Oral products with improved binding of active ingredients

Abstract

The present disclosure provides a product configured for oral use, the product comprising a composition including a filler component comprising a negatively charged group and an active ingredient comprising a positively charged group, wherein the active ingredient can be retained by the filler component at least in part through a bond between the negatively charged group and the positively charged group such that the active ingredient can be released from the product when placed in the oral cavity of a consumer.

Description

[Technical Field]

[0001] The present disclosure relates to flavored products intended for human use. These 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 used by inserting some form of processed tobacco or tobacco-containing formulation into the user's mouth. Traditional forms of such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed almost entirely from finely divided, granulated, or shredded tobacco and are either divided by the user or presented to the user individually, for example, in a disposable pouch or sachet. Other traditional forms of smokeless products include compressed or agglomerated forms such as plugs, tablets, or pellets. Alternative product forms, such as tobacco-containing gums and mixtures of tobacco with other plant materials, are also known.See, for example, U.S. Patent No. 1,376,586 to Schwartz; U.S. Patent No. 4,513,756 to Pittman et al.; U.S. Patent No. 4,528,993 to Sensabaugh, Jr. et al.; U.S. Patent No. 4,624,269 to Story et al.; U.S. Patent No. 4,991,599 to Tibbetts; U.S. Patent No. 4,987,907 to Townsend; U.S. Patent No. 5,092,352 to Sprinkle, III et al.; and U.S. Patent No. 5,092,352 to White. No. 5,387,416 to Williams et al.; U.S. Patent No. 6,668,839 to Williams; U.S. Patent No. 6,834,654 to Williams; U.S. Patent No. 6,953,040 to Atchley et al.; U.S. Patent No. 7,032,601 to Atchley et al.; and U.S. Patent No. 7,694,686 to Atchley et al.; U.S. Patent Application Publication No. 2004 / 0020503 to Williams; U.S. Patent Application Publication No. 2004 / 0020503 to Quinter et al. 05 / 0115580; Strickland et al., U.S. Patent Publication No. 2006 / 0191548; Holton, Jr. et al., U.S. Patent Publication No. 2007 / 0062549; Holton, Jr. et al., U.S. Patent Publication No. 2007 / 0186941; Strickland et al., U.S. Patent Publication No. 2007 / 0186942; Dube et al., U.S. Patent Publication No. 2008 / 0029110; Robinson et al., U.S. Patent Publication No. 2008 / 00 See, for example, 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, and International Patent Application Publication No. WO 2004 / 095959 to Arnarp et al., each of which is incorporated herein by reference.

[0003] Smokeless tobacco product configurations that combine tobacco materials with various binders and fillers have recently been proposed, with product formats including lozenges, pastilles, gels, extruded forms, etc. 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 U.S. Patent Application Publication No. 2012 / 0138074; 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., each of which is incorporated herein by reference.

[0004] All-white snus portions are becoming increasingly popular and offer a discrete, aesthetically pleasing alternative to traditional snus. Such modern "white" pouch products may contain bleached tobacco or may be tobacco-free. This type of product can suffer from certain drawbacks, such as poor product stability, which can lead to product discoloration and / or undesirable organoleptic properties. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 1,376,586 [Patent Document 2] U.S. Patent No. 4,513,756 [Patent Document 3] U.S. Patent No. 4,528,993 [Patent Document 4] U.S. Patent No. 4,624,269 [Patent Document 5] U.S. Patent No. 4,991,599 [Patent Document 6] U.S. Patent No. 4,987,907 [Patent Document 7] U.S. Patent No. 5,092,352 [Patent Document 8] U.S. Patent No. 5,387,416 [Patent Document 9] U.S. Patent 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. Patent 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]

[0006] (Abstract) The present disclosure generally provides products configured for oral use. These products may be configured to impart a flavor when used orally and may additionally or alternatively deliver an active ingredient, such as nicotine, to the consumer. In particular, the products and methods of the present disclosure may provide improved binding of materials containing positively charged groups via binding with components containing negatively charged groups. [Means for solving the problem]

[0007] In one aspect, an oral product is provided that includes an active ingredient comprising a positively charged group and a filler comprising a negatively charged group, wherein the active ingredient is retained by the filler through bonds between the positively charged group and the negatively charged group, and wherein the active ingredient is configured to be released when the product is present in the oral cavity.

[0008] In some embodiments, the active ingredient is selected from the group consisting of a nicotine component, a botanical, a stimulant, an amino acid, a vitamin, a cannabinoid, a cannabimimetic, a terpene, a nutraceutical, and combinations thereof, hi some embodiments, the active ingredient comprises protonated nicotine.

[0009] In some embodiments, the product further comprises one or more flavoring agents. In some embodiments, the one or more flavoring agents comprise compounds having a carbon-carbon double bond, a carbon-oxygen double bond, or both. In some embodiments, the one or more flavoring agents comprise one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensory elicitors, or combinations thereof. In some embodiments, the one or more flavoring agents comprise one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, and citral.

[0010] In some embodiments, the filler is in particulate form.

[0011] In some embodiments, the negatively charged groups of the filler include at least a carboxyl group.

[0012] In some embodiments, the filler is a cellulosic material or a cellulose derivative. In some embodiments, the filler is microcrystalline cellulose. In some embodiments, the filler is carboxylated microcrystalline cellulose.

[0013] In some embodiments, the product comprises about 10% or less by weight of tobacco material, excluding any nicotine component present, based on the total weight of the mixture.

[0014] In some embodiments, at least the active ingredient and filler are combined as a mixture that is enclosed within a pouch to form the pouch product, the mixture optionally being in free-flowing particulate form.

[0015] In some embodiments, the product further comprises one or more salts, one or more sweeteners, one or more binders, one or more humectants, one or more gums, tobacco materials, buffers, or combinations thereof.

[0016] In some embodiments, the positively charged group of the active ingredient comprises at least one amine group.

[0017] In another aspect, a method is provided for improving binding of an active ingredient in an oral product, comprising mixing an active ingredient that includes a positively charged group with a filler that includes a negatively charged group such that the active ingredient is retained by the filler through bonds between each positively and negatively charged group, and such that the active ingredient so retained is configured to be released from the filler when the product is present in the oral cavity.

[0018] In some embodiments, the active ingredient is selected from the group consisting of a nicotine component, a botanical, a stimulant, an amino acid, a vitamin, a cannabinoid, a cannabimimetic, a terpene, a nutraceutical, and combinations thereof, hi some embodiments, the active ingredient comprises protonated nicotine.

[0019] In some embodiments, the positively charged group of the active ingredient comprises at least one amine group. In some embodiments, the negatively charged group of the filler comprises at least one carboxyl group. In some embodiments, the filler component is a cellulose material or a cellulose derivative. In some embodiments, the filler component is microcrystalline cellulose. In some embodiments, the filler component is carboxylated microcrystalline cellulose.

