized as having less than 0.001% tobacco by weight, or less than 0.0001%, or even 0% tobacco by weight. When present, botanicals are typically at a concentration of about 0.01 w / w% to about 10 w / w%, for example, from about 0.01% w / w, about 0.05 w / w%, about 0.1 w / w%, or about 0.5 w / w%, up to about 1 w / w%, about 2 w / w%, about 3 w / w%, about 4 w / w%, about 5 w / w%, about 6 w / w%, about 7 w / w%, about 8 w / w%, about 9 w / w%, or about 10 w / w%, about 11 w / w%, about 12 w / w%, about 13 w / w%, about 14 w / w%, or about 15% by weight based on the total weight of the composition.

[0095] Botanical materials useful in the present disclosure can include, without limitation, any of the compounds and sources described herein, including mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemical agents" or "functional foods." Certain botanicals find use in traditional herbal medicines as botanical materials or botanical extracts, and are further described herein.Non-limiting examples of plants or plant-derived materials include ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, chai fu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus, clove, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, carrots (e.g., Panax ginseng), green tea, Griffonia simplicifolia, and the like. simplicifolia, guarana, hemp, cannabis, hops, jasmine, Kaempferia parviflora (turmeric), kava, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, oil-based extract of Nardostachys chinensis, Viola odorata, peppermint, quercetin, resveratrol, Rhizoma gastrodiae, Rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum, Schisandra chinensis, skullcap, spearmint extract, spikenard, terpenes, herbal tea, turmeric, Turnera aphrodisiaca aphrodisiaca), valerian, mulberry and yerba mate.

[0096] In some embodiments, the active ingredient comprises lemon balm. Lemon balm (Melissa officinalis) is a mild lemon-scented herb in the same family as mint (Lamiaceae). The herb is native to Europe, North Africa and Western Asia. Lemon balm teas, as well as essential oils and extracts, are used in traditional and alternative medicines. In some embodiments, the active ingredient comprises lemon balm extract. In some embodiments, the lemon balm extract is present in an amount of about 1 to about 4% by weight, based on the total weight of the composition.

[0097] In some embodiments, the active ingredient comprises ginseng. Ginseng is the root of the Panax plant and is characterized by the presence of unique steroidal saponin phytochemical agents (ginsenosides) and gintonin. Ginseng finds use as a dietary supplement in energy drinks or herbal teas and traditional medicines. Cultivated species include P. ginseng (P. Ginseng), P. notoginseng (P. notoginseng) and P. quinquefolius (P. quinquefolius). American ginseng and P. ginseng differ in the types and amounts of various ginsenosides present. In some embodiments, the ginseng is American ginseng or P. ginseng. In certain embodiments, the active ingredient comprises P. ginseng. In some embodiments, the ginseng is present in an amount of about 0.4 to about 0.6% by weight based on the total weight of the composition.

[0098] Stimulants In some embodiments, the active ingredient comprises one or more stimulants. As used herein, the term "stimulant" refers to a material that increases the activity of the central nervous system and / or the body, for example, enhancing focus, cognition, energy, mood, alertness, etc. Non-limiting examples of stimulants include caffeine, theacrine, theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid structurally related to caffeine and has stimulating, analgesic, and anti-inflammatory properties. Stimulants present may be natural, derived from nature, or completely synthetic. For example, certain botanical materials (such as guarana, tea, coffee, cocoa, etc.) may have stimulant properties due to the presence of, for example, caffeine or related alkaloids, and are therefore "natural" stimulants. "Naturally derived" means that the stimulant (e.g., caffeine, theacrine) is in a purified form outside of its natural (e.g., botanical) matrix. For example, caffeine can be obtained by extraction and purification from botanical sources (e.g., tea). "Fully synthetic" means that the stimulant is obtained by chemical synthesis. In some embodiments, the active ingredient comprises caffeine. In some embodiments, the caffeine is present in an encapsulated form. One example of encapsulated caffeine is Vitashure®, available from Balchem ​​Corp., 52 Sunrise Park Road, New Hampton, NY, 10958.

[0099] When present, the stimulant or combination of stimulants (e.g., caffeine, theacrine, and combinations thereof) will typically be at a concentration of about 0.1% w / w to about 15% by weight, for example, from about 0.1% w / w, about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, or about 0.9 w / w%, to about 1 w / w%, about 2 w / w%, about 3 w / w%, about 4 w / w%, about 5 w / w%, about 6 w / w%, about 7 w / w%, about 8 w / w%, about 9 w / w%, about 10 w / w%, about 11 w / w%, about 12 w / w%, about 13 w / w%, about 14 w / w%, or about 15% by weight, based on the total weight of the composition. In some embodiments, the composition comprises caffeine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition.

[0100] amino acid In some embodiments, the active ingredient comprises an amino acid. As used herein, the term "amino acid" refers to an organic compound containing an amine (-NH2) and a carboxyl (-COOH) or sulfonic acid (SO3H) functional group, with a side chain (R group) that is specific to each amino acid. An amino acid may be proteinogenic or non-proteinogenic. "Proteogenic" means that the amino acid is one of the 20 naturally occurring amino acids found in proteins. Proteinogenic amino acids include alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine. "Non-proteinogenic" means that the amino acid is not naturally found in proteins or produced directly by cellular machinery (e.g., is a product of post-translational modification). Non-limiting examples of non-proteinogenic amino acids include gamma-aminobutyric acid (GABA), taurine (2-aminoethanesulfonic acid), theanine (L-gamma-glutamylethylamide), hydroxyproline, and beta-alanine. In some embodiments, the active ingredient comprises theanine. In some embodiments, the active ingredient comprises GABA. In some embodiments, the active ingredient comprises a combination of theanine and GABA. In some embodiments, the active ingredient is a combination of theanine, GABA, and lemon balm. In some embodiments, the active ingredient is a combination of caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises taurine. In some embodiments, the active ingredient is a combination of caffeine and taurine.

[0101] When present, the amino acid or combination of amino acids (e.g., theanine, GABA, and combinations thereof) will typically be at a concentration of about 0.1% w / w to about 15% by weight, for example, from about 0.1% w / w, about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, or about 0.9 w / w%, to about 1 w / w%, about 2 w / w%, about 3 w / w%, about 4 w / w%, about 5 w / w%, about 6 w / w%, about 7 w / w%, about 8 w / w%, about 9 w / w%, about 10 w / w%, about 11 w / w%, about 12 w / w%, about 13 w / w%, about 14 w / w%, or about 15% by weight, based on the total weight of the composition.

[0102] vitamin In some embodiments, the active ingredient comprises a vitamin or a combination of vitamins. As used herein, the term "vitamin" refers to an organic molecule (or set of related molecules) that is a major micronutrient required for the proper functioning of metabolism in mammals. Thirteen vitamins are required for human metabolism, and these are as follows: vitamin A (all-trans-retinol, all-trans-retinyl-esters, and all-trans-β-carotene and other provitamin A carotenoids), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin), vitamin B9 (folic acid or folate), vitamin B12 (cobalamin), vitamin C (ascorbic acid), vitamin D (calciferol), vitamin E (tocopherols and tocotrienols), and vitamin K (quinones). In some embodiments, the active ingredient comprises vitamin C. In some embodiments, the active ingredient is a combination of vitamin C, caffeine and taurine.

