Pouch product containing a dissolvable composition

Abstract

A pouch product is provided that includes an outer water-permeable pouch defining a cavity and a composition configured for oral use located within the cavity, the composition being at least partially dissolvable in the oral cavity and including one or more dissolvable fillers in an amount of at least about 45% by weight based on the total weight of the composition, a humectant in an amount of up to about 25% by weight based on the total weight of the composition, and at least one active ingredient, at least one flavoring agent, or both at least one active ingredient and at least one flavoring agent.

Description

[Technical field]

[0001] The present disclosure relates to pouch products containing compositions 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 contain 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. Oral products of similar formats that do not contain tobacco have also been proposed. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Pat. No. 1,376,586 [Patent Document 2] U.S. Pat. No. 4,513,756 [Patent Document 3] U.S. Pat. No. 4,528,993 [Patent Document 4] U.S. Pat. No. 4,624,269 [Patent Document 5] U.S. Pat. No. 4,991,599 [Patent Document 6] U.S. Pat. No. 4,987,907 [Patent Document 7] U.S. Patent No. 5,092,352 [Patent Document 8] U.S. Pat. No. 5,387,416 [Patent Document 9] U.S. Pat. No. 6,668,839 [Patent Document 10] U.S. Patent No. 6,834,654 [Patent Document 11] U.S. Patent No. 6,953,040 [Patent Document 12] U.S. Patent No. 7,032,601 [Patent Document 13] U.S. Pat. No. 7,694,686 [Patent Document 14] US Patent Application Publication No. 2004 / 0020503 [Patent Document 15] US Patent Application Publication No. 2005 / 0115580 [Patent Document 16] US Patent Application Publication No. 2006 / 0191548 [Patent Document 17] US Patent Application Publication No. 2007 / 0062549 [Patent Document 18] US Patent Application Publication No. 2007 / 0186941 [Patent Document 19] US Patent Application Publication No. 2007 / 0186942 [Patent Document 20] US Patent Application Publication No. 2008 / 0029110 [Patent Document 21] US Patent Application Publication No. 2008 / 0029116 [Patent Document 22] US Patent Application Publication No. 2008 / 0173317 [Patent Document 23] US Patent Application Publication No. 2008 / 0209586 [Patent Document 24] US Patent Application Publication No. 2009 / 0065013 [Patent Document 25] US Patent Application Publication No. 2010 / 0282267 [Patent Document 26] International Publication No. 2004 / 095959 [Patent Document 27] US Patent Application Publication No. 2008 / 0196730 [Patent Document 28] US Patent Application Publication No. 2008 / 0305216 [Patent Document 29] US Patent Application Publication No. 2009 / 0293889 [Patent Document 30] US Patent Application Publication No. 2010 / 0291245 [Patent Document 31] US Patent Application Publication No. 2011 / 0139164 [Patent Document 32] US Patent Application Publication No. 2012 / 0037175 [Patent Document 33] US Patent Application Publication No. 2012 / 0055494 [Patent Document 34] US Patent Application Publication No. 2012 / 0138073 [Patent Document 35] US Patent Application Publication No. 2012 / 0138074 [Patent Document 36] US Patent Application Publication No. 2013 / 0074855 [Patent Document 37] US Patent Application Publication No. 2013 / 0074856 [Patent Document 38] US Patent Application Publication No. 2013 / 0152953 [Patent Document 39] US Patent Application Publication No. 2013 / 0274296 [Patent Document 40] US Patent Application Publication No. 2015 / 0068545 [Patent Document 41] US Patent Application Publication No. 2015 / 0101627 [Patent Document 42] US Patent Application Publication No. 2015 / 0230515 Summary of the Invention [Problem to be solved by the invention]

[0005] There is a continuing need in the art to develop product formats for oral products that enhance the consumer's sensory experience. [Means for solving the problem]

[0006] The present disclosure generally provides a pouch product comprising an outer water-permeable pouch defining a cavity and a composition configured for oral use located within the cavity, the composition being at least partially dissolvable, the composition comprising one or more dissolvable fillers in an amount of at least about 45% by weight, based on the total weight of the composition; a humectant in an amount of up to about 25% by weight, based on the total weight of the composition; and at least one active ingredient, at least one flavoring agent, or both at least one active ingredient and at least one flavoring agent.

[0007] In some embodiments, the composition is at least about 50% by weight dissolvable in the oral cavity, hi some embodiments, about 95% to about 100% by weight of the composition is dissolvable in the oral cavity.

[0008] In some embodiments, the one or more soluble fillers are selected from the group consisting of sugars, sugar alcohols, soluble starches, soluble fibers, and combinations thereof. In some embodiments, the one or more soluble fillers include a sugar alcohol. In some embodiments, the sugar alcohol is isomalt. In some embodiments, the one or more soluble fillers further include maltodextrin.

[0009] In some embodiments, the humectant is present in an amount of about 15 to about 20% by weight, based on the total weight of the composition, hi some embodiments, the humectant is glycerin, propylene glycol, or a mixture thereof.

[0010] In some embodiments, the composition further comprises at least one sweetening agent.

[0011] In some embodiments, the composition is in a granular form, a granulated form, or in the form of one or more pellets or tablets.

[0012] In some embodiments, the one or more dissolvable fillers include sugar alcohols and maltodextrin, and optionally, the composition further comprises microcrystalline cellulose in an amount up to about 40% by weight of the composition.

[0013] In some embodiments, the composition is in the form of beads, and the composition comprises sugar alcohol in an amount of about 67% to about 78% by weight based on the total weight of the composition, and glycerin in an amount of about 16% to about 20% by weight based on the total weight of the composition.

[0014] In some embodiments, the sugar alcohol is isomalt.

[0015] In some embodiments, the composition further comprises microcrystalline cellulose in an amount up to about 5% by weight of the composition.

[0016] In some embodiments, at least a portion of the beads are coated with a release-modifying agent selected from the group consisting of lipids, waxes, cellulose derivatives, binders, and combinations thereof.

[0017] In some embodiments, the pouch product comprises a mixture of beads having different dissolution rates.

[0018] In some embodiments, the pouch product further comprises microcrystalline cellulose in the form of a physical mixture with the beads.

[0019] In some embodiments, the at least one active ingredient is selected from the group consisting of botanical materials, stimulants, amino acids, vitamins, antioxidants, cannabinoids, cannabimetics, terpenes, medicinal agents, and combinations thereof. In some embodiments, the at least one active ingredient comprises a nicotine component. In some embodiments, the nicotine component comprises resin-bound nicotine. In some embodiments, the nicotine component is resin-bound nicotine.

[0020] In some embodiments, the composition further comprises one or more organic acids, one or more alkali metal salts of organic acids, or both.

[0021] In some embodiments, the one or more organic acids or alkali metal salts thereof are present in the composition in an amount by weight of about 0.1 to about 10%, or about 0.1 to about 0.5%, based on the total weight of the composition.

[0022] In some embodiments, the one or more organic acids include citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, toluic acid, salicylic acid, or combinations thereof. In some embodiments, the one or more organic acids include benzoic acid. In some embodiments, at least a portion of the organic acid, the alkali metal salt of the organic acid, or both, is associated with at least a portion of the nicotine component in the form of an ion pair.

[0023] In some embodiments, the outer water-permeable pouch is biodegradable, hi some embodiments, the outer water-permeable pouch is dissolvable.

[0024] The present disclosure includes, without limitation, the following embodiments.

[0025] Embodiment 1: A pouch product comprising an outer water-permeable pouch defining a cavity and a composition configured for oral use located within the cavity, wherein the composition is at least partially dissolvable and comprises one or more dissolvable fillers in an amount of at least about 45% by weight based on the total weight of the composition; a humectant in an amount of up to about 25% by weight based on the total weight of the composition; and at least one active ingredient, at least one flavoring agent, or both at least one active ingredient and at least one flavoring agent.

[0026] Embodiment 2: The pouch product of embodiment 1, wherein the composition is at least about 50% buccally dissolvable, by weight.

[0027] Embodiment 3: The pouch product of embodiment 1 or 2, wherein about 95% to about 100% of the composition by weight is oral dissolvable.

[0028] Embodiment 4: The pouch product of any one of embodiments 1-3, wherein the one or more dissolvable fillers are selected from the group consisting of sugars, sugar alcohols, soluble starches, soluble fibers, and combinations thereof.

[0029] Embodiment 5: The pouch product of any one of claims 1 to 4, wherein the one or more dissolvable fillers comprises a sugar alcohol.

[0030] Embodiment 6: The pouch product of embodiment 5, wherein the sugar alcohol is isomalt.

[0031] Embodiment 7: The pouch product of embodiment 5 or 6, wherein the one or more dissolvable fillers further comprise maltodextrin.

[0032] Embodiment 8: The pouch product of any one of embodiments 1 to 7, wherein the humectant is present in an amount of about 15 to about 20% by weight, based on the total weight of the composition.

[0033] Embodiment 9: The pouch product of any one of embodiments 1-8, wherein the humectant is glycerin, propylene glycol, or a mixture thereof.

[0034] Embodiment 10: The pouch product of any one of embodiments 1-9, wherein the composition further comprises at least one sweetening agent.

[0035] Embodiment 11: The pouch product of embodiment 1, wherein the composition is in a granular form, a granulated form, or in the form of one or more pellets or tablets.

[0036] Embodiment 12: The pouch product of embodiment 11, wherein the one or more dissolvable fillers comprise sugar alcohols and maltodextrin, and optionally, the composition further comprises microcrystalline cellulose in an amount up to about 40% by weight of the composition.

[0037] Embodiment 13: The pouch product of embodiment 1, wherein the composition is in the form of beads and comprises sugar alcohol in an amount of at least 45% by weight, for example about 67% to about 78% by weight, based on the total weight of the composition, and glycerin in an amount of at least 10% by weight, for example about 16% to about 20% by weight, based on the total weight of the composition.

[0038] Embodiment 14: The pouch product of embodiment 13, wherein the sugar alcohol is isomalt.

[0039] Embodiment 15: The pouch product of embodiment 13 or 14, wherein the composition further comprises microcrystalline cellulose in an amount up to about 5% by weight of the composition.

[0040] Embodiment 16: The pouch product of any one of embodiments 13-15, wherein at least a portion of the beads are coated with a release-modifying agent selected from the group consisting of lipids, waxes, cellulose derivatives, binders, and combinations thereof.

[0041] Embodiment 17: The pouch product of any one of embodiments 13-16, comprising a mixture of beads having different dissolution rates.

[0042] Embodiment 18: The pouch product of any one of embodiments 13-17, further comprising microcrystalline cellulose in the form of a physical mixture with beads.

[0043] Embodiment 19: The pouch product of any one of embodiments 1 to 18, wherein the at least one active ingredient is selected from the group consisting of botanical materials, stimulants, amino acids, vitamins, antioxidants, cannabinoids, cannabimetics, terpenes, medicinal agents, and combinations thereof.

[0044] Embodiment 20: The pouch product of any one of embodiments 1-19, wherein the at least one active ingredient comprises a nicotine ingredient.

[0045] Embodiment 21: The pouch product of embodiment 20, wherein the nicotine component comprises resin-bound nicotine.

[0046] Embodiment 22: The pouch product of any one of embodiments 1 to 21, wherein the composition further comprises one or more organic acids, one or more alkali metal salts of organic acids, or both.

[0047] Embodiment 23: The pouch product of embodiment 23, wherein the one or more organic acids or alkali metal salts thereof are present in the composition in an amount by weight of about 0.1 to about 10% or about 0.1 to about 0.5%, based on the total weight of the composition.

[0048] Embodiment 24: The pouch product of embodiment 22 or 23, wherein the one or more organic acids comprise citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, toluic acid, salicylic acid, or a combination thereof.

[0049] Embodiment 25: The pouch product of any one of embodiments 22-24, wherein the one or more organic acids comprise benzoic acid.

[0050] Embodiment 26: The pouch product of any one of embodiments 1 to 25, wherein the outer water-permeable pouch is biodegradable.

[0051] Embodiment 27: The pouch product of any one of embodiments 1 to 26, wherein the outer water-permeable pouch is dissolvable.

[0052] 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.

[0053] Having thus described aspects of the present disclosure in the foregoing general section, 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]

[0054] [Figure 1] FIG. 1 is a perspective view of a pouch product according to an exemplary embodiment of the present disclosure, comprising a pouch at least partially filled with a composition of the present disclosure. [Diagram 2] FIG. 2 is a perspective view of a pouch product according to an exemplary embodiment of the present disclosure, cut along the length of the product, showing a pouch at least partially filled with a composition of the present disclosure. [Diagram 3] FIG. 2 is another perspective view of a pouch product according to an exemplary embodiment of the present disclosure, cut along the length of the product, showing a pouch at least partially filled with a composition of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0055] The present disclosure provides a composition configured for oral use, which is enclosed in an outer water-permeable pouch. The composition comprises a soluble filler that is at least partially soluble, for example in an amount of at least about 45% by weight, based on the total weight of the composition; a humectant, for example in an amount of up to about 25% by weight, based on the total weight of the composition; and at least one active ingredient, at least one flavoring agent, or both at least one active ingredient and at least one flavoring agent. The present disclosure will now be described more fully hereinafter with reference to the exemplary embodiments. These exemplary embodiments are described so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Indeed, the present disclosure may be embodied in many different forms, and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements.

[0056] As used in this specification and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0057] The term "about" is used throughout this specification to describe and take into account slight variations. For example, the term "about" can refer to ±10% or less, such as ±5% or less, ±2% or less, ±1% or less, ±0.5% or less, ±0.2% or less, ±0.1% or less, or ±0.05% or less. All numerical values ​​are modified herein by the term "about", whether or not expressly indicated. Values ​​modified by the term "about" are, of course, inclusive of the specified value. For example, "about 5.0" must include 5.0.

[0058] References to "dry weight percent" or "dry weight basis" refer to weight based on dry ingredients (i.e., all ingredients excluding water). References to "wet weight" refer to the weight of the composition including water. Unless otherwise indicated, references to the "weight percent" of a composition reflect the total wet weight of the composition (i.e., including water).

[0059] composition In certain embodiments, the dissolvable composition described herein comprises a dissolvable filler in an amount of at least about 45% by weight based on the total weight of the composition; a humectant in an amount of up to about 25% by weight based on the total weight of the composition; and at least one active ingredient, at least one flavoring agent, or both at least one active ingredient and at least one flavoring agent. In some embodiments, the composition may further comprise a sweetener, one or more organic acids, and various other additives. The relative amounts of various components in the composition may vary and are usually selected to provide the desired sensory and performance characteristics to the oral product. Exemplary individual components of the composition are described herein below.