[0020] The present disclosure includes, but is not limited to, the following embodiments.

[0021] Embodiment 1: An oral product comprising an active ingredient comprising a positively charged group and a filler comprising a negatively charged group, wherein the active ingredient is retained by the filler via a bond between the positively charged group and the negatively charged group, and wherein the active ingredient is configured to be released when the product is present in the oral cavity.

[0022] Embodiment 2: The product of embodiment 1, wherein the active ingredient may be selected from the group consisting of a nicotine component, a botanical, a stimulant, an amino acid, a vitamin, a cannabinoid, a cannabimimetic, a terpene, a nutraceutical, and combinations thereof.

[0023] Embodiment 3: The product of embodiment 1 or 2, wherein the active ingredient can include protonated nicotine.

[0024] Embodiment 4: The product of any one of embodiments 1 to 3, wherein the product may further comprise one or more flavoring agents.

[0025] Embodiment 5: The product of any one of embodiments 1-4, wherein the one or more flavoring agents may include a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both.

[0026] Embodiment 6: The product of any one of embodiments 1 to 5, wherein the one or more flavoring agents may comprise one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensory elicitors, or combinations thereof.

[0027] Embodiment 7: The product of any one of embodiments 1-6, wherein the one or more flavoring agents may include one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, and citral.

[0028] Embodiment 8: The product of any one of embodiments 1 to 7, wherein the filler can be in particulate form.

[0029] Embodiment 9: The product of any one of embodiments 1 to 8, wherein the negatively charged groups of the filler can include at least a carboxyl group.

[0030] Embodiment 10: The product of any one of embodiments 1-9, wherein the filler can be a cellulose material or a cellulose derivative.

[0031] Embodiment 11: The product of any one of embodiments 1 to 10, wherein the filler can be microcrystalline cellulose.

[0032] Embodiment 12: The product of any one of embodiments 1-11, wherein the filler can be carboxylated microcrystalline cellulose.

[0033] Embodiment 13: The product of any one of embodiments 1 to 12, wherein the product may comprise no more than about 10% by weight of tobacco material, excluding any nicotine component present, based on the total weight of the mixture.

[0034] Embodiment 14: The product of any one of embodiments 1-13, wherein at least the active ingredient and filler can be combined as a mixture that is enclosed within a pouch to form the pouch product, the mixture optionally being in free-flowing particulate form.

[0035] Embodiment 15: The product of any one of embodiments 1 to 14, wherein the product may further comprise one or more salts, one or more sweeteners, one or more binders, one or more humectants, one or more gums, tobacco materials, buffers, or combinations thereof.

[0036] Embodiment 16: The product of any one of embodiments 1 to 15, wherein the positively charged group of the active ingredient can include at least one amine group.

[0037] Embodiment 17: A method for improving binding of an active ingredient in an oral product, comprising mixing an active ingredient that includes a positively charged group with a filler that includes a negatively charged group, such that the active ingredient is retained by the filler via bonds between each positively and negatively charged group, and such that the active ingredient so retained is configured to be released from the filler when the product is present in the oral cavity.

[0038] Embodiment 18: The method of embodiment 17, wherein the active ingredient may be selected from the group consisting of a nicotine component, a botanical, a stimulant, an amino acid, a vitamin, a cannabinoid, a cannabimimetic, a terpene, a nutraceutical, and combinations thereof.

[0039] Embodiment 19: The method of embodiment 17 or 18, wherein the active ingredient can include protonated nicotine.

[0040] Embodiment 20: The method of any one of embodiments 17-19, wherein the negatively charged groups of the filler can include at least one carboxyl group.

[0041] Embodiment 21: The method of any one of embodiments 17-20, wherein the positively charged group of the active ingredient can include at least one amine group.

[0042] Embodiment 22: The method of any one of embodiments 17-21, wherein the filler component can be a cellulose material or a cellulose derivative.

[0043] Embodiment 23: The method of any one of embodiments 17-22, wherein the filler component can be microcrystalline cellulose.

[0044] Embodiment 24: The method of any one of embodiments 17-23, wherein the filler component can be carboxylated microcrystalline cellulose.

[0045] Embodiment 25: Use of a charged group to improve binding of an active ingredient in an oral product by forming the oral product by mixing an active ingredient comprising a positively charged group with a filler comprising a negatively charged group, such that the active ingredient is retained by the filler via a bond between each positively and negatively charged group, and such retained active ingredient is configured to be released from the filler when the product is present in the oral cavity.

[0046] These and other features, aspects, and advantages of the present disclosure will become apparent from a reading of the following detailed description in conjunction with the accompanying drawings, which are briefly described below. The present invention includes any combination of two, three, four, or more of the above-described embodiments and 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. This disclosure is intended to be read as a whole, and should be understood to mean that 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 indicates otherwise.

[0047] Having thus described aspects of the present disclosure in the foregoing general terms, reference is now made to the accompanying drawings, which are not necessarily drawn to scale, and which are merely illustrative and should not be construed as limiting the disclosure. [Brief explanation of the drawings]

[0048] [Figure 1] 1 is a perspective view of a pouch product according to an exemplary embodiment of the present disclosure, comprising a pouch or fleece at least partially filled with a composition for oral use. DETAILED DESCRIPTION OF THE INVENTION

[0049] The present disclosure provides compositions and products formed therefrom, particularly compositions and products configured for oral use. The compositions and products can incorporate one or more components effective to retain a releasable component and then release the releasable component at a desired time, such as upon contact with the oral cavity. In some embodiments, the component for retaining the releasable component can be adapted or configured to provide improved binding of the releasable component.

[0050] The present disclosure will now be described more fully hereinafter with reference to exemplary embodiments thereof. 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 disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. 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 mixture, including water. Unless otherwise specified, references to "weight percent" of a mixture reflect the total wet weight of the mixture (i.e., including water).

[0051] The present disclosure provides compositions and products that can include these compositions. More specifically, these compositions can be provided in a variety of forms, particularly in substantially solid forms such as aggregates of particles, fibers, and the like, as further described herein. Thus, the product can include the composition itself or the composition disposed within a unitized structure, such as a pouch. In some embodiments, the compositions or products described herein can include a carrier / filler and a releasable material. Preferably, at least a portion of the carrier / filler can be adapted or configured to include charged groups. Furthermore, in one or more embodiments, at least a portion of the releasable material can be at least partially bound to the filler via oppositely charged groups present on the releasable material.

