Products with enhanced sensory properties

Abstract

Provided herein are oral products containing sensates that affect capsaicin receptors in the consumer's oral cavity to provide a spicy / hot sensation.Some such products are pouch products that include an outer water-permeable pouch that defines a cavity and contains a composition that includes a water-soluble component that is releasable through the water-permeable pouch.Other such products include lozenges, meltable products, chewable products, and the like.

Description

[Technical field]

[0001] The present disclosure relates to flavored products intended for human use. The products are configured for oral use and deliver substances such as flavors and / or active ingredients during use. Such products may include tobacco or 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 substantially entirely of granulated, granular, or cut tobacco and either divided by the user or provided to the user in individual portions, e.g., disposable pouches or sachets. Other traditional forms of smokeless products include compressed or agglomerated forms, e.g., 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] Smokeless tobacco product configurations that combine tobacco materials with a variety of binders and fillers have been proposed recently, 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 products and the various types of smokeless tobacco formulations, ingredients, and processing methodologies mentioned in the background art described in U.S. Patent Publication No. 2011 / 0303511 to Brinkley et al. and U.S. Patent Publication No. 2013 / 0206150 to Duggins et al., which are incorporated herein by reference. During use, these pouches or sachets are inserted into the mouth of a user, and the water-soluble ingredients contained within the pouches or sachets 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 ground tobacco material incorporated into a sealed pouch. Representative types of snus products have been manufactured in Europe, particularly in Sweden, by or through companies such as Swedish Match AB (e.g., brands such as General, Ettan, Goteborgs Rape, and Grovsnus); Fiedler & Lundgren AB (e.g., brands such as Lucky Strike, Granit, Krekt, and Mocca); JTI Sweden AB (e.g., brands such as Gustavus) and Rocker Production AB (e.g., 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., brands such as Marlboro Snus); US Smokeless Tobacco Company (e.g., brands such as SKOAL Snus) and RJ Reynolds Tobacco Company (e.g., 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 standard. 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.; U.S. Patent Publication No. 2010 / 0018539 to Brinkley et al.; U.S. Patent Publication Nos. 2010 / 0059069 to Boldrini; U.S. Patent Publication Nos. 2010 / 0071711 to Boldrini; and U.S. Patent Publication Nos. 2010 / 006337 to Boldrini; and U.S. Patent Publication Nos. 2010 / 0071721 to Boldrini. 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 such as those available from Merz Verpackungmaschinen GmBH as SB 51-1 / T, SBL 50, and SB 53-2 / T.

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

[0008] Certain types of products have been utilized that utilize pouches or sachets to contain nicotine, such as those used for 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 No. 2009 / 0293895 to Axelsson et al. and U.S. Pat. Publication No. 2011 / 0268809 to Brinkley et al.; and pouch materials and nicotine-containing formulations of the type described in PCT Publication No. WO 2010 / 031552 to Axelsson et al. and PCT Publication No. WO 2012 / 134380 to Nilsson, which are incorporated herein by reference.

[0009] All-white snus portions are becoming increasingly popular and offer an alternative, aesthetically pleasing alternative to traditional snus. Such modern "white" pouch products may contain bleached tobacco or may be tobacco-free. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] US Patent Application Publication No. 2011 / 0303511 [Patent Document 2] US Patent Application Publication No. 2013 / 0206150 [Patent Document 3] U.S. Pat. No. 8,067,046 [Patent Document 4] U.S. Patent No. 7,861,728 [Patent Document 5] US Patent Application Publication No. 2004 / 0118422 [Patent Document 6] US Patent Application Publication No. 2008 / 0202536 [Patent Document 7] US Patent Application Publication No. 2009 / 0025738 [Patent Document 8] US Patent Application Publication No. 2011 / 0180087 [Patent Document 9] US Patent Application Publication No. 2010 / 0218779 [Patent Document 10] US Patent Application Publication No. 2010 / 0294291 [Patent Document 11] US Patent Application Publication No. 2010 / 0300465 [Patent Document 12] US Patent Application Publication No. 2011 / 0061666 [Patent Document 13] US Patent Application Publication No. 2011 / 0303232 [Patent Document 14] US Patent Application Publication No. 2012 / 0067362 [Patent Document 15] US Patent Application Publication No. 2012 / 0085360 [Patent Document 16] US Patent Application Publication No. 2012 / 0103353 [Patent Document 17] US Patent Application Publication No. 2012 / 0247492 [Patent Document 18] International Publication No. 2005 / 063060 [Patent Document 19] International Publication No. 2008 / 056135 [Patent Document 20] U.S. Pat. No. 4,607,479 [Patent Document 21] U.S. Pat. No. 4,631,899 [Patent Document 22] US Patent Application Publication No. 2008 / 0156338 [Patent Document 23] US Patent Application Publication No. 2010 / 0018539 [Patent Document 24] US Patent Application Publication No. 2010 / 0059069 [Patent Document 25] US Patent Application Publication No. 2010 / 0071711 [Patent Document 26] US Patent Application Publication No. 2010 / 0101189 [Patent Document 27] US Patent Application Publication No. 2010 / 0101588 [Patent Document 28] US Patent Application Publication No. 2010 / 0199601 [Patent Document 29] US Patent Application Publication No. 2010 / 0200005 [Patent Document 30] US Patent Application Publication No. 2010 / 0252056 [Patent Document 31] US Patent Application Publication No. 2011 / 0284016 [Patent Document 32] US Patent Application Publication No. 2011 / 0239591 [Patent Document 33] US Patent Application Publication No. 2011 / 0303511 [Patent Document 34] US Patent Application Publication No. 2012 / 0055493 [Patent Document 35] US Patent Application Publication No. 2012 / 0103349 [Patent Document 36] International Publication No. 2008 / 081341 [Patent Document 37] International Publication No. 2008 / 146160 [Patent Document 38] U.S. Pat. No. 5,167,244 [Patent Document 39] U.S. Patent No. 7,950,399 [Patent Document 40] US Patent Application Publication No. 2005 / 0061339 [Patent Document 41] US Patent Application Publication No. 2011 / 0041860 [Patent Document 42] US Patent Application Publication No. 2011 / 0247640 [Patent Document 43] U.S. Pat. No. 4,907,605 [Patent Document 44] US Patent Application Publication No. 2009 / 0293895 [Patent Document 45] US Patent Application Publication No. 2011 / 0268809 [Patent Document 46] International Publication No. 2010 / 031552 [Patent Document 47] International Publication No. 2012 / 134380 [Non-patent literature]

[0011] [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

[0012] There is a continuing interest in the art to develop additional products for oral consumption that enhance the sensory experience of the consumer. [Means for solving the problem]

[0013] (Brief summary) The present disclosure relates to products incorporating one or more components that can affect the sensory properties that the product provides to consumers. Specifically, in some embodiments, such components can specifically affect capsaicin receptors in the oral cavity of consumers. Some such products incorporating these components according to the present disclosure are pouch products that include an outer water-permeable pouch that defines a cavity and contains a composition that includes a water-soluble component that can be released through the water-permeable pouch. Other such products can be, for example, lozenges, meltable products, chewable products, etc.

[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 (i.e., designed for extraction of liquids) that is adapted for steeping or brewing, such as a tea or coffee material. Thus, in certain embodiments, the composition in the cavity of the pouch can include, for example, particulate or fibrous plant material found in various teas or tea variants. In some embodiments, the composition in the cavity can include flavor ingredients so that flavors can be added to liquids (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 a composition adapted for oral use located within the cavity and comprising a water soluble component, the composition comprising a filler and vanillyl butyl ether ("VBE") in an amount of about 10 ppm to about 800 ppm.

[0017] Embodiment 2: The pouch product of embodiment 1, wherein the composition comprises a VBE in an amount of about 100 ppm to about 800 ppm.

[0018] Embodiment 3: The pouch product of embodiment 1 or 2, wherein the composition comprises VBE in an amount of about 100 ppm to about 500 ppm.

[0019] Embodiment 4: The pouch product of any one of embodiments 1 to 3, wherein the composition comprises VBE in an amount of about 250 ppm to about 500 ppm.

[0020] Embodiment 5: A pouch product according to any one of embodiments 1 to 4, wherein the composition further comprises at least one of a particulate tobacco material, an active ingredient, a particulate non-tobacco material that has been processed to contain an active ingredient and / or a flavoring agent, and a fibrous plant material carrying a tobacco extract.

[0021] Embodiment 6: The pouch product of any of embodiments 1-5, wherein the composition further comprises a whitened tobacco material.

[0022] Embodiment 7: The pouch product of any of embodiments 1-5, wherein the composition is substantially free of tobacco materials.

[0023] Embodiment 8: The pouch product of any of embodiments 1-7, wherein the composition comprises one or more active ingredients selected from the group consisting of nicotine, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimetics, terpenes, pharmaceutical agents, and combinations thereof.

[0024] Embodiment 9: The pouch product of any one of embodiments 1 to 8, wherein the composition comprises one or more components selected from the group consisting of one or more additional fillers, binders, pH adjusters, buffers, colorants, disintegration aids, antioxidants, moisturizers, and preservatives.

[0025] Embodiment 10: The pouch product of any one of embodiments 1 to 9, wherein the composition comprises one or more of a cellulose-based filler, a sweetener, salt, water, and a flavoring agent.

[0026] Embodiment 11: The pouch product of any one of embodiments 1 to 9, wherein the composition comprises one or more flavoring agents.

[0027] Embodiment 12: The pouch product of embodiment 11, wherein the one or more flavoring agents exhibit a spicy character.

[0028] Embodiment 13: The pouch product of embodiment 11 or 12, wherein the one or more flavoring agents are selected from the group consisting of cinnamon, ginger, and combinations thereof.

[0029] Embodiment 14: The pouch product of embodiment 11, wherein the one or more flavoring agents exhibit a fruity character.

[0030] Embodiment 15: The pouch product of embodiment 11 or 14, wherein the one or more flavoring agents are selected from the group consisting of berry, pina colada, orange, lemon, lime, grapefruit, peach, mango, pineapple, cherry, and combinations thereof.

[0031] Embodiment 16: The pouch product of embodiment 11, wherein the one or more flavoring agents exhibit botanical, spicy, or floral characteristics.

[0032] Embodiment 17: The pouch product of embodiment 11 or 16, wherein the one or more flavoring agents are selected from the group consisting of cardamom, lemongrass, licorice, nutmeg, clove, sandalwood, anise, sage, jasmine, lavender, vanilla, orange blossom, and combinations thereof.

[0033] Embodiment 18: The pouch product of any one of embodiments 1 to 17, having a moisture content of about 30 to about 50 weight percent.

[0034] Embodiment 19: A pouch product comprising an outer water-permeable pouch defining a cavity and a composition adapted for oral use located within the cavity and comprising a water-soluble component, the composition comprising a filler and vanillyl butyl ether ("VBE") in an amount of about 1100 ppm or greater.

[0035] Embodiment 20: The pouch product of embodiment 19, wherein the composition comprises VBE in an amount of about 1100 ppm to about 2000 ppm.

[0036] Embodiment 21: The pouch product of embodiment 19 or 20, wherein the composition comprises VBE in an amount of about 1100 ppm to about 1800 ppm.

[0037] Embodiment 22: The pouch product of any one of embodiments 19 to 21, wherein the composition comprises VBE in an amount of about 1200 ppm to about 1500 ppm.

[0038] Embodiment 23: A pouch product according to any of embodiments 19 to 22, wherein the composition further comprises at least one of a particulate tobacco material, a particulate non-tobacco material processed to contain an active ingredient and / or a flavoring agent, and a fibrous plant material carrying a tobacco extract.