[0060] Filler The compositions described herein include at least one or more fillers. Such fillers can fulfill multiple functions, such as enhancing certain organoleptic properties, such as texture and mouthfeel, enhancing the cohesiveness or compressibility of the product, and the like. Generally, fillers are porous granular materials and are cellulose-based. For example, suitable fillers are any non-tobacco plant material or derivatives thereof, including cellulosic 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 filler components include maltodextrin, dextrose, lactose, mannitol, xylitol, and sorbitol. Combinations of fillers can also be used.

[0061] In some embodiments, the filler comprises starch. The term "starch" as used herein can refer to pure starch from any source, modified starch, or starch derivatives. 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 may be selected for inclusion in a product based on the ability of the starch material to impart certain organoleptic properties to the product. Starches from various sources may be used. For example, the main sources of starch include cereals (e.g., rice, wheat, and corn) and root vegetables (e.g., potato and cassava). Other examples of sources of starch include acorns, arrowroot, arracachá, banana, barley, legumes (e.g., broad beans, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnut, colocasia, dogtooth violet, kudzu, malanga, millet, oats, oka, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam.

[0062] 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 "modified" starches. Other starches are obtained and subsequently modified. For example, modified starches can be starches that have been subjected to chemical reactions, such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of a base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, enzyme treatment, acetylation, hydroxypropylation and / or partial hydrolysis. Other starches are modified by heat treatment, such as pregelatinization, dextrinization and / or cold water swelling processes. Certain modified starches include phosphorylated starch, glycerol cross-linked starch, phosphate cross-linked starch esterified with sodium trimetaphosphate, phosphorylated phosphate cross-linked starch, acetylated phosphate cross-linked starch, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated adipate cross-linked starch, acetylated glycerol cross-linked starch, hydroxypropylated starch, hydroxypropylated glycerol cross-linked starch, and sodium starch octenylsuccinate.

[0063] In some embodiments, the filler comprises a cellulose material. In some embodiments, the cellulose-based material 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 some embodiments, the product comprises mcc. The amount of mcc present in the products described herein can vary depending on the desired properties.

[0064] In some embodiments, the filler comprises cellulose derivatives, such as cellulose ethers (including carboxyalkyl ethers), which refers to cellulose polymers in which the hydrogen of one or more hydroxyl groups in the cellulose structure is replaced by an alkyl group, a hydroxyalkyl group, or an aryl group.Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethylcellulose, and carboxymethylcellulose ("CMC").Suitable cellulose ethers include hydroxypropylcellulose, such as Klucel H from Aqualon Co.; hydroxypropylmethylcellulose, such as Methocel K4MS from DuPont; hydroxyethylcellulose, such as Natrosol250 MRCS from Aqualon Co.; methylcellulose, such as Methocel A4M, K4M, and E15 from DuPont; and sodium carboxymethylcellulose, such as CMC 7HF, CMC 7LF, and CMC 7H4F from Aqualon Co. In some embodiments, the at least one filler is one or more cellulose ethers (e.g., a single cellulose ether or a combination of several cellulose ethers, e.g., two or three). In some embodiments, the filler is a cellulose ether selected from the group consisting of methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethylcellulose, carboxymethylcellulose, and combinations thereof. In some embodiments, the at least one filler is carboxymethylcellulose.

[0065] Other suitable fillers include gums, such as natural gums. As used herein, natural gums refer to polysaccharide materials of natural origin that have binding properties and are also useful as thickeners or gelling agents. 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.

[0066] In some embodiments, the filler comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides, with partial or complete hydrogenation. Sugar alcohols, for example, have from about 4 to about 20 carbon atoms, and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). In some embodiments, the filler comprises erythritol, isomalt, maltitol, mannitol, sorbitol, or combinations thereof. In some embodiments, the filler is a combination of mannitol and maltodextrin. In some embodiments, the filler comprises isomalt. Isomalt is an equimolar mixture of two disaccharides, each consisting of two sugars: glucose and mannitol (α-D-glucopyranoside-1,6-mannitol); and glucose and sorbitol (α-D-glucopyranoside-1,6-sorbitol). In some embodiments, the bulking agent comprises a mixture of glucose and starch derived polysaccharides. One such suitable mixture of glucose and starch derived polysaccharides is EMDEX® available from JRS PHARMA LP, USA, 2981 Route 22, Patterson, NY 12563-2359. In some embodiments, the bulking agent comprises EMDEX®.

[0067] In some embodiments, the filler is soluble. "Soluble" means that the filler is water-soluble, such that the soluble filler is substantially or completely soluble in saliva present in the mouth of a user of the composition. "Completely soluble" means that no residue of the soluble filler remains in solid form in the mouth of a user after a normal period of use of a product containing the soluble filler. In some embodiments, the soluble filler comprises a soluble fiber, such as inulin or corn fiber. In some embodiments, the soluble filler comprises a soluble starch. In some embodiments, the soluble starch is maltodextrin. In some embodiments, the soluble filler comprises a sugar. In some embodiments, the soluble filler comprises a sugar alcohol. In some embodiments, the soluble filler is a combination of isomalt and maltodextrin.

[0068] The amount of dissolvable filler may vary, but is typically greater than about 45% and up to about 95% of the composition by weight, based on the total weight of the composition. Typical ranges of dissolvable fillers within the compositions can be from about 45 to about 95% by weight, for example, from about 45, about 50, about 55, about 60, or about 65 to about 70, about 75, about 80, about 85, about 90, or about 95% by weight of the total weight of each composition. In embodiments in which the composition includes more than one dissolvable filler, it is understood that the stated weight basis of the dissolvable filler reflects the total weight of the combination of dissolvable fillers, based on the total weight of the composition.

[0069] In some embodiments, the composition further comprises a filler that is not soluble or is only partially soluble. The amount of non-soluble or partially soluble filler that may be present may vary, but is typically less than about 40% by weight of the composition, for example, about 1 to about 40% by weight, about 1 to about 20% by weight, or about 1 to about 5% by weight based on the total weight of the composition. In some embodiments, the non-soluble filler is microcrystalline cellulose. In some embodiments, the composition further comprises microcrystalline cellulose in an amount of up to about 5% by weight based on the total weight of the composition. In some embodiments, the composition further comprises microcrystalline cellulose in an amount of up to about 40% by weight, for example, about 1 to about 40% by weight based on the total weight of the composition. Without wishing to be bound by theory, it is believed that the inclusion of a partially soluble or non-soluble filler such as microcrystalline cellulose may be advantageous in carrying flavorings or active ingredients, and may provide a more uniform distribution throughout such products.

[0070] Wetting Agent In certain embodiments, one or more humectants may be utilized in the composition. Examples of humectants include, but are not limited to, glycerin, propylene glycol, and the like. When included, humectants are typically provided in an amount sufficient to provide the composition with the desired moisture characteristics. Additionally, in some cases, humectants can impart desirable flow characteristics to the composition for pouring into molds, extruding products, and / or forming beads. In some cases, humectants can help prevent particulate embodiments (e.g., powders) from forming airborne dust or drying out during heat sealing of pouches. In some cases, humectants can aid in the formation of beads by extrusion, spheronization, rolling, and combinations thereof. In some embodiments, the humectant is propylene glycol. In some embodiments, the humectant is glycerin.

[0071] When present, the humectant typically comprises about 25% or less by weight of the composition (e.g., from about 0.1 to about 25% by weight), for example, from about 0.1% to about 1% by weight, from about 1% to about 5% by weight, from about 5 to about 15% by weight, or from about 15 to about 20% by weight, based on the total weight of the composition.

[0072] Binder The binder (or combination of binders) can be utilized in a sufficient amount to provide the composition with desired physical characteristics and physical integrity in certain embodiments, and the binder often also functions as a thickening or gelling agent. Typical binders can be organic or inorganic, or combinations thereof. Representative binders include cellulose derivatives (e.g., cellulose ethers), 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.

[0073] The amount of binder utilized in the composition can vary based on the binder and the desired composition properties, but typically is up to about 25% by weight, with certain embodiments characterized by a binder content of at least about 0.1% by weight, such as from about 0.5 to about 20% by weight, or from about 1 to about 10% by weight, based on the total weight of the composition.

[0074] In one embodiment, the binder comprises a cellulose derivative. 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 some embodiments, the cellulose derivative is HPC. In one embodiment, the cellulose derivative is a combination of HPC and HPMC. In some embodiments, the composition comprises about 1 to about 5% HPC by weight of the composition, for example, about 1%, about 2%, or about 3% to about 4% or about 5% by weight.

[0075] In certain embodiments, the binder includes an alginate (e.g., sodium alginate or ammonium alginate). When present, the alginate binder is typically present in an amount of up to about 1% by weight, for example, from about 0.1, about 0.2, about 0.3, about 0.4 or about 0.5% by weight to about 0.6, about 0.7, about 0.8, about 0.9 or about 1% by weight, based on the total weight of the composition.

[0076] In certain embodiments, the binder includes an elastomeric polymer, which may include materials used in the manufacture of chewing gum, such as polyvinyl acetate or butadiene-styrene.

[0077] In certain embodiments, the binder comprises a gum, such as a natural gum. As used herein, natural gum refers to a polysaccharide material of natural origin that has binding properties and is also useful as a thickening or gelling agent. Representative natural gums derived from plants, which are usually water-soluble to some extent, include xanthan gum, guar gum, gum arabic, gum ghatti, gum tragacanth, gum karaya, locust bean gum, gellan gum, and combinations thereof. In certain embodiments, the binder comprises gum arabic. Natural gum binder materials, when present, are typically present in an amount of up to about 25% by weight, for example, from about 1%, about 2%, about 3%, about 4% or about 5% by weight, up to about 10%, about 15%, about 20% or about 25% by weight, based on the total weight of the composition.

[0078] In some embodiments, the composition includes a binder, for example, coated on the surface of beads, tablets, or granular particles that include the composition. Without wishing to be bound by theory, such coatings can modify the dissolution rate of components within the composition or the composition itself. Suitable binders for coatings include, but are not limited to, cellulose derivatives and polymeric materials.

[0079] active ingredient In some embodiments, the compositions disclosed herein include one or more active ingredients. As used herein, "active ingredient" refers to one or more substances that belong to any of the following categories: API (active pharmaceutical ingredient), food additive, natural drug, and naturally derived substances that may have an effect on humans. Exemplary active ingredients include any ingredient known to affect one or more biological functions in the body, such as ingredients that provide pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or that affect the structure or any function of the human body (e.g., provide a stimulating effect on the central nervous system, have an energizing effect, an antipyretic or analgesic effect, or have other effects that are beneficial to the body). In some embodiments, the active ingredient may be of the type commonly referred to as a dietary supplement, nutraceutical, "phytochemical agent," or "functional food." These types of additives are sometimes defined in the art to include substances commonly available from natural sources (e.g., botanical materials) that provide one or more beneficial biological effects (e.g., health promotion, disease prevention, or other pharmacological effects) but that are not classified or regulated as drugs.

[0080] Non-limiting examples of active ingredients include those that fall into the categories of botanical ingredients (e.g., hemp, lavender, peppermint, eucalyptus, rooibos, fennel, clove, chamomile, basil, rosemary, clove, citrus, ginger, hemp, carrot, maca, and herbal teas), stimulants (e.g., caffeine or guarana), amino acids (e.g., taurine, theanine, phenylalanine, tyrosine, and tryptophan), vitamins (e.g., B6, B12, and C), antioxidants, nicotine ingredients, pharmaceutical ingredients (e.g., nutraceutical and medicinal ingredients), cannabinoids (e.g., tetrahydrocannabinol (THC) or cannabidiol (CBD)), and / or melatonin. Each of these categories is further described herein below. The particular choice of active ingredient will depend on the desired flavor, texture, and desired characteristics of the particular product.

[0081] Additionally, any of the above types of active ingredients may be encapsulated in the composition, final product, or both to avoid chemical degradation of these actives or to reduce strong taste, including, but not limited to, caffeine, vitamin A, and iron (Fe). Additionally, these encapsulated actives may have to be paired with excipients in the composition to increase their solubility and / or bioavailability. Non-limiting examples of these excipients include beta-carotene, lycopene, vitamin D, vitamin E, coenzyme Q10, vitamin K, and curcumin.

[0082] 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% by weight, for example, about 0.5% w / w to about 10% by weight, about 1% to about 10% by weight, or about 1% to about 5% by weight, based on the total weight of the composition. In some embodiments, the active ingredient or combination of active ingredients is present in 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%, about 0.08%, about 0.08%, about 0.09%, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07 ... %, about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8% or about 0.9% by weight 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. More suitable ranges for certain active ingredients are provided herein below.

[0083] 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-bearing 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 botanical materials as "non-tobacco" is intended to exclude tobacco materials (i.e., does not include any Nicotiana species).

[0084] 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%, about 0.1%, or about 0.5% by weight, 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.

[0085] Botanical materials useful in the present disclosure can include, without limitation, any of the compounds and sources described herein, including mixtures thereof. Certain botanical materials of this type are sometimes referred to as dietary supplements, nutraceuticals, "phytochemical agents" or "functional foods." Certain botanicals find use in traditional herbal medicines as botanical materials or botanical extracts, and are further described herein.Non-limiting examples of plants or plant-derived materials include ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, chai fu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus, clove, cocoa, cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, Ginkgo biloba, carrots (e.g., Panax ginseng), green tea, Griffonia simplicifolia, and the like. simplicifolia, Guarana, Cannabis, Hops, Jasmine, Kaempferia parviflora (Turmeric), Kava, Lavender, Lemon Balm, Lemongrass, Licorice, Lutein, Maca, Matcha, Oil-based Extract of Nardostachys chinensis, Viola odorata, Peppermint, Quercetin, Resveratrol, Rhizoma gastrodiae, Rhodiola, Rooibos, Rose Essential Oil, Rosemary, Sceletium tortuosum, Schisandra chinensis, Skullcap, Spearmint Extract, Spikenard, Terpenes, Herbal Tea, Turmeric, Turnera aphrodisiaca aphrodisiaca, valerian, mulberry, and yerba mate. In some embodiments, the botanical material is present in an encapsulated form.

[0086] 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. In some embodiments, the active ingredient comprises theacrine. In some embodiments, the active ingredient comprises a combination of caffeine and theacrine.

[0087] When present, the stimulant or combination of stimulants (e.g., caffeine, theacrine, and combinations thereof) will typically be at a concentration of about 0.1% w / w to about 15% by weight, for example, from about 0.1% w / w, about 0.2% w / w, about 0.3% w / w, about 0.4% w / w, about 0.5% w / w, about 0.6% w / w, about 0.7% w / w, about 0.8% w / w, or about 0.9% w / w, to about 1%, 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.