[0103] When present, a vitamin or combination of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or a combination thereof) is typically present in an amount of from about 0.01% w / w to about 6% by weight, for example, about 0.01 w / w%, about 0.02 w / w%, about 0.03 w / w%, about 0.04 w / w%, about 0.05 w / w%, about 0.06 w / w%, about 0. The concentration is from about 0.07 w / w%, about 0.08 w / w%, about 0.09 w / w%, or about 0.1 w / w%, to about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w% about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, about 1 w / w%, about 2 w / w%, about 3 w / w%, about 4 w / w%, about 5 w / w%, or about 6 w / w%.

[0104] Antioxidants In some embodiments, the active ingredient comprises one or more antioxidants. As used herein, the term "antioxidant" refers to a substance that prevents or inhibits oxidation by terminating free radical reactions, which can slow or prevent some types of cell damage. Antioxidants can be naturally occurring or synthetic. Naturally occurring antioxidants include those found in foods and botanical materials. Non-limiting examples of antioxidants include certain botanical materials, vitamins, polyphenols, and phenol derivatives.

[0105] Examples of botanical ingredients with antioxidant properties include, without limitation, acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot, black pepper, blueberry, borage seed oil, burdock, cacao, calamus root, catnip, catuaba, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato skin, grape seed, carrot, ginkgo biloba, St. John's wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, cloves, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew, ginger, goldenseal, hawthorn, and hibiscus. flowers, gynostemma, kava, lavender, licorice, origanum, milk thistle, mint, oolong tea, beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rose hips, rosemary, sage, clary sage, savory, spearmint, spirulina, slippery elm bark, sorghum bran high tannin, sorghum seed high tannin, sumac bran, comfrey leaf and root, goji berry, gotu kola, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, bacopa monniera, ashwagandha, yamabushitake and silybum marianum. Such botanical materials may be provided in fresh or dried form, in essential oils, or in the form of extracts. Botanical materials (as well as their extracts) often contain various classes of compounds known to provide antioxidant benefits, such as minerals, vitamins, isoflavones, phytosterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles, lignans, flavonoids, polyphenols, and carotenoids.Examples of compounds found in botanical extracts or oils include ascorbic acid, peanut endocarp, resveratrol, sulforaphane, β-carotene, lycopene, lutein, coenzyme Q, carnitine, quercetin, kaempferol, etc. See, e.g., Santhosh et al., Phytomedicine, vol. 12 (2005) pp. 216-220, incorporated herein by reference.

[0106] Other non-limiting examples of suitable antioxidants include citric acid, vitamin E or a derivative thereof, tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperosides, polyphenols, catechol, resveratrol, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tertiary butylhydroquinone (TBHQ), and combinations thereof.

[0107] When present, the antioxidant is typically at a concentration of about 0.001% w / w to about 10% by weight, for example, from about 0.001 w / w%, about 0.005 w / w%, about 0.01 w / w%, about 0.05 w / w%, about 0.1 w / w%, or about 0.5 w / w%, to about 1 w / w%, about 2 w / w%, about 3 w / w%, about 4 w / w%, about 5 w / w%, about 6 w / w%, about 7 w / w%, about 8 w / w%, about 9 w / w%, or about 10 w / w%, based on the total weight of the composition.

[0108] Nicotine content In certain embodiments, the pouch product of the present disclosure can include a nicotinic acid compound. Various nicotinic acid compounds and methods for their administration are described in U.S. Patent Publication No. 2011 / 0274628 to Borschke, which is incorporated herein by reference. As used herein, "nicotinic acid compound" or "nicotine source" often refers to naturally derived or synthetic nicotinic acid compounds taken from plant material, meaning that the compound is at least partially purified and is not contained in a plant structure, such as tobacco leaves. Most preferably, the nicotine is naturally derived and obtained as an extract from Nicotiana species (e.g., tobacco). Nicotine can have the enantiomeric form S(-)-nicotine, R(+)-nicotine, or a mixture of S(-)-nicotine and R(+)-nicotine. Most preferably, the nicotine is in the form of S(-)-nicotine (e.g., a form that is substantially all S(-)-nicotine) or a racemic mixture composed primarily or predominantly of S(-)-nicotine (e.g., a mixture composed of about 95 parts by weight of S(-)-nicotine and about 5 parts by weight of R(+)-nicotine). Most preferably, the nicotine is utilized in a substantially pure form or in an essentially pure form. Highly preferred nicotine utilized has a purity of greater than about 95 percent, more preferably greater than about 98 percent, and most preferably greater than about 99 percent, on a weight basis.

[0109] In certain embodiments, the nicotine component may be included in the mixture in free base form, salt form, as a complex, or as a solvate. By "nicotine component" is meant any suitable form of nicotine (e.g., free base or salt) to provide 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 nicotine salt. In some embodiments, the nicotine is in free base form and can be easily adsorbed, for example, on a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, the discussion of nicotine in free base form in Hansson, U.S. Patent Application Publication No. 2004 / 0191322, incorporated herein by reference.

[0110] In some embodiments, at least a portion of the nicotine can be utilized in the form of a salt. The nicotine salt can be provided using the types of ingredients and techniques described in U.S. Patent No. 2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., vol. 12:43-54 (1983), which are incorporated herein by reference. Additionally, salts of nicotine are available from sources such as, for example, 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, nicotine salts, such as hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and zinc nicotine chloride. In some embodiments, the nicotine component or a portion thereof is a nicotine salt with one or more organic acids.

[0111] In some embodiments, at least a portion of the nicotine can be in the form of a resin complex of nicotine, where the nicotine is bound to an ion exchange resin, such as nicotine polacrilex, which is, for example, nicotine bound to polymethacrilic, such as Amberlite IRP64, Purolite C115HMR, or Doshion P551. See, for example, U.S. Patent No. 3,901,248 to Lichtneckert et al., which is incorporated herein by reference. Another example is a nicotine-polyacrylcarbomer complex, such as Carbopol 974P. In some embodiments, the nicotine can be present in the form of a nicotine polyacryl complex.

[0112] Typically, the nicotine component (calculated as the free base), if present, is at a concentration of at least about 0.001% by weight of the mixture, e.g., in the range of about 0.001% to about 10%. In some embodiments, the nicotine component, calculated as the free base, is present in a concentration of about 0.1% w / w to about 10% by weight, e.g., about 0.1% w / w, about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, or about 0.9 w / w%, up to about 1 w / w%, about 2 w / w%, about 3 w / w%, about 4 w / w%, about 5 w / w%, about 6 w / w%, about 7 w / w%, about 8 w / w%, about 9 w / w%, or about 10% by weight, based on the total weight of the mixture. In some embodiments, the nicotine component is present in a concentration of about 0.1% w / w to about 3% by weight, calculated as the free base, based on the total weight of the mixture, e.g., about 0.1% w / w to about 2.5%, about 0.1 w / w% to about 2.0 w / w%, about 0.1 w / w% to about 1.5 w / w%, or about 0.1 w / w% to about 1% by weight. These ranges may also apply to other active ingredients noted herein.

[0113] In some embodiments, the products or compositions of the present disclosure can be characterized as being free of any nicotine components (e.g., any embodiment disclosed herein can be completely or substantially free of any nicotine components). By "substantially free" we mean that no nicotine has been intentionally added, e.g., beyond trace amounts that may be naturally present in botanical materials. For example, certain embodiments can be characterized as having less than 0.001% nicotine by weight, calculated as the free base, or less than 0.0001% nicotine by weight, or even less than 0% nicotine by weight.