[0039] Embodiment 24: The pouch product of any of embodiments 19-23, wherein the composition further comprises a whitened tobacco material.

[0040] Embodiment 25: The pouch product of any of embodiments 19-23, wherein the composition is substantially free of tobacco materials.

[0041] Embodiment 26: The pouch product of any of embodiments 19 to 25, wherein the composition comprises one or more active ingredients selected from the group consisting of nicotine, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimetics, terpenes, pharmaceutical agents, and combinations thereof.

[0042] Embodiment 27: A pouch product according to any one of embodiments 19 to 26, wherein the composition comprises one or more components selected from the group consisting of one or more additional fillers, binders, pH adjusters, buffers, colorants, disintegration aids, antioxidants, moisturizers, and preservatives.

[0043] Embodiment 28: A pouch product according to any one of embodiments 19 to 27, wherein the composition comprises one or more of a cellulose-based filler, a sweetener, salt, water, and a flavoring agent.

[0044] Embodiment 29: A pouch product according to any one of embodiments 19 to 28, wherein the composition comprises one or more flavoring agents.

[0045] Embodiment 30: The pouch product of embodiment 29, wherein the one or more flavoring agents exhibit a spicy character.

[0046] Embodiment 31: The pouch product of embodiment 29 or 30, wherein the one or more flavoring agents are selected from the group consisting of cinnamon, ginger, and combinations thereof.

[0047] Embodiment 32: The pouch product of embodiment 29, wherein the one or more flavoring agents exhibit a fruity character.

[0048] Embodiment 33: The pouch product of embodiment 29 or 32, wherein the one or more flavoring agents are selected from the group consisting of berry, pina colada, orange, lemon, lime, grapefruit, peach, mango, pineapple, cherry, and combinations thereof.

[0049] Embodiment 34: The pouch product of embodiment 29, wherein the one or more flavoring agents exhibit botanical, spicy, or floral characteristics.

[0050] Embodiment 35: The pouch product of embodiment 29 or 34, wherein the one or more flavoring agents are selected from the group consisting of cardamom, lemongrass, licorice, nutmeg, clove, sandalwood, anise, sage, jasmine, lavender, vanilla, orange blossom, and combinations thereof.

[0051] Embodiment 36: A pouch product according to any one of embodiments 19 to 35, having a moisture content of about 30 to about 50 percent by weight.

[0052] Embodiment 37: An oral product in the form of a gel, pastille, chew, melt, tablet, or lozenge comprising vanillyl butyl ether ("VBE").

[0053] Embodiment 38: The oral product of embodiment 37, wherein the VBE is present in an amount from about 10 ppm to about 2000 ppm.

[0054] Embodiment 39: An oral product according to embodiment 37 or 38, further comprising at least one of a particulate tobacco material, an active ingredient, a particulate non-tobacco material processed to contain an active ingredient and / or a flavoring agent, and a fibrous plant material carrying a tobacco extract.

[0055] Embodiment 40: The oral product of any one of embodiments 37 to 39, which is substantially free of tobacco material.

[0056] Embodiment 41: The oral product of any of embodiments 37-40, further comprising one or more active ingredients selected from the group consisting of nicotine, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimetics, terpenes, pharmaceutical agents, and combinations thereof.

[0057] Embodiment 42: The oral product of any one of embodiments 37 to 41, further comprising one or more components selected from the group consisting of one or more fillers, binders, pH adjusters, buffers, colorants, disintegration aids, antioxidants, humectants, and preservatives.

[0058] Embodiment 43: The oral product of any of embodiments 37-42, further comprising one or more flavoring agents.

[0059] Embodiment 44: The oral product of embodiment 43, wherein the one or more flavoring agents exhibit a spicy character.

[0060] Embodiment 45: The oral product of embodiment 43 or 44, wherein the one or more flavoring agents are selected from the group consisting of cinnamon, ginger, and combinations thereof.

[0061] Embodiment 46: The oral product of embodiment 43, wherein the one or more flavoring agents exhibit a fruity character.

[0062] Embodiment 47: The oral product of embodiment 43 or 46, wherein the one or more flavoring agents are selected from the group consisting of berry, pina colada, orange, lemon, lime, grapefruit, peach, mango, pineapple, cherry, and combinations thereof.

[0063] Embodiment 48: The oral product of embodiment 43, wherein the one or more flavoring agents exhibit botanical, spicy, or floral characteristics.

[0064] Embodiment 49: The oral product of embodiment 43 or 48, wherein the one or more flavoring agents are selected from the group consisting of cardamom, lemongrass, licorice, nutmeg, clove, sandalwood, anise, sage, jasmine, lavender, vanilla, orange blossom, and combinations thereof.

[0065] Embodiment 50: A composition comprising a filler and vanillyl butyl ether ("VBE") in an amount of about 10 ppm to about 800 ppm, or a filler and vanillyl butyl ether ("VBE") in an amount of about 1100 ppm or more, in the form of a pouch product.

[0066] Embodiment 51: The composition of embodiment 50, comprising VBE in an amount of about 100 ppm to about 800 ppm.

[0067] Embodiment 52: The composition of embodiment 50, comprising VBE in an amount of about 100 ppm to about 500 ppm.

[0068] Embodiment 53: The composition of embodiment 50, comprising VBE in an amount of about 250 ppm to about 500 ppm.

[0069] Embodiment 54: The composition of embodiment 50, comprising VBE in an amount of about 1100 ppm to about 2000 ppm.

[0070] Embodiment 55: The composition of embodiment 50, comprising VBE in an amount from about 1100 ppm to about 1800 ppm.

[0071] Embodiment 56: The composition of embodiment 50, comprising VBE in an amount of about 1200 ppm to about 1500 ppm.

[0072] Embodiment 57: The composition of any of embodiments 50 to 56, further comprising at least one of a particulate tobacco material, an active ingredient, a particulate non-tobacco material processed to contain an active ingredient and / or a flavoring agent, and a fibrous plant material carrying a tobacco extract.

[0073] Embodiment 58: The composition of any one of embodiments 50 to 57, further comprising a whitened tobacco material.

[0074] Embodiment 59: The composition of any of embodiments 50-57, which is substantially free of tobacco material.

[0075] Embodiment 60: The composition of any of embodiments 50 to 59, further comprising one or more active ingredients selected from the group consisting of nicotine, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimetics, terpenes, pharmaceutical agents, and combinations thereof.

[0076] Embodiment 61: The composition of any one of embodiments 50 to 60, further comprising one or more components selected from the group consisting of one or more additional fillers, binders, pH adjusters, buffers, colorants, disintegration aids, antioxidants, moisturizers, and preservatives.

[0077] Embodiment 62: The composition of any one of embodiments 50-61, comprising one or more of a cellulose-based filler, a sweetener, salt, water, and a flavoring agent.

[0078] Embodiment 63: A composition according to any one of embodiments 50 to 62, comprising one or more flavoring agents.

[0079] Embodiment 64: The composition of embodiment 63, wherein the one or more flavoring agents exhibit a spicy note.

[0080] Embodiment 65: The composition of embodiment 63 or 64, wherein the one or more flavoring agents are selected from the group consisting of cinnamon, ginger, and combinations thereof.

[0081] Embodiment 66: The composition of embodiment 63, wherein the one or more flavoring agents exhibit fruity notes.

[0082] Embodiment 67: The composition of embodiment 63 or 66, wherein the one or more flavoring agents are selected from the group consisting of berry, pina colada, orange, lemon, lime, grapefruit, peach, mango, pineapple, cherry, and combinations thereof.

[0083] Embodiment 68: The composition of embodiment 63, wherein the one or more flavoring agents exhibit botanical, spicy, or floral characteristics.

[0084] Embodiment 69: The composition of embodiment 63 or 68, wherein the one or more flavoring agents are selected from the group consisting of cardamom, lemongrass, licorice, nutmeg, clove, sandalwood, anise, sage, jasmine, lavender, vanilla, orange blossom, and combinations thereof.

[0085] 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.

[0086] Having thus described aspects of the present disclosure in the foregoing general paragraphs, reference is now made to the accompanying drawings, which are not necessarily drawn to scale, and which are illustrative only and should not be construed as limiting the disclosure. [Brief description of the drawings]

[0087] [Figure 1] FIG. 1 is a front perspective view illustrating a pouch product according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0088] 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.

[0089] 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.

[0090] According to the present disclosure, a product is provided that is constructed for oral use, comprising one or more flavoring agents that can be classified as sensates. As used herein, a "sensate" is a component that can modify a consumer's experience when a product containing the component is placed in the consumer's oral cavity (compared to the consumer's experience with a comparable product that does not contain the sensate). The sensates provided herein can provide various sensory characteristics to the products in which they are incorporated. For example, sensates can provide a warming sensation, a tingling sensation, a "heat" sensation, a spicy sensation, and the like. In some embodiments, the sensate is a compound that activates the Transient Receptor Potential Vanilloid 1 ("TRPV1") receptor.

[0091] Sensate agents include, but are not limited to, capsaicin (8-methyl-N-vanillyl-6-nonenamide), which is the active ingredient of hot peppers, and various analogs thereof, including other capsaicinoids. Additional, non-limiting analogs include homocapsaicin, homodihydrocapsaicin, and vanillylnonanamide, as well as alkyl alcohol ether derivatives, including, for example, vanillyl propyl ether, vanillyl butyl ether, vanillyl pentyl ether, and vanillyl hexyl ether. Additional compounds include capsiates, piperine, sanshool, 1-monoacylglycerol, and certain lactones, which contain oleic acid, linoleic acid, and α-linoleic acid, eicosanoids, and lysophosphatidic acid. See, for example, Tobita et al., Biochem. Biophys. Res. Comm. 534 (2021):547-552, the entire contents of which are incorporated by reference herein.

[0092] Indeed, one example of a sensate that is an analog of capsaicin that may be utilized in accordance with embodiments of the present disclosure is vanillyl butyl ether ("VBE"), also known as 4-(butoxymethyl)-2-methoxyphenol, the structure of which is provided below.

[0093] [ka]

[0094] In some embodiments, the sensate described herein is included in the product as the only flavoring. In other embodiments, the sensate is included in combination with one or more additional flavorings (described herein below). In some embodiments, the characteristics provided by the sensate complement the characteristics provided by one or more of the other components in the product (e.g., an active agent, another flavoring agent, etc.). In some embodiments, the sensate can enhance the burning / tingling / warming type sensations sometimes exhibited by nicotine (such that a product containing a combination of nicotine and a sensate can mimic the sensory characteristics of a product with a higher concentration of nicotine). In some embodiments, the sensate can provide a burning / tingling / warming type sensation that complements the additional flavors that can typically accompany such sensations (e.g., including but not limited to, cinnamon and ginger). In still further embodiments, the sensate may provide a burning / tingling / warming type sensation that complements other flavors (which in some embodiments may not normally be associated with such sensations), including, but not limited to, fruit flavors such as apple, berry (e.g., strawberry), cherry, peach, mango, pineapple, or citrus flavors (e.g., orange, lemon, lime, and / or grapefruit), alcoholic drink flavors (not themselves alcoholic), such as pina colada flavors (including, for example, pineapple and coconut flavors), and herbal, floral, or spice-derived flavors (e.g., cardamom, lemongrass, licorice, nutmeg, clove, sandalwood, anise, sage, jasmine, lavender, vanilla, and orange blossom). In further embodiments, the presence of the sensate may distract the consumer from other flavors or sensations that may be associated with other components present in the composition (e.g., flavors or sensations that are perceived by consumers as being less pleasant). For example, in some embodiments, the inclusion of a sensate can distract the consumer from the bitter or sour taste notes that can be associated with certain active ingredients, such as nicotine.