[0088] 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, along with a side chain (R group). This 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.

[0089] When present, the amino acid or combination of amino acids (e.g., taurine, theanine, 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.

[0090] In some embodiments, the amino acid is taurine, theanine, phenylalanine, tyrosine, tryptophan, or a combination thereof. In some embodiments, the amino acid is taurine. In some embodiments, the active ingredient comprises a combination of taurine and caffeine. In some embodiments, the active ingredient comprises a combination of taurine, caffeine, and guarana. In some embodiments, the active ingredient comprises a combination of taurine, maca, and cordyceps. In some embodiments, the active ingredient comprises a combination of theanine and caffeine. In some embodiments, the active ingredient comprises a combination of theanine and caffeine. In some embodiments, the active ingredient comprises a combination of theanine and GABA. In some embodiments, the active ingredient comprises a combination of theanine, GABA, and lemon balm. In some embodiments, the active ingredient comprises a combination of caffeine, taurine, and vitamin C. In some embodiments, the active ingredient is a combination of caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises taurine.

[0091] Vitamins and Minerals 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. In some embodiments, the active ingredient includes one or more of vitamins B6 and B12. In some embodiments, the active ingredient includes theanine and one or more of vitamins B6 and B12.

[0092] If 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 1% 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 wt%, about 0.3 wt%, about 0.4 wt%, about 0.5 wt%, about 0.6 wt%, about 0.7 wt%, about 0.8 wt%, about 0.9 wt%, or about 1 wt%, based on the total weight of the composition.

[0093] In some embodiments, the active ingredient comprises Vitamin A. In some embodiments, the Vitamin A is encapsulated. In some embodiments, the vitamin is Vitamin B6, Vitamin B12, Vitamin E, Vitamin C, or a combination thereof.

[0094] In some embodiments, the active ingredient comprises a mineral. As used herein, the term "mineral" refers to an inorganic molecule (or set of related molecules) that is an essential micronutrient required for the proper functioning of various systems in mammals. Non-limiting examples of minerals include iron, zinc, copper, selenium, chromium, cobalt, manganese, calcium, phosphorus, sulfur, magnesium, and the like. In some embodiments, the active ingredient comprises iron. Suitable iron sources include, but are not limited to, ferrous salts, such as ferrous sulfate and ferrous gluconate. In some embodiments, the iron is encapsulated.

[0095] In some embodiments, the active ingredients described herein may be susceptible to degradation (e.g., oxidative, photolytic, thermal, volatilizing) during processing or storage of the oral product. In such embodiments, the active ingredients (e.g., caffeine, vitamin A, and iron (Fe)) may be encapsulated or the matrix may be modified, particularly with fillers, binders, etc., to provide the active ingredients with enhanced stability. For example, binders, such as functional celluloses (e.g., cellulose ethers, including but not limited to hydroxypropyl cellulose), may be used to enhance the stability of such actives against degradation. Furthermore, the encapsulated actives may need to be paired with excipients in the composition to increase their solubility and / or bioavailability. Non-limiting examples of suitable excipients include beta-carotene, lycopene, vitamin D, vitamin E, coenzyme Q10, vitamin K, and curcumin.

[0096] In other embodiments, the initial amount of active ingredient may be increased to compensate for losses that occur over time due to decomposition to provide a desired concentration by weight of active ingredient, and thus initial amounts greater than those disclosed herein are contemplated by the present disclosure.

[0097] 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.

[0098] 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, 12 (2005) pp. 216-220, which is incorporated herein by reference.

[0099] Other suitable antioxidants include, but are not limited to, 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. In some embodiments, the antioxidant is vitamin E or a derivative thereof, a flavonoid, a polyphenol, a carotenoid, or a combination thereof.

[0100] When present, antioxidants are typically at a concentration of about 0.001% w / w to about 10% by weight, for example, 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, up 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 composition.

[0101] Nicotine content In certain embodiments, the active ingredient comprises a nicotine ingredient. In some embodiments, the active ingredient is a nicotine ingredient (i.e., nicotine is the only active ingredient). By "nicotine ingredient" is meant any suitable form of nicotine (e.g., free base or salt) to provide for oral absorption of at least a portion of the nicotine present.

[0102] The nicotine source may be varied, natural or synthetic. Most preferably, the nicotine is natural and obtained as an extract from Nicotiana species (e.g., tobacco). The nicotine may have the enantiomeric forms 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 mostly 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, by weight.

[0103] Typically, the nicotine component is selected from the group consisting of nicotine free base and nicotine salt.In some embodiments, the nicotine component is nicotine in free base form, which can be easily adsorbed, for example, on microcrystalline cellulose material to form microcrystalline cellulose-nicotine carrier complex.See, for example, US Patent Application No. 2004 / 0191322 to Hansson, which relates to nicotine in free base form.This is incorporated herein by reference.

[0104] In some embodiments, at least a portion of the nicotine component 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 is nicotine bitartrate. In some embodiments, the nicotine component includes or is nicotine benzoate.

[0105] 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, e.g., nicotine polacrilex, which is nicotine bound to polymethacrylic acid, such as Amberlite IRP64, Purolite C115HMR, or Doshion P551. See, e.g., U.S. Patent No. 3,901,248 to Lichtneckert et al., which is incorporated herein by reference. Another example is a nicotine-polyacryl carbomer complex, e.g., Carbopol 974P. In some embodiments, the nicotine can be in the form of a nicotine polyacryl complex. In some embodiments, the composition comprises nicotine polacrilex.

[0106] In some embodiments, the only nicotine present in the composition is added in the form of resin-bound nicotine (e.g., nicotine polacrilex). In some embodiments, the composition comprises resin-bound nicotine (e.g., nicotine polacrilex) and further comprises free base nicotine, a nicotine salt, ion-paired nicotine, or a combination thereof. In some embodiments, at least a portion of the nicotine present in the composition is present as an ion pair, as further described herein below.

[0107] Typically, the nicotine component (calculated as the free base), if present, is present in the mixture at least about 0.001% by weight of the composition, 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 from about 0.1% w / w to about 3% by weight, calculated as the free base, based on the total weight of the composition, e.g., from about 0.1% to about 2.5% by weight, from about 0.1% to about 2.0% by weight, from about 0.1% to about 1.5% by weight, or from about 0.1% to about 1% by weight.

[0108] The total amount of nicotine present may be provided by more than one nicotine source, such as any of various combinations of nicotine free base, nicotine salts, ion-paired nicotine, and resin-bound nicotine (e.g., nicotine polacrilex).

[0109] In other embodiments, the products or compositions of the present disclosure can be characterized as being completely free or substantially 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.

[0110] Cannabinoids In some embodiments, the active ingredient comprises one or more cannabinoids. As used herein, the term "cannabinoid" refers to a class of diverse natural or synthetic chemical compounds that act on intracellular cannabinoid receptors (i.e., CB1 and CB2) to alter neurotransmitter release in the brain. Cannabinoids are cyclic molecules that exhibit certain properties, such as the ability to easily cross the blood-brain barrier. Cannabinoids can be naturally derived from plants, such as cannabis (phytocannabinoids), from animals (endocannabinoids), or artificially produced (synthetic cannabinoids). Cannabis species express at least 85 different phytocannabinoids, including cannabigerol, cannabichromene, cannabidiol, tetrahydrocannabinol, cannabinol and cannabinodiol, as well as other cannabinoids such as cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and cannabinodiol (CBDL), cannabicyclol ( Cannabinol can be divided into subclasses including: cannabivarin (CBV), tetrahydrocannabivarin (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).

[0111] In some embodiments, the cannabinoid is selected from the group consisting of cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN) and 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), tetrahydrocannabivarinic acid (THCV A), and mixtures thereof. In some embodiments, the cannabinoid comprises at least tetrahydrocannabinol (THC). In some embodiments, the cannabinoid is tetrahydrocannabinol (THC). In some embodiments, the cannabinoid comprises at least cannabidiol (CBD). In some embodiments, the cannabinoid is cannabidiol (CBD). In some embodiments, the CBD is synthetic CBD. Notably, CBD has a logP value of about 6.5, which makes it insoluble in an aqueous environment (e.g., saliva).

[0112] In some embodiments, the cannabinoid (e.g., CBD) is added to the oral product 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.

[0113] In some embodiments, the cannabinoid is an isolate of CBD at a high degree of purity and the amount of any other cannabinoids in the oral product is about 1% or less by weight of the oral product, such as about 0.5% or less by weight of the oral product, such as about 0.1% or less by weight of the oral product, for example about 0.01% or less by weight of the oral product.

[0114] The selection of cannabinoids and the specific percentages that may be present in the disclosed oral products will vary depending on the desired flavor, texture, and other characteristics of the oral product.

[0115] In some embodiments, the cannabinoid (such as CBD) is present in the composition at a concentration of at least about 0.001% by weight of the oral product, for example, in the range of about 0.001% to about 2% by weight of the oral product. In some embodiments, the cannabinoid (such as CBD) is present in the composition at a concentration of about 0.1% to about 1.5% by weight, based on the total weight of the composition. In some embodiments, the cannabinoid (such as CBD) is present in a concentration of about 0.4% to about 1.5% by weight, based on the total weight of the oral composition.

[0116] Alternatively, or in addition to cannabinoids, the active ingredient may include cannabimetics, a class of compounds derived from plants other than cannabis that have biological effects on the endocannabinoid system similar to cannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin (also classified as terpenes), cyanidin, curcumin (turmeric), catechin, quercetin, salvinorin A, N-acylethanolamines, and N-alkylamide lipids. Such compounds may be used in the same amounts and in the same ratios as specified herein for cannabinoids.

[0117] Terpenes Active ingredients suitable for use in the present disclosure may 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.

[0118] 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 regard 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.

[0119] Pharmaceutical Ingredients Pharmaceutical moieties can be any known agent adapted for therapeutic, prophylactic or diagnostic use. These can include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, inorganic compounds, and nucleic acid sequences having therapeutic, prophylactic or diagnostic activity. Non-limiting examples of pharmaceutical moieties include analgesics and antipyretics (e.g., acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic acid).

[0120] Bleached active ingredients In some embodiments, the composition comprises an active ingredient disclosed herein, characterized in that the active ingredient is bleached. Such a bleached active ingredient may be desirable, for example, to prevent tooth discoloration during use of the oral product, or so that any residue remaining in the user's mouth after use of the product is not visible and is unlikely to cause staining of textile materials, such as clothing, that may come into contact with the residue. By "bleached" active ingredient is meant an active ingredient (e.g., a botanical material or a derivative thereof) that is colored in its natural state and has been treated to reduce or eliminate the color. By "color" is meant a characterization of human vision, described by a classification of colors by names such as red, blue, yellow (primary colors), or brown, orange, green, purple, etc., derived from combinations of the primary colors. Such a sense of color is derived from the stimulation of cone cells in the human eye by electromagnetic radiation in the visible spectrum associated with an object, depending on the wavelength of light reflected from the object. This reflection is governed by the physical properties of the object, such as, for example, the absorption and emission spectrum of the entire electromagnetic spectrum.

[0121] Certain active ingredients impart color to the active ingredient due to naturally occurring chemical compounds therein that reflect light in the visible range of the electromagnetic spectrum (e.g., chlorophyll or pigment breakdown products in certain botanical materials that cause green and brown colors, respectively). Such chemical compounds, or portions thereof, may be chemically altered or removed by various treatments that cause the color of the active ingredient. In some embodiments, the treatment is effective to remove at least 70% of the chemicals present in the active ingredient that have a maximum transmittance of wavelengths in the visible range of the electromagnetic spectrum, based on the weight of the naturally occurring compounds. For example, such treatments may be effective to remove 70%, 80%, 90%, 95%, 99%, or even 100% of the naturally occurring compounds that cause the visible color of the active ingredient.

[0122] In some embodiments, the treatment for bleaching (i.e., modification or removal of color-bearing chemical compounds from the active ingredient) includes extraction, chemical bleaching, or a combination thereof. One particularly suitable extraction method is supercritical carbon dioxide (CO2) extraction. Chemical bleaching methods for, for example, botanical materials, including tobacco, are known and include, by way of non-limiting example, treatment with hydrogen peroxide, ozone, or other oxidizing agents. For example, bleached active ingredients (e.g., bleached botanical materials or tobacco materials) can be produced by a variety of whitening methods using a variety of bleaching or oxidizing agents. Exemplary oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorites, chlorates, perchlorates, hypochlorites, ozone, ammonia, potassium permanganate, and combinations thereof. An oxidation catalyst can be used. Exemplary oxidation catalysts are titanium dioxide, manganese dioxide, and combinations thereof.

[0123] Bleaching methods known for bleaching tobacco may be applied to the present active ingredients. Processes for treating tobacco with bleaching agents are described, for example, in U.S. Patent No. 787,611 to Daniels, Jr.; U.S. Patent No. 1,086,306 to Oelenheinz; U.S. Patent No. 1,437,095 to Delling; U.S. Patent No. 1,757,477 to Rosenhoch; U.S. Patent No. 2,122,421 to Hawkinson; U.S. Patent No. 2,148,147 to Baier; U.S. Patent No. 2,170,107 to Baier; U.S. Patent No. 2,274,649 to Baier; U.S. Patent No. 2,770,239 to Pratz et al.; U.S. Patent No. 2,274,649 to Pratz et al.; U.S. Patent No. 2,3 ...274,649 to Pratz et al.; U.S. Patent No. 2,274,649 to Pratz et al.; U.S. Patent No. 2,274 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.

[0124] In some embodiments, the bleached activator, or a composition or product containing the bleached activator, 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 bleached activator, or a composition or product containing the bleached activator, 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.

[0125] In some embodiments, the bleached activator can be characterized by a lightened color (e.g., "whitened") compared to the untreated activator. The color white is often defined with reference to the International Commission on Illumination (CIE) chromaticity diagram. The bleached activator, or a composition or product comprising the bleached activator, can, in certain embodiments, be characterized as being closer to pure white on the chromaticity diagram than the untreated activator, or a composition or product comprising the untreated activator.

[0126] The whiteness value of bleached active ingredients, compositions, and pouch products containing such ingredients can be determined in accordance with the International Commission on Illumination (CIE) model, for example, using a portable colorimeter to compare with a control product (see "Precise Color Communication; Color Control from Perception to Instrumentation", Konica Minolta, 2007; http: / / konicaminolta.com / instruments / about / network, which is incorporated herein by reference). The color change from white can be evaluated by the E313 whiteness index, in accordance with ASTM method E313, using the formula WI=3.388Z-3Y, where Y and Z are CIE tristimulus values, measured by a portable instrument.