[0114] In some embodiments, the active ingredient comprises a nicotine component (e.g., in addition to comprising any active ingredient or combination of active ingredients disclosed herein, any product or composition of the present disclosure can further comprise a nicotine component).

[0115] Cannabinoids In some embodiments, the active ingredient comprises one or more cannabinoids.As used herein, the term "cannabinoid" refers to a class of diverse chemical compounds that act on cannabinoid receptors, also known as the endocannabinoid system in cells, and change neurotransmitter release in the brain.The ligands for these receptor proteins include the endocannabinoids that are naturally produced in the body by animals; the phytocannabinoids found in cannabis; and the synthetic cannabinoids that are artificially produced. Cannabinoids found in cannabis include, without limitation: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), thrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabinotriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A). In certain embodiments, the cannabinoid is selected from tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis, and cannabidiol (CBD), another major component of cannabis that does not contain psychoactive properties. All of the above compounds can be used in isolated or synthetically derived form from plant material.

[0116] Alternatively, the active ingredient can be a cannabis analogue, which is a class of compounds derived from plants other than cannabis that have biological actions on the endocannabinoid system similar to cannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin (also classified as terpenes), cyanidin, curcumin (turmeric), catechin, quercetin, salvinorin A, N-acylethanolamines and N-alkylamide lipids.

[0117] If present, the cannabinoid (e.g., CBD) or cannabis analogue will typically be at a concentration of at least about 0.1% by weight of the composition, for example, in the range of about 0.1% to about 30% 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%, or about 0.9% by weight, up to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20%, or about 30% by weight, based on the total weight of the composition.

[0118] Terpenes Active ingredients suitable for use in the present disclosure can also be classified as terpenes, many of which are associated with biological effects, such as sedative effects. Terpenes have the general formula (C5H8): n Terpenes are believed to have the formula: and include monoterpenes, sesquiterpenes, and diterpenes. Terpenes can be acyclic, monocyclic, or bicyclic structures. Some terpenes provide an entourage effect when used in combination with cannabinoids or cannabis analogues. Examples include beta-caryophyllene, linalool, limonene, beta-citronellol, linalyl acetate, pinene (alpha or beta), geraniol, carvone, eucalyptol, menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, and germacrene, which can be used individually or in combination.

[0119] Pharmaceutical Ingredients In some embodiments, the active ingredient comprises an active pharmaceutical ingredient (API). APIs can be any known pharmaceutical agent adapted for therapeutic, prophylactic or diagnostic use. These can include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrates), neurotransmitters or their precursors (e.g., serotonin, 5-hydroxytryptophan, oxytriptan, acetylcholine, dopamine, melatonin) and nucleic acid sequences, which have therapeutic, prophylactic or diagnostic activity. Non-limiting examples of APIs include analgesics and antipyretics (e.g., acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine, myo-inositol, docosahexaenoic acid (DHA, omega-3), arachidonic acid (AA, omega-6), S-adenosylmethionine (SAM), beta-hydroxy-beta-methylbutyrate (HMB), citicoline (cytidine-5'-diphosphate-choline), and cotinine. In some embodiments, the active ingredient comprises citicoline. In some embodiments, the active ingredient is a combination of citicoline, caffeine, theanine, and carrot. In some embodiments, the active ingredient comprises sunflower lecithin. In some embodiments, the active ingredient is a combination of sunflower lecithin, caffeine, theanine, and carrot.

[0120] The amount of API may vary. For example, when present, the API is typically present in an amount of from about 0.001% w / w to about 10 w / w%, for example, about 0.01 w / w%, about 0.02 w / w%, about 0.03 w / w%, about 0.04 w / w%, about 0.05 w / w%, about 0.06 w / w%, about 0.07 w / w%, about 0.08 w / w%, about 0.09 w / w%, about 0.1% w / w, about The concentrations are from about 0.2 w / w%, about 0.3 w / w%, about 0.4 w / w%, about 0.5 w / w%, about 0.6 w / w%, about 0.7 w / w%, about 0.8 w / w%, about 0.9 w / w%, or about 1 w / w%, up to about 2 w / w%, about 3 w / w%, about 4 w / w%, about 5 w / w%, about 6 w / w%, about 7 w / w%, about 8 w / w%, about 9 w / w%, or about 10% by weight.

[0121] In some embodiments, the composition is substantially free of any API. By "substantially free of any API" is meant that the composition does not contain and specifically excludes the presence of any API as defined herein, e.g., any Food and Drug Administration (FDA) approved therapeutic agent intended to treat any medical condition.

[0122] Tobacco Materials In some embodiments, the mixture can include tobacco material. The tobacco material can vary in species, variety, and form. Typically, the tobacco material is obtained from harvested plants of Nicotiana species. Exemplary Nicotiana species include N. tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei, N. kawakami, N. kawakamii, N. kawakamiii ... akamii, N. knightiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata, Nx sanderae sanderae, N. africana, N. amplexicaulis, N. benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N. occidentalis, N. paniculata, N. plumbagii N. plumbaginifolia, N. raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbratica, N. velutina, N. wigandioides, N. acaulis, N. acuminata, N. attenuata.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. hesperis subsp. Hersperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia and N. spegazzinii. Various other representative species of plants of the Nicotiana species are described in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); U.S. Patent No. 4,660,577 to Sensabaugh, Jr. et al.; U.S. Patent No. 5,387,416 to White et al.; U.S. Patent No. 7,025,066 to Lawson et al.; U.S. Patent No. 7,798,153 to Lawrence, Jr., and U.S. Patent No. 8,186,360 to Marshall et al., each of which is incorporated herein by reference. Descriptions of various tobacco varieties, cultivation practices, and harvesting practices are described in Tobacco Production, Chemistry and Technology, Davis et al. (eds.) (1999), which is incorporated herein by reference.

[0123] Nicotiana species from which suitable tobacco material can be obtained can be derived using genetic modification or cross-breeding techniques (e.g., tobacco plants can be genetically engineered or cross-bred to increase or decrease the production of a component, characteristic or trait). See, for example, the types of genetic modifications of plants described in U.S. Patent No. 5,539,093 to Fitzmaurice et al.; U.S. Patent No. 5,668,295 to Wahab et al.; U.S. Patent No. 5,705,624 to Fitzmaurice et al.; U.S. Patent No. 5,844,119 to Weigl; U.S. Patent No. 6,730,832 to Dominguez et al.; U.S. Patent No. 7,173,170 to Liu et al.; U.S. Patent No. 7,208,659 to Colliver et al. and U.S. Patent No. 7,230,160 to Benning et al.; U.S. Patent Application Publication No. 2006 / 0236434 to Conkling et al.; and PCT WO2008 / 103935 to Nielsen et al. See also the types of cigarettes described 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.

[0124] In some embodiments, Nicotiana species can be selected for the content of various compounds present therein. For example, plants can be selected based on being plants that produce relatively large amounts of one or more compounds that one wishes to isolate. In certain embodiments, Nicotiana species plants (e.g., Nicotiana galpaocomun) are specifically cultivated for their abundance of these foliar compounds. Tobacco plants can be grown in greenhouses, growth chambers, or outdoor fields, or grown hydroponically.