[0095] The amount of sensate incorporated into compositions, pouch products, and other oral products according to the present disclosure can vary depending, for example, on the composition of the sensate, the type and size of the product in which it is incorporated, the other components of the product in which it is incorporated, and the desired sensory characteristics to be achieved. In some embodiments, the sensate is incorporated in an amount of about 25 ppm to about 1500 ppm. In some embodiments, the sensate is incorporated in an amount of more than about 1000 ppm (e.g., at least about 1100 or at least about 1100 ppm and up to about 1500 ppm), and in other embodiments, the sensate is incorporated in an amount of less than about 1000 ppm (e.g., less than about 900 ppm or less than about 800 ppm and as low as about 25 ppm). Certain embodiments include the sensate in an amount of about 50 to about 1000 ppm, e.g., about 100 to about 800 ppm, about 100 to about 600 ppm, or about 100 to about 500 ppm.

[0096] Built for oral use The term "constructed for oral use," as used herein, means that the composition is provided in a form such that, during use, one or more of the components of the composition (e.g., basic amine, flavoring agent, and / or active ingredient) are carried to the user's mouth by the user's oral saliva. In certain embodiments, the composition is adapted to deliver a component to the user via the user's oral mucosa, the user's digestive system, or both, and in some cases, the component is a nicotine component or an active ingredient (including, but not limited to, for example, nicotine, stimulants, vitamins, amino acids, botanicals, or combinations thereof) that can be absorbed via the oral mucosa or that can be absorbed via the digestive tract when the product is used.

[0097] The compositions described herein that are designed for oral use can take a variety of forms, including, but not limited to, gels, pastilles, gums, chews, melts, tablets, lozenges, granular materials, powders, and pouch products. The types of components described below with respect to the mixtures in the pouch products (e.g., active ingredients, fillers, sweeteners, etc.) may be relevant in the context of various other types of compositions.

[0098] Lozenges, pastels, gels, chewable tablets, meltable tablets, etc. Certain compositions of the present disclosure are in solid form. Certain compositions can, for example, exhibit one or more of the following characteristics: crispy, granular, chewy, sweet, pasty, fluffy, smooth, and / or creamy. Gels can be soft or hard. In certain embodiments, the desired textural properties can be selected from the group consisting of adhesiveness, tackiness, density, dryness, brittleness, granularity, gummyness, hardness, weightiness, moisture absorption, moisture release, mouth-coating, roughness, slipperiness, smoothness, viscosity, wetness, and combinations thereof.

[0099] Certain compositions of the present disclosure may be dissolvable. As used herein, the terms "dissolve", "dissolving" and "dissolvable" refer to a composition having water-soluble components that interact with moisture in the oral cavity and go into solution, thereby causing slow consumption of the composition. According to one embodiment, a dissolvable composition is capable of remaining in the user's mouth for a given period of time until it is completely dissolved. The dissolution rate may vary over a wide range, from about 1 minute or less to about 60 minutes. For example, a fast release composition typically dissolves and / or releases the desired components (e.g., active ingredients, flavors, etc.) in about 2 minutes or less, often about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). Dissolution may occur by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical degradation, or disruption of interactions between the components of the composition. In other embodiments, the product does not dissolve during the product's residence in the user's mouth.

[0100] In some embodiments, the composition can be chewable, meaning that the composition has a slight elasticity or "spring back" upon chewing and retains a desirable degree of malleability. The chewable form of the composition may be completely dissolved or may be in the form of a non-dissolving gum in which only certain components (e.g., active ingredients, flavors, sweeteners) dissolve, leaving behind a non-dissolving matrix. Chewable embodiments typically include a binder, such as a natural gum or pectin. In some embodiments, the chewable form of the composition includes pectin and an organic acid, together with one or more sugar alcohols, in an amount of at least 50% by weight, based on the total weight of the composition. Typically, the pectin is present in an amount of about 1 to about 3% by weight, based on the total weight of the composition.

[0101] Examples of suitable types of oral products and methods for making such products include, but are not limited to, U.S. Pat. Nos. 9,084,439; 9,155,321; 9,204,667; 9,420,825; 9,901,113; 9,993,020; 10,357,054; 10,568,355; 10,772,349; 10,772,356; 10,772,357; and 10,772,359. 50; U.S. Patent No. 10,952,461; U.S. Patent No. 10,980,271; U.S. Patent No. 11,116,237; and U.S. Patent No. 11,166,486; as well as those disclosed in U.S. Patent Application Publication No. 2013 / 0263870; U.S. Patent Application Publication No. 2016 / 0073676; U.S. Patent Application Publication No. 2020; U.S. Patent Application Publication No. 0367551; U.S. Patent Application Publication No. 2021 / 0161196; U.S. Patent Application Publication No. 2021 / 0169792; and U.S. Patent Application Publication No. 2021 / 0195936.

[0102] Certain compositions designed for oral use are in the form of pastilles. As used herein, the term "pastel" refers to a dissolvable oral composition made by solidifying a liquid or gel composition such that the final composition is a somewhat hardened, solid gel. The stiffness of the gel can be highly variable.

[0103] In some embodiments, the composition can be meltable, for example, as discussed in U.S. Patent Application Publication No. 2012 / 0037175 to Cantrell et al., which is incorporated herein by reference in its entirety. As used herein, "melt," "melting," and "meltable" refer to the ability of a composition to change from a solid to a liquid state. That is, melting occurs when a substance (e.g., a composition disclosed herein) changes from a solid to a liquid, usually by the application of heat. The application of heat, in the context of the compositions disclosed herein, is brought about by the internal temperature of the user's mouth. Thus, the term "meltable" refers to a composition that is capable of liquefying in the mouth of a user as the composition changes phase from solid to liquid, and is intended to distinguish from compositions that simply dissolve in the oral cavity via loss of viscosity when the water-soluble components of the composition interact with moisture, in compositions that simply dissolve in the oral cavity. Generally, meltable compositions include lipids, as described herein above. In some embodiments, the composition in meltable form comprises lipid in an amount of about 35 to about 50% by weight based on the total weight of the composition, and sugar alcohol in an amount of about 35 to about 55% by weight based on the total weight of the composition. The sugar alcohol can be any sugar alcohol mentioned elsewhere herein. In some embodiments, the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof. In some embodiments, the sugar alcohol is isomalt.

[0104] In certain embodiments, the composition is in the form of a compressed or molded pellet. Exemplary pellets range in weight from about 250 mg to about 1500 mg, for example, from about 250 mg to about 700 mg, or from about 700 mg to about 1500 mg. The pellets can have any of a variety of shapes, including traditional pill or tablet shapes. Generally, the composition in tablet form comprises a glucose-polysaccharide blend and a sugar alcohol. In some embodiments, the glucose-polysaccharide blend is present in an amount of about 35 to about 50% by weight based on the total weight of the composition, and the sugar alcohol is present in an amount of about 30 to about 45% by weight based on the total weight of the composition. Examples or sugar alcohols useful in such pellets include those mentioned elsewhere herein, such as isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof. In some embodiments, the sugar alcohol is isomalt.

[0105] In some embodiments, the composition may be in the form of a dissolvable, lightly chewable pastille product for use in the oral cavity. As used herein, the term "pastel" refers to a dissolvable oral product made by solidifying a liquid or gel composition, e.g., a composition that includes a gelling agent or binder such that the final product is a hardened solid gel. Examples of gelling agents and binders are described elsewhere herein. A pastille product may alternatively be referred to as a soft lozenge. In certain embodiments, the pastille product of the present disclosure is characterized by sufficient cohesiveness to withstand light chewing action in the oral cavity without disintegrating rapidly. The pastille product of the present disclosure does not typically exhibit the highly malleable chewing quality found in conventional chewing gum. See, for example, the smokeless tobacco pastilles, pastille compositions, pastille configurations, pastille characteristics, and techniques for formulating or manufacturing pastilles described in U.S. Patent No. 9,204,667 to Cantrell et al.; U.S. Patent No. 9,775,376 to Cantrell et al.; and U.S. Patent No. 10,357,054 to Marshall et al., which are incorporated herein by reference. The gum (or a combination of two or more gums) can be utilized in an amount sufficient to provide the pastille product with the desired physical attributes and physical integrity. The pastille product of the present disclosure can include at least one sugar alcohol in the form of a filler component. Sugar alcohols are particularly advantageous as filler components in the pastilles of the present disclosure, since such materials provide some sweetness and do not destroy the desired chewable characteristics of the final product. In some embodiments, isomalt may be incorporated as the only filler component. In some embodiments, the filler includes one or more of a sugar substitute, such as allulose, soluble tapioca fiber, and inulin. Such sugar substitutes may be a replacement for sugar alcohols or may be used in combination with one or more sugar alcohols.

[0106] In some embodiments, the composition may be in the form of a dissolvable lozenge product designed for oral use. Exemplary lozenge-type products of the present invention have the form of lozenges, tablets, microtabs, or other tablet-type products. See, for example, U.S. Patent No. 4,967,773 to Shaw; U.S. Patent No. 5,110,605 to Acharya; U.S. Patent No. 5,733,574 to Dam; U.S. Patent No. 6,280,761 to Santus; U.S. Patent No. 6,676,959 to Andersson et al.; U.S. Patent No. 6,248,760 to Wilhelmsen; and U.S. Patent No. 7,374,779 to Wilhelmsen; U.S. Patent Publication No. 2001 / 0016593 to Wilhelmsen; U.S. Patent No. 6,280,761 to Santus; U.S. Patent No. 6,676,959 to Andersson et al.; U.S. Patent Publication No. 6,248,760 to Wilhelmsen; and U.S. Patent No. 7,374,779 to Liu et al., all of which are incorporated herein by reference. See U.S. Patent Publication No. 2004 / 0101543; U.S. Patent Publication No. 2006 / 0120974 to Mcneight; U.S. Patent Publication No. 2008 / 0020050 to Chau et al.; U.S. Patent Publication No. 2009 / 0081291 to Gin et al.; and U.S. Patent Publication No. 2010 / 0004294 to Axelsson et al., which describe types of nicotine-containing lozenges, lozenge formulations, lozenge formats and configurations, lozenge characteristics, and techniques for formulating or manufacturing lozenges.

[0107] Lozenge products are generally described as "hard" and thus distinguished from soft lozenges (i.e., pastilles). Hard lozenges are a mixture of sugars and / or carbohydrates in an amorphous state. They are made from an aqueous syrup, but the water initially present evaporates as the syrup boils during processing, resulting in a very low moisture content in the final product, e.g., 0.5%-1.5% by weight. To obtain a hard, non-sticky lozenge, the temperature of the melt must generally reach the hard crack stage, an exemplary temperature range being 149°C-154°C.

[0108] In some embodiments, lozenge-type products may exhibit translucency or transparency. The desired transparency or translucency of a product can be quantified by any known method. For example, optical methods such as turbidity (or nephelometry) and colorimetry can be used to quantify the turbidity (light scattering) and color (light absorption) of the product, respectively. Translucency can also be confirmed by visual inspection by simply holding the product up to a light source and determining whether the light travels in a diffuse manner through the material or product.