[0052] Carrier / filler components The compositions described herein comprise at least one component that can be characterized as a carrier component and / or a filler component. In some embodiments, the composition may comprise both a carrier and a filler, and various materials may function as both a carrier and a filler. A carrier component according to the present disclosure may preferably be adapted or configured to hold at least one releasable material described herein, and in some embodiments, may hold substantially all of the additional components of the composition. The filler component may serve multiple functions, such as enhancing certain sensory characteristics, such as texture and mouthfeel, or enhancing product cohesiveness or compressibility. Generally, the filler component is a porous and / or particulate material. In some embodiments, the composition may comprise a carrier. In further embodiments, the composition may comprise a carrier and a filler.

[0053] In some embodiments, the carrier component and / or filler component may be cellulosic. For example, a suitable particulate component may be any non-tobacco plant material or derivative thereof, including cellulosic materials derived from such sources. Examples of cellulosic non-tobacco plant materials include grains (e.g., corn, oats, barley, rye, buckwheat, etc.), sugar beets (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 starch (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulosic materials. Further examples of potential particulate carrier and / or filler components include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of materials may also be used.

[0054] As used herein, "starch" can refer to pure starch, modified starch, or starch derivatives from any source. Starch is typically 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, sprouts, fruits, grains, and stems). Starches can vary not only in composition but also in granular shape and size. Starches from various sources often have different chemical and physical properties. A particular starch can be selected for inclusion in a mixture based on the starch material's ability to impart specific sensory properties to the composition. Starches from various sources can be used. For example, primary sources of starch include grains (e.g., rice, wheat, and corn) and root vegetables (e.g., potato and cassava). Other examples of starch sources include acorn, arrowroot, arracacha, banana, barley, beans (e.g., fava, lentil, mung bean, pea, chickpea), breadfruit, buckwheat, canna, chestnut, taro, dogtooth violet, kudzu, malanga, millet, oat, oka, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches have been subjected to one or more structural modifications, often designed to alter their high-heat properties. Some starches have been developed through genetic modification and are considered "genetically modified" starches. Other starches are obtained and then modified by chemical, enzymatic, or physical means. For example, modified starch can be starch that has been subjected to chemical reactions such as acid-catalyzed esterification, etherification, oxidation, depolymerization (thinning) or oxidation in the presence of a base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), cross-linking, acetylation, hydroxypropylation, and / or partial hydrolysis. Enzyme treatment includes subjecting native starch to enzyme isolates or concentrates, microbial enzymes, and / or naturally occurring enzymes from plant material, e.g., amylases present in corn kernels, to modify corn starch.Other starches are modified by heat treatment, e.g., pregelatinization, dextrinization, and / or cold water swelling processes. Specific modified starches include phosphated starch, glycerol cross-linked starch, phosphate cross-linked starch esterified with sodium trimetaphosphate, phosphate monoesterified 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, hydroxypropyl starch, hydroxypropylated glycerol cross-linked starch, and starch sodium octenyl succinate.

[0055] In some embodiments, the carrier component and / or filler component may be a cellulose material or a cellulose derivative. One material particularly suitable for use in the products described herein is microcrystalline cellulose ("MCC"). MCC may be synthetic or semi-synthetic, or may be derived entirely from natural cellulose. The MCC may be selected from the group consisting of AVICEL® grades PH-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-302, VIVACEL® grades 101, 102, 12, 20, and EMOCEL® grades 50M and 90M, and the like, and mixtures thereof. In one embodiment, the compositions described herein may include MCC as a particulate filler component and / or as a carrier component. The amount of MCC present in the compositions described herein may vary depending on the desired properties. In some embodiments, cellulose derivatives or combinations of such derivatives may be used, particularly in combination with different carrier components, including cellulose derivatives such as cellulose ethers (including carboxyalkyl ethers), i.e., cellulose polymers in which the hydrogen of one or more hydroxyl groups in the cellulose structure is replaced with an alkyl, hydroxyalkyl, or aryl group. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethylcellulose, and carboxymethylcellulose ("CMC"). In one embodiment, the cellulose derivative is one or more of methylcellulose, HPC, HPMC, hydroxyethylcellulose, and CMC. In one embodiment, the cellulose derivative is HPC.

[0056] In some embodiments, the carrier / filler material may include one or more charged groups thereon. The charged groups may be inherently present in the material in its substantially normal state. Alternatively, or in addition, the carrier / filler material may be explicitly modified to include such group(s). Thus, the carrier / filler may be functionalized to include one or more charged functional groups that would not normally be expected to be present in the material's substantially normal state. In some embodiments, the charged group(s) may be negatively charged groups. For example, suitable negatively charged groups on the carrier / filler may include one or more carboxyl groups. In other embodiments, one or more phosphate groups, alcohol / hydroxyl groups, and / or halogens may be utilized as negatively charged groups. As a non-limiting example, carboxylated cellulose materials, such as carboxylated microcrystalline cellulose, among others, may be used as carrier / filler materials that include negatively charged groups thereon. In some embodiments, the charged group(s) may be positively charged groups. For example, one or more amine groups may be utilized.

[0057] The presence of negatively charged groups on the carrier / filler can be beneficial in stabilizing one or more releasable materials that may be included in the present compositions and products. In particular, any releasable material that includes one or more positively charged groups thereon can be bound to the carrier / filler via ionic, hydrogen, or similar bonding chemistry, such that the releasable material is substantially stabilized in the composition while remaining releasable therefrom when the composition or product is in the oral cavity.

[0058] The total amount of carrier component(s) and filler component(s) present in the composition can vary, but is typically up to about 75 weight percent of the composition, based on the total weight of the composition. A typical range of the total carrier and / or filler components in the composition can be about 10 to about 75 weight percent of the total weight of the composition, e.g., about 10 weight percent, about 15 weight percent, about 20 weight percent, about 25 weight percent, or about 30 weight percent to about 35 weight percent, about 40 weight percent, about 45 weight percent, or about 50 weight percent (e.g., about 20 to about 50 weight percent or about 25 to about 45 weight percent). In certain embodiments, the total amount of carrier / filler components is at least about 10 weight percent, e.g., at least about 20 weight percent, or at least about 25 weight percent, or at least about 30 weight percent, or at least about 35 weight percent, or at least about 40 weight percent, based on the total weight of the composition.

[0059] In one or more embodiments, the carrier component may be adapted or configured to substantially surround or encase additional components of the composition. For example, the carrier may be configured as a packet, pouch, fleece, etc., and such structures are further described herein. The term "fleece" may be used herein specifically as a general term for such structures and should not be construed as limiting the nature of the structure.

[0060] For example, a suitable fleece may be formed from multiple fibers. As used herein, the term "fiber" includes both finite length fibers, such as conventional staple fibers and nanofibers, and substantially continuous structures, such as continuous filaments, unless otherwise specified. The fibers may have a substantially round or circular cross-section or a non-circular cross-section (e.g., oval, rectangular, multilobal, etc.). The fibers may be provided in a variety of configurations, and the fibers may particularly include multicomponent fibers.