[0127] Flavoring Agent In some embodiments, the composition comprises a flavoring agent. As used herein, a "flavoring agent" or "flavoring agent" is any flavorful or fragrant substance capable of modifying the sensory characteristics associated with an oral product. Examples of sensory characteristics that can be modified with a flavoring agent include taste, mouthfeel, moistness, cooling / heating, and / or flavor / aroma. Flavoring agents can be natural or synthetic, and the resulting flavor characteristics can be described as fresh, sweet, herbal, confectionery, floral, fruity, or spicy, without limitation. Specific types of flavors include, but are not limited to, vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, trigeminal sensate, terpene, and any combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, RJ Reynolds Tobacco Company (1972), which is incorporated herein by reference. Flavoring agents can also include components that are considered to be humectants, coolants, 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 WO 05 / 041699 to Quinter et al., each of which is incorporated herein by reference.

[0128] In some cases, the flavoring agent may be provided in a spray-dried or liquid form. In some embodiments, the liquid flavoring agent is disposed (i.e., adsorbed or absorbed) in or on a porous particulate carrier, such as microcrystalline cellulose, which is then combined with other composition ingredients. The embodiment using a flavoring agent that is present in a dry form (e.g., in or on microcrystalline cellulose) may be advantageous in providing a more uniform product.

[0129] The amount of flavoring utilized in the composition may vary, but will typically be up to about 10 weight percent, with certain embodiments being 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 5 weight percent, or from about 2 to about 4 weight percent, based on the total weight of the composition.

[0130] Taste modifiers To improve the organoleptic properties of the compositions disclosed herein, the compositions may include one or more taste modifiers ("taste modifiers") that can act, for example, to mask, modify, block or improve the flavor of the compositions described herein. Non-limiting examples of such taste modifiers include analgesic or anesthetic herbs, spices and flavors that produce a sensation of cooling (e.g., menthol, eucalyptus, mint), warmth (e.g., cinnamon) or pain (e.g., capsaicin). Certain taste modifiers fall into more than one overlapping category.

[0131] In some embodiments, the taste modifier modifies one or more of bitter, sweet, salty or sour tastes. In some embodiments, the taste modifier targets pain receptors. In some embodiments, the composition includes an active ingredient having a bitter taste and a taste modifier that masks or blocks the sensation of this bitter taste. In some embodiments, the taste modifier is a substance that targets pain receptors (e.g., vanilloid receptors) in the user's oral cavity, for example, to mask the bitter taste of another component (e.g., an active ingredient). In some embodiments, the taste modifier is capsaicin.

[0132] In some embodiments, the taste modifier is the amino acid gamma-aminobutyric acid (GABA), as herein above referred to with respect to amino acids. Studies in mice suggest that GABA may function in taste buds in addition to synaptic inhibition. See, for example, Dvoryanchikov et al., J Neurosci. 2011 Apr. 13;31(15):5782-91. Without wishing to be bound by theory, GABA may suppress the perception of certain tastes, such as bitterness. In some embodiments, the composition comprises caffeine and GABA.

[0133] In some embodiments, the taste modifier is adenosine monophosphate (AMP). AMP is a natural nucleotide substance that can block the bitter flavor of food or enhance sweetness. AMP does not directly modify bitter flavor, but may modify the human perception of "bitterness" by blocking the associated receptor.

[0134] In some embodiments, the taste modifier is lactisol. Lactisol is an antagonist of sweet taste receptors. Transient blocking of sweet taste receptors can, for example, enhance umami taste.

[0135] When present, representative amounts of taste modifiers are about 0.01% by weight or more, about 0.1% by weight or more, or about 1.0% by weight or more, but typically comprise less than about 10% by weight of the total weight of the composition (e.g., from about 0.01%, about 0.05%, about 0.1% or about 0.5% by weight to about 1%, about 5% or about 10% by weight of the total weight of the composition).

[0136] salt In some embodiments, the composition includes a salt (e.g., an alkali metal salt), typically utilized in an amount sufficient to provide the composition with desired sensory attributes. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, sodium acetate, sodium citrate, and the like. In some embodiments, the salt is sodium chloride, ammonium chloride, or a combination thereof.

[0137] Representative amounts of salt, if present, will comprise about 0.5% by weight or more, about 1.0% by weight or more, or about 1.5% by weight or more, but will usually comprise about 10% by weight or less, or about 7.5% by weight or less, or about 5% by weight or less (e.g., from about 0.5 to about 5%) of the total weight of the composition.

[0138] Sweetener To improve the sensory properties of the composition according to the present disclosure, one or more sweeteners may be added. 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 fructose, sucrose, glucose, maltose, isomaltulose, mannose, galactose, lactose, stevia, honey, etc. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, etc. In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides, with partial or complete hydrogenation. Sugar alcohols, for example, have from about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). In some embodiments, the sweetener is xylitol, sucralose, or combinations thereof.

[0139] When present, the sweetener or combination of sweeteners may comprise from about 0.1 to about 20% or more by weight of the composition, for example, from about 0.1 to about 1%, from about 1 to about 5%, from about 5 to about 10%, or from about 10 to about 20% by weight of the total weight of the composition. In some embodiments, the combination of sweeteners is present in a concentration of from about 1% to about 3% by weight of the composition.

[0140] water The water content of the composition may vary depending on the desired properties prior to consumer use of the pouch product. Typically, the composition will have less than about 15% water by weight, generally about 0.01 to about 10% by weight, e.g., about 0.01 to about 1, about 1 to about 10, or about 1 to about 5% by weight, based on the total weight of the composition.

[0141] Ion pairing In some embodiments, the compositions disclosed herein include a basic amine. "Basic amine" refers to a molecule that includes at least one basic amine functional group. Examples of basic amines include, but are not limited to, alkaloids. "Basic amine functional group" refers to a group that contains a nitrogen atom that has a lone pair of electrons. The basic amine functional group is attached to or incorporated within a molecule via one or more covalent bonds to said nitrogen atom. Basic amines may be primary, secondary, or tertiary amines, meaning that the nitrogen has one, two, or three covalent bonds to a carbon atom. Due to the lone pair of electrons on the nitrogen atom, such amines are referred to as "basic", meaning that the lone pair is available for hydrogen bonding. The basicity of basic amines (i.e., the electron density on the nitrogen atom, and therefore the availability and strength of hydrogen bonding to the nitrogen atom) can be affected by the nature of the neighboring atoms, the steric bulk of the molecule, and the like.

[0142] Generally, the basic amine is present in the composition or is present as an active ingredient in the composition, as described hereinabove. In some embodiments, the basic amine is caffeine. In some embodiments, the basic amine is nicotine or a nicotine component, each as described hereinabove. Generally, the basic amine (e.g., nicotine) is released from the composition and absorbed through the oral mucosa, thereby entering the bloodstream, where it is circulated throughout the body.

[0143] In some embodiments, the compositions described herein comprise an organic acid, an alkali metal salt thereof, or a combination thereof, each as further described herein below. In some embodiments, at least a portion of the basic amine is combined with at least a portion of the organic acid or alkali metal salt thereof. Depending on a number of variables (such as the concentration, pH, nature of the organic acid), the basic amine present in the composition can exist in a number of forms, including as a paired ion, in solution (i.e., fully solvated), as a free base, as a cation, as a salt, or any combination thereof. In some embodiments, the combination between the basic amine and at least a portion of the organic acid or alkali metal salt thereof is in the form of an ion pair between the basic amine and the conjugate base of the organic acid.

[0144] 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 and a conjugate base of an organic acid). By "conjugate base" is meant the base 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 will be present at any one time, but the formation and dissociation of ion pairs is continuous. In the compositions disclosed herein and / or upon use of the compositions in the oral cavity (e.g., upon contact with saliva), the basic amine 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 decomposition of the basic amine and / or enhance the oral availability of the basic amine (e.g., nicotine).

[0145] Those skilled in the art will recognize that the extent of ion pairing in the disclosed compositions, both before and during use by the consumer, may vary based on, for example, pH, the nature of the organic acid present in the composition, the concentration of the basic amine (e.g., nicotine), the concentration of the organic acid or the conjugate base of the organic acid, the water content of the composition, and the like. Those skilled in the art will also recognize that ion pairing is an equilibrium process that is influenced by the aforementioned variables. Thus, quantification of the extent of ion pairing is difficult or impossible by calculation or direct observation. However, the presence of ion pairing may be demonstrated by surrogate measurements, such as partitioning between octanol and water, or membrane permeation of an aqueous solution of, for example, nicotine plus the organic acid and / or their conjugate base. In particular, octanol-water partitioning, which favors the distribution of the basic amine-organic acid ion pair into octanol, predicts good absorption of the basic amine present in the composition through the oral mucosa.

[0146] organic acid As described hereinabove, in some embodiments, the composition includes an 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 (-CO2H) or sulfonic acids (-SO2OH). As used herein, reference to an organic acid refers to an organic acid that is intentionally added. In this context, an organic acid can be intentionally added as a particular composition component, as opposed to an organic acid that is simply naturally present as a component of another composition component (e.g., a small amount of organic acid that may be naturally present in a composition component, such as a tobacco material).

[0147] Suitable organic acids usually have a range of lipophilicity (i.e., have polarity that provides an appropriate balance between aqueous and organic solubility). 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. Typically, the lipophilicity of suitable organic acids, expressed as logP, ranges 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., 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 lipophilic range (i.e., logP values ​​greater than 4.5, e.g., about 4.5 to about 8.0).

[0148] 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 basic amine-containing active ingredients (e.g., nicotine), which results in better octanol-water partitioning of the ion pair, and thus are polar to partition the active ingredient (e.g., nicotine) into octanol rather than water. Such partitioning into octanol predicts favorable oral availability of the active ingredient. 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.

[0149] 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.

[0150] 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.

[0151] "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).

[0152] 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.

[0153] "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.

[0154] "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.

[0155] 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.

[0156] 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.

[0157] 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.

[0158] 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.

[0159] 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.

[0160] 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.

[0161] 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.

[0162] Examples of suitable acids include, but are not limited to, the list of organic acids in Table 1.

[0163] [Table 1] TIFF2024523362000003.tif67169

[0164] In some embodiments, the organic acid is a monoester of a diacid or polyacid, such as monooctyl succinate, monooctyl fumarate, etc. For example, in some embodiments, the organic acid is a monoester of a dicarboxylic acid or polycarboxylic acid. In some embodiments, the dicarboxylic acid is malonic acid, succinic acid, glutaric acid, adipic acid, fumaric acid, maleic acid, or a combination thereof. In some embodiments, the dicarboxylic acid is succinic acid, glutaric acid, fumaric acid, maleic acid, or a combination thereof. In some embodiments, the dicarboxylic acid is succinic acid, glutaric acid, or a combination thereof.

[0165] In some embodiments, the alcohol forming monoester of a dicarboxylic acid is a lipophilic alcohol. Examples of suitable lipophilic alcohols include, but are not limited to, octanol, menthol, and tocopherol. In some embodiments, the organic acid is an octyl monoester of a dicarboxylic acid, such as monooctyl succinate, monooctyl fumarate, and the like. In some embodiments, the organic acid is a monomenthyl ester of a dicarboxylic acid. Certain menthyl esters may be desirable in the oral compositions described herein because they can provide a cooling sensation upon use of a product containing the composition. In some embodiments, the organic acid is monomenthyl succinate, monomenthyl fumarate, monomenthyl glutarate, or combinations thereof. In some embodiments, the organic acid is a monotocopheryl ester of a dicarboxylic acid. Certain tocopheryl esters may be desirable in the oral compositions described herein because they can provide an antioxidant effect. In some embodiments, the organic acid is tocopheryl succinate, tocopheryl fumarate, tocopheryl glutarate, or combinations thereof.

[0166] In some embodiments, the organic acid is a carotenoid derivative having one or more carboxylic acids. Carotenoids are tetraterpenes, meaning that they are generated from eight isoprene molecules and contain 40 carbon atoms. Thus, they are usually lipophilic due to the presence of long unsaturated aliphatic chains, and are generally yellow, orange, or red in color. Certain carotenoid derivatives can be advantageous in oral compositions by providing both ion pairing and acting as coloring agents in the composition. In some embodiments, the organic acid is 2E,4E,6E,8E,10E,12E,14E,16Z,18E)-20-methoxy-4,8,13,17-tetramethyl-20-oxoicosa-2,4,6,8,10,12,14,16,18-nonaenoic acid (bixin) or an isomer thereof. Bixin is an apocarotenoid found in annatto seeds from the achiote tree (Bixa orellana) and is the naturally occurring pigment that provides annatto with its reddish-orange color. Bixin is soluble in fats and alcohol but insoluble in water, and when isolated, is chemically unstable and is converted via isomerization to the double bond isomer, trans-bixin (β-bixin), which has the following structure:

[0167] [ka]

[0168] In some embodiments, the organic acid is (2E,4E,6E,8E,10E,12E,14E,16E,18E)-4,8,13,17-tetramethylicosa-2,4,6,8,10,12,14,16,18-nonenedioic acid (norbixin), a water soluble hydrolysis product of bixin, having the following structure:

[0169] [ka]

[0170] The selection of an organic acid may further depend on additional properties, in addition to or without consideration of the mlogP 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.

[0171] 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. In some embodiments, the organic acid is benzoic acid.

[0172] In some embodiments, more than one organic acid may be present. For example, a composition may include two, three, 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, 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 the combination 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 undesirable from a sensory standpoint.For example, in some embodiments, the organic acid can include about 1 to about 5 molar equivalents or more of benzoic acid relative to the basic amine-containing active ingredient (e.g., nicotine), for example, combined with about 0.2 molar equivalents of octanoic acid or its salt, and 0.2 molar equivalents of decanoic acid or its salt.

[0173] 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.

[0174] 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 metals 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.

[0175] In some embodiments, the composition comprises benzoic acid and sodium benzoate, octanoic acid and sodium octanoate, decanoic acid and sodium decanoate, or combinations thereof. In some embodiments, the composition comprises benzoic acid and sodium benzoate. In some embodiments, the composition comprises sodium benzoate. 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 an 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. One of skill in the art will recognize that the relative amounts are determined by the desired pH of the composition, as well as the desired ionic strength. For example, an organic acid may be added in an amount that provides the desired pH level of the composition, while an alkali metal (e.g., sodium) salt is added in an amount that provides the desired range of ion pairing. Those skilled in the art will appreciate that the amount of organic acid (i.e., protonated form) present in a composition relative to the alkali metal salt or conjugate base form present in the composition will vary depending on the pH of the composition and the pKa of the organic acid, as well as the actual relative amount initially added to the composition. The amount of organic acid or its alkali metal salt present in a composition relative to the basic amine-containing active ingredient (e.g., nicotine) may vary. In general, as the concentration of the organic acid (or its conjugate base) increases, the proportion of the basic amine-containing active ingredient (e.g., nicotine) that forms an ion pair with the organic acid increases. This usually results in a logP (log of the partition coefficient) of the organic acid. 10 The partitioning of a basic amine-containing active ingredient (e.g., nicotine) in the form of an ion pair into octanol versus water is increased as measured by . In some embodiments, the compositions include 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 basic amine-containing active ingredient (e.g., nicotine), calculated as the amine-containing active ingredient free base.