[0109] The lozenge-type products of the present disclosure may incorporate a variety of different additives in addition to the sensates mentioned hereinabove, and may be prepared according to a variety of different methods generally known in the art for preparing lozenge-type products. In some embodiments, the lozenge products include one or more active ingredients. In some embodiments, the lozenge products include a sugar substitute. In certain embodiments, the sugar substitute is capable of forming a glassy matrix. The formation of a glassy matrix is ​​generally characterized by a translucent / transparent appearance. Typically, the sugar substitute is substantially non-hygroscopic. Non-hygroscopic materials typically do not absorb, adsorb, and / or retain significant amounts of moisture from the air. The sugar substitute can be any sugarless material (i.e., a material that does not contain sucrose) and can be natural or synthetically produced. The sugar substitutes used in the products described herein can be nutritive or non-nutritive. For example, the sugar substitute is generally a sugar alcohol, such as those described elsewhere herein. Sugar alcohols that may be useful in certain lozenges according to the present disclosure include, but are not limited to, erythritol, threitol, arabitol, xylitol, ribotol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol, polyglycitol, and mixtures thereof. The moisture content of the lozenges described herein prior to use of the product by the consumer may vary within such ranges according to the desired properties and characteristics, as well as dictating the final form of the product. For example, lozenge-type products typically have a moisture content within the range of about 0.1 to about 5 weight percent based on the total weight of the composition.

[0110] In some embodiments, the oral products provided herein may be in the form of a center-filled pastille or lozenge, such as a form in which the interior (or at least a portion) of the product has one or more sensory characteristics (e.g., texture, mouthfeel, taste, etc.) from its exterior (or other portions thereof). For example, one or both of such portions may include a sensate as provided herein. Such center-filled pastille or lozenge formulations may include a liquid and / or gel and / or meltable and / or chewable and / or gummy surrounded by a harder outer shell that may be bonded to the pastille or lozenge products described herein. In such embodiments, the center-fill may be described as less rigid and / or more flexible compared to the outer shell. In some embodiments, the center-fill may or may not include an active ingredient therein. For example, in some embodiments, both the outer shell and the center-fill formulation may include an active ingredient, thereby providing a sustained release of the active ingredient therefrom. In some embodiments, at least the outer shell formulation includes a pastille formulation as described herein above. In other embodiments, both the outer shell formulation and the center-fill formulation may include pastille formulations described herein having similar or different sensory properties.

[0111] The compositions disclosed herein can be formed into a variety of shapes, including pills, tablets, spheres, strips, films, sheets, coins, cubes, beads, ovals, oblong shapes, cylinders, bean shapes, sticks or rods. The cross-sectional shapes of the compositions can vary, with exemplary cross-sectional shapes including round, square, oval, rectangular, etc. Such shapes can be formed in a variety of manners, for example, using equipment such as moving belts, nips, extruders, granulating devices, compression devices, etc.

[0112] Pouch Products In some embodiments, the present disclosure provides products in the form of a mixture of one or more components (including sensates as described herein above) disposed within a moisture-permeable container (e.g., a water-permeable pouch). A pouch product generally includes an intra-pouch mixture that typically includes, in addition to an exterior pouch base, one or more active ingredients and / or one or more flavoring agents, as well as a variety of other optional ingredients (in addition to sensates as described herein). The composition of the intra-pouch material provided herein is not particularly limited and can include, in addition to sensates, any fill composition, including those included within conventional pouch products. Such compositions are generally mixtures of two or more components, and thus, in some cases, the compositions are referred to herein below as "mixtures". Certain components that can be advantageously included in the mixture within certain embodiments of the pouches provided herein are generally outlined below. However, it should be understood that this discussion is not intended to limit the components that can be incorporated within the disclosed pouches. Additionally, while the discussion herein regarding pouch products has focused on the inclusion of sensates within the composition within the pouch, it is noted that the sensates may alternatively (or additionally) be included in different portions of the pouch (e.g., within a material external to the pouch base). In some embodiments, the sensates may be contained within the mixture or within the exterior of the pouch base in the form of a capsule that can be selectively crushed / broken by the consumer to obtain the associated sensory experience (e.g., sensation of heat / spicy) at a desired time.

[0113] 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. Typically, 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. The pouch is preferably not chewed or swallowed. Exposure to saliva then allows some of the components in the mixture (e.g., flavorings 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 before the pouch loses its physical integrity.

[0114] 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 outer water-permeable pouch as well as the type and nature of the composition adapted for oral use illustrated herein are not to be construed as limiting.

[0115] Filler Ingredients The material in the pouch described herein typically includes 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.

[0116] "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.

[0117] In some embodiments, the particulate filler component is a cellulose material or a cellulose derivative. One particulate filler component particularly suitable 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.

[0118] The amount of particulate filler component can vary, but is typically up to about 75 weight percent of the material contained in the pouch (i.e., the mixture) based on the total weight of the mixture. 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., from about 10, about 15, about 20, about 25, or about 30, to about 35, about 40, about 45, or about 50 weight percent (e.g., about 20 to about 50 weight percent, about 25 to about 45 weight percent, or about 50 to about 80 weight percent, or about 60 to about 80 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.

[0119] 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 certain embodiments comprise 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 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 0 wt. % to about 5 wt. % of HPC, for example, about 1 wt. % to about 3 wt. % of HPC, based on the total weight of the mixture.

[0120] In some further embodiments, the composition includes as a filler a by-product of the pulping process, such as citrus rind. In some embodiments, the composition includes as a filler wheat straw. Such fillers can be used in combination with any of the types of particulate fillers referenced herein above.

[0121] water The water content of the mixture in the pouch products described herein prior to use of the product by the consumer can vary depending on the desired properties. Typically, the mixture present in the product prior to insertion into the mouth of the user 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, at least about 10 weight percent water, at least about 15 weight percent water, and at least about 20 weight percent water.

[0122] Flavoring Agent As used herein, a "flavoring agent" or "flavoring agent" is any flavorful or fragrant substance capable of modifying the sensory properties associated with an oral product. Examples of sensory properties that can be modified with a flavoring agent include taste, mouthfeel, moistness, cool / heat, and / or flavor / aroma. Flavoring agents may be natural or synthetic, and the flavor characteristics they provide may be described, without limitation, as fresh, sweet, herbal, confectionery, floral, fruity, or spicy. Specific types of flavors include, but are not limited to, vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, trigeminal sensates, melatonin, terpenes, and any combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, R. J. Reynolds Tobacco Company (1972), incorporated herein by reference. Flavorings can also include components that are considered to be humectants, cooling agents, or smoothing agents, such as eucalyptus. These flavors may be provided pure (i.e., alone) or in complexes and may be utilized as concentrates or flavor packages (e.g., 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 No. WO 05 / 041699 to Quinter et al., each of which is incorporated herein by reference. In some cases, the flavorings may be provided in a spray-dried or liquid form.

[0123] 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 ingredient 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 ingredient comprises ethyl vanillin.

[0124] The additional flavoring agent is optional. In some embodiments, the sensate provided herein above is the only flavoring agent included in the composition. In other embodiments, the sensate is provided in combination with one or more flavoring agents. In some embodiments, the one or more flavoring agents are selected to complement the spicy / heat sensation associated with the sensate, as indicated above. In some embodiments, the optional additional flavoring agent is a flavoring agent that does not contain menthol. In some embodiments, the optional additional flavoring agent is a flavoring agent other than mint and eucalyptus. Without intending to be limited by theory, it is believed that the inclusion of such flavoring agents may also negatively impact the sensory properties of the product. If present, the amount of flavoring agent utilized in the mixture / composition may vary, but is typically up to about 10 weight percent, with certain embodiments characterized by 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. Such amounts are generally provided in addition to the amount of sensate provided herein.

[0125] 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 flavor components. In one embodiment, the concentration of one or more of the at least one volatile flavor components present is higher than the concentration of one or more volatile flavor 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.

[0126] salt In some embodiments, the mixture may further include a salt (e.g., an alkali metal salt), typically utilized in an amount sufficient to impart desired sensory attributes to the mixture. 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.

[0127] 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, and the like. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, and the like. In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides, having a partially or fully hydrogenated form. 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, on a weight basis, from about 0.1 to about 20 weight percent or more 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, based on the total weight of the mixture.

[0128] Binder In certain embodiments, a 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. In some embodiments, the binder comprises pectin or carrageenan, or combinations thereof.

[0129] The binder may be utilized in an amount sufficient to provide the mixture with the desired physical characteristics and physical integrity. The amount of binder utilized in the mixture may 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, e.g., 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.

[0130] In certain embodiments, the binder comprises a gum, e.g., a natural gum. As used herein, a 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 typically present in an amount of up to about 5% by weight, e.g., from about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, 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.

[0131] 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, about 0.1% to about 0.5% by weight, or about 1% to about 5% by weight, based on the total weight of the mixture.

[0132] Processing Aids If necessary for downstream processing of the composition, such as granulation, mixing, or molding, a glidant can also be added to the composition to enhance the flowability of the composition. In some embodiments, the composition (e.g., in melt and chew form) can be surface treated with an anti-adherent, such as oil, silicone, etc. Exemplary glidants include microcrystalline cellulose, silica, polyethylene glycol, stearic acid, calcium stearate, magnesium stearate, zinc stearate, sodium stearyl fumarate, carnauba wax, and combinations thereof. In some embodiments, the glidant is sodium stearyl fumarate. When present, a representative amount of glidant can comprise at least about 0.5 percent or at least about 1 percent of the total dry weight of the composition. Preferably, the amount of glidant in the composition does not exceed about 5 percent, and often does not exceed about 3 percent, of the total dry weight of the mixture / composition.

[0133] 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 0.1% to about 1%, about 0.1% to about 0.5%, or 0.5% to about 5%, e.g., about 0.75% to about 4%, about 0.75% to about 3%, or about 1% to about 2% by weight of the mixture. Non-limiting examples of suitable buffers include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof.

[0134] Oral care ingredients Oral care ingredients provide the ability to inhibit caries or tooth loss, inhibit gum disease, relieve mouth pain, whiten or inhibit tooth staining, induce salivary stimulation, inhibit bad breath, freshen breath, etc. For example, ingredients such as thyme oil, eucalyptus oil, and zinc (such as those in the formulations available from Discus Dental under the trademark ZYTEX®) can be incorporated into the composition in effective amounts. Other examples of ingredients that can be incorporated in the compositions of the present invention in desired effective amounts include those incorporated into oral care compositions of the type described in Takahashi et al., Oral Microbiology and Immunology, Vol. 19(1), pp. 61-64 (2004); Thistle, U.S. Patent No. 6,083,527; and Jakubowski, U.S. Patent Application Publication No. 2006 / 0210488 and Cummins et al., U.S. Patent Application Publication No. 2006 / 02228308. Other exemplary components of tobacco-containing formulations include those contained in formulations marketed by Roquette as MALTISORB® and by NatraRx as DENTIZYME®. When present, a representative amount of oral care additive is at least about 1%, often at least about 3%, and often at least about 5% of the total dry weight of the composition. The amount of oral care additive in the composition typically does not exceed about 30%, often does not exceed about 25%, and often does not exceed about 20% of the total dry weight of the mixture / composition.

[0135] Coloring agent Colorants can be utilized in amounts 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, about 0.1%, about 0.5%, or about 1% to about 3% by weight based on the total weight of the mixture.

[0136] 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: APIs (active pharmaceutical ingredients), food additives, natural drugs, 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, 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," 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).

[0137] 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.

[0138] In certain embodiments, the active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof. For example, the active ingredient can include a combination of caffeine, theanine, and optionally ginseng. In another embodiment, the active ingredient includes a combination of theanine, gamma-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 B vitamins (e.g., vitamin B6 or B12). In yet a further embodiment, the active ingredient includes a combination of caffeine, taurine, and vitamin C.

[0139] 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 w / w% to about 10 w / w%, for example, about 0.5 w / w% to about 10 w / w%, about 1 w / w% to about 10 w / w%, about 1 w / w% 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.

[0140] 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.

[0141] If present, the botanicals will typically be at a concentration of about 0.01% w / w to about 10% by weight, 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%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.