[0061] In some embodiments, the fleece may be in the form of a nonwoven material. The term "nonwoven" is used herein to refer to a fibrous material, web, mat, batt, or sheet in which the fibers are aligned in an undefined or random orientation. In some embodiments, the plurality of fibers used to form the fleece may include heat-sealable and / or meltable binder fibers. Additional aspects of suitable pouches or fleeces are further described below.

[0062] Releasable materials As used herein, "releasable material" may refer to any material retained by a filler / carrier that is releasable therefrom upon contact with the oral cavity of a consumer. The releasable material may preferably be adapted to bind to the carrier / filler, such as through ionic bonding, hydrogen bonding, and similar bonding chemistries. In this manner, the releasable material may be retained with a desired level of stability and / or configured to be released from the carrier / filler. A wide variety of releasable materials may be utilized. In some embodiments, multiple releasable materials may be used. In some embodiments, different releasable materials may be adapted or configured to preferentially bind with particular carriers / fillers. For example, a first releasable material may include charged groups and thus be adapted or configured to bind to a carrier / filler that includes oppositely charged groups, while a second releasable material may be adapted or configured to bind to the carrier / filler through other means, such as by being absorbed and / or adsorbed into the pores of the carrier / filler.

[0063] active ingredient In some embodiments, the releasable material can be an active ingredient. For example, the releasable material can include a single active ingredient or multiple active ingredients. If desired, one or more active ingredients can be carried by one or more carrier / filler materials.

[0064] As used herein, "active ingredient" refers to one or more substances belonging to any of the following categories: APIs (active pharmaceutical ingredients), food additives, natural medicines, and naturally occurring 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 effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or that affect the structure or any function of the human body (e.g., ingredients that provide a stimulating effect on the central nervous system, an energizing effect, an antipyretic or analgesic effect, or otherwise have a beneficial effect on the body). In some embodiments, the active ingredient may be of the type commonly referred to as a dietary supplement, nutraceutical, "phytochemical," or "functional food." These types of additives are sometimes defined in the art to encompass substances typically available from naturally occurring sources (e.g., botanical materials) that provide one or more beneficial biological effects (e.g., health promotion, disease prevention, or other pharmacological properties), but are not classified or regulated as drugs.

[0065] Non-limiting examples of active ingredients include those that fall into the following categories: botanical ingredients (e.g., hemp, lavender, peppermint, eucalyptus, rooibos, fennel, clove, chamomile, basil, rosemary, cloves, citrus fruits, ginger, cannabis, ginseng, maca, and tisane), 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., nutraceuticals and medicinal ingredients), cannabinoids (e.g., tetrahydrocannabinol (THC) or cannabidiol (CBD)), and / or melatonin. Each of these categories is further described below. The specific selection of active ingredients will vary depending on the desired flavor, texture, and desired characteristics of a particular product.

[0066] The specific percentage of active ingredients present will vary depending on the desired properties 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, e.g., in the range of about 0.001% to about 20% by weight. In some embodiments, the active ingredient or combination of active ingredients is present at a concentration of about 0.1% to about 10% by weight, e.g., about 0.5% 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 about 0.001 wt%, about 0.01 wt%, about 0.1 wt%, or about 1 wt% to about 20 wt%, for example, about 0.001 wt%, about 0.002 wt%, about 0.003 wt%, about 0.004 wt%, about 0.005 wt%, about 0.006 wt%, about 0.007 wt%, about 0.008 wt%, about 0.009 wt%, about 0.01 wt%, about 0.02 wt%, about 0.03 wt%, about 0.04 wt%, about 0.05 wt%, about 0.06 wt%, about 0.07 wt%, about 0. ...9 wt%, about 0.01 wt%, about 0.02 wt%, about 0.03 wt%, about 0.04 wt%, about 0.05 wt%, about 0.06 wt%, about 0.07 wt%, about 0.08 wt%, about 0.09 wt%, about 0.01 wt%, about 0.02 wt%, about 0.03 wt%, about 0.04 wt%, about 0.05 wt%, about 0.06 wt%, about 0.07 wt%, about 0.08 wt%, about 0.09 wt%, about 0.01 wt%, about 0.02 wt%, about 0.03 wt%, about 0.04 The active ingredient may be present in a concentration of about 0.07%, about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, or about 0.9% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19%, or about 20% by weight. Further suitable ranges for particular active ingredients are provided herein below.

[0067] botanical In some embodiments, the active ingredient comprises a botanical ingredient. As used herein, the term "botanical ingredient" or "botanical" refers to any plant or fungal-derived material, including plant material in its natural form, such as an extract or isolate from a plant material or processed plant material, and plant material derived from a natural plant material (e.g., plant material that has been subjected to heat treatment, fermentation, bleaching, or other treatment processes that can alter 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 express persistent woody tissue and are often valued for their medicinal or sensory properties (e.g., tea or tisane). Reference to botanical materials as "non-tobacco" is intended to exclude tobacco materials (i.e., not including Nicotiana species).

[0068] If present, the botanicals are typically at a concentration of about 0.01% to about 10% by weight, for example, about 0.01%, about 0.05%, about 0.1%, or about 0.5% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.

[0069] Botanical materials useful in the present disclosure may include, but are not limited to, 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, "phytochemicals," or "functional foods." Certain botanicals, as plant materials or extracts thereof, have found use in traditional herbal medicine and are further described herein. Non-limiting examples of botanicals or botanical-derived materials include hemp, eucalyptus, rooibos, fennel, citrus fruits, clove, lavender, peppermint, chamomile, basil, rosemary, ginger, turmeric, green tea, white mulberry, cannabis, cacao, ashwagandha, baobab, chlorophyll, cordyceps, damiana, ginseng, guarana, and maca. In some embodiments, the composition includes green tea, turmeric, and white mulberry.

[0070] Ashwagandha (Withania somnifera) is a plant in the Solanaceae family (nightshade). As a medicinal herb, ashwagandha is used in the Indian Ayurvedic system of medicine, where it is also known as "Indian winter cherry" or "Indian ginseng." In some embodiments, the active ingredient comprises ashwagandha.

[0071] Baobab is the common name for a family of deciduous trees in the genus Adansonia. Baobab pulp and seeds are generally consumed as a food or dietary supplement after drying. In some embodiments, the active ingredient comprises baobab.

[0072] Chlorophyll is any of several related green pigments found in the mesosomes of cyanobacteria and the chloroplasts of algae and plants. Chlorophyll has been used as a food additive (colorant) and dietary supplement. Chlorophyll can be provided from natural plant materials (e.g., botanicals) or in the form of an extract or dry powder. In some embodiments, the active ingredient comprises chlorophyll.