[0125] Various parts or portions of a plant of the Nicotiana species may be included in the mixtures disclosed herein. For example, substantially all of the plant (e.g., the whole plant) may be harvested and utilized as is. Alternatively, various parts or pieces of the plant may be harvested or separated for further use after harvest. For example, flowers, leaves, stems, stems, roots, seeds, and various combinations thereof may be isolated for further use or processing. In some embodiments, the tobacco material comprises tobacco leaves (lamina). The mixtures disclosed herein may include processed tobacco parts or pieces, dry processed and aged tobacco in essentially natural lamina and / or stem form, tobacco extracts, extracted tobacco pulp (e.g., using water as a solvent), or mixtures of the foregoing (e.g., mixtures of extracted tobacco pulp that is granulated, dry processed, and combined with aged natural tobacco lamina).

[0126] In certain embodiments, the tobacco material comprises a solid tobacco material selected from the group consisting of lamina and stem. The tobacco used in the mixture most preferably comprises tobacco lamina or a mixture of tobacco lamina and stem, at least a portion of which is smoked. A portion of the tobacco in the mixture may have a processed form, such as processed tobacco stems (e.g., cut rolled stems, cut rolled expanded stems, or cut puff stems), or volume-expanded tobacco (e.g., puffed tobacco, e.g., dry ice expanded tobacco (DIET)). See, for example, the tobacco expansion processes described in U.S. Patent No. 4,340,073 to de la Burde et al.; U.S. Patent No. 5,259,403 to Guy et al.; and U.S. Patent No. 5,908,032 to Poindexter et al.; and U.S. Patent No. 7,556,047 to Poindexter et al., all of which are incorporated by reference. In addition, the mixture may incorporate tobacco that is optionally fermentable. See the types of tobacco processing techniques described in Atchley et al., PCT WO2005 / 063060, which is incorporated herein by reference.

[0127] Tobacco materials are typically used in a form that can be described as particulate (i.e., shredded, milled, granulated, or powdered form). The manner in which tobacco materials are provided in finely divided or powdered form types can vary. Preferably, plant parts or pieces are pulverized, milled, or pulverized into particulate form using equipment and techniques for milling, milling, and the like. Most preferably, the plant material is in a relatively dry form during milling or milling using equipment such as hammer mills, cutter heads, air controlled mills, and the like. For example, tobacco parts or pieces can be milled or milled when their moisture content is less than about 15 weight percent or less than about 5 weight percent. Most preferably, tobacco materials are utilized in the form of parts or pieces having an average particle size between 1.4 millimeters and 250 microns. In some cases, the tobacco particles can be sized to pass a screen mesh to obtain the required particle size range. If desired, air classification equipment can be used to ensure collection of small sized tobacco particles of the desired size or size range. If desired, different size pieces of granulated tobacco can be mixed together.

[0128] The manner in which tobacco is provided in finely divided or powder-type form may vary. Preferably, tobacco parts or pieces are pulverized, milled, or pulverized into a powder-type form using equipment and techniques for milling, milling, and the like. Most preferably, the tobacco is in a relatively dry form during milling or milling using equipment such as hammer mills, cutter heads, air-controlled mills, and the like. For example, tobacco parts or pieces can be milled or milled when their moisture content is less than about 15 weight percent to less than about 5 weight percent. For example, tobacco plants or portions thereof can be separated into individual parts or pieces (e.g., leaves can be removed from the stems, and / or stems and leaves can be removed from the trunks). Harvested plants or individual parts or pieces can be further subdivided into parts or pieces (e.g., leaves can be chopped, cut, powdered, pulverized, milled, or milled into pieces or portions, which pieces or portions can be characterized as filler-type pieces, granules, granular, or fine powders). The plant, or a portion thereof, can be subjected to an external force or pressure (e.g., by pressing or rolling). When such processing conditions are performed, the plant or a portion thereof can have a moisture content that approximates its natural moisture content (e.g., its moisture content immediately after harvesting), a moisture content achieved by adding moisture to the plant or a portion thereof, or a moisture content resulting from drying the plant or a portion thereof. For example, powdered, pulverized, milled, or milled pieces of a plant or a portion thereof can have a moisture content of less than about 25 weight percent, often less than about 20 weight percent, and frequently less than about 15 weight percent.

[0129] For the preparation of oral products, it is common to subject harvested plants of Nicotiana species to a curing process. The tobacco materials incorporated into the mixture for inclusion in the products disclosed herein are appropriately cured and / or aged. Descriptions of different types of curing processes for different types of tobacco are provided in Tobacco Production, Chemistry and Technology, Davis et al. (eds.) (1999). Examples of techniques and conditions for curing flue-cured tobacco are provided in Nestor et al., Beitrage Tabakforsch.Int., Vol. 20, pp. 467-475 (2003) and U.S. Patent No. 6,895,974 to Peele, which are incorporated herein by reference. Exemplary techniques and conditions for air-curing tobacco are described in U.S. Patent No. 7,650,892 to Groves et al.; Roton et al., Beitrage Tabakforsch. Int., Vol. 21, pp. 305-320 (2005) and Staaf et al., Beitrage Tabakforsch. Int., Vol. 21, pp. 321-330 (2005), which are incorporated herein by reference. Certain types of tobacco may also be subjected to alternative types of air-curing processes, such as flame curing or sun curing.

[0130] In certain embodiments, tobacco materials that may be utilized include flue-cured or Virginia (e.g., K326), Burley, sun-cured (e.g., Indian Kurnool and Oriental tobaccos, including Katerini, Pre-Rip, Komotini, Xanthi, and Yambol tobaccos), Maryland, dark, dark-fired, dark air-cured (e.g., Madol, Pasanda, 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 aforementioned tobaccos.

[0131] The tobacco material can also have a so-called "blend" form. For example, the tobacco material can include a mixture of flue-cured, burley (e.g., Malawi Burley) and oriental tobacco parts or pieces (e.g., tobacco composed of or derived from tobacco lamina, or a mixture of tobacco lamina and tobacco stem). For example, a representative blend can incorporate, on a dry weight basis, 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). Other exemplary tobacco blends incorporate, on a dry weight basis, 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. Other exemplary tobacco blends incorporate, on a dry weight basis, from about 20 to about 30 parts Oriental tobacco and from about 70 to about 80 parts flue-cured tobacco.

[0132] The tobacco material used in the present disclosure can be subjected to, for example, fermentation, bleaching, etc. If desired, the tobacco material can also be subjected to, for example, irradiation, pasteurization, or otherwise controlled heat treatment. Such treatment processes are detailed, for example, in U.S. Patent No. 8,061,362 to Mua et al., which is incorporated herein by reference. In certain embodiments, the tobacco material can be treated with water and an additive capable of inhibiting the 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 divalent and trivalent cations, asparaginase, certain non-reducing sugars, certain reducing agents, phenolic compounds, certain compounds having at least one free thiol group or functional group, 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. Patent Publication Nos. 8,434,496, 8,944,072, and 8,991,403 to Chen et al., all of which are incorporated herein by reference. In certain embodiments, this type of treatment is useful when the original tobacco material is subjected to heat in the previously described processes.