[0142] Botanical materials useful in the present disclosure can include any of the compounds and sources described herein, including but not limited to mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemicals" 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 botanicals or botanically derived materials include acai berry (Euterpe oleracea martius), acerola (Malpighia glabra), alfalfa, allspice, angelica root, anise (e.g., star anise), annatto seed, apple (Malus domestica), apricot oil, ashwagandha, bacopa monniera, baobab, basil (Ocimum basilicum), bay, bee balm, beet root, bergamot, blackberry (Morus nigra), black cohosh, black pepper, black tea, blueberry, boldo (Peumus boldus), borage, ambrosia, cacao, calamus root, camu camu (Myrciaria dubia), hemp / marijuana, caraway seed, cardamom, blackcurrant, catnip, catuaba, cayenne pepper, Centella asiatica, chaga mushroom, chai fu, chamomile, cherry, chervil, chives, chlorophyll, chocolate, cilantro, cinnamon (Cinnamomum cassia), citron grass (Cymbopogon citratus), citrus, clary sage, clove, coconut (Cocos nucifera)nucifera), coffee, comfrey leaves and root, Phyllostomum spp., coriander seed, cranberry, cumin, curcumin, damiana, dandelion, Dorstenia arifolia, Dorstenia odorata, echinacea, elderberry, elderflower, endorhea (Anethum graveolens), evening primrose, eucalyptus, fennel, feverfew, flax, Galphimia glauca, garlic, ginger (Zingiber officinale), ginkgo, ginseng, goji berry, goldenseal, grape seed, grapefruit, grapefruit rosé (Citrus paradesi) paradisi), Graviola (Annona muricata), Green Tea, Guarana, Gotu Kola, Hawthorn, Hazel, Cannabis, Hibiscus Flower (Hibiscus sabdariffa), Honeybush, Hops, Jiaogulan, Jambu (Spilanthes oleraceae), Jasmine (Jasminum officinale), Juniper Berry (Juniperus communis), Kaempferia parviflora (Thai ginseng), Birch, Laurel, Lavender, Lemon (Citrus limon), limon), lemon balm, lemongrass, licorice, lilac, Yamabushitake mushroom, lutein, maca (Lepidium meyenii), mace, origanum vulgare, matcha, milk thistle, mint (mantle), mulberry, Nardostachys chinensis, nutmeg, olive, oolong tea, orange (Citrus sinensis), oregano, papaya, paprika, pennyroyal, peppermint (Mentha piperita),piperita), pimento, potato skin, primrose, quercetin, quince, red clover, resveratrol, Rhizoma gastrodiae, Rhodiola, rooibos (red or green), rose hips (Rosa canina), rosemary, saffron, sage, St. John's wort, sandalwood, salvia (Salvia officinalis), savory, saw palmetto, Sceletium tortuosum, siberian oak, milk thistle, skullcap, spearmint, spikenard, spirulina, slippery elm bark, sorghum bran high tannin, sorghum seed high tannin, spearmint (Mentha spicata) spicata), spirulina, star anise, sumac bran, tarragon, thyme, tisane, turmeric, Turnera aphrodisiaca, uva ursi, valerian, vanilla, Viola odorata, mulberry, wild yam root, wintergreen, ashwagandha, yacon root, yellow dock, yerba mate, and yerba santa.

[0143] 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.

[0144] 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 phytochemicals (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.

[0145] 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.

[0146] When present, the stimulant or combination of stimulants (e.g., caffeine, theacrine, and combinations thereof) is typically at a concentration of about 0.1% w / w to about 15% by weight, for example, 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%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition. In some embodiments, the composition comprises caffeine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition.

[0147] 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.

[0148] 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%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.

[0149] 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.

[0150] When present, the vitamin or combination of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or combinations thereof) will typically be at a concentration of about 0.01% w / w to about 6% by weight, for example, from 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, or about 0.1% w / w, to about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5%, or about 6% by weight, based on the total weight of the composition.

[0151] 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.

[0152] 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.

[0153] 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.

[0154] 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%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, based on the total weight of the mixture / composition.

[0155] 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.

[0156] In certain embodiments, the nicotine component may be included in the mixture in free base form, salt form, complex, or solvate form. 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, to 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.

[0157] 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.

[0158] To increase customer satisfaction, it may be desirable to provide a basic amine-containing oral product constructed for oral use that retains the initial basic amine content (e.g., nicotine content) during storage and delivers substantially the entire amount of basic amine (e.g., nicotine) initially present in the oral product. In some such embodiments, nicotine or other basic amine is utilized in conjunction with at least a portion of an organic acid or an alkali metal salt thereof (referred to herein as "ion pairing"). The film embodiments disclosed herein can include at least one binder, plasticizer, basic amine, such as nicotine or a nicotine component; water; and an organic acid, an alkali metal salt of an organic acid, or a combination thereof, where the organic acid has a logP value of about 1.4 to about 8.0.

[0159] As disclosed herein, at least a portion of the basic amine (e.g., nicotine) is bound to at least a portion of the organic acid or its alkali metal salt. For purposes of this disclosure, it is noted that the basic amine may be included instead of or in addition to other active ingredients described in more detail herein. Depending on several variables (concentration, pH, nature of organic acid, etc.), the basic amine present in the composition may exist in several forms, including as paired ions, in solution (i.e., fully solvated), as a free base, as a cation, as a salt, or any combination thereof. The relative amounts of various components in the oral product composition may vary and are usually selected to provide the oral product with the desired sensory and performance characteristics. In some embodiments, the bond between the basic amine and at least a portion of the organic acid or its alkali metal salt is in the form of an ion pair between the basic amine and the conjugate base of the organic acid.

[0160] Ion pairing describes the partial binding of oppositely charged ions in a relatively concentrated solution to form distinct chemical species called ion pairs. The strength of the binding (i.e., ion pairing) depends on the electrostatic force of attraction between a positive ion and a negative ion (i.e., a protonated basic amine, e.g., nicotine, and a conjugate base of an organic acid). By "conjugate base" is meant the base that is generated from the deprotonation of the corresponding acid (e.g., benzoate ion is the conjugate base of benzoic acid). On average, a certain population of these ion pairs exists at any one time, but the formation and dissociation of ion pairs is continuous. In the oral products disclosed herein and / or during oral use of the oral products (e.g., during contact with saliva), the basic amine, e.g., nicotine, and the conjugate base of the organic acid are at least partially present in the form of ion pairs. Without wishing to be bound by theory, it is believed that such ion pairing can minimize chemical degradation of basic amines and / or enhance the oral availability of basic amines (e.g., nicotine). At alkaline pH values ​​(e.g., about 7.5 to about 9), certain basic amines, such as nicotine, exist primarily in a free base form, which is less water soluble and less stable with respect to evaporation and oxidative degradation, but has a higher mucosal availability. Conversely, at acidic pH values ​​(e.g., about 6.5 to about 4), certain basic amines, such as nicotine, exist primarily in a protonated form, which is more water soluble and more stable with respect to evaporation and oxidative degradation, but has a lower mucosal availability. Surprisingly, in accordance with the present disclosure, it has been found that the nicotine stability, solubility, and availability properties in compositions formulated for oral use can be mutually enhanced through ion pairing or salt formation of nicotine with suitable organic acids and / or their conjugate bases. Specifically, moderately lipophilic nicotine-organic acid ion pairs provide favorable stability and absorption characteristics. Lipophilicity is conveniently measured in terms of logP, the partition coefficient of a molecule between a lipophilic phase and an aqueous phase, usually octanol and water, respectively.Octanol-water partitioning, which favors distribution of the basic amine-organic acid ion pair in octanol, predicts good absorption across the oral mucosa of the basic amines present in the composition.

[0161] As noted above, at alkaline pH values ​​(e.g., from about 7.5 to about 9), nicotine exists primarily in the free base form (hence, high partitioning into octanol), while at acidic pH values ​​(e.g., from about 6.5 to about 4), nicotine exists primarily in the protonated form (hence, low partitioning into octanol). Ion pairs between certain organic acids, e.g., ion pairs having logP values ​​of from about 1.4 to about 8.0, e.g., from about 1.4 to about 4.5, allow nicotine to partition into octanol, which is consistent with the predicted partitioning of nicotine into octanol at pH 8.4.

[0162] Those skilled in the art will recognize that the extent of ion pairing of the disclosed compositions, both before and during use by the consumer, may vary based on, for example, pH, the nature of the organic acid, the concentration of nicotine, the concentration of the organic acid or the conjugate base of the organic acid present in the composition, the water content of the composition, the ionic strength of the composition, etc. Those skilled in the art will also recognize that ion pairing is an equilibrium process that is influenced by the aforementioned variables. Thus, the extent of ion pairing is difficult or impossible to quantify by calculation or direct observation. However, as disclosed herein, the presence of ion pairing can be demonstrated via surrogate measurements, such as the partitioning of nicotine between octanol and water or the membrane permeation of an aqueous solution of a basic amine plus an organic acid and / or their conjugate base.

[0163] organic acid As used herein, the term "organic acid" refers to an organic (i.e., carbon-based) compound characterized by acid properties. Typically, organic acids are relatively weak acids (i.e., they do not completely dissociate in the presence of water), such as carboxylic acids (-COH) or sulfonic acids (-SOOH). As used herein, reference to an organic acid refers to an organic acid that has been intentionally added. In this context, an organic acid may be intentionally added as a particular composition component, as opposed to an organic acid that is simply naturally present as a constituent of another composition component (e.g., a small amount of an organic acid that may be naturally present in a composition component, e.g., a tobacco material).

[0164] Suitable organic acids typically have a range of lipophilicity (i.e., polarity that provides an appropriate balance between water and organic solubility). Typically, the lipophilicity of suitable organic acids, as expressed in logP, varies between about 1.4 and about 4.5 (more soluble in octanol than in water). In some embodiments, the organic acid has a logP value of about 1.5 to about 4.0, e.g., from about 1.5, about 2.0, about 2.5, or about 3.0 to about 3.5, about 4.0, about 4.5, or about 5.0. Particularly suitable organic acids have a logP value of about 1.7 to about 4, e.g., from about 2.0, about 2.5, or about 3.0 to about 3.5, or about 4.0. In certain embodiments, the organic acid has a logP value of about 2.5 to about 3.5. In some embodiments, organic acids outside this range can also be utilized for various purposes and in various amounts, as described further herein below. For example, in some embodiments, the organic acid can have a logP value greater than about 4.5, e.g., from about 4.5 to about 8.0. In particular, the presence of certain solvents or solubilizers (e.g., inclusion of glycerin or propylene glycol in the composition) can extend the range of lipophilicity (i.e., logP values ​​greater than 4.5, e.g., from about 4.5 to about 8.0).

[0165] Without wishing to be bound by theory, it is believed that moderately lipophilic organic acids (e.g., logP of about 1.4 to about 4.5) form ion pairs with nicotine, which is bipolar, resulting in good octanol-water partitioning of the ion pair, and thus partitioning nicotine into octanol versus water. As discussed above, such partitioning into octanol predicts favorable oral availability. In some embodiments, the organic acid has a logP value of about 1.4 to about 4.5, e.g., about 1.5, about 2, about 2.5, about 3, about 3.5, about 4, or about 4.5. In some embodiments, the organic acid has a logP value of about 2.5 to about 3.5.

[0166] In some embodiments, the organic acid is a carboxylic acid or a sulfonic acid. The carboxylic acid or sulfonic acid functional group may, for example, be an organic acid having 1 to 20 carbon atoms (C1 to C 20 ) may be attached to any alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl group having the formula: In some embodiments, the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl, or heteroaryl carboxyl or sulfonic acid.