[0073] Cordyceps is a diverse genus of ascomycete (sac) fungi that are abundant in moist temperate and tropical forests. Members of the Cordyceps family are widely used in traditional Chinese medicine. In some embodiments, the active ingredient comprises Cordyceps.

[0074] Damiana is a small woody shrub of the Passifloraceae family. It is native to southern Texas, Central America, Mexico, South America, and the Caribbean. Damiana produces small, fragrant flowers followed by fruit that tastes similar to figs. Extracts from Damiana have been found to inhibit aromatase activity, including the isolated compounds pinocembrin and acacetin. In some embodiments, the active ingredient comprises Damiana.

[0075] Guarana is a vine of the Sapindaceae family native to the Amazon Basin. Its fruit seeds, which are roughly the same size as coffee beans, contain high levels of caffeine and, as a result, have a stimulating effect. In some embodiments, the active ingredient comprises guarana. In some embodiments, the active ingredient comprises guarana, honey, and ashwagandha.

[0076] Ginseng is the root of plants in the Panax genus, characterized by the presence of unique steroid saponin phytochemicals (ginsenosides) and gintonin. Ginseng finds use in energy drinks and herbal teas, as well as in traditional medicine as a dietary supplement. Cultivated species include Korean ginseng (P. ginseng), Southern Chinese ginseng (P. notoginseng), and American ginseng (P. quinquefolius). American ginseng and Korean ginseng differ in the types and amounts of various ginsenosides present. In some embodiments, the active ingredient comprises ginseng. In some embodiments, the ginseng is American ginseng or Korean ginseng. In certain embodiments, the active ingredient comprises Korean ginseng.

[0077] Maca is a plant that grows in the central Peru highlands of the Andes Mountains.It is a relative of radish and has a smell similar to butterscotch.Maca has been used in traditional medicine (e.g., herbal medicine).In some embodiments, the active ingredient comprises maca.

[0078] stimulants In some embodiments, the active ingredient comprises one or more stimulants. As used herein, the term "stimulant" refers to a material that increases central nervous system and / or physical activity, e.g., enhances focus, cognition, energy, mood, attention, 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 stimulant, analgesic, and anti-inflammatory effects. Current stimulants can be natural, naturally derived, or fully synthetic. For example, certain botanical materials (e.g., guarana, tea, coffee, cacao, etc.) can have stimulant effects due to the presence of 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). "Totally synthetic" means that the stimulant is obtained by chemical synthesis.

[0079] When present, the stimulant or combination of stimulants (e.g., caffeine, theacrine, and combinations thereof) is typically present at a concentration of about 0.1% to about 15% by weight, e.g., about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, or about 0.9% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.

[0080] In some embodiments, the active ingredient comprises caffeine, hi some embodiments, the active ingredient comprises theacrine, hi some embodiments, the active ingredient comprises a combination of caffeine and theacrine.

[0081] 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) specific to each amino acid. Amino acids can be proteinogenic or non-proteinogenic. "Proteinogenic" 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 is not 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.

[0082] When present, the amino acid or combination of amino acids (e.g., taurine, theanine, and combinations thereof) is typically present at a concentration of about 0.1% to about 15% by weight, e.g., about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, or about 0.9% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight, based on the total weight of the composition.

[0083] 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.

[0084] vitamin In some embodiments, the active ingredient comprises a vitamin or a combination of vitamins. As used herein, the term "vitamin" refers to an organic molecule (or set of related molecules) that is an essential micronutrient required for the proper functioning of mammalian metabolism. There are 13 vitamins required for human metabolism: vitamin A (as 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).

[0085] If present, the vitamin or combination of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or a combination thereof) is typically at a concentration of about 0.01% to about 1% by weight, e.g., about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% to about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1% by weight, based on the total weight of the composition.

[0086] In some embodiments, the vitamin is vitamin B6, vitamin B12, vitamin E, vitamin C, or a combination thereof. In some embodiments, the active ingredient comprises a combination of vitamin B6, caffeine, and theanine. In some embodiments, the active ingredient comprises vitamin B6, vitamin B12, and taurine. In some embodiments, the active ingredient comprises a combination of vitamin B6, vitamin B12, ginseng, and theanine. In some embodiments, the active ingredient comprises a combination of vitamin C, baobab, and chlorophyll.

[0087] In certain embodiments, the active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof. For example, the active ingredient may include a combination of caffeine, theanine, and optionally ginseng. In another embodiment, the active ingredient includes a combination of theanine, gamma-aminobutyric acid (GABA), and lemon balm extract. In a further embodiment, the active ingredient includes theanine, theanine and tryptophan, or theanine and one or more B vitamins (e.g., vitamin B6 or B12). In yet another embodiment, the active ingredient includes a combination of caffeine, taurine, and vitamin C.

[0088] antioxidants In some embodiments, the active ingredient comprises one or more antioxidants. As used herein, the term "antioxidant" refers to a substance that can prevent or inhibit oxidation by quenching free radical reactions, slowing or preventing certain 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.

[0089] Examples of botanical ingredients associated with antioxidant properties include acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot, black pepper, blueberry, borage seed oil, bugleweed, cacao, calamus root, catnip, catuaba, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato peel, grapeseed, ginseng, 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, and ginger. , goldenseal, hawthorn, hibiscus flower, jiaogulan, kava, lavender, licorice, marjoram, milk thistle, mint (menth), oolong tea, beetroot, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rosehips, rosemary, sage, clary sage, savory, spearmint, spirulina, slippery elm bark, sorghum bran high tannin, sorghum grain high tannin, sumac bran, comfrey leaf and root, goji berry, gutkola, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, bacopa monniera These include, but are not limited to, monniera, Withania somnifera, lionsmane, and silybum marianum. Such botanical materials may be provided in fresh or dried form, in essential oils, or in extract form. Botanical materials (and their extracts) often include various classes of compounds known to provide antioxidant benefits, such as minerals, vitamins, isoflavones, phytoesterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles, lignans, flavonoids, polyphenols, and carotenoids.Examples of compounds found in botanical extracts or oils include ascorbic acid, peanut endocarp, resveratrol, sulforaphane, β-carotene, lycopene, lutein, coenzyme Q, carnitine, quercetin, kaempferol, etc. See, e.g., Santhosh et al., Phytomedicine, 12 (2005) 216-220, which is incorporated herein by reference.

[0090] Non-limiting examples of other suitable antioxidants include citric acid, vitamin E or a derivative thereof, tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperosides, polyphenols, catechol, resveratrol, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tert-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.

[0091] When present, the antioxidant is typically at a concentration of about 0.001% to about 10% by weight, e.g., about 0.001%, about 0.005%, about 0.01%, about 0.05%, about 0.1%, or about 0.5% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, based on the total weight of the composition.