[0133] In some embodiments, a type of tobacco material is first selected that is somewhat lighter in color than other tobacco materials when visually inspected (e.g., whitened or bleached). In certain embodiments, the tobacco pulp can be whitened by any means known in the art. For example, bleached tobacco materials produced by various whitening methods using various bleaching or oxidizing agents and oxidation catalysts can be used. Exemplary oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorites, chlorates, perchlorates, hypochlorites, ozone, ammonia, potassium permanganate, and combinations thereof. Exemplary oxidation catalysts are titanium dioxide, manganese dioxide, and combinations thereof.Processes for treating tobacco with bleaching agents are described, 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 Pratz et al., all of which are incorporated herein by reference. No. 3,612,065 to Rosen; U.S. Patent No. 3,851,653 to Rosen; U.S. Patent No. 3,889,689 to Rosen; U.S. Patent No. 3,943,940 to Minami; U.S. Patent No. 3,943,945 to Rosen; U.S. Patent No. 4,143,666 to Rainer; U.S. Patent No. 4,194,514 to Campbell; U.S. Patent Nos. 4,366,823, 4,366,824, and 4,388,933 to Rainer et al.; U.S. Patent No. 4,641,667 to Schmekel et al.; U.S. Patent No. 5,713,376 to Berger; Byrd 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 U.S. Patent Application Publication No. 2012 / 0067361 to Bjorkholm et al.; U.S. Patent Application Publication No. 2016 / 0073686 to Crooks; U.S. Patent Application Publication No. 2017 / 0020183 to Bjorkholm; and U.S. Patent Application Publication No. 2017 / 0112183 to Bjorkholm, as well as PCT Published Application No. WO1996 / 031255 to Giolvas and PCT Published Application No. WO2018 / 083114 to Bjorkholm.

[0134] 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 ranging from about 50% to about 90%, from about 55% to about 75%, or from about 60% to about 70%. ISO brightness can be measured according to ISO 3688:1999 or ISO 2470-1:2016.

[0135] In some embodiments, whitened tobacco materials can be characterized by a lightened color (e.g., "whitened") as compared to untreated tobacco materials. White color is often defined with reference to the International Commission on Illumination (CIE) chromaticity diagram. In certain embodiments, whitened tobacco materials can be characterized as being closer to pure white on the chromaticity diagram than untreated tobacco materials.

[0136] In various embodiments, the tobacco material can be processed to extract soluble components of the tobacco material therefrom. "Tobacco extract" as used herein refers to isolated components of tobacco material extracted from solid tobacco pulp by a solvent that is contacted with the tobacco material in an extraction process. Various extraction techniques for tobacco materials can be used to obtain tobacco extracts and tobacco solid materials. See, for example, the extraction process described in U.S. Patent Application Publication No. 2011 / 0247640 to Beeson et al., which is incorporated herein by reference.Other exemplary techniques for extracting tobacco components include those 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; and U.S. Pat. No. 4,589,428 to Soga et al., all of which are incorporated herein by reference. No. 4,605,016 to Poulose et al.; U.S. Patent No. 4,716,911 to Niven, Jr. et al.; U.S. Patent No. 4,727,889 to Bernasek et al.; U.S. Patent No. 4,887,618 to Clapp et al.; U.S. Patent No. 4,941,484 to Clapp et al.; U.S. Patent No. 4,967,771 to Fagg et al.; U.S. Patent No. 4,986,286 to Roberts et al.; U.S. Patent No. 5,005,593 to Fagg et al.; U.S. Patent No. 5,018,540 to Grubbs et al.; U.S. Patent No. 5,060,669 to White et al.; U.S. Patent No. 5,070,671 to Fagg et al. No. 5,065,775; U.S. Patent No. 5,074,319 to White et al.; U.S. Patent No. 5,099,862 to White et al.; U.S. Patent No. 5,121,757 to White et al.; U.S. Patent No. 5,131,414 to Fagg; U.S. Patent No. 5,131,415 to Munoz et al.; U.S. Patent No. 5,148,819 to Fagg; U.S. Patent No. 5,197,494 to Kramer; U.S. Patent No. 5,230,354 to Smith et al.; U.S. Patent No. 5,234,008 to Fagg; U.S. Patent No. 5,243,999 to Smith; U.S. Patent No. 5,251,149 to Raymond et al. No. 5,301,694 to Gonzalez-Parra et al.; U.S. Pat. No. 5,318,050 to Teague; U.S. Pat. No. 5,343,879 to Newton; 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.

[0137] Typical inclusion ranges for tobacco materials may vary depending on the nature and type of tobacco material and the intended effect on the final mixture, with exemplary ranges being 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) (e.g., from about 0.1 to about 15% by weight) based on the total weight of the mixture.

[0138] In some embodiments, the products of the present disclosure may be characterized as being completely free or substantially free of tobacco material (other than purified nicotine as the active ingredient). For example, certain embodiments may be characterized as having less than 1% by weight, or less than 0.5% by weight, or less than 0.1% by weight, or 0% by weight tobacco material.

[0139] Other Additives Other additives may be included in the disclosed mixtures. For example, the mixtures may be processed, blended, formulated, combined and / or mixed with other materials or ingredients. The additives may be artificial or may be obtained or derived from herbal or biological sources. Examples of further types of additives include thickening or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil and zinc), preservatives (e.g., potassium sorbate, etc.), zinc or magnesium salts selected for their relative water solubility (e.g., magnesium gluconate or zinc gluconate) for compositions with high water solubility or for compositions with low water solubility (e.g., magnesium oxide or zinc oxide) for their relative water insolubility, disintegration aids, or combinations thereof. See, for example, representative components, combinations of components, relative amounts of the components, and modes and methods for utilizing the components, as described in U.S. Patent No. 9,237,769 to Mua et al., U.S. Patent No. 7,861,728 to Holton, Jr. et al., U.S. Patent Application Publication No. 2010 / 0291245 to Gao et al., and U.S. Patent Application Publication No. 2007 / 0062549 to Holton, Jr. et al., each of which is incorporated herein by reference. Typical inclusion ranges for such additional additives may vary depending on the nature and function of the additive and its intended effect on the final mixture, with exemplary ranges being up to about 10% by weight (e.g., from about 0.1 to about 5% by weight) based on the total weight of the mixture.

[0140] The above-mentioned additives can be used together (e.g., as an additive blend) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final mixture). Furthermore, the above-mentioned types of additives can be encapsulated when provided in the final product or mixture. Exemplary encapsulated additives are described, for example, in WO2010 / 132444 to Atchley, previously incorporated by reference herein.

[0141] In some embodiments, any one or more of the filler components, tobacco materials, and overall oral products described herein may be described as particulate materials. As used herein, the term "particulate" refers to a material in the form of a plurality of individual particles, some of which may be in the form of agglomerates of a plurality of particles, the particles having an average length to width ratio of less than 2:1, such as less than 1.5:1, for example less than about 1:1. In various embodiments, the particles of the particulate material may be described as being substantially spherical or granular.

[0142] The particle size of a granular material can be measured by sieve analysis. As those skilled in the art will readily recognize, sieve analysis (otherwise known as gradient testing) is a method used to measure the particle size distribution of a granular material. Typically, sieve analysis involves a column of nested sieves, the sieves preferably comprising screens in the form of wire mesh fabric. A pre-weighed sample can be introduced into the top or uppermost sieve in the column, which has the largest screen opening or mesh size (i.e., the largest pore diameter of the sieve). Each sieve lower in the column has a progressively smaller screen opening or mesh size than the sieve at the top. Typically, the bottom of the sieve column has a receiver section that collects any particles having a particle size smaller than the screen opening or mesh size (smallest screen opening or mesh size) of the bottom or lowest sieve in the column.