[0176] In some embodiments, the composition comprises about 2 to about 10, or about 2 to about 5 molar equivalents of an organic acid, an alkali metal salt thereof, or a combination thereof, relative to nicotine on a free base nicotine basis. In some embodiments, the organic acid, an alkali metal salt thereof, or a combination thereof is present in a molar ratio with the basic amine-containing active ingredient (e.g., nicotine) that is from about 1, about 2, about 3, about 4, or about 5, to about 6, about 7, about 8, about 9, or about 10. In embodiments in which more than one organic acid, an alkali metal salt thereof, or both are present, it should be understood that such molar ratio reflects the total amount of organic acid present.

[0177] In certain embodiments, the inclusion of the organic acid is sufficient to provide the composition with a pH of about 3.0 to about 9.5, e.g., about 3.0 to about 9.0, or about 3.0 to about 8.5, or about 3.0 to about 8.0, or about 3.5 to about 7.5, or about 4.5 to about 7.0, or about 5.5 to about 7.0, or about 4.0 to about 5.5, or about 7.0 to about 9.5. In some embodiments, the inclusion of the organic acid is sufficient to provide the composition with a pH of about 3.0, about 3.5, about 4.0, about 4.5, about 5.0, about 5.5, about 6.0, about 6.5, about 7.0, about 7.5, about 8.0, about 8.5, or about 9.0. In some embodiments, the inclusion of an organic acid is sufficient to provide a composition pH of about 4.5 to about 6.5, e.g., from 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., from 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. In particular, at alkaline pH values ​​(e.g., about 7.5 to about 9, etc.), nicotine is present predominantly in the free base form (and therefore exhibits high partitioning into octanol), while at acidic pH values ​​(e.g., about 6.5 to about 4), nicotine is present predominantly in the protonated form (and therefore exhibits lower partitioning into octanol). In some embodiments, a buffer, such as a carbonate or bicarbonate, is added to adjust and / or maintain the desired pH value. Other suitable buffers are described further herein below.

[0178] In some embodiments, the organic acid is added to the 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 the 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-containing active ingredient (e.g., nicotine) are combined to form a salt prior to addition to the composition or the salt is formed within the composition and remains in the composition. In other embodiments, the organic acid and the basic amine-containing active ingredient (e.g., nicotine) are present in the composition as individual components and form an ion pair upon contact with moisture (saliva in the consumer's mouth).

[0179] In some embodiments, the composition further comprises a solubility enhancer to increase the solubility of at least one of the organic acids or salts thereof. Suitable solubility enhancers include, but are not limited to, humectants as described herein, such as glycerin or propylene glycol.

[0180] Buffer In certain embodiments, the compositions 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, such as metal carbonates (e.g., potassium carbonate or sodium carbonate), or metal bicarbonates, such as sodium bicarbonate. Non-limiting examples of suitable buffers include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof. In some embodiments, the buffering agent is sodium bicarbonate. In some embodiments, the buffering agent is sodium carbonate.

[0181] When present, the buffer is typically present in an amount of less than about 5% by weight based on the weight of the composition, for example, from about 0.1% to about 5% by weight, for example, from about 0.1% to about 1% by weight or from about 0.1% to about 0.5% by weight based on the total weight of the composition.

[0182] Coloring agent Coloring agent can be used in an amount sufficient to bring desired physical properties to the composition.Examples of coloring agent include various dyes and pigments, such as caramel coloring agent and titanium dioxide.The amount of coloring agent utilized in the composition can vary, but when present, is usually from about 3% by weight, for example, about 0.1% by weight, about 0.5% by weight, or about 1% by weight, to about 3% by weight, based on the total weight of the composition.

[0183] Tobacco Materials In some embodiments, the composition may include tobacco material. The tobacco material may 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.

[0184] 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.

[0185] 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.

[0186] Various parts or portions of a plant of the Nicotiana species may be included in the compositions 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 leaf (lamina). The compositions disclosed herein may include processed tobacco parts or pieces, dry processed and aged tobacco in essentially natural lamina and / or stem form, tobacco extract, extracted tobacco pulp (e.g., using water as a solvent), or mixtures of the foregoing (e.g., mixtures of extracted tobacco pulp granulated, dry processed, and combined with aged natural tobacco lamina).

[0187] 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.

[0188] 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% by weight or less than about 15% by weight. 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.

[0189] 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, 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% to less than about 5% by weight. 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% by weight, often less than about 20%, and frequently less than about 15% by weight.

[0190] 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 suitably 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.

[0191] 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.

[0192] 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.

[0193] The tobacco material used in the present disclosure can be subjected to, for example, fermentation, bleaching, etc. If desired, the tobacco material can also be subjected to, for example, irradiation, pasteurization, or otherwise controlled heat treatment. Such treatment processes are detailed, for example, in U.S. Patent No. 8,061,362 to Mua et al., which is incorporated herein by reference. In certain embodiments, the tobacco material can be treated with water and an additive capable of inhibiting the reaction of asparagine to form acrylamide upon heating of the tobacco material (e.g., an additive selected from the group consisting of lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, compositions incorporating divalent and trivalent cations, asparaginase, certain non-reducing sugars, certain reducing agents, phenolic compounds, certain compounds having at least one free thiol group or functional group, oxidizing agents, oxidation catalysts, natural plant extracts (e.g., rosemary extract), and combinations thereof). See, for example, the types of treatment processes described in U.S. Patent Publication Nos. 8,434,496, 8,944,072, and 8,991,403 to Chen et al., all of which are incorporated herein by reference. In certain embodiments, this type of treatment is useful when the original tobacco material is subjected to heat in the previously described processes.

[0194] 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.

[0195] In some embodiments, a type of tobacco material is first selected that is visually somewhat lighter in color than the other tobacco materials (e.g., whitened or bleached). In certain embodiments, the tobacco pulp may be whitened according to any of the means known in the art and described above for bleaching active ingredients.

[0196] Typical inclusion ranges for tobacco material may vary depending on the nature and type of tobacco material and its intended effect on the final composition, with exemplary ranges being up to about 30% by weight (or up to about 20% by weight, or up to about 10% by weight, or up to about 5% by weight) based on the total weight of the composition (e.g., about 0.1 to about 15% by weight). In some embodiments, products of the present disclosure may be characterized as being completely free or substantially free of tobacco material (other than purified nicotine as the active ingredient). For example, certain embodiments may be characterized as having less than 1% by weight, or less than 0.5% by weight, or less than 0.1% by weight tobacco material, or 0.01% by weight tobacco material, or 0% by weight tobacco material.

[0197] Oral Care Additives In some embodiments, the composition includes an oral care ingredient (or a mixture of such ingredients) that provides the ability to prevent tooth decay or tooth loss, prevent gum disease, relieve oral pain, whiten teeth, or otherwise prevent tooth staining, induce saliva stimulation, prevent bad breath, freshen breath, etc. For example, effective amounts of ingredients such as thyme oil, eucalyptus oil, and zinc (e.g., ingredients of a formulation commercially available as ZYTEX® from Discus Dental) can be incorporated into the composition. Other examples of ingredients that may be incorporated in the compositions of the present invention in desired effective amounts include those incorporated in the types of oral care compositions described in Takahashi et al., Oral Microbiology and Immunology, 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 ingredients of tobacco-containing formulations include those contained in formulations marketed as MALTISORB® by Roquette and DENTIZYME® by NatraRx. Representative amounts of oral care additives, if present, are at least about 1%, often at least about 3%, and frequently at least about 5% of the total dry weight of the composition. The amount of oral care additive in the composition will usually not exceed about 30%, often not exceed about 25%, and frequently not exceed about 20% of the total dry weight of the composition.

[0198] Processing Aids Processing aids (e.g., flow aids) can also be included in product ingredients, for example, to enhance the flow or compaction of the ingredients, if necessary for downstream processing of the product ingredients, such as granulation or blending, or the product itself, such as tabletting. Exemplary processing aids 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 processing aid is a flow aid or lubricant. In some embodiments, the flow aid or lubricant is silica, stearic acid, magnesium stearate, sodium stearyl fumarate, or combinations thereof.

[0199] A representative amount of processing aid, when present, may comprise at least about 0.5 percent or at least about 1 percent of the total weight of the composition. Preferably, the amount of processing aid in the composition does not exceed about 5 percent, and often does not exceed about 3 percent, of the total weight of the composition.

[0200] Other Additives Other additives may be included in the disclosed compositions. For example, the compositions 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, 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 composition, 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 composition.

[0201] The above-mentioned additives can be used together (e.g., as an additive blend) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final composition). Furthermore, the above-mentioned types of additives can be encapsulated when provided in the final product or composition. Exemplary encapsulated additives are described, for example, in Atchley, WO2010 / 132444, previously incorporated by reference herein.

[0202] granular In some embodiments, any one or more components of the composition, or the composition as a whole, may be described as a granular material or as being in granular form. As used herein, the term "granular" refers to a material in the form of a plurality of individual particles, some of which may be in the form of an agglomeration 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, such as less than about 1:1. In various embodiments, the particles of the granular material may be described as being substantially spherical or granular.

[0203] The particle size of a granular material may be measured by sieve analysis. As one skilled in the art will readily appreciate, sieve analysis (otherwise known as gradient testing) is a method used to measure the particle size distribution of a granular material. Typically, sieve analysis involves a column of nested sieves, the sieves preferably comprising screens in the form of wire mesh fabric. A pre-weighed sample may be introduced into the upper or top sieve in the column, which has the largest screen opening or mesh size (i.e. the largest pore diameter of the sieve). Each sieve lower in the column has a progressively smaller screen opening or mesh size than the sieve at the top. Typically, the bottom of the sieve column has a receiver section that collects any particles having a particle size smaller than the screen opening or mesh size of the bottom or bottommost sieve in the column (which has the smallest screen opening or mesh size).

[0204] 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 run for a predetermined period of time to ensure that all particles are collected on the correct sieve. In some embodiments, the column of sieves is agitated for a period of 0.5 minutes to 10 minutes, such as 1 minute to 10 minutes, such as 1 minute to 5 minutes, such as approximately 3 minutes. Once the agitation of the sieves in the column is complete, the material collected on each sieve is weighed. The weight of each sample on each sieve is then divided by the total weight to obtain the percentage of mass retained on each sieve. Those skilled in the art will readily recognize that the screen opening size or mesh size for each sieve in the column used for sieve analysis 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 sieve analysis, the column comprising 2 to 20 sieves, for example 5 to 15 sieves. In some embodiments, a column of sieves may be used for sieve analysis, the column comprising 10 sieves. In some embodiments, the largest screen opening or mesh size of the sieve used for sieve analysis may be 2000 μm, for example 1500 μm, for example 1000 μm or for example 500 μm.

[0205] In some embodiments, any material referred to herein (e.g., fillers, active ingredients, and the overall composition) characterized as being in granular form may have at least 50% by weight of particles having a particle size of about 2000 μm or less, such as about 1500 μm or less, such as about 700 μm or less, as measured by sieve analysis. In some embodiments, at least 60% by weight of particles of any granular material referred to herein have a particle size of about 2000 μm or less, such as about 1500 μm or less, such as about 700 μm or less, as measured by sieve analysis. In some embodiments, at least 70% by weight of particles of any granular material referred to herein have a particle size of about 2000 μm or less, such as about 1500 μm or less, such as about 700 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 2000 μm or less, such as about 1500 μm or less, such as about 700 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 2000 μm or less, such as about 1500 μm or less, such as about 700 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 2000 μm or less, such as about 1500 μm or less, such as about 700 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 2000 μm or less, such as about 1500 μm or less, such as about 700 μm or less, as measured by sieve analysis. In some embodiments, substantially 100% by weight of the particles of any particulate material referred to herein have a particle size of about 2000 μm or less, such as about 1500 μm or less, for example about 700 μm or less, as measured by sieve analysis.

[0206] In some embodiments, at least 50% by weight, such as at least 60% by weight, such as at least 70% by weight, such as at least 80% by weight, such as at least 90% by weight, such as at least 95% by weight, such as at least 99% by weight, of the particles of any particulate material referred to herein have a particle size of about 0.01 μm to about 2000 μm, such as about 0.05 μm to about 1500 μm, such as about 0.1 μm to about 750 μm, as measured by sieve analysis. In some embodiments, at least 50% by weight, such as at least 60% by weight, such as at least 70% by weight, such as at least 80% by weight, such as at least 90% by weight, such as at least 95% by weight, such as at least 99% by weight, of the particles of any particulate material referred to herein have a particle size of about 700 μm to about 2000 μm, such as about 700 μm to about 1500 μm, as measured by sieve analysis.

[0207] Constructed for oral use Provided herein is a pouch product comprising a composition configured for oral use. The term "configured for oral use" as used herein means that the composition is provided in such a form that one or more components of the composition (e.g., flavoring agent and / or active ingredient) are carried into the mouth of the user by the saliva in the user's mouth during use. In certain embodiments, the composition is configured 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 an active ingredient (e.g., including but not limited to, stimulants, vitamins, taste modifiers, or combinations thereof) that can be absorbed via the oral mucosa or absorbed via the digestive tract when the product is used.

[0208] In some embodiments, the compositions configured for oral use described herein include the compositions of the present disclosure disposed within a moisture-permeable container (e.g., a water-permeable pouch). Such compositions in a water-permeable pouch format are typically used by placing one of the pouches containing the composition in the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's oral cavity, e.g., under the lips, in the same manner that moist snuff products are typically used. Preferably, the pouch is not chewed or swallowed. Exposure to saliva then allows some of the components of the composition therein (e.g., flavoring agents and / or active ingredients) to pass through, e.g., the water-permeable pouch, providing flavor and satisfaction to the user. After about 5 minutes to about 60 minutes, typically about 10 minutes to about 30 minutes of use / enjoyment, a substantial amount of the composition is released and absorbed through the oral mucosa of the human subject, and the pouch can be removed from the human subject's mouth for disposal.