[0092] Nicotine content In certain embodiments, a nicotine component may be included in the mixture. By "nicotine component" is meant nicotine in any suitable form (e.g., free base or salt) to provide for buccal absorption of at least a portion of the nicotine present. Typically, the nicotine component is selected from the group consisting of nicotine free base and nicotine salts. In some embodiments, the nicotine is in its free base form, which can be readily adsorbed onto, for example, a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, the discussion of nicotine in the free base form in U.S. Patent Publication No. 2004 / 0191322 to Hansson, which is incorporated herein by reference.

[0093] In some embodiments, at least a portion of the nicotine may be used in the form of a salt. Nicotine salts can be provided using ingredients and techniques of the type described in U.S. Patent No. 2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983), which are incorporated herein by reference. Additionally, nicotine salts are available from suppliers such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically, the nicotine component is selected from the group consisting of nicotine free base, nicotine salts such as hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride. In some embodiments, the nicotine component or a portion thereof is a nicotine salt. Nicotine salts are forms of nicotine characterized by the interaction between nicotine in ionic form and a coformer (e.g., an acid) in ionic form via the transfer of one or more protons from the coformer donor to the nicotine acceptor. Nicotine's structure is such that it contains two nitrogen atoms that can accept protons from the coformer, and therefore, in a given sample, it can exist in unprotonated, monoprotonated, and / or diprotonated forms. Thus, protonated nicotine is a non-limiting example of a positively charged active ingredient that can be combined with a carrier / filler that contains a negatively charged group thereon. More specifically, protonated nicotine can contain an amine group, which can be positively charged as described above. Similarly, other active ingredients can contain an amine group or similar positively charged group and therefore can be used according to the present disclosure.

[0094] In some embodiments, at least a portion of the nicotine may be in the form of a nicotine resin complex, where the nicotine is bound to an ion exchange resin such as nicotine polacrilex, which is nicotine bound to polymethacrylic acid or the like, e.g., 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-polyacrylic acid carbomer complex, such as Carbopol 974P. In some embodiments, the nicotine may be present in the form of a nicotine polyacrylic acid complex.

[0095] Typically, the nicotine component (calculated as the free base or protonated form), if present, is at a concentration of at least about 0.001% by weight of the mixture, e.g., in the range of about 0.001% to about 10%. In some embodiments, the nicotine component, calculated as the free base, is at a concentration of about 0.1% to about 10% by weight, e.g., about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, or about 0.9% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight, based on the total weight of the mixture. In some embodiments, the nicotine component is present at a concentration of about 0.1% to about 3% by weight, calculated as the free base, based on the total weight of the mixture, e.g., about 0.1% to about 2.5% by weight, about 0.1% to about 2.0% by weight, about 0.1% to about 1.5% by weight, or about 0.1% to about 1% by weight. These ranges may also apply to other active ingredients mentioned herein.

[0096] In some embodiments, products or compositions of the present disclosure may be characterized as being free of any nicotine components (e.g., any embodiment as disclosed herein may be completely or substantially free of any nicotine components). By "substantially free," it is meant that nicotine has not been intentionally added beyond trace amounts that may be naturally present, for example, in botanical materials. For example, certain embodiments may be characterized as having less than 0.001% nicotine by weight, or less than 0.0001% nicotine by weight, or even 0% nicotine by weight, calculated as the free base.

[0097] In one or more embodiments, nicotine, in particular, may be utilized as the charged group to be transferred via interactions as described herein below. Other non-limiting examples of suitable active ingredients that may be utilized in such a manner include, but are not limited to, caffeine, theobromine, eugenol, geraniol, flavonoids, polyphenols, and the like.

[0098] cannabinoids In some embodiments, the active ingredient comprises one or more cannabinoids.As used herein, the term "cannabinoid" refers to a diverse class of chemical compounds that act on cannabinoid receptors (also known as the endocannabinoid system) in cells to change neurotransmitter release in the brain.The ligands of these receptor proteins include endocannabinoids that animals naturally produce in their bodies; plant cannabinoids found in cannabis; and artificially produced synthetic cannabinoids. Cannabinoids found in cannabis include, but are not limited to, cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabiditriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A). In certain embodiments, the cannabinoid is selected from tetrahydrocannabinol (THC), the primary psychoactive compound in cannabis, and cannabidiol (CBD), another major component of the plant that lacks psychoactivity. All of the foregoing compounds can be used in the form of isolates from plant material or can be synthetically derived.

[0099] Alternatively, the active ingredient may be a cannabimimetic, a class of compounds derived from plants other than cannabis that have a biological effect on the endocannabinoid system similar to cannabinoids. Examples include yangonin, α-amyrin or β-amyrin (also classified as terpenes), cyanidin, curcumin (turmeric), catechin, quercetin, salvinorin A, N-acylethanolamines, and N-alkylamide lipids.

[0100] If present, the cannabinoid (e.g., CBD) or cannabimimetic is typically at a concentration of at least about 0.1% by weight of the composition, for example, from about 0.1% to about 30% by weight, for example, from about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, or about 0.9% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20%, or about 30% by weight, based on the total weight of the composition.

[0101] terpenes Active ingredients suitable for use in the present disclosure can also be classified as terpenes, many of which are associated with biological effects such as calming effects. Terpenes are compounds of the formula (C5H8) n The general formula is: and is understood to include monoterpenes, sesquiterpenes, and diterpenes. Terpenes can be acyclic, monocyclic, or bicyclic in structure. Some terpenes, when used in combination with cannabinoids or cannabimimetics, produce an entourage effect. Examples include β-caryophyllene, linalool, limonene, β-citronellol, linalyl acetate, pinene (α or β), geraniol, carvone, eucalyptol, menthone, isomenthone, piperitone, myrcene, β-bourbonene, and germacrene, which can be used alone or in combination.

[0102] Pharmaceutical ingredients The pharmaceutical moiety 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 with 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).

[0103] charged group In some embodiments, the active ingredient may include one or more charged groups thereon. The charged groups may be inherently present in the active ingredient in its substantially normal state. Alternatively, or in addition, the active ingredient may be expressly modified to include such group(s). Thus, the active ingredient may be functionalized to include one or more charged functional groups that would not normally be expected to be present in the material's substantially normal state. In some embodiments, the charged group(s) may be positively charged groups. In other embodiments, the charged group(s) may be negatively charged groups. The charged groups on the active ingredient may be adapted or configured to allow the active ingredient to be retained by the carrier / filler material via binding between the charged groups on the active ingredient and oppositely charged groups on the carrier / filler, as discussed above. Preferably, the engagement / binding / retention between the active ingredient and the carrier / filler is adapted or configured to allow at least a portion of the active ingredient to be released from the composition or product when the composition or product is in the mouth of a consumer.