[0143] In some embodiments, the column of sieves can be placed on or in a mechanical agitator. The agitator causes vibration of each of the sieves in the column. The mechanical agitator can be run for a predetermined period of time to ensure that all particles are collected on the correct sieve. In some embodiments, the column of sieves is agitated for a period of 0.5 minutes to 10 minutes, such as 1 minute to 10 minutes, such as 1 minute to 5 minutes, such as 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 is then divided by the total weight to obtain the percentage of mass retained on each sieve. Those skilled in the art will readily recognize that the screen opening size or mesh size for each sieve in the column used for sieve analysis can be selected based on the particle size of the sample to be analyzed or the known maximum / minimum particle size. In some embodiments, a column of sieves may be used for sieve analysis, the column comprising 2 to 20 sieves, e.g., 5 to 15 sieves. In some embodiments, a column of sieves may be used for sieve analysis, the column comprising 10 sieves. In some embodiments, the largest screen opening or mesh size of a sieve used for sieve analysis may be 1000 μm, e.g., 500 μm, e.g., 400 μm, e.g., 300 μm.

[0144] In some embodiments, any particulate material referred to herein (e.g., filler components, tobacco materials, and overall oral products) may be characterized in that at least 50% by weight of the particles have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 60% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 70% by weight of the particles of any granular material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 80% by weight of the particles of any granular material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 90% by weight of the particles of any granular material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 95% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 99% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis.In some embodiments, approximately 100% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis.

[0145] In some embodiments, at least 50% by weight, such as at least 60% by weight, for example at least 70% by weight, such as at least 80% by weight, for example at least 90% by weight, for example at least 95% by weight, for example at least 99% by weight, of the particles of any particulate material referred to herein have a particle size of from about 0.01 μm to about 1000 μm, such as from about 0.05 μm to about 750 μm, for example from about 0.1 μm to about 500 μm, for example from about 0.25 μm to about 500 μm, as measured by sieve analysis. 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 referred to herein have a particle size of about 10 μm to about 400 μm, such as about 50 μm to about 350 μm, such as about 100 μm to about 350 μm, such as about 200 μm to about 300 μm, as measured by sieve analysis. In certain embodiments, the particles of the particulate material may have a size in the range of about 200 μm to about 3 mm, such as about 200 μm to about 300 μm or about 1 mm to about 3 mm.

[0146] Preparation of mixtures The manner in which the various components of the mixture are combined may vary. Thus, the overall mixture of the various components with, for example, the powdered mixture components, may be relatively homogenous in nature. The above-mentioned components may be in liquid or dry solid form and may be blended in a pre-treatment step prior to mixing with any remaining components of the mixture, or may simply be mixed together with all other liquid or dry components. The various components of the mixture may be contacted, combined, or mixed together using any mixing technique or device known in the art. Any mixing method that brings the mixture components into intimate contact may be used, such as a mixing device featuring an impeller or other agitating structure. Examples of mixing devices include casing drums, conditioning cylinders or drums, liquid spray devices, conical-type blenders, ribbon blenders, FKM130, FKM600, FKM1200, FKM2000, and FKM3000 mixers available from Littleford Day, Inc., Plough Share type mixer cylinders, Hobart mixers, and the like. See, for example, the types of methods described in U.S. Patent No. 4,148,325 to Solomon et al.; U.S. Patent No. 6,510,855 to Korte et al.; and U.S. Patent No. 6,834,654 to Williams et al., each of which is incorporated herein by reference. In some embodiments, the components forming the mixture are prepared so that the mixture can be used in a starch molding process to form the mixture. The manner and method of blending the mixture will be clear to those skilled in the art. See, for example, the types of methods described in U.S. Patent No. 4,148,325 to Solomon et al.; U.S. Patent No. 6,510,855 to Korte et al.; and U.S. Patent No. 6,834,654 to Williams, U.S. Patent No. 4,725,440 to Ridgway et al., and U.S. Patent No. 6,077,524 to Bolder et al., each of which is incorporated herein by reference.

[0147] In certain embodiments, the composition in the pouch product may include a lozenge or pastille type composition, which is then milled prior to insertion into the fleece material. The manner and method used to formulate and manufacture the lozenge / pastel product may vary. For example, the composition may be prepared via any method commonly used for the preparation of hard confections. Exemplary methods for the preparation of hard confections can be found, for example, in LFRA Ingredients Handbook, Sweeteners, edited by Janet M. Dalzell, Leatherhead Food RA (December 1996), pages 21-44, which is incorporated herein by reference in its entirety. See also U.S. Patent Publication No. 2018 / 0228204 to Holton Jr. et al., which is incorporated herein by reference in its entirety.

[0148] Typically, a first mixture of ingredients is prepared. The composition of the first mixture of ingredients may vary. However, the first mixture usually includes a sugar substitute and may contain various additional substances (e.g., sugar alcohol syrup, NaCl, preservatives, as well as sweeteners, water and / or flavorings). In certain embodiments, the first mixture includes a sugar substitute, salt and vanillin. In other embodiments, the first mixture includes a sugar substitute and a sugar alcohol syrup. Typically, the first mixture of ingredients does not contain an active ingredient.

[0149] The first mixture of ingredients is heated until melted, and the mixture is subsequently heated to or past the hard crack stage. In the making of confections, the hard crack stage is defined as the temperature at which a thread of the heated mixture (obtained by pulling up a sample of cooled syrup between thumb and index finger) becomes brittle, or at which attempting to pour the syrup into a mold results in cracking. According to the present disclosure, depending on the particular composition of the product mixture, the temperature at which the hard crack stage is achieved may vary, but is generally between about 145°C and about 170°C. Typically, the mixture is not heated above about 171°C, since at this temperature caramelization begins to occur. In the process of the present disclosure, the mixture is typically heated to or above the hard crack stage temperature and then allowed to cool. Heating can be performed at atmospheric pressure or under vacuum. Typically, the method of the present disclosure is performed at atmospheric pressure.

[0150] In one exemplary embodiment, the first mixture of ingredients includes a high percentage of isomalt and the mixture is heated to about 143° C. Once all components are dissolved, the temperature is increased past the hard crack stage (e.g., to about 166° C.). The mixture is heated to this temperature and then removed from the heat source and the mixture is allowed to cool.

[0151] In certain embodiments, the active ingredient and, optionally, additional components as described above (e.g., additional sweeteners, fillers, flavorings, and water) are combined separately. The active ingredient-containing mixture is typically added to the first mixture of ingredients after the first mixture of ingredients is removed from the heat source. In some embodiments, the addition of the active ingredient-containing mixture can occur only after the heated first mixture of ingredients has cooled to a predetermined temperature (e.g., in certain embodiments, to about 132°C). In certain embodiments, one or more flavoring agents are added to the active ingredient-containing mixture just before the mixture is added to the heated first mixture of ingredients. Certain flavoring agents are volatile and thus are preferably added after the mixture has cooled somewhat.

[0152] The combined mixture is then formed into a desired shape. In certain embodiments, the mixture is poured directly into a mold and formed (e.g., rolled or pressed) into the desired shape, or extruded. If desired, the mixture can be extruded or injection molded. In certain embodiments, the mixture is formed in an enclosed system or extruded into a mold to obtain the desired shape, which may require a reduction in temperature and may limit the evaporation of certain mixture components. For example, such a system may limit the evaporation of volatile ingredients, including, but not limited to, flavorings. Other methods of producing oral products (e.g., lozenges) are also intended to be encompassed herein.