[0209] The compositions of the present disclosure are at least partially dissolvable. As used herein, the terms "dissolve", "dissolving" and "dissolvable" refer to compositions having water-soluble components that interact with moisture in the oral cavity to go into solution, thus causing gradual consumption of the product. In various embodiments, the compositions can be made or configured to at least partially dissolve or completely dissolve in the oral cavity over a period of time. In some embodiments, the dissolvable composition can last in the user's mouth for a given time until it is completely dissolved or completely dissolved. The dissolution rate can vary over a wide range, from about 1 minute or less to about 60 minutes. For example, fast release compositions usually dissolve and / or release the desired components (e.g., active ingredients, flavors, etc.) within about 2 minutes, often within about 1 minute (e.g., within about 50 seconds, within about 40 seconds, within about 30 seconds, or within about 20 seconds). In some embodiments, the dissolution rate is more gradual, for example dissolving and / or releasing the desired components (e.g., active ingredients, flavors, etc.) within a period of about 60 minutes, for example, about 45 minutes, about 30 minutes, or about 15 minutes. The dissolution rate can vary depending on factors such as the size, density, and surface area of ​​the composition present in the pouch, and the amount of the composition by weight present in the pouch. Furthermore, the dissolution rate and extent of dissolution can vary depending on the selection of fillers and the solubility of other components present in the composition. Dissolution can occur by any means, for example, melting, mechanical destruction (e.g., chewing), enzymatic or other chemical degradation, or by disruption of interactions between the components of the composition.

[0210] In certain embodiments, the composition comprises only saliva-soluble substances, and thus the composition dissolves completely when placed in the oral cavity. In other embodiments, the composition further comprises an insoluble component, and thus a portion of the composition remains undissolved. In some embodiments, at least about 1% by weight of the composition dissolves in the oral cavity within a period of about 60 minutes, for example, about 45 minutes, about 30 minutes, or about 15 minutes. In some embodiments, at least about 5%, at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 95%, at least about 99%, or about 100% by weight of the composition dissolves in the oral cavity within a period of about 60 minutes, for example, about 45 minutes, about 30 minutes, or about 15 minutes. In certain embodiments, at least about 95% by weight of the composition is dissolved in the oral cavity within a period of about 60 minutes, such as about 45 minutes, about 30 minutes, or about 15 minutes, e.g., about 95%, about 96%, about 97%, about 98%, about 99%, or even 100% by weight.

[0211] The compositions configured for oral use described herein can take a variety of forms, including pellets, tablets, granules, beads, and powders, any of which may be placed in a pouch. The compositions disclosed herein can be formed into a variety of shapes, including pills, tablets, spheres, beads, ovals, obloids, and the like. The cross-sectional shapes of the compositions can vary, with example cross-sectional shapes including round, square, oval, rectangular, and the like. Such shapes can be formed in a variety of ways using equipment, such as moving belts, nips, extruders, granulators, compression equipment, and the like.

[0212] In some embodiments, the composition is in a particulate form (eg, a powder or granules) enclosed within a pouch and substantially dissolves in less than about 10 minutes, for example, in about 5 to about 10 minutes.

[0213] In some embodiments, the composition is in bead form (e.g., roughly spherical beads) enclosed in a pouch and substantially dissolves in less than about 30 minutes, e.g., about 10 to about 15 minutes. In certain embodiments, the beads are configured to be substantially (i.e., greater than 95%) dissolvable within about 15 minutes. The rate of dissolution may vary based on the size of the beads and the particular bulking agent utilized. The size of the beads may vary, but is generally about 10 to about 25 mesh (about 700 to about 2000 μm). Beaded embodiments generally include a large relative amount of sugar alcohol as a dissolvable bulking agent, e.g., isomalt. In some embodiments, the beaded composition includes a humectant, e.g., glycerin or propylene glycol, in an amount of up to about 25% by weight, e.g., about 16 to about 20% by weight.

[0214] In some embodiments, the composition in bead form can include an optional outer coating that includes a release modifier. Such release modifier coatings can provide delayed and / or sustained release of components (e.g., flavors, active ingredients, sweeteners, soluble fillers, etc.) from the composition. The coating typically includes a film-forming polymer, such as a cellulosic material, an optional plasticizer, and optional flavors, colors, salts, sweeteners, or other additives of the type described herein. The coating composition is typically aqueous in nature and can be applied using any coating technique known in the art, such as pan coating. Exemplary film-forming polymers include cellulosic materials. Exemplary plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional possible coatings include food grade shellac, lipids, waxes, and combinations thereof. In some embodiments, at least a portion of the beads are coated with a release modifier selected from the group consisting of lipids, cellulose derivatives, binders, and combinations thereof.

[0215] Non-limiting examples of suitable lipids include oils and waxes of natural (e.g., vegetable or animal-based) or synthetic (e.g., derived from petroleum) origin. Suitable lipids may be hydrogenated, partially hydrogenated, or unhydrogenated. In some embodiments, the lipids are food grade oils, such as vegetable oils (e.g., acai oil, almond oil, amaranth oil, apricot oil, apple seed oil, argan oil, avocado oil, babassu oil, beech nut oil, ben oil, bitter melon oil, black seed oil, blackcurrant seed oil, borage seed oil, Borneo tallow nut oil, gourd oil, Brazil nut oil, buffalo oil, butternut squash seed oil, cape chestnut oil, canola oil, locust oil, oleander ... Cashew oil, cocoa butter, cockle oil, coconut oil, corn oil, cochle oil, coriander seed oil, cottonseed oil, date seed oil, dika oil, egus seed oil, evening primrose oil, false linseed oil, linseed oil, grapeseed oil, grapefruit seed oil, hazelnut oil, hemp oil, kapok seed oil, kenaf seed oil, lalemantia oil, lemon oil, linseed oil, macadamia oil, mafra oil, marula oil, medfoam seed oil, mongongo nut oil , Mustard oil, Niger seed oil, Nutmeg butter, Okra seed oil, Olive oil, Orange oil, Palm oil, Palm stearin, Papaya seed oil, Peanut oil, Pecan oil, Perilla oil, Persimmon oil, Pequi oil, Pili nut oil, Pine nut oil, Pistachio oil, Pomegranate seed oil, Poppy seed oil, Prakash oil, Prune kernel oil, Pumpkin seed oil, Quinoa oil, Rapeseed oil, Rice bran oil, Royle oil, Sacha inchi oil, Safflower oil, Sa Potato oil, cejae oil, sesame oil, shea butter, soybean oil, sunflower oil, tarramilla oil, tea seed oil, thistle oil, tiger nut oil, tobacco seed oil, tomato seed oil, walnut oil, melon seed oil, wheat germ oil, and combinations thereof), animal oils, beef fats (e.g., buffalo fat, sheep fat, goat fat, pork fat, lard, camel fat, tallow, liquid margarine, fish oil, fish liver oil, whale oil, seal oil, and combinations thereof), and mineral oils. In some embodiments, the lipid is a wax, such as beeswax, carnauba wax, or paraffin wax.

[0216] Non-limiting examples of suitable cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethylcellulose and carboxymethylcellulose ("CMC").

[0217] Non-limiting examples of suitable binders include povidone, alginates, starch-based binders, pectins, gums, carrageenan, pullulan, zein, and the like, and combinations thereof.

[0218] In some embodiments, the composition in bead form includes an optional outer coating comprising shellac, carnauba wax, paraffin wax, beeswax, palm oil, sunflower oil, or combinations thereof.

[0219] In some embodiments, a mixture of coated and uncoated beads is placed in the pouch. In some embodiments, a mixture of beads with different dissolution rates is placed in the pouch. For example, the beads may be formed from different compositions (e.g., with different amounts of fillers or different types of fillers) that dissolve at different rates when contacted with saliva. In some embodiments, the pouch comprises a composition disclosed herein in bead form, and further comprises microcrystalline cellulose as a physical mixture with the beads. In some embodiments, the flavor, active ingredient, or both are present in or on the microcrystalline cellulose. In some embodiments, the microcrystalline cellulose comprises a liquid flavoring agent disposed on its surface (i.e., adsorbed or absorbed in or on the microcrystalline cellulose). In some embodiments, the microcrystalline cellulose comprises a dry liquid flavoring agent disposed on its surface (i.e., adsorbed or absorbed in or on the microcrystalline cellulose). An embodiment using a flavoring agent present in or on the microcrystalline cellulose may be advantageous in providing a more uniform product.

[0220] In some embodiments, the composition is in the form of one or more compressed or molded pellets (e.g., one or more tablets) enclosed in a pouch, and the composition substantially dissolves in less than about 30 minutes, for example, in about 20 to about 30 minutes. In some embodiments, the compressed or molded pellets in the pouch are subjected to mechanical force, such as breaking, crushing, or chewing the pouched composition, before or when placed in the mouth of the user, to increase the dissolution rate of the composition and the individual components therein (e.g., flavorings, active ingredients, etc.). In some embodiments, a single compressed tablet or pellet is placed in the pouch. In some embodiments, multiple compressed tablets or pellets are placed in the pouch.

[0221] Certain embodiments of the present disclosure are described with reference to FIG. 1, and these described embodiments include snus-type products having an outer pouch and containing a composition as described herein. Such embodiments are presented by way of example only. The composition / structure of such packets or pouches, such as the container pouch 102 of the embodiment illustrated in FIG. 1, may vary as described herein above. With reference to FIG. 1, an embodiment of a pouch product 100 is shown. The pouch product 100 includes a moisture-permeable container in the form of a pouch 102 that contains a substance 104 that includes a composition as described herein. With reference to FIG. 2, an embodiment of a pouch product 100 is shown that includes a moisture-permeable container in the form of a pouch 102 that contains a composition as described herein in tablet form 105. With reference to FIG. 3, an embodiment of a pouch product 100 is shown that includes a moisture-permeable container in the form of a pouch 102 that contains a composition as described herein as powder, granules, multiple pellets, tablets, or beads 106.

[0222] The pouches described herein have three dimensions: length, width and thickness. One skilled in the art will recognize that such dimensions may vary depending on the intended size and volume of the overall pouch, as well as the amount of material desired in the pouch. The amount of material contained in each pouch may vary. In some embodiments, the weight of the composition 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 to about 700 mg. In some smaller embodiments, the weight of the composition in each pouch may be about 100 mg to about 300 mg. For larger embodiments, the weight of the material in each pouch may be about 300 mg to about 700 mg.

[0223] Other components can be placed in each pouch if desired. For example, at least one flavored strip, piece or sheet of flavored water-dispersible or water-soluble material (e.g., breath freshening edible film type material) can be placed in each pouch with or without at least one capsule. Such strip or sheet can be easily incorporated into the 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 EFSA Journal (2004) 85, pages 1-32. In some embodiments, the pouch contents further include microcrystalline cellulose as described herein above.

[0224] The type of pouch may vary. Suitable pouches of the type used in the manufacture of smokeless tobacco products 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. The composition may be pouched and packaged in a manner and using the type of components used in the manufacture of conventional snus types of products. The pouch provides a type of liquid-permeable container that may be considered similar in nature to the mesh-like type of material used in the construction of tea bags. The components of the composition diffuse easily from the pouch into the mouth of the user.

[0225] Non-limiting examples of suitable types of pouches are described in, for example, U.S. Pat. Nos. 5,167,244 to Kjerstad and 8,931,493 to Sebastian et al., as well as U.S. Patent Application Publication Nos. 2016 / 0000140 to Sebastian et al.; 2016 / 0073689 to Sebastian et al.; 2016 / 0157515 to Chapman et al.; and 2016 / 0192703 to Sebastian et al., each of which is incorporated herein by reference. The pouches may be provided as individual pouches or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches) may be linked or connected together (e.g., in an end-to-end manner) so that a single patch or individual portion can be easily removed from the linked chain or matrix of pouches one at a time for use.

[0226] The pouches of the present disclosure can be formed from fleece materials, such as fibrous nonwoven webs. As used herein, the term "fiber" is defined as the basic element of a textile product. 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 includes two or more components that have different physical or chemical properties, including bicomponent fibers. Specifically, the term "multicomponent fiber" includes staple and continuous fibers prepared from two or more polymers that exist in separate structured domains within the fiber, as opposed to blends, where the domains tend to be dispersed, random, or unstructured.

[0227] "Fleece material," as used herein, can be formed from various types of fibers, as described in more detail herein below, and can form a conventional fleece fabric or other conventional pouch material. For example, the fleece material can be provided in the form of a woven or nonwoven fabric. Suitable types of fleece materials are described, for example, in U.S. Patent No. 8,931,493 to Sebastian et al.; and U.S. Patent Application Publication No. 2015 / 0128978 to Sebastian et al., U.S. Patent Application Publication No. 2016 / 0000140 to Sebastian et al., and U.S. Patent Application Publication No. 2016 / 0073689 to Sebastian et al., all of which are incorporated herein by reference.

[0228] The term "nonwoven" is used herein in reference to a fibrous material, web, mat, batt, or sheet in which the fibers are aligned in an undefined or random direction. Nonwoven fibers are initially presented as unbonded fibers or filaments. A key step in the manufacture of nonwovens involves bonding the various fibers or filaments together. The manner in which the fibers or filaments are bonded may vary and include thermal, mechanical, and chemical techniques that are selected in part based on the desired characteristics of the final product, as discussed in more detail herein below.

[0229] In some embodiments, the pouch may be biodegradable or dissolvable. In some embodiments, after use, the entire composition, and in certain embodiments, the entire pouch material that originally contained the composition, is dissolved and can be ingested by the user for oral use, leaving no pouch product to be removed from the user's mouth. Exemplary dissolvable pouches may be manufactured in such a manner from materials such that the pouch undergoes controlled dispersion or dissolution during use by the user. Such pouch materials may have the form of mesh, screen, perforated paper, permeable fabric, and the like. For example, pouch materials manufactured from rice paper or mesh-like forms of perforated rice paper can dissolve in the user's mouth. As a result, the pouch and composition each can undergo complete dispersion in the user's mouth during normal conditions of use, and thus both the pouch and the composition can be ingested by the user. In various embodiments, the pouch material can be dissolvable (i.e., ingestible into the mouth) such that the pouch material dissolves completely under normal conditions of use (i.e., upon contact with saliva in the user's mouth). Preferably, the pouch material dissolves after a significant amount of the soluble components of the composition within the pouch (e.g., active ingredients and / or flavorings) have permeated through the pouch material and into the user's mouth. For example, the pouch material can be configured to dissolve at a rate such that the pouch material holds the composition together for a sufficient period of time to allow release of substantially all of the water-soluble components.

[0230] As described herein, the composition within the pouch material is at least partially dissolvable. In such embodiments, the pouch material can be configured to dissolve at a rate similar to that at which the composition dissolves. In certain embodiments, the pouch material can be adapted or configured 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 configured 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 configured 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 including dissolvable or biodegradable pouch materials can provide environmental benefits.