[0167] As used herein, "alkyl" refers to any straight or branched chain hydrocarbon. The alkyl group may be saturated (i.e., all sp 3 As used herein, the term "unsaturated" refers to a carbon-carbon, sp , or cyclic alkyl group at one or more positions within an alkyl group. 2It refers to the presence of a double bond. Unsaturated alkyl groups may be monounsaturated or polyunsaturated. Representative straight chain alkyl groups include, but are not limited to, methyl, ethyl, n-propyl, n-butyl, n-pentyl, and n-hexyl. Branched chain alkyl groups include, but are not limited to, isopropyl, sec-butyl, isobutyl, tert-butyl, isopentyl, and 2-methylbutyl. Representative unsaturated alkyl groups include, but are not limited to, ethylene or vinyl, allyl, 1-butenyl, 2-butenyl, isobutylenyl, 1-pentenyl, 2-pentenyl, 3-methyl-1-butenyl, 2-methyl-2-butenyl, 2,3-dimethyl-2-butenyl, and the like. The alkyl groups may be unsubstituted or substituted.

[0168] "Cycloalkyl" as used herein refers to a carbocyclic group, which may be monocyclic or bicyclic. Cycloalkyl groups include rings having 3 to 7 carbon atoms as a monocycle or rings having 7 to 12 carbon atoms as a bicycle. Examples of monocyclic cycloalkyl groups include cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl, and cyclooctyl. Cycloalkyl groups may be unsubstituted or substituted and may contain one or more sites of unsaturation (e.g., cyclopentenyl or cyclohexenyl).

[0169] The term "aryl" as used herein refers to a carbocyclic aromatic group. Examples of aryl groups include, but are not limited to, phenyl and naphthyl. Aryl groups can be unsubstituted or substituted.

[0170] "Heteroaryl" and "heterocycloalkyl," as used herein, refer to an aromatic or non-aromatic ring system, respectively, in which one or more ring atoms are heteroatoms, such as nitrogen, oxygen, and sulfur. A heteroaryl or heterocycloalkyl group contains up to 20 carbon atoms and 1-3 heteroatoms selected from N, O, and S. A heteroaryl or heterocycloalkyl may be monocyclic having 3-7 ring members (e.g., 2-6 carbon atoms and 1-3 heteroatoms selected from N, O, and S) or bicyclic having 7-10 ring members (e.g., 4-9 carbon atoms and 1-3 heteroatoms selected from N, O, and S), such as a bicyclo[4,5], [5,5], [5,6], or [6,6] system. Examples of heteroaryl groups include, by way of example and not limitation, pyridyl, thiazolyl, tetrahydrothiophenyl, pyrimidinyl, furanyl, thienyl, pyrrolyl, pyrazolyl, imidazolyl, tetrazolyl, benzofuranyl, thianaphthalenyl, indolyl, indolenyl, quinolinyl, isoquinolinyl, benzimidazolyl, isoxazolyl, pyrazinyl, pyridazinyl, indolizinyl, isoindolyl, 3H-indolyl, 1H-indazolyl, purinyl, 4H- Examples include quinolidinyl, phthalazinyl, naphthyridinyl, quinoxalinyl, quinazolinyl, cinnolinyl, pteridinyl, 4aH-carbazolyl, carbazolyl, phenanthridinyl, acridinyl, pyrimidinyl, phenanthrolinyl, phenazinyl, phenothiazinyl, furazanyl, phenoxazinyl, isochromanyl, chromanyl, imidazolidinyl, imidazolinyl, pyrazolidinyl, pyrazolinyl, benzotriazolyl, benzisoxazolyl, and isatinoyl.Examples of heterocycloalkyl include, by way of example and not limitation, dihydropyridyl, tetrahydropyridyl (piperidyl), tetrahydrothiophenyl, piperidinyl, 4-piperidonyl, pyrrolidinyl, 2-pyrrolidonyl, tetrahydrofuranyl, tetrahydropyranyl, bis-tetrahydropyranyl, tetrahydroquinolinyl, tetrahydroisoquinolinyl, decahydroquinolinyl, octahydroisoquinolinyl, piperazinyl, quinuclidinyl, and morpholinyl. Heteroaryl and heterocycloalkyl groups can be unsubstituted or substituted.

[0171] "Substituted" as used herein and when applied to any of the above alkyl, aryl, cycloalkyl, heteroaryl, and heterocyclyl means that one or more hydrogen atoms are each independently replaced with a substituent. Exemplary substituents include, but are not limited to, -Cl, Br, F, alkyl, -OH, -OCH3, NH2, -NHCH3, -N(CH3)2, -CN, -NC(=O)CH3, -C(=O)-, -C(=O)NH2, and -C(=O)N(CH3)2. Whenever a group is described as "optionally substituted," the group can be substituted with one or more of the above substituents, selected independently for each occurrence. In some embodiments, the substituents can be one or more methyl groups or one or more hydroxyl groups.

[0172] In some embodiments, the organic acid is an alkyl carboxylic acid. Non-limiting examples of alkyl carboxylic acids include formic acid, acetic acid, propionic acid, butyric acid, valeric acid, caproic acid, heptanoic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, and the like.

[0173] In some embodiments, the organic acid is an alkylsulfonic acid. Non-limiting examples of alkylsulfonic acids include propanesulfonic acid, heptanesulfonic acid, and octane sulfonic acid.

[0174] In some embodiments, the alkyl carboxyl or sulfonic acid is substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid.

[0175] In some embodiments, the organic acid can contain more than one carboxylic acid group or more than one sulfonic acid group (e.g., 2, 3 or more carboxylic acid groups). Non-limiting examples include oxalic acid, fumaric acid, maleic acid, and glutaric acid. In organic acids containing multiple carboxylic acids (e.g., 2-4 carboxylic acid groups), one or more of the carboxylic acid groups may be esterified. Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl citrate, or dimethyl citrate.

[0176] In some embodiments, the organic acid can contain more than one carboxylic acid group and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid, citric acid, and the like.

[0177] In some embodiments, the organic acid is an aryl carboxylic acid or aryl sulfonic acid. Non-limiting examples of aryl carboxylic and sulfonic acids include benzoic acid, toluic acid, salicylic acid, benzenesulfonic acid, and p-toluenesulfonic acid.

[0178] Further non-limiting examples of organic acids that may be useful in certain embodiments include 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-oxoglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, adipic acid, ascorbic acid (L), aspartic acid (L), alpha-methylbutyric acid, camphoric acid (+), camphor-10-sulfonic acid (+), cinnamic acid, cyclamic acid, dodecylsulfuric acid, ethane-1,2-disulfonic acid, ethanesulfonic acid, furoic acid, and galactaric acid. , gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glycerophosphoric acid, glycolic acid, hippuric acid, isobutyric acid, isovaleric acid, lactobionic acid, lauric acid, levulinic acid, malic acid, malonic acid, mandelic acid, methanesulfonic acid, naphthalene-1,5-disulfonic acid, naphthalene-2-sulfonic acid, oleic acid, palmitic acid, pamoic acid, phenylacetic acid, pyroglutamic acid, pyruvic acid, sebacic acid, stearic acid, and undecylenic acid.

[0179] Examples of suitable acids include, but are not limited to, the list of organic acids in Table 1.

[0180] [Table 1]

[0181] In some embodiments, the organic acid is a monoester of a diacid or polyacid, such as monooctyl succinate, monooctyl fumarate, and the like.

[0182] The selection of an organic acid may further depend on additional properties, in addition to or without consideration of the logP value. For example, the organic acid should be one that is recognized as safe for human consumption and has acceptable flavor, odor, volatility, stability, etc. The determination of suitable organic acids is within the purview of one of ordinary skill in the art.

[0183] In some embodiments, the organic acid is benzoic acid, toluic acid, benzenesulfonic acid, toluenesulfonic acid, hexanoic acid, heptanoic acid, decanoic acid, or octanoic acid. In some embodiments, the organic acid is benzoic acid, octanoic acid, or decanoic acid. In some embodiments, the organic acid is octanoic acid.

[0184] In some embodiments, more than one organic acid may be present. For example, a composition may include two, or three, or four or more organic acids. Thus, reference herein to an "organic acid" contemplates a mixture of two or more organic acids. The relative amounts of the organic acids may vary. For example, a composition may include equal amounts of two, or three or more organic acids, or may include different relative amounts. Thus, it is possible to include certain organic acids (e.g., citric acid or myristic acid) that have logP values ​​outside of the desired range, such that when combined with other organic acids, they provide a desired average logP range for the combination. In some embodiments, it may be desirable to include organic acids that provide, for example, but not limited to, desirable organoleptic properties, stability, as flavor ingredients, in compositions that have logP values ​​outside of the desired range for a purpose. Additionally, certain lipophilic organic acids have adverse flavor and / or aroma characteristics that preclude their presence as the only organic acid (e.g., in equimolar or greater amounts compared to nicotine). Without wishing to be bound by theory, it is believed that combinations of different organic acids can provide the desired ion pairing while keeping the concentration of any single organic acid in the composition below the threshold that has been found to be objectionable from a sensory standpoint.

[0185] For example, in some embodiments, the organic acid can include about 1 to about 5 or more molar equivalents of benzoic acid relative to nicotine, in combination with, for example, about 0.2 molar equivalents of octanoic acid or a salt thereof, and 0.2 molar equivalents of decanoic acid or a salt thereof.

[0186] In some embodiments, the organic acid is a combination of any two organic acids selected from the group consisting of benzoic acid, toluic acid, benzenesulfonic acid, toluenesulfonic acid, hexanoic acid, heptanoic acid, decanoic acid, and octanoic acid. In some embodiments, the organic acid is a combination of benzoic acid, octanoic acid, and decanoic acid, or benzoic acid and octanoic acid. In some embodiments, the composition comprises citric acid in addition to one or more of benzoic acid, toluic acid, benzenesulfonic acid, toluenesulfonic acid, hexanoic acid, heptanoic acid, decanoic acid, and octanoic acid.

[0187] In some embodiments, the composition comprises an alkali metal salt of an organic acid. For example, at least a portion of the organic acid may be present in the composition in the form of an alkali metal salt. Suitable alkali metal salts include lithium, sodium, and potassium. In some embodiments, the alkali metal is sodium or potassium. In some embodiments, the alkali metal is sodium. In some embodiments, the composition comprises an organic acid and a sodium salt of the organic acid.

[0188] In some embodiments, the composition comprises benzoic acid and sodium benzoate, octanoic acid and sodium octanoate, decanoic acid and sodium decanoate, or combinations thereof.

[0189] In some embodiments, the ratio of organic acid to sodium salt of organic acid is from about 0.1 to about 10, e.g., from about 0.1, about 0.25, about 0.3, about 0.5, about 0.75, or about 1, to about 2, about 5, or about 10. For example, in some embodiments, both the organic acid and its sodium salt are added to the other components of the composition, and the organic acid is added in an amount in excess of the sodium salt, in an equimolar amount to the sodium salt, or as a portion of the sodium salt. Those skilled in the art will appreciate that the relative amounts are determined by the desired pH of the composition, as well as the desired ionic strength. For example, the organic acid may be added in an amount that results in a desired pH level of the composition, while the alkali metal (e.g., sodium) salt is added in an amount that results in a desired range of ion pairing. Those skilled in the art will appreciate that the amount of organic acid (i.e., protonated form) present in the composition relative to the alkali metal salt or conjugate base form present in the composition will vary with the pH of the composition and the pKa of the organic acid, as well as with the actual relative amounts initially added to the composition.