[0153] Once the orally ingestible product is formed, the product can then be milled into a composition suitable for insertion into the pouch product described herein and dissolvable in the mouth. In some embodiments, the product may be provided in granular form and may have a variety of average particle sizes. For example, the particle size may range from about 0.01 mm to about 20 mm. In some embodiments, the particle size may be from about 0.01 mm to about 5 mm, from about 0.1 mm to about 5 mm, or from about 0.5 mm to about 4 mm. In some embodiments, the particle size may be from about 1 mm to about 20 mm, from about 2 mm to about 15 mm, or from about 2 mm to about 10 mm. Method for making pouch products Various manufacturing equipment and methods can be used to create the pouch products described herein. For example, Novak, III et al., US Publication No. 2012 / 0055493, previously incorporated by reference in its entirety, relates to an apparatus and process for providing a pouch material formed into a tube for use in the manufacture of smokeless tobacco products. Similar equipment incorporating an apparatus for providing a continuous supply of pouch material (e.g., a pouch processing unit adapted to feed the pouch material to a continuous tube forming unit to form a continuous tubular member from the pouch material) can be used to create the pouch products described herein. Representative equipment for forming a continuous tube of such pouch material is disclosed, for example, in Boldrini et al., US Patent Application Publication No. 2010 / 0101588, previously incorporated by reference in its entirety. The apparatus further includes a device for supplying a pouch material to the continuous tubular member such that when the continuous tubular member is subdivided and sealed into separate pouch portions, each pouch portion contains a filler material of a composition adapted for oral use. A representative device for supplying a filler material is disclosed, for example, in US Patent Application Publication No. 2010 / 0018539 to Brinkley, which is incorporated herein by reference in its entirety. In some cases, the apparatus may include a subdivision unit for subdividing the continuous tubular member into individual pouch portions, and may include a sealing unit for sealing at least one end of each pouch portion when subdivided into individual pouch portions. In other cases, the continuous tubular member may be sealed by a sealing unit into individual pouch portions, and thus, when the individual pouch portions are sealed, the continuous tubular member may be subdivided into separate individual pouch portions by subdividing the continuous tubular member with a subdivision unit between the sealed ends of the pouch portions arranged in series. In still other cases, sealing (closure) of the individual pouch portions of the continuous tubular member may occur substantially simultaneously with its subdivision using closure and division units. It is noted that in certain embodiments of the present disclosure where a low melting point binder material is used, the temperature required for sealing the seams of the pouch product may be lower than that required for conventional processes involving conventional binder materials.As a result, pouch manufacturing processes according to the present disclosure require less energy and / or faster production of pouch products compared to conventional processes. For at least these reasons, certain processes of the present disclosure can be more economical than conventional processes.

[0154] An exemplary apparatus for manufacturing oral pouch products is illustrated in Figures 1-5 of U.S. Publication No. 2012 / 0055493 to Novak, III et al. However, this apparatus is used for general and illustrative purposes only and not for limiting purposes. It should also be recognized that the following manufacturing process and associated apparatus are not limited to the process sequence described below. In various embodiments of the present disclosure, an apparatus similar to that described in U.S. Publication No. 2012 / 0055493 can be constructed to removably receive a first bobbin on an unwind spindle assembly, the first bobbin having a continuous length of material, such as pouch material, wound thereon. When the first bobbin engages the apparatus, the pouch material can take a path from the first bobbin toward a forming unit, which is constructed to form a continuous supply of pouch material into a continuous tubular member defining a longitudinal axis.

[0155] Thus, as the pouch material unwinds from the first bobbin, it can be directed around an arrangement of roller members (also referred to herein as dancer assemblies). The forming unit can be constructed to cooperate with the first bobbin and dancer assembly to take up slack in the pouch material and maintain a certain amount of longitudinal tension on the pouch material while the pouch material is unwound from the first bobbin and fed to the forming unit, for example, by a drive system. Those skilled in the art will recognize that between the first bobbin and the forming unit, the pouch material can be supported, routed, and / or guided by any number of appropriately aligned series of, for example, idler rollers, guide posts, air bars, turning bars, guides, tracks, tunnels, etc., for directing the pouch material along a desired path. A typical bobbin used in conventional automated pouch making equipment contains a continuous strip of pouch material that can often vary in length. Thus, the apparatus described herein can be constructed to handle that type and size of bobbins.

[0156] The forming unit can include one or more roller members that are configured to direct the pouch material around the hollow shaft so that a continuous supply of pouch material can be formed into a continuous tubular member. The forming unit can include a sealing device that is configured to seal, secure, or otherwise engage side edges of the pouch material to form a longitudinally extending seam, thereby forming a longitudinally extending continuous tubular member. In various embodiments, the inserting unit can be configured to introduce a filler material of a composition adapted for oral use into the continuous tubular member through the hollow shaft. The inserting unit can be directly or indirectly engaged with the hollow shaft.

[0157] The leading or end (also referred to as the lateral spreading seam) of the continuous tubular member can be closed / sealed such that the filling material of the composition adapted for oral use inserted by the insert unit is contained proximal to the leading end within the continuous tubular member. The leading end can be closed / sealed via a closing and dividing unit that is constructed to close / seal a first portion of the continuous tubular member to form a closed leading end of the pouch member portion. The closing and dividing unit can also be constructed to form a closed trailing edge or end of the leading pouch member portion. In this regard, the closing and dividing unit can also be constructed to close a second portion of the continuous tubular member to form a closed terminal end of the pouch member portion. In this regard, the closing and dividing unit can close the end by heat sealing, or other suitable sealing mechanism.

[0158] As illustrated in Figures 20-22 of U.S. Publication No. 2012 / 0055493 to Novak, III et al., the closure and division unit can be constructed to divide the continuous tubular member into a plurality of separate pouch member portions along the longitudinal axis of the continuous tubular member between the closed ends and closed ends of the serially arranged pouch member portions, such that each separate pouch member portion contains a portion of the oral composition from the insert unit. In this regard, the closure and division unit can include a blade, hot wire, or other cutting arrangement for severing the continuous tubular member into separate pouch member portions. For example, the closure and division unit can include first and second arm members constructed to interact to close and divide the continuous tubular member.

[0159] In operation, fill material of the composition adapted for oral use (i.e., an appropriate amount for an individual pouch member portion) can be delivered by the insert unit to the pouch member portion after the leading end is closed but before the trailing end is closed. In various embodiments, after receiving the fill material of the oral composition, separate individual pouch member portions can be formed by closing the trailing ends and severing the closed pouch member portions from the continuous tubular member to form individual pouch products.

[0160] The amount of material contained in each pouch may vary. In various embodiments, the weight of the mixture in each pouch is at least about 50 mg, e.g., about 50 mg to about 2 grams, about 100 mg to about 1.5 grams, or about 200 mg to about 700 mg. In certain smaller embodiments, the weight of the material in each pouch is at least about 50 mg to about 150 mg. For some larger embodiments, the weight of the material in each pouch is preferably not more than about 300 mg to about 500 mg. In some embodiments, each pouch / container can have a flavoring member disposed therein, as described in more detail in U.S. Patent No. 7,861,728 to Holton, Jr. et al., which is incorporated herein by reference. 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 material) can be disposed in each pouch, with or without at least one capsule. Such strips or sheets can be easily incorporated into a pouch by folding or crumpling. See, for example, U.S. Patent No. 6,887,307 to Scott et al. and U.S. Patent No. 6,923,981 to Leung et al., which are incorporated herein by reference; and the types of materials and techniques described in The EFSA Journal (2004) Vol. 85, pp. 1-32.