[0104] Flavoring agents In some embodiments, the releasable material may be a flavoring agent. As used herein, a "flavoring agent" or "flavoring substance" is any flavorful or aromatic substance that can alter the sensory characteristics associated with an oral product. Examples of sensory characteristics that can be modified by a flavoring agent include taste, mouthfeel, moisture, coolness / heat, and / or aroma / fragrance. Flavoring agents may be natural or synthetic, and the flavor characteristics imparted thereby may be described as, but are not limited to, fresh, sweet, herbal, confectionery, floral, fruity, or spicy. In some embodiments, the releasable material may include a single flavoring agent or multiple flavoring agents. If desired, one or more flavoring agents may be carried by one or more carrier / filler materials, as described herein.

[0105] Non-limiting examples of flavoring agents that may be used as releasable materials herein and / or otherwise included in the present compositions and / or products include vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, trigeminal sensory elicitors, terpenes, and any combination thereof. See also Leffingwell et al., "Tobacco Flavoring for Smoking Products," R.J. Reynolds Tobacco Company (1972), which is incorporated herein by reference. Flavoring agents may include components such as terpenes, terpenoids, aldehydes, ketones, esters, and the like. In some embodiments, the flavoring agent is a trigeminal sensory elicitor. As used herein, "trigeminal sensory elicitor" refers to a flavoring agent that affects the trigeminal nerve and produces sensations including heating, cooling, tingling, and the like. Non-limiting examples of trigeminal sensory elicitor flavoring agents include capsaicin, citric acid, menthol, Sichuan peony, erythritol, and cubeb. Flavors can also include ingredients considered moisturizing, cooling, or soothing agents, such as eucalyptus. These flavors can be provided neat (i.e., alone) or in complexes and can be used as concentrates or flavor packages (e.g., spearmint and menthol, orange and cinnamon; lime, pineapple, etc.). Representative types of ingredients are also described in U.S. Pat. No. 5,387,416 to White et al.; U.S. Patent Application Publication No. 2005 / 0244521 to Strickland et al.; and International Patent Application Publication No. WO 05 / 041699 to Quinter et al., each of which is incorporated herein by reference. In some cases, the flavoring agent may be provided in spray-dried or liquid form.

[0106] Flavoring agents generally include at least one volatile flavor component. As used herein, "volatile" refers to a chemical that readily forms vapor at ambient temperature (i.e., has a high vapor pressure at a given temperature compared to non-volatile substances). Typically, volatile flavor components have a molecular weight of less than about 400 Da and often contain at least one carbon-carbon double bond, carbon-oxygen double bond, or both. In one embodiment, the at least one volatile flavor component includes one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or combinations thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde, cuminaldehyde, benzaldehyde, and citronellal. Non-limiting examples of ketones include 1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenon-1-one. Non-limiting examples of esters include allyl hexanoate, ethyl heptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate. Non-limiting examples of terpenes include sabinene, limonene, gamma-terpinene, beta-farnesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, the at least one volatile flavor component comprises one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, or citral. In one embodiment, the at least one volatile flavor component comprises ethyl vanillin.

[0107] The amount of flavoring agent utilized in the mixture can vary but is typically up to about 10 weight percent, with particular embodiments characterized by a flavoring agent content of at least about 0.1 weight percent, e.g., from about 0.5 to about 10 weight percent, from about 1 to about 6 weight percent, or from about 2 to about 5 weight percent, based on the total weight of the mixture.

[0108] Tobacco Materials In some embodiments, the compositions and / or products may include tobacco material. The tobacco material may vary in species, type, and form. Generally, tobacco material is obtained from harvested plants of the Nicotiana species. Examples of Nicotiana species include N. tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei, and N. kawakami. ii), 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. plum N. plumbaginifolia, N. raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbratica, N. velutina, N. wigandioides, N. acaulis, N. acuminata, N.N. attenuata, N. benthamiana, N. cavicola, N. clevelandii, N. cordifolia, N. corymbosa, N. fragrans, N. goodspeedii, N. linearis, N. miersii, N. nudicaulis, N. obtusifolia, N. occidentalis subsp. herperis subsp. Hersperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia and N. spegazzinii. Various representative other types of plants from the Nicotiana species are described in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); U.S. Pat. No. 4,660,577 to Sensabaugh, Jr. et al.; U.S. Pat. No. 5,387,416 to White et al.; U.S. Pat. No. 7,025,066 to Lawson et al.; U.S. Pat. No. 7,798,153 to Lawrence, Jr.; and U.S. Pat. No. 8,186,360 to Marshall et al., each of which is incorporated herein by reference. A description of various types of tobacco, growing practices, and harvesting practices is provided in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999), which is incorporated herein by reference.

[0109] Nicotiana species from which suitable tobacco materials can be obtained can be derived using genetic modification or cross-breeding techniques (e.g., tobacco plants can generally be genetically engineered or cross-bred to increase or decrease the production of components, characteristics, or attributes). See, for example, 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 International Patent Application Publication No. WO2008 / 103935 to Nielsen et al., for the types of genetic modification of plants described therein. See also the types of tobacco 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.

[0110] In some embodiments, Nicotiana species can be selected for the content of various compounds present therein. For example, plants can be selected based on the plants' production of relatively large amounts of one or more of the compounds desired to be isolated therefrom. In certain embodiments, Nicotiana species (e.g., Galpao commun tobacco) are specifically cultivated for their abundance of leaf surface compounds. Tobacco plants can be grown in greenhouses, growth chambers, or outdoor fields, or grown hydroponically.

[0111] Various parts or portions of a Nicotiana species plant can be included in the mixtures disclosed herein. For example, virtually the entire plant (e.g., the whole plant) can be harvested and used per se. Alternatively, various parts or fragments of the plant can be harvested or separated for further use after harvest. For example, flowers, leaves, stems, trunks, roots, seeds, and various combinations thereof can be isolated for further use or processing. In some embodiments, the tobacco material includes tobacco leaf (lamina). The mixtures disclosed herein can include processed tobacco parts or fragments, cured 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., a mixture of extracted tobacco pulp combined with granulated, cured, and aged natural tobacco lamina).

[0112] 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 has been soot-treated). The tobacco portion of the mixture may have a processed form, such as processed tobacco stems (e.g., cut-rolled stems, cut-rolled-expanded stems, or cut-expanded stems) or volume-expanded tobacco (e.g., expanded tobacco, such as dry ice expanded tobacco (DIET)). See, for example, the tobacco expansion processes described in U.S. Patent Nos. 4,340,073 to de la Burde et al.; 5,259,403 to Guy et al.; and 5,908,032 to Poindexter et al.; and 7,556,047 to Poindexter et al., all of which are incorporated by reference. Additionally, the mixture may optionally incorporate fermented tobacco. Reference is also made to tobacco processing techniques of the type described in Atchley et al., International Patent Application Publication No. WO 2005 / 063060, which is incorporated herein by reference.