[0190] The amount of organic acid or its alkali metal salt present in the composition relative to nicotine can vary. Generally, as the concentration of the organic acid (or its conjugate base) increases, the percentage of nicotine that forms an ion pair with the organic acid increases. This is usually expressed as logP (log of the partition coefficient). 10 ), increases the partitioning of nicotine in the form of ion pairs into octanol versus water. In some embodiments, the composition comprises from about 0.05, about 0.1, about 1, about 1.5, about 2, or about 5 to about 10, about 15, or about 20 molar equivalents of an organic acid, an alkali metal salt thereof, or a combination thereof, relative to the nicotine component calculated as free base nicotine.

[0191] In some embodiments, the composition comprises about 2 to about 10, or about 2 to about 5 molar equivalents of organic acid, alkali metal salt thereof, or combination thereof, to nicotine on a free base nicotine basis. In some embodiments, the organic acid, alkali metal salt thereof, or combination thereof is present in a molar ratio with nicotine of from about 2, about 3, about 4, or about 5, to about 6, about 7, about 8, about 9, or about 10. In embodiments where more than one organic acid, alkali metal salt thereof, or both are present, such molar ratios are understood to reflect the totality of organic acids present.

[0192] In certain embodiments, the inclusion of the organic acid is sufficient to provide a composition pH of about 4.0 to about 9.0, e.g., about 4.5 to about 7.0, or about 5.5 to about 7.0, about 4.0 to about 5.5, or about 7.0 to about 9.0. In some embodiments, the inclusion of the organic acid is sufficient to provide a composition pH of about 4.5 to about 6.5, e.g., about 4.5, about 5.0, or about 5.5, to about 6.0, or about 6.5. In some embodiments, the organic acid is provided in an amount sufficient to provide a composition pH of about 5.5 to about 6.5, e.g., about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, or about 6.0, to about 6.1, about 6.2, about 6.3, about 6.4, or about 6.5. In other embodiments, a mineral acid (e.g., hydrochloric acid, sulfuric acid, phosphoric acid, etc.) is added to adjust the pH of the composition to a desired value.

[0193] In some embodiments, the organic acid is added to other composition components as a free acid, in pure form (i.e., natural solid or liquid form) or as a solution, e.g., a solution in water. In some embodiments, the alkali metal salt of the organic acid is added to other composition components in pure form or as a solution, e.g., a solution in water. In some embodiments, the organic acid and the basic amine (e.g., nicotine) are combined to form a salt, either before addition to the composition, or the salt is formed therein and present in the composition as such. In other embodiments, the organic acid and the basic amine (e.g., nicotine) are present in the composition as individual components, and form an ion pair upon contact with moisture (e.g., saliva in the consumer's mouth).

[0194] 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 polymethacrylic acid, 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.

[0195] 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.

[0196] 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.

[0197] 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).

[0198] 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, to 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 / or cannabidiol (CBD), another major component of the plant, which does not contain psychoactive properties. All of the above compounds can be used in the form of isolates from plant material or synthetically derived forms.

[0199] In some embodiments, the cannabinoid (e.g., CBD) is added to the composition in the form of an isolate, which is an extract from a plant, e.g., cannabis, in which the active substance of interest (in this case the cannabinoid, e.g., CBD) is present at a high degree of purity, e.g., greater than 95%, greater than 96%, greater than 97%, greater than 98%, or around 99% purity.

[0200] In some embodiments, the cannabinoid is an isolate of CBD at a high degree of purity and the amount of any other cannabinoid in the composition is about 1% or less by weight of the composition, such as about 0.5% or less by weight of the composition, such as about 0.1% or less by weight of the composition, for example about 0.01% or less by weight of the composition.

[0201] Alternatively, the active ingredient can be a cannabimetic, 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.

[0202] When present, the cannabinoid (e.g., CBD) or cannabimetics will typically be present 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. The choice of cannabinoid and the specific percentages thereof that may be present in the disclosed compositions will vary depending on the desired flavor, texture, and other characteristics of the composition.

[0203] 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): nTerpenes 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 cannabimetics. 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.

[0204] In some embodiments, the terpene is a terpene derivable from a phytocannabinoid-producing plant, such as a plant of the Cannabis sativa species, e.g., a strain of cannabis. Suitable terpenes in this context include so-called "C10 terpenes" (such terpenes containing 10 carbon atoms), and so-called "C15 terpenes" (such terpenes containing 15 carbon atoms). In some embodiments, the active ingredient comprises more than one terpene. For example, the active ingredient may comprise one, two, three, four, five, six, seven, eight, nine, ten or more terpenes as defined herein. In some embodiments, the terpene is selected from pinene (alpha and beta), geraniol, linalool, limonene, carvone, eucalyptol, menthone, iso-menthone, piperitone, myrcene, beta-bourbonene, germacrene, and mixtures thereof.

[0205] Pharmaceutical Ingredients In some embodiments, the active ingredient comprises an active pharmaceutical ingredient (API). The API 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.

[0206] 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, ...2 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 0.0 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 w / w%.

[0207] 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 selectively 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.

[0208] 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.

[0209] 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.

[0210] 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.

[0211] 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).

[0212] 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.

[0213] 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.

[0214] 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.

[0215] 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.

[0216] 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.

[0217] 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.

[0218] 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. Additional methods are disclosed, for example, in International Patent Application Publication Nos. WO2013 / 122948; WO / 2020 / 128971; WO / 2021 / 048769; WO / 2021 / 048768; WO / 2021 / 048770; and PCT / IB2021 / 058063, all of which are incorporated herein by reference in their entireties. In certain embodiments, this type of treatment is useful when the original tobacco material is subjected to heat in the processes previously described.

[0219] 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.

[0220] 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.

[0221] 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.

[0222] 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.

[0223] Typical inclusion ranges for tobacco material may vary depending on the nature and type of tobacco material and the intended effect on the final mixture (or composition), with exemplary ranges being up to about 30% (or up to about 20%, or up to about 10%, or up to about 5%) by weight, based on the total weight of the mixture (e.g., from about 0.1% to about 15%). In some embodiments, the tobacco material (e.g., whitened tobacco material) is present in relatively small amounts (e.g., from about 0.01% to about 0.1%).

[0224] 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 of tobacco material, 0.5% or less, 0.1% or less, or 0% by weight of tobacco material.

[0225] Other Additives Other additives may be included in the disclosed mixtures (or compositions). 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, 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.

[0226] The above-mentioned additives can be utilized 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 as provided in the final product or mixture. Exemplary encapsulated additives are described, for example, in WO2010 / 132444 to Atchley, previously incorporated by reference herein.

[0227] In some embodiments, any one or more of the filler components, tobacco materials, and overall oral products described herein can 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 can be described as being substantially spherical or granular.

[0228] The particle size of a granular material can be measured by sieve analysis. As one skilled in the art will readily recognize, sieve analysis (also known as gradient testing) is a method that has been used to measure the particle size distribution of granular materials. Typically, sieve analysis involves a column of nested sieves, preferably including screens in the form of a wire mesh fabric. A pre-weighed sample can be introduced into the top or uppermost sieve of the column, which has the largest screen opening or mesh size (i.e., the largest pore size of the sieve). Each sieve on the lower side of the column has a screen opening or mesh size that is progressively smaller than the sieve on the upper side. Typically, at the bottom of the column of sieves, there is a receiver section that collects any particles having a particle size smaller than the screen opening or mesh size of the bottom or lowest sieve of the column (which has the smallest screen opening or mesh size).

[0229] In some embodiments, the column of sieves may be placed on or in a mechanical agitator. The agitator causes vibration of each of the sieves in the column. The mechanical agitator may be operated for a predetermined period of time to ensure that all particles are collected in the correct sieve. In some embodiments, the column of sieves is agitated for a period of 0.5 minutes to 10 minutes, for example, 1 minute to 10 minutes, for example, 1 minute to 5 minutes, for example, 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. As one skilled in the art would readily recognize, the screen opening size or mesh size for each sieve in the column used for sieve analysis may 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 the sieve analysis, where the column contains 2 to 20 sieves, e.g., 5 to 15 sieves. In some embodiments, a column of sieves may be used for the sieve analysis, where the column contains 10 sieves. In some embodiments, the largest screen opening or mesh size of the sieve used for the sieve analysis may be 1000 μm, e.g., 500 μm, e.g., 400 μm, e.g., 300 μm.

[0230] In some embodiments, any particulate material referred to herein (e.g., filler components, tobacco materials, and all oral products) may be characterized as having at least 50% by weight of particles having 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 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 99% 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, 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, for example about 300 μm or less, as measured by sieve analysis.

[0231] 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, as measured by sieve analysis, 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. 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, as measured by sieve analysis, of from about 10 μm to about 400 μm, such as from about 50 μm to about 350 μm, for example from about 100 μm to about 350 μm, for example from about 200 μm to about 300 μm.

[0232] Preparation of mixtures The manner in which the various components of the mixture are combined may vary. Thus, the overall mixture with the various components, e.g., the components of a powdered mixture, may be of relatively uniform nature. The components mentioned above 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, e.g., 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, mixers available from Littleford Day, Inc., e.g., FKM130, FKM600, FKM1200, FKM2000, and FKM3000, Plough Share type mixer cylinders, Hobart mixers, and the like. Also see, for example, the type of methodology 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, 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 for formulating the mixture will be clear to those skilled in the art. See, for example, the type of methodology 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.

[0233] In some embodiments, the compositions can be prepared such that a mixture of the compositions can be used in a starch-free or starch-based molding process. Exemplary types of molds that can be used in the production process include, for example, starch molds, starch-free molds, pectin molds, plastic tray molds, silicone tray molds, metal tray molds, neoprene tray molds, and the like.

[0234] In various embodiments, a moisture-permeable packet or pouch can act as a container for the use of the composition. For example, the pouch provides a type of liquid-permeable container that can be considered similar in nature to the mesh-type materials used in the construction of tea bags. If desired, flavor ingredients, disintegration aids, and other desired components can 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, can vary as described herein. For example, suitable packets, pouches, or containers of the type used in the manufacture of smokeless tobacco products can 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.

[0235] The pouch can be formed from a fleece material, such as a fibrous nonwoven web. 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 are present in separate structured domains within the fiber, as opposed to blends, where the domains tend to be dispersed, random, or unstructured.

[0236] "Fleece material", as used herein, can be formed from various types of fibers (e.g., cellulosic fibers; e.g., viscose fibers, regenerated cellulose fibers, cellulose fibers, and wood pulp; cotton fibers; other natural fibers; or polymer / synthetic type fibers) 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. 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.

[0237] 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 nonwoven fabrics 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 below.

[0238] In various embodiments, the pouch material can be dissolvable (i.e., ingestible for oral use) such that the pouch material dissolves under normal conditions of 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 in the pouch (e.g., active ingredients and / or flavorings) 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 herein, in certain embodiments, the composition in 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.

[0239] 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, for example, by using cross-linking techniques between alginate or pectin and 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 a hydrophilic polymer. 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.

[0240] 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.

[0241] Regenerated cellulose fibers (e.g., viscose or lyocell fibers) can be particularly advantageous and are typically prepared by extracting non-cellulosic compounds from wood and contacting the extracted wood with caustic soda, followed by carbon disulfide and then sodium hydroxide to obtain a viscous solution. The solution is then extruded through a spinneret head to create viscous threads of the regenerated fibers. 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 rayon and TENCEL processes. Various manufacturers of regenerated cellulose are known, including Lenzing (Austria), Cordenka (Germany), Aditya Birla (India), and Daicel (Japan).

[0242] 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 monocomponent (i.e., compositionally uniform throughout the fiber) or multicomponent fiber types, including, but not limited to, fibers having a sheath / core structure or fibers having 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.

[0243] 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, 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 preferred 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. In various embodiments, each fiber may measure from about 4 to 10 crimps per cm, or from about 5 to 8 crimps per cm. To ensure a preferred blend and directionality of the fibers in the nonwoven web, it may be advantageous for all fibers in the nonwoven web to have similar fiber size and crimp characteristics.