[0231] In various embodiments, dissolvable pouch materials can include, but are 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 can be controlled by using cross-linking techniques, for example, with alginate or pectin and calcium salts. Other examples of pouch materials may be manufactured using materials in combination with water-dispersible film-forming materials (e.g., binders such as carboxymethylcellulose, xanthan gum, pullulan, etc.), and materials such as ground cellulose derivatives (e.g., finely divided wood pulp). Preferred pouch materials are water-dispersible or dissolvable, but can be designed and manufactured such that under normal conditions of use, a significant amount of the contents of the composition will permeate through the pouch material before the pouch loses its physical integrity. If desired, flavoring ingredients, disintegration aids, and other desired components can be incorporated into or applied to the pouch material.

[0232] In certain embodiments, the dissolvable pouch material can 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, 42(2), pp. 469-480, which is incorporated by reference herein in its entirety.

[0233] 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, polyhydroxyalkanoates, 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 from 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, polyglycolic acid, polylactic acid, polyhydroxyalkanoates, and combinations thereof. Pouches containing such polymers can be described as biodegradable.

[0234] Regenerated cellulose fibers can be particularly advantageous, and are typically prepared by extracting non-cellulosic compounds from wood, contacting the extracted wood with caustic soda, followed by carbon disulfide, then sodium hydroxide to obtain a viscous solution. The solution is then extruded through a spinneret head to produce a viscous thread of regenerated fiber. Exemplary methods for the preparation of regenerated cellulose are provided in U.S. Patent No. 4,237,274 to Leoni, U.S. Patent No. 4,268,666 to Baldini et al., U.S. Patent No. 4,252,766 to Baldini et al., U.S. Patent No. 4,388,256 to Ishida et al., U.S. Patent No. 4,535,028 to Yokogi et al., U.S. Patent No. 5,441,689 to Laity, U.S. Patent No. 5,997,790 to Vos et al., and U.S. Patent No. 8,177,938 to Sumnicht, which are incorporated herein by reference. The manner in which regenerated cellulose is made is not limited and can include, for example, both the rayon process and the TENCEL process. Various manufacturers of regenerated cellulose are known, including Lenzing (Austria), Cordenka (Germany), Aditya Birla (India), and Daicel (Japan).

[0235] The morphology of the fibers used in the nonwoven webs according to the present disclosure may vary and may include fibers having any type of cross section, including, but not limited to, circular, rectangular, square, elliptical, triangular, and multilobal. In certain embodiments, the fibers may have one or more void spaces, and the void spaces may have, for example, circular, rectangular, square, elliptical, triangular, or multilobal cross sections. As previously described, the fibers may be selected from monocomponent (i.e., compositionally uniform throughout the fiber) or multicomponent fiber types, including, but not limited to, fibers having a sheath / core structure and 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.

[0236] The physical parameters of the fibers present in the nonwoven web may vary. For example, the fibers used in the nonwoven web may have different size (e.g., length, denier per filament (dpf)) and crimp characteristics. In some embodiments, the fibers used in the nonwoven web may be nanofibers, submicron fibers, and / or micron-sized fibers. In certain embodiments, the fibers of the nonwoven webs useful herein may measure from about 1.5 dpf to about 2.0 dpf, or from about 1.6 dpf to about 1.90 dpf. In various embodiments, each fiber may measure from about 4 to 10 crimps per cm, or from about 5 to 8 crimps per cm. In some embodiments, each fiber may be a continuous filament fiber. In certain embodiments, each fiber may be a staple fiber. Each fiber length may measure, for example, from about 35 mm to about 60 mm, or from about 38 mm to about 55 mm. To ensure a preferred blend and orientation of the fibers in the nonwoven web, it can be advantageous for all of the fibers in the nonwoven web to have similar fiber size and crimp characteristics.

[0237] The fibrous web can have different thicknesses, porosities, and other parameters. The nonwoven web can be formed to retain the composition adapted for oral use enclosed within the outer water permeable pouch and still allow the consumer to enjoy the flavor of the composition, depending on the fiber orientation and porosity of the pouch product formed from the nonwoven web. For example, in some embodiments, the fibrous web can have a basis weight of about 20 gsm to about 35 gsm, or about 25 gsm to about 30 gsm. In a preferred embodiment, the fibrous web can have a basis weight of about 28 gsm. The basis weight of the woven fabric can be measured, for example, using ASTM D3776 / D3776M-09a(2013) (Standard Test Methods for Mass Per Unit Area(Weight)of Fabric). In various embodiments, the fibrous web can have a thickness of about 0.1 mm to about 0.15 mm (e.g., about 0.11 mm). The fibrous web can have an elongation of about 70% to about 80%, e.g., about 78%. In some embodiments, the fibrous web can have a peak load of about 4 lbs. to about 8 lbs., e.g., about 5.5 lbs. The elongation and breaking strength of textile fabrics can be measured, for example, using ASTM D5034-09(2013) (Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)). In various embodiments, the fibrous web can have a Tensile Energy Absorption (TEA) of about 35 to about 40, e.g., about 37. In certain embodiments, the fibrous web can have a Tensile Energy Absorption (TEA) of about 10,000 ml / min / cm. 2The porosity of the fiber fabric can be measured by, for example, the force required to break the sample under a tensile load applied per side area of ​​the sample. The porosity, or air permeability, of the fiber fabric can be measured by, for example, ASTM D737-04(2012) (Standard Test method for Air Permeability of Textile Fabrics).

[0238] In various embodiments of the pouch product described herein, the outer water-permeable pouch is made from the nonwoven web described above. In some embodiments, the pouch is constructed from a single layer of the nonwoven web. In various embodiments, the pouch material comprises a multi-layer composite made from two or more nonwoven layers, each layer being oral ingestible. Each nonwoven layer can be formed by the process discussed below. In the multi-layer structure, the first layer can be relatively hydrophilic and the second layer can be relatively hydrophobic (relative to each other). In some embodiments, the outer water-permeable pouch can comprise an outer hydrophilic layer and an inner hydrophobic layer that can contact the composition intended for oral use. Thus, the hydrophobic layer can retain any moisture in the composition intended 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 in the hydrophobic layer can allow moisture to escape to the mouth of the user, so that the flavor is released in the oral cavity upon use. In this way, the pouch material can enhance storage stability without significantly compromising the end user's enjoyment of the product. The two layers can be bonded together using any means known in the art, for example, adhesives or stitching to form a multi-layer composite nonwoven material. The hydrophobicity of the woven material can be evaluated as known in the art, for example, by measuring the contact angle between a liquid droplet and the surface of the woven material.

[0239] In certain embodiments, the pouch material can include a flavor component (e.g., any of the flavor components noted 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 in the outer pouch material can be different from the flavor contained in the internal composition configured for oral use. For example, in certain embodiments, the pouch material can have a first flavor component, and after the pouch material dissolves, more moisture can reach the composition in the pouch material, and the flavor component in the composition can be enhanced. In this way, the product can be designed to provide multiple, different sensory experiences, where in a first sensory experience, the flavor in the outer pouch material migrates into the user's mouth, and in a second sensory experience, which typically occurs at a later time, the flavor of the internal composition migrates into the user's mouth.

[0240] In some embodiments, a heat-sealable binder coating or binder material (e.g., a coating or other additive) can be added to the fibers before, during, or after forming the fleece material. As used herein, "heat-sealable binder coating" refers to a coating material, e.g., an acrylic polymer composition, that is applied to a substrate (e.g., a nonwoven web or fleece material) that allows for sealing of individual pouch seams upon heating. In some embodiments, the binder material can be added to the web fibers before or during lamination of the fibrous webs (i.e., before the fibrous webs are bonded to form the fleece material). In certain embodiments, the binder material can be added to the fleece material after it is formed. In various embodiments, the binder material is in the form of a liquid coating. In certain embodiments, a binder powder can be applied to the fleece material. For example, powdered polyethylene can be used as the binder material. A liquid or powder coating can be applied between the fibrous layers, for example, in cross-lamination, air lamination, or after processing. A brief exposure in an oven is sufficient to melt and fuse the binder material.

[0241] The pouch products described herein can be packaged in any suitable inner wrapping material and / or outer container, see, for example, U.S. Patent No. 7,014,039 to Henson et al., U.S. Patent No. 7,537,110 to Kutsch et al., U.S. Patent No. 7,584,843 to Kutsch et al., U.S. Patent No. 8,397,945 to Gelardi et al., D592,956 to Thiellier et al., D594,154 to Patel et al., and D625,178 to Bailey et al., U.S. Patent Publication No. 2008 / 0173317 to Robinson et al., U.S. Patent Publication No. 2009 / 0014343 to Clark et al., U.S. Patent Publication No. 2009 / 0014450 to Bjorkholm, and U.S. Patent Publication No. 2009 / 0014450 to Bellamy et al., all of which are incorporated herein by reference. See also U.S. Patent Publication No. 2009 / 0250360 to Ah et al.; U.S. Patent Publication No. 2009 / 0266837 to Gelardi et al.; U.S. Patent Publication No. 2009 / 0223989 to Gelardi; U.S. Patent Publication No. 2009 / 0230003 to Thiellier; U.S. Patent Publication No. 2010 / 0084424 to Gelardi; and the various types of containers for smokeless type products described in U.S. Patent Publication No. 2010 / 0133140 to Bailey et al.; U.S. Patent Publication No. 2010 / 0264157 to Bailey et al.; and U.S. Patent Publication No. 2011 / 0168712 to Bailey et al.

[0242] Although the compositions described herein that are configured for oral use are generally described as being disposed in the pouches described, the products of the present disclosure are not limited to such pouch embodiments.Thus, any of the disclosed compositions embodiments may be used in the absence of a pouch.For example, the compositions described herein that are configured for oral use may simply be applied directly to the oral cavity, for example, as a powder, granule, bead, tablet, pellet, etc.

[0243] Preparation of the Composition The compositions of the present disclosure may generally be prepared, for example, by dry blending the dry ingredients, such as fillers, active ingredients, salts, buffers, flavorings, etc., combining the dry mixture with any liquid ingredients, such as wetting agents, and then replacing the composition in a pouch.

[0244] The manner in which the various components of the composition are combined can vary. Thus, the overall mixture of the entire composition, for example, with the powdered composition components, can be of a relatively homogeneous nature. The above-mentioned components can be in liquid or dry solid form and can be blended in a pre-treatment step before mixing with any remaining components of the composition, or can simply be mixed together with all other liquid or dry components. In certain embodiments, the liquid flavoring is combined with a porous granular carrier, for example, microcrystalline cellulose, to form a dry flavoring mixture. This dry flavoring can then be combined with other components of the composition (e.g., dissolvable fillers, active ingredients, etc.). Introducing the flavoring in this manner can be beneficial in achieving a more homogeneous product and avoiding clumping that may otherwise occur when liquid flavoring is combined with other dry materials. Such clumping is undesirable, as it reduces the homogeneity of the product and requires further processing, for example, settling time and milling. In other embodiments, the flavoring is added to other components in dry form, for example, as a spray-dried powder.

[0245] The various components of the composition can be contacted, combined, or mixed together using any mixing technique or device known in the art. Any mixing method that brings the composition components into intimate contact can be used, such as a mixing device that features 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., such as FKM130, FKM600, FKM1200, FKM2000 and FKM3000, Plough Share type mixer cylinders, Hobart mixers, and the like. Also see, for example, the types of methodologies 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. The manner and methods for formulating the compositions will be apparent to those skilled in the art, see, for example, the types of methods described in U.S. Patent No. 4,148,325 to Solomon et al., U.S. Patent No. 6,510,855 to Korte et al., and U.S. Patent No. 6,834,654 to Williams, U.S. Patent No. 4,725,440 to Ridgway et al., and U.S. Patent No. 6,077,524 to Bolder et al., each of which is incorporated herein by reference.

[0246] In some embodiments, the composition (e.g., dry blend) is compressed or otherwise processed before being enclosed in a pouch. In some embodiments, the composition may be compressed using conventional tableting techniques. Compressed pellets or tablets may be produced by compressing a dry blend containing any of the relevant formulation components in the form of pellets, tablets, etc. Exemplary compression equipment, such as compression presses, are available as Colton 2216 and Colton 2247 from Vector Corporation, and 1200i, 2200i, 3200, 2090, 3090, and 4090 from Fette Compacting. Equipment for applying an outer coating layer to a compressed pelletized product is available as CompuLab 24, CompuLab 36, Accela-Cota 48, and Accela-Cota 60 from Thomas Engineering.

[0247] In some embodiments, after compression, the composition is in a compressed shape of a predetermined form. The cross-sectional shape of the composition may vary, and exemplary cross-sectional shapes include circular, square, rectangular, oblong, etc. In certain embodiments, the composition is in the form of compressed or molded pellets, which can have any of a variety of shapes, including traditional pill or tablet shapes. The exact shape and size will depend on the desired application.

[0248] In some embodiments, prior to or as an alternative to compression, the dry mixture is granulated to form a plurality of granules. Granulation is a process in which particles of individual components, for example in powder form, are made to adhere to form large, uniform, and multiple particulate entities called granules. Granulation is particularly suitable in embodiments in which the product includes milled non-tobacco botanical materials, botanical extracts, or certain flavorings. Milled botanical materials and extracts, as well as certain flavorings, due to their high moisture and / or oil content, tend to stick together and form agglomerates that may result in a non-uniform product in the absence of granulation. Such agglomeration is also undesirable during processing, as it may lead to difficulties in achieving proper flowability, which is particularly undesirable in compressed (e.g., tableted) embodiments. Any suitable means for granulation may be utilized. For example, granulation may be performed in a granulator under high shear, low shear, fluidized bed, rotor, or melt granulation.

[0249] The dry mixture can be mixed with a liquid binder or binder solution (e.g., by spraying the binder solution into a granulator) and granulated to a desired particle size, e.g., about 100 to about 200 microns. As understood in the art, the binder solution promotes agglomeration of the dry powder granulation mixture into larger granules. The binder solution used in the granulation process can be either an aqueous or alcohol-based solution containing a suitable binder or combination of binders. In some embodiments, the binder comprises a cellulose ether as described hereinabove. In some embodiments, the binder comprises polyvinylpyrrolidone or a combination of cellulose ether and polyvinylpyrrolidone. In some embodiments, the binder is polyvinylpyrrolidone. The molecular weight of the polyvinylpyrrolidone can vary and is generally designated by reference to the letter "K" followed by a number. For example, in some embodiments, the polyvinylpyrrolidone is K29 / 32 or K30, meaning that the polyvinylpyrrolidone has an average molecular weight of 29,000 to 32,000 or 30,000, respectively.