[0161] In various embodiments, the nonwoven web can be sufficiently sticky to cause problems with high speed pouch equipment. Thus, in certain embodiments, a Teflon coating, or similar material, can be applied to one or more surfaces of the pouch equipment, such as rollers, cutting equipment, and heat sealing devices, that contact the nonwoven web to reduce and / or mitigate any problems with the pouch material sticking to the pouch equipment during processing.

[0162] As illustrated in FIG. 2, for example, a method of manufacturing a pouch product can include several general, non-limiting operations that can be performed in any desired order. In operation 100, a continuous supply of pouch material in the form of a nonwoven web including at least a portion of fibers according to the present disclosure can be provided. In operation 105, the pouch material is formed into a continuous tubular member by sealing side edges of the pouch material to form a longitudinally extending seam. As described herein, the seam can be formed, for example, by applying conventional heat sealing techniques to the pouch material to cause softening and / or melting of a heat sealable binder material in the nonwoven web to form a seal. In operation 110, a fill material of a composition adapted for oral use can be inserted into the continuous tubular member. In operation 115, the continuous tubular member can be subdivided at predetermined intervals to form a plurality of pouch member portions, each pouch member portion including a fill material of the composition. In operation 120, each separate pouch portion can be completely sealed to form an outer water-permeable pouch that encloses the composition. This second sealing step can include applying conventional heat sealing techniques to the pouch material to cause softening and / or melting of the heat-sealable binder material in the nonwoven web to form the seal. Thus, aspects of the present disclosure are specifically constructed to provide separate pouch products. The operations described herein and the order of the illustrated method steps are not to be construed as limiting thereto.

[0163] The pouch product may further include product identifying information printed or dyed or imprinted (e.g., embossed, debossed, or otherwise pressed) on the outer water-permeable pouch, as described, for example, in U.S. Patent Application Publication No. 2014 / 0255452 to Reddick et al., filed March 11, 2013, which is incorporated herein by reference. As mentioned above, flavorings may also be incorporated into the nonwoven web, if desired, for example, by coating or printing an edible flavoring ink onto the nonwoven web. See, for example, U.S. Patent Application Publication No. 2012 / 0085360 to Kawata et al. and U.S. Patent Application Publication No. 2012 / 0103353 to Sebastian et al., each of which is incorporated herein by reference.

[0164] The pouch products described herein can be packaged in any suitable inner wrapping material and / or outer container, see, for example, U.S. Patent No. 7,014,039 to Henson et al., U.S. Patent No. 7,537,110 to Kutsch et al., U.S. Patent No. 7,584,843 to Kutsch et al., U.S. Patent No. 8,397,945 to Gelardi et al., D592,956 to Thiellier et al., D594,154 to Patel et al., and D625,178 to Bailey et al., U.S. Patent Publication No. 2008 / 0173317 to Robinson et al., U.S. Patent Publication No. 2009 / 0014343 to Clark et al., U.S. Patent Publication No. 2009 / 0014450 to Bjorkholm, and U.S. Patent Publication No. 2009 / 0014450 to Bellamy et al., all of which are incorporated herein by reference. See also U.S. Patent Publication No. 2009 / 0250360 to Ah et al.; U.S. Patent Publication No. 2009 / 0266837 to Gelardi et al.; U.S. Patent Publication No. 2009 / 0223989 to Gelardi; U.S. Patent Publication No. 2009 / 0230003 to Thiellier; U.S. Patent Publication No. 2010 / 0084424 to Gelardi; and the various types of containers for smokeless type products described in U.S. Patent Publication No. 2010 / 0133140 to Bailey et al.; U.S. Patent Publication No. 2010 / 0264157 to Bailey et al.; and U.S. Patent Publication No. 2011 / 0168712 to Bailey et al.

[0165] The disclosed products constructed for oral use may be packaged and stored in any suitable packaging in much the same manner that conventional types of smokeless tobacco products are packaged and stored. For example, multiple packets or pouches may be contained in a cylindrical container. The shelf life of the product after preparation may vary. As used herein, "shelf life" refers to the period after preparation of the disclosed product. In some embodiments, one or more characteristics of the products disclosed herein (e.g., retention of whiteness, lack of discoloration, retention of volatile flavor components) are exhibited over some or all of the storage period. In some embodiments, the shelf life (i.e., preparation after period) is at least 1 day. In some embodiments, the shelf life is from about 1 day, about 2 days, or about 3 days, up to about 1 week, or from about 1 week to about 2 weeks, about 2 weeks to about 1 month, about 1 month to about 2 months, about 2 months to about 3 months, about 3 months to about 4 months, or about 4 months to about 5 months. In some embodiments, the shelf life is any number of days between about 1 day and about 150 days. In certain embodiments, the storage period may be greater than 5 months, for example, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, or about 12 months.

[0166] Many variations and other embodiments of the invention to which this invention pertains will be devised by one skilled in the art having the benefit of the teachings presented in the foregoing description. It is to be understood, therefore, that the invention is not limited to the specific embodiments disclosed, and that variations 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.

Claims

1. an outer water-permeable pouch defining a cavity; and 1. A pouch product comprising an oral composition located within a cavity, the pouch comprising: Both the outer water-permeable pouch and the composition are dissolvable in the mouth; The oral composition comprises: At least one of an active ingredient and a flavoring agent in an amount of about 0.1% to about 10% by weight; a sugar substitute in an amount of at least about 80% by weight, and Sugar alcohol syrup Pouch products, including:

2. The composition comprises at least one of an active ingredient and a flavoring agent in an amount of at least about 3% by weight.

2. The pouch product of claim 1, comprising:

3. 10. The pouch product of claim 1, wherein the sugar substitute is a non-hygroscopic sugar alcohol capable of forming a glassy matrix.

4. 2. The pouch product of claim 1, wherein the sugar substitute is isomalt.

5. 10. The pouch product of claim 1, wherein the sugar substitute is present in an amount of at least about 85% by weight.

6. 10. The pouch product of claim 1, wherein the sugar substitute is present in an amount of at least about 90% by weight.

7. 2. The pouch product of claim 1, wherein the sugar alcohol syrup is maltitol syrup.

8. 10. The pouch product of claim 1, wherein the oral composition comprises an active ingredient selected from the group consisting of nicotine components, botanicals, stimulants, nutraceuticals, amino acids, vitamins, cannabinoids, cannabis analogs, terpenes, and combinations thereof.

9. 10. The pouch product of claim 1, wherein the oral composition is in the form of a granular material having a size ranging from about 0.1 mm to about 5 mm.

10. 10. The pouch product of claim 1, wherein the oral composition comprises a filler selected from the group consisting of polyols, glucose, maltodextrin, and combinations thereof.

11. 10. The pouch product of claim 1, wherein the oral composition comprises at least one flavoring agent.

12. 12. The pouch product of claim 11, wherein the amount of flavoring agent is from about 0.1 to about 0.5 percent by weight of the oral composition.

13. The pouch product of any one of claims 1 to 12, wherein the oral composition is substantially free of tobacco materials.

14. 10. The pouch product of claim 1, wherein the outer water permeable pouch comprises a fibrous material.

15. 10. The pouch product of claim 1, wherein the outer water-permeable pouch comprises at least one hydrophilic polymer.

16. 10. The pouch product of claim 1, wherein the outer water permeable pouch comprises polyvinylpyrrolidone, polyvinyl alcohol, alginate, gluten, carrageenan, or combinations thereof.

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