[0244] 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 60 gsm, 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).

[0245] 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 nonwoven web. In various embodiments, the pouch material comprises a multi-layer composite made of 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 include 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 during storage of the pouch product, so that the flavor in the composition is not lost due to moisture loss. However, the capillaries of the hydrophobic layer can allow moisture to escape to the user's mouth, which releases the flavor to the oral cavity upon use. In this manner, the pouch material can have enhanced storage stability without significant compromise in terms of end-user enjoyment of the product. In a less preferred embodiment, the relatively hydrophilic layer can be located inside the multi-layer structure. The two layers can be formed into a multi-layer composite nonwoven material using any means known in the art, such as by bonding the two layers together using adhesives or stitching. The hydrophobicity of the fibrous material can be evaluated, for example, by measuring the contact angle between a drop of liquid and the surface of the fibrous material, as known in the art.

[0246] In certain embodiments, the pouch material can include a flavor component (e.g., a sensate or any of the flavor components described herein), which can be applied to the nonwoven layer in any conventional manner, such as by coating, printing, etc. In some embodiments of the pouch products described herein, the flavor (or sensate) in the outer pouch material can be different from the flavor (or sensate) contained in the inner composition adapted for oral use. For example, in certain embodiments, the pouch material can have a first flavor component (or sensate), and after the pouch material dissolves, more moisture can reach the composition in the pouch material, enhancing the flavor component (or sensate) in the composition. In this manner, the product can be designed to provide multiple, different sensory experiences, i.e., a first sensory experience in which the flavor of the outer pouch material is transferred to the user's mouth, and a second sensory experience in which the flavor of the inner composition is transferred to the user's mouth, which usually occurs at a later time.

[0247] While this application is primarily focused on embodiments in which the sensate is contained within the inner composition (e.g., mixture 25 of pouch product 10 in FIG. 1), the sensate can alternatively (or additionally) be bound in some manner to the outer pouch material (e.g., material 20 of pouch product 10 in FIG. 1). As mentioned in the previous paragraph, methods for binding components within fleece materials (e.g., embedding them, coating them, printing them, etc.) are generally known in the art and can be used to provide such embodiments of the present disclosure.

[0248] 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 the 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.

[0249] The means of producing the nonwoven web may vary. Web formation can be accomplished by any means known in the art. 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 a 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.

[0250] 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.

[0251] 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 the 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.

[0252] 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.

[0253] In other embodiments, the nonwoven web can be subjected to hydroentanglement. The terms "hydroentangled" or "spunlaced" as applied to the nonwoven fabrics herein are 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 flavor transfer through the nonwoven pouch material.

[0254] 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.

[0255] 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.

[0256] 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.

[0257] Various manufacturing equipment and methods can be used to create the pouch products described herein. For example, U.S. Publication No. 2012 / 0055493 to Novak, III et al., which is incorporated by reference in its entirety, relates to an apparatus and process for providing a pouch material formed into a tubular shape for use in the manufacture of smokeless tobacco products. The pouch material can include a binder material (e.g., a binder material including an aliphatic polyester) according to the present disclosure. A similar apparatus 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. A representative apparatus for forming a continuous tube of such pouch material is disclosed, for example, in U.S. Patent Application Publication No. 2010 / 0101588 to Boldrini et al., which is 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 filling 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 serially arranged pouch portions. In still other cases, sealing (closure) of the individual pouch portions of the continuous tubular member may occur substantially simultaneously with its subdivision using a closure and division unit.

[0258] 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 is engaged with 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.

[0259] 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 equipment described herein can be constructed to handle that type and size of bobbins.

[0260] 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.

[0261] 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 insertion 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.

[0262] As illustrated in Figures 20-22 of U.S. Publication No. 2012 / 0055493 to Novak, III et al., the closing and dividing 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 terminal end and the closed leading end 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 closing and dividing unit can include a blade, hot wire, or other cutting arrangement for severing the continuous tubular member into the separate pouch member portions. For example, the closing and dividing unit can include first and second arm members constructed to interact to close and divide the continuous tubular member.

[0263] In operation, a fill material of the composition adapted for oral use (i.e., an appropriate amount for the individual pouch member portions) can be delivered by the insertion unit to the pouch member portions after the leading ends are closed but before the trailing ends are 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.

[0264] 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 dry weight of the material in each pouch is at least about 50 mg to about 150 mg. For some larger embodiments, the dry 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.

[0265] 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.

[0266] 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.

[0267] 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; 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; U.S. Patent Publication No. 2009 / 0014450 to Bell et al., all of which are incorporated herein by reference. See U.S. Patent Publication No. 2009 / 0250360 to amah 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 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., various types of containers for smokeless products.

[0268] 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. EXAMPLES

[0269] According to the following examples, several nonwoven pouch materials were produced containing blends including VBE.

[0270] [Example 1] Pouch containing VBE with 48% moisture A first series of pouches was prepared using different flavorings in combination with VBE. The composition of the mixture in each pouch is provided in Table 1 below (all values ​​are provided as weight percentages based on the total weight of the mixture plus additional water added). The components (except for the final "Water" heading) were combined and approximately 400-500 mg of the mixture was placed into a non-woven fleece pouch. Additional water was then sprayed into the pouch to a total water content of 48%, resulting in a final pouch weight of approximately 700 mg. The nicotine content of the final pouch was approximately 3-5% by weight (based on the weight of the pouch).

[0271] [Table 2]

[0272] [Example 2] Pouch containing VBE with 32% moisture A first series of pouches was prepared using different flavorings in combination with VBE. The composition of the mixture in each pouch is provided in Table 2 below (all values ​​are provided as weight percentages relative to the total weight of the mixture). The components (except for the final "Water" heading) were combined and approximately 400-500 mg of the mixture was placed in a non-woven fleece pouch. Additional water was then sprayed into the pouch to a total water content of 32%, resulting in a final pouch weight of approximately 590 mg. The nicotine content of the final pouch (relative to the weight of the pouch) was approximately 3-5% by weight.

[0273] [Table 3]

[0274] 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 A composition adapted for oral use located within a cavity and including a water-soluble component An oral product in the form of a pouch product comprising: the composition comprises a filler and vanillyl butyl ether (“VBE”) in an amount of 10 ppm to 800 ppm; or the composition comprising a filler and 1100 ppm or more of vanillyl butyl ether (“VBE”); Oral products.

2. the composition comprising VBE in an amount of 100 ppm to 800 ppm; The oral product of claim 1.

3. the composition comprising VBE in an amount of 1100 ppm to 2000 ppm; The oral product of claim 1.

4. An oral product as described in claim 1 having a moisture content of 30 to 50 weight percent.

5. An oral product in the form of a gel, pastille, chew, melt, tablet, or lozenge, comprising vanillyl butyl ether ("VBE").

6. 6. The oral product of claim 5, wherein the VBE is present in an amount of from 10 ppm to 2000 ppm.

7. 7. The oral product of claim 1, further comprising at least one of a particulate tobacco material, an active ingredient, a particulate non-tobacco material processed to contain an active ingredient and / or a flavoring agent, and a fibrous plant material carrying a tobacco extract.

8. The oral product of any one of claims 1 to 6, further comprising a whitened tobacco material.

9. The oral product of any one of claims 1 to 6, wherein the composition or oral product is substantially free of tobacco materials.

10. 7. The oral product of any of claims 1 to 6, further comprising one or more active ingredients selected from the group consisting of nicotine, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimetics, terpenes, pharmaceutical agents, and combinations thereof.

11. Further comprising one or more components selected from the group consisting of one or more additional fillers, binders, pH adjusters, buffers, colorants, disintegration aids, antioxidants, humectants, and preservatives, e.g., one or more of a cellulose-based filler, a sweetener, salt, water, and a flavoring agent. The oral product according to any one of claims 1 to 6, comprising:

12. An oral product according to any preceding claim, which comprises one or more flavouring agents.

13. 13. The oral product of claim 12, wherein the one or more flavoring agents exhibit a spicy character.

14. 13. The oral product of claim 12, wherein the one or more flavoring agents exhibit a fruity character.

15. 13. The oral product of claim 12, wherein the one or more flavoring agents exhibit botanical, spice-derived, or floral characteristics.

16. a filler and vanillyl butyl ether (“VBE”) in an amount of 10 ppm to 800 ppm; or 1. A composition comprising a filler and vanillyl butyl ether (“VBE”) in an amount of 1100 ppm or greater, The composition is in the form of a pouch product.

17. 17. The composition of claim 16, wherein the composition comprises VBE in an amount of 100 ppm to 800 ppm.

18. 17. The composition of claim 16, wherein the composition comprises VBE in an amount of 1100 ppm to 2000 ppm.

19. 17. The composition of claim 16, wherein the composition further comprises at least one of a particulate tobacco material, an active ingredient, a particulate non-tobacco material that has been processed to contain an active ingredient and / or a flavoring agent, and a fibrous plant material bearing a tobacco extract.

20. The composition of any of claims 16 to 19, further comprising a whitened tobacco material.

21. The composition of any one of claims 16 to 19, wherein the composition is substantially free of tobacco material.

22. 20. The composition of any of claims 16-19, further comprising one or more active ingredients selected from the group consisting of nicotine, nutraceuticals, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimetics, terpenes, pharmaceutical agents, and combinations thereof.

23. 20. The composition of any one of claims 16 to 19, further comprising one or more components selected from the group consisting of one or more additional fillers, binders, pH adjusters, buffers, colorants, disintegration aids, antioxidants, humectants, and preservatives, e.g., the composition comprises one or more of a cellulose-based filler, a sweetener, salt, water, and a flavoring agent.

24. The composition of any one of claims 16 to 19, wherein the composition comprises one or more flavoring agents.

25. 25. The composition of claim 24, wherein the one or more flavoring agents exhibit a spicy character.

26. 25. The composition of claim 24, wherein the one or more flavoring agents exhibit a fruity character.

27. 25. The composition of claim 24, wherein the one or more flavoring agents exhibit botanical, spice-derived, or floral characteristics.

28. An oral product as described in claim 1, wherein the composition contains VBE in an amount of 100 ppm to 500 ppm.

29. An oral product as described in claim 1, wherein the composition contains VBE in an amount of 250 ppm to 500 ppm.

30. An oral product as described in claim 1, wherein the composition contains VBE in an amount of 1100 ppm to 1800 ppm.

31. An oral product as described in claim 1, wherein the composition contains VBE in an amount of 1200 ppm to 1500 ppm.

32. The oral product of claim 12, wherein the one or more flavoring agents are selected from the group consisting of cinnamon, ginger, berry, piña colada, orange, lemon, lime, grapefruit, peach, mango, pineapple, cherry, cardamom, lemongrass, licorice, nutmeg, clove, sandalwood, anise, sage, jasmine, lavender, vanilla, orange blossom, and combinations thereof.

33. The composition of claim 16, wherein the composition comprises VBE in an amount of 100 ppm to 500 ppm.

34. The composition of claim 16, wherein the composition comprises VBE in an amount of 250 ppm to 500 ppm.

35. The composition of claim 16, wherein the composition comprises VBE in an amount of 1100 ppm to 1800 ppm.

36. The composition of claim 16, wherein the composition comprises VBE in an amount of 1200 ppm to 1500 ppm.

37. The composition of claim 24, wherein the one or more flavoring agents are selected from the group consisting of cinnamon, ginger, berry, piña colada, orange, lemon, lime, grapefruit, peach, mango, pineapple, cherry, cardamom, lemongrass, licorice, nutmeg, clove, sandalwood, anise, sage, jasmine, lavender, vanilla, orange blossom, and combinations thereof.

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