[0250] The binder solution typically has a solids content of about 3 to about 20 percent (w / w), and suitable solvents include water and ethanol. The binder solution used in the granulation process can be aqueous in nature. In some embodiments, the binder solution includes at least one active ingredient, at least one flavoring agent, or a combination thereof. The binder solution, the dry mix, or both, can contain other additives, including any of the additives discussed herein, such as salts, buffers, non-tobacco botanical materials, sweeteners, processing aids, and the like. Such additives may be added before or after granulation.

[0251] In some embodiments, the compositions of the present disclosure may be prepared into bead form using various methods, including extrusion and spheronization, prilling, spray granulation, briquetting, and / or roller compaction. Typically, a mixture of components (e.g., soluble filler, active ingredient and / or flavoring agent and humectant) is granulated as described herein above to form agglomerates. Without wishing to be bound by theory, it is believed that utilizing a humectant, such as glycerin, in an amount of up to about 20% by weight of the composition is advantageous both to provide the composition with desired properties and to facilitate processing. Typically, the agglomerates are then extruded. Extrusion can be performed using an extruder, such as a screw, sieve, basket, roll, and ram type extruder, to extrude the agglomerates through a screen with appropriately sized holes. Any suitable extrudate shape may be used. In some embodiments, the agglomerates are extruded into a rod. The extrudate is then processed in a spheronizer (such as a spheronizer (Marumerizer) available from Caleva Process Solutions Ltd. or LCI Corporation) for a suitable time (e.g., 10 minutes) at a suitable rotation speed (e.g., 1200 RPM). For example, spheronization can be performed using a spinning friction plate that rounds the particles of the extrudate. After spheronization, the composition is obtained in the form of sized beads. The sized beads can be processed through a series of screens to produce a desired size range, e.g., from about 700 to about 2000 μm in diameter.

[0252] The composition in the form of beads or compressed pellets or tablets can include an optional outer coating, which can help improve the storage stability of the composition and improve the packaging process by reducing friability and dusting. Thus, in some embodiments, the method further includes a step of coating the composition in bead or compressed form. The coating typically includes a film-forming polymer, such as a cellulosic material, an optional plasticizer, and optional flavorings, colorants, salts, sweeteners, or other additives of the type described herein. The coating composition is typically aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as pan coating. Exemplary film-forming polymers include cellulosic materials, such as methylcellulose, hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose, and carboxymethylcellulose (CMC). Exemplary plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potential coating agents include food grade shellac, waxes such as carnuaba wax, paraffin wax and beeswax, oils such as palm oil and sunflower oil, and combinations thereof. In some embodiments, the composition in the form of beads, or compressed pellets or tablets, can include a modified release coating as described herein above.

[0253] Method for making pouch products Various manufacturing apparatuses and methods can be used to make the pouch products described herein. For example, Novak, III et al., US Publication No. 2012 / 0055493, previously incorporated by reference in its entirety, relates to an apparatus and process for providing a pouch material formed into a tube for use in the manufacture of smokeless tobacco products. Similar 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. Representative apparatus for forming a continuous tube of such pouch material is disclosed, for example, in Boldrini et al., US Patent Publication No. 2010 / 0101588, previously incorporated by reference in its entirety. The apparatus further includes a device for supplying a pouch material to the continuous tubular member such that when the continuous tubular member is subdivided and sealed into separate pouch portions, each pouch portion contains a filler material of a composition adapted for oral use. An exemplary 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 individual pouch portions of a continuous tubular member may occur substantially simultaneously with its subdivision using closure and division units. It is noted that in certain embodiments of the present disclosure where a low melting point binder material is used, the temperature required for sealing the seams of the pouch product may be lower than that required for conventional processes involving conventional binder materials.

[0254] In some embodiments, the composition is introduced into the pouch material in the form of a granular material (e.g., as a dry powder). In dry powder embodiments, it has been found that pouching of dry powder compositions involves drawbacks such as airborne fines, melting of powder on heat seal knives, and scorching on the pouch. In accordance with the present disclosure, it has been found that introducing a wetting agent, such as propylene glycol, in an amount of up to about 5% by weight based on the total weight of the composition can reduce or stop dusting and the problems associated with such dusting. Furthermore, in accordance with the present disclosure, it has been found that introducing the composition in the form of beads, or compressed pellets or tablets also avoids such problems. Thus, in some embodiments, the composition is introduced into the pouch material in the form of beads. In some embodiments, the composition is introduced into the pouch material in the form of one or more compressed tablets or pellets.

[0255] 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. EXAMPLES

[0256] Aspects of the present invention are more fully illustrated by the following examples, which are presented to illustrate certain specific aspects of the invention and should not be construed as limiting the invention.

[0257] Example 1. Pouch Product - Beaded Composition Pouch products according to embodiments of the present disclosure were prepared from the formulations presented in Table 2. The actual ingredients and percentages may vary depending on the desired properties of the final product.

[0258] The liquid flavor was absorbed into the microcrystalline cellulose and mixed until uniform. The absorbed flavoring was then added to the other components. The materials were mixed and then extruded through a 1.5 mm die. The extruded material was spheronized in a marumerizer and the formed beads were classified to obtain a bead mixture having a size range of about 25 to 10 mesh, e.g., about 14 mesh size. The beaded composition (about 500 mg) was packaged in a fleece pouch containing viscose and a viscose polyester blend with an acrylate binder.

[0259] The pouch oral product was found to provide a gradual release of nicotine and dissolution of the inner contents. After dissolution of the contents, the thickness of the pouch decreased, indicating product completion.

[0260] [Table 2]

[0261] Example 2. Pouch Product - Beaded Composition A pouch product according to an embodiment of the present disclosure was prepared using the beaded material of Example 1 (500 mg) and a fleece comprising lyocell, PHA and PLA.

[0262] The pouch oral product was found to provide a gradual release of nicotine and dissolution of the inner contents. After dissolution of the contents, the thickness of the pouch decreased, indicating product completion.

[0263] Example 3. Pouch Product - Beaded Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations presented in Table 3. The materials were mixed as in Example 1 and extruded through a 1.5 mm die. The extruded materials were spheronized in a marumerizer and the formed beads were classified to obtain a bead mixture having a size range of about 25 to 10 mesh, e.g., about 14 mesh size. The beaded composition (about 500 mg) was encapsulated in a fleece pouch comprising viscose and a viscose polyester blend with an acrylate binder.

[0264] The pouch oral product was found to provide a gradual release of nicotine and dissolution of the inner contents. After dissolution of the contents, the thickness of the pouch decreased, indicating product completion.

[0265] [Table 3]

[0266] Example 4. Pouch Product - Beaded Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations presented in Table 4. The materials were mixed as in Example 1 and extruded through a 1.5 mm die. The extruded materials were spheronized in a marumerizer and the formed beads were classified to obtain a bead mixture having a size range of about 25 to 10 mesh, e.g., about 14 mesh size. The beaded composition (about 500 mg) was encapsulated in a fleece pouch comprising viscose and a viscose polyester blend with an acrylate binder.

[0267] The pouch oral product was found to provide a gradual release of nicotine and dissolution of the inner contents. After dissolution of the contents, the thickness of the pouch decreased, indicating product completion.

[0268] [Table 4]

[0269] Example 5. Pouch Product - Beaded Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations presented in Table 5. The materials were mixed as in Example 1 and then extruded through a 1.5 mm die. The extruded materials were spheronized in a marumerizer and the formed beads were classified to obtain a bead mixture having a size range of about 25 to 10 mesh, e.g., about 14 mesh size. The beaded composition (about 500 mg) was encapsulated in a fleece pouch comprising viscose and a viscose polyester blend with an acrylate binder.

[0270] The pouch oral product was found to provide a gradual release of nicotine and dissolution of the inner contents. After dissolution of the contents, the thickness of the pouch decreased, indicating product completion.

[0271] [Table 5]

[0272] Example 6. Pouch Product - Coated Bead Composition A pouch product according to an embodiment of the present disclosure was prepared using the beaded material of Example 5. Melted palm oil (4.8% by weight) was added to the beaded material and mixed by hand to coat the beaded material. The coated material was used to form a pouch oral product comprising approximately 500 mg of beaded material and a fleece comprising a viscose polyester blend with viscose and an acrylate binder.

[0273] It was found that the pouch oral product provides a gradual release of nicotine and dissolution of the inner contents.After dissolution of the contents, the thickness of the pouch decreases, indicating the completion of the product.It was found that the pouch made with the coating material has a delayed release of nicotine compared to the pouch material made with the beads of Example 5.

[0274] Example 7. Pouch Product - Powder Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations provided in Table 6. These materials were mixed to form a composition. Approximately 500 mg of the composition was enclosed in a fleece pouch to form the pouch product. Upon use, the materials within the pouch were dissolved, leaving the fleece behind.

[0275] [Table 6]

[0276] Example 8. Pouch Product - Powder Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations provided in Table 7. These materials were mixed to form a composition. Approximately 500 mg of the composition was enclosed in a fleece pouch to form the pouch product. Upon use, the materials within the pouch were dissolved, leaving behind the fleece.

[0277] [Table 7]

[0278] Example 9. Pouch Product - Powder Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations provided in Table 8. These materials were mixed to form a composition. Approximately 500 mg of the composition was enclosed in a fleece pouch to form the pouch product. Upon use, the materials within the pouch were dissolved, leaving behind the fleece.

[0279] [Table 8]

[0280] Example 10. Pouch Product - Powder Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations provided in Table 9. These materials were mixed to form a composition. Approximately 500 mg of the composition was enclosed in a fleece pouch to form the pouch product. Upon use, the materials within the pouch were dissolved, leaving behind the fleece.

[0281] [Table 9]

[0282] Example 11. Pouch Product - Powder Composition A pouch product according to an embodiment of the present disclosure was prepared using the formulations provided in Table 10. These materials were mixed to form a composition. Approximately 500 mg of the composition was enclosed in a fleece pouch to form the pouch product. Upon use, the materials within the pouch were dissolved, leaving behind the fleece.

[0283] [Table 10]

[0284] Example 12. Pouch Product - Beaded Composition with Elastomeric Component A pouch product according to an embodiment of the present disclosure was prepared using the formulations presented in Table 11. The materials were mixed and then extruded through a 1.5 mm die. The extruded materials were spheronized in a marumerizer and the formed beads were classified to obtain a bead mixture having a size range of about 25 to 10 mesh, e.g., about 14 mesh size. The beaded composition (about 400 mg) was encapsulated in a fleece pouch comprising viscose and a viscose polyester blend with an acrylate binder.

[0285] The pouch oral product was found to provide nicotine release and partial dissolution (approximately 50% or more by weight) of the inner contents. The pouch exhibited chewing gum-like properties.

[0286] [Table 11]

Claims

1. A pouch product comprising an outer water-permeable pouch outlining a cavity and a composition configured for oral use located within the cavity, wherein the composition is at least partially soluble, and the composition is One or more soluble fillers in an amount of at least about 45% by weight relative to the total weight of the composition, A humectant in an amount of up to approximately 25% by weight relative to the total weight of the composition, and At least one active ingredient, at least one fragrance agent, or both at least one active ingredient and at least one fragrance agent. Pouch products, including [this item].

2. The pouch product according to claim 1, wherein the composition is at least about 50% by weight that is soluble in the mouth.

3. The pouch product according to claim 1 or 2, wherein approximately 95% to approximately 100% of the composition by weight is soluble in the mouth.

4. The pouch product according to claim 1, wherein one or more soluble fillers are selected from the group consisting of sugars, sugar alcohols, soluble starch, soluble fiber, and combinations thereof.

5. The pouch product according to claim 1, wherein one or more soluble fillers contain a sugar alcohol.

6. The pouch product according to claim 5, wherein the sugar alcohol is isomalt.

7. The pouch product according to claim 5, wherein one or more soluble fillers further comprises maltodextrin.

8. The pouch product according to claim 1, wherein the wetting agent is present in an amount of about 15 to about 20% by weight relative to the total weight of the composition.

9. The pouch product according to claim 1, wherein the wetting agent is glycerin, propylene glycol, or a mixture thereof.

10. The pouch product according to claim 1, wherein the composition further comprises at least one sweetener.

11. The pouch product according to claim 1, wherein the composition is in the form of granules, granulated form, or one or more pellets or tablets.

12. The pouch product according to claim 11, wherein one or more soluble fillers comprise a sugar alcohol and maltodextrin, and optionally the composition further comprises microcrystalline cellulose in an amount of up to about 40% by weight of the composition.

13. The pouch product according to claim 1, wherein the composition is in the form of beads, and the composition comprises a sugar alcohol in an amount of about 67% to about 78% by weight relative to the total weight of the composition, and a glycerin in an amount of about 16% to about 20% by weight relative to the total weight of the composition.

14. The pouch product according to claim 13, wherein the sugar alcohol is isomalt.

15. The pouch product according to claim 13, wherein the composition further comprises microcrystalline cellulose in an amount of up to about 5% by weight of the composition.

16. The pouch product according to claim 13, wherein at least a portion of the beads are coated with a release modifier selected from the group consisting of lipids, waxes, cellulose derivatives, binders, and combinations thereof.

17. The pouch product according to claim 13, comprising a mixture of beads having different dissolution rates.

18. The pouch product according to claim 13, further comprising microcrystalline cellulose in the form of a physical mixture with beads.

19. The pouch product according to claim 1, wherein at least one active ingredient is selected from the group consisting of botanical materials, stimulants, amino acids, vitamins, antioxidants, cannabinoids, cannabimetics, terpenes, pharmaceuticals, and combinations thereof.

20. The pouch product according to claim 1, wherein at least one active ingredient contains a nicotine component.

21. The pouch product according to claim 20, wherein the nicotine component contains resin-bound nicotine.

22. The pouch product according to claim 1, wherein the composition further comprises one or more organic acids, one or more alkali metal salts of organic acids, or both thereof.

23. The pouch product according to claim 22, wherein one or more organic acids or alkali metal salts thereof are present in the composition in an amount by weight of about 0.1 to about 10% or about 0.1 to about 0.5% of the total weight of the composition.

24. The pouch product according to claim 22, wherein one or more organic acids are citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, toluic acid, salicylic acid, or a combination thereof.

25. The pouch product according to claim 22, wherein at least a portion of an organic acid, an alkali metal salt of an organic acid, or both thereof is bound to at least a portion of the nicotine component in the form of an ion pair.

26. The pouch product according to claim 1, wherein the outer water-permeable pouch is biodegradable.

27. The pouch product according to claim 1, wherein the outer water-permeable pouch is dissolvable.

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