[0113] Tobacco materials are typically used in a form that can be described as particulate (i.e., shredded, crushed, granulated, or powdered). The techniques for providing tobacco materials in a finely divided or powdered form can vary. Preferably, plant parts or fragments are comminuted, crushed, or pulverized into a particulate form using equipment and techniques for crushing, grinding, or the like. Most preferably, the plant material is relatively dry during crushing or grinding, using equipment such as hammer mills, cutterheads, air-controlled mills, or the like. For example, tobacco parts or fragments can be crushed or crushed when their moisture content is less than about 15 weight percent or less than about 5 weight percent. Most preferably, tobacco materials are used in the form of parts or fragments having an average particle size between 1.4 millimeters and 250 microns. In some cases, tobacco particles can be sized to pass through a screen mesh to obtain the required particle size range. If desired, air classification equipment can be used to ensure that small-sized tobacco particles of the desired size or size range can be collected. If desired, different sized pieces of granulated tobacco can be mixed together.

[0114] Techniques for providing tobacco in a finely divided or powder-type form can vary. Preferably, tobacco parts or pieces are comminuted, crushed, or pulverized into a powder-type form using equipment and techniques for crushing, grinding, and the like. Most preferably, the tobacco is in a relatively dry state during crushing or grinding, using equipment such as a hammer mill, cutter head, air-controlled mill, or the like. For example, tobacco parts or pieces can be crushed or ground when their moisture content is less than about 15 weight percent or less than about 5 weight percent. For example, tobacco plants or portions thereof can be separated into individual parts or pieces (e.g., leaves can be removed from the stems and / or stems and leaves can be removed from the trunks). Harvested plants or individual parts or pieces can be further subdivided into parts or pieces (e.g., leaves can be shredded, cut, pulverized, pulverized, ground, or crushed into pieces or pieces that can be characterized as filler-type pieces, grains, particulates, or fine powder). The plant or its part can be subjected to external force or pressure (e.g., by pressing or rolling). When subjected to such processing conditions, the plant or its part can have a moisture content that is close to its natural moisture content (e.g., its moisture content immediately after harvesting), a moisture content achieved by adding moisture to the plant or its part, or a moisture content resulting from drying the plant or its part. For example, powdered, pulverized, crushed, or ground pieces of the plant or its part can have a moisture content of less than about 25 weight percent, often less than about 20 weight percent, and often less than about 15 weight percent.

[0115] In preparing oral products, harvested plants of Nicotiana species are typically subjected to a curing process. The tobacco materials incorporated into the mixture for inclusion in the products disclosed herein are appropriately cured and / or aged. Descriptions of various types of curing processes for various types of tobacco are found in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999). Examples of techniques and conditions for curing flue-cured tobacco are found in Nestor et al., Beitrage Tabakforsch. Int., 20, 467-475 (2003) and U.S. Patent No. 6,895,974 to Peele, which are incorporated herein by reference. Representative 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., 21, 305-320 (2005); and Staaf et al., Beitrage Tabakforsch. Int., 21, 321-330 (2005), which are incorporated herein by reference. Certain types of tobacco can be subjected to alternative types of curing processes, such as fire-curing or sun-curing.

[0116] In certain embodiments, tobacco materials that may be used include fluid-cured or Virginia (e.g., K326), Burley, sun-cured (e.g., Indian Kurnool and Oriental tobaccos, including Katerini, Prelip, Komotini, Xanthi, and Yambol tobaccos), Maryland, dark, dark-fired, dark air-cured (e.g., Madruk, 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 foregoing tobaccos.

[0117] Tobacco materials can also be in so-called "blended" form. For example, tobacco materials can include a mixture of flue-cured, burley (e.g., Malawi burley), and Oriental tobacco parts or fragments (e.g., tobacco consisting of or derived from tobacco lamina, or a mixture of tobacco lamina and tobacco stem). For example, a typical blend might 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. Another exemplary tobacco blend incorporates, 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.

[0118] Tobacco materials used in the present disclosure may be subjected to, for example, fermentation, bleaching, etc. If desired, the tobacco material may be irradiated, pasteurized, or otherwise subjected to controlled heat treatment, for example. Such treatment processes are described in detail, for example, in U.S. Pat. No. 8,061,362 to Mua et al., which is incorporated herein by reference. In certain embodiments, the tobacco material may 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 Chen et al., U.S. Patent Publication Nos. 8,434,496, 8,944,072, and 8,991,403, 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 aforementioned processes.

[0119] In some embodiments, the type of tobacco material is selected so that its color is initially visually lighter (e.g., whitened or bleached) to some degree than other tobacco materials. In certain embodiments, tobacco pulp can be whitened by any means known in the art. For example, bleached tobacco materials produced by various whitening methods using various bleaching or oxidizing agents and oxidation catalysts can be used. Exemplary oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorites, chlorates, perchlorates, hypochlorites, ozone, ammonia, potassium permanganate, and combinations thereof. Exemplary oxidation catalysts are titanium dioxide, manganese dioxide, and combinations thereof.Processes for treating tobacco with bleach are described, for example, in U.S. Pat. No. 787,611 to Daniels, Jr.; U.S. Pat. No. 1,086,306 to Oelenheinz; U.S. Pat. No. 1,437,095 to Delling; U.S. Pat. No. 1,757,477 to Rosenhoch; U.S. Pat. No. 2,122,421 to Hawkinson; U.S. Pat. No. 2,148,147 to Baier; U.S. Pat. No. 2,170,107 to Baier; U.S. Pat. No. 2,274,649 to Baier; U.S. Pat. No. 2,770,239 to Prats et al.; U.S. Pat. No. 3,770,239 to Rosenhoch; No. 612,065; Rosen U.S. Pat. No. 3,851,653; Rosen U.S. Pat. No. 3,889,689; Minami U.S. Pat. No. 3,943,940; Rosen U.S. Pat. No. 3,943,945; Rainer U.S. Pat. No. 4,143,666; Campbell U.S. Pat. No. 4,194,514; Rainer et al. U.S. Pat. Nos. 4,366,823, 4,366,824, and 4,388,933; Schmekel et al. U.S. Pat. No. 4,641,667; Berger U.S. Pat. No. 5,713,376; 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.; and U.S. Pat. Application Publication No. 2012 / 0067361 to Bjorkholm et al.; U.S. Pat. Application Publication No. 2016 / 0073686 to Crooks; U.S. Pat. Application Publication No. 2017 / 0020183 to Bjorkholm; and U.S. Pat. Application Publication No. 2017 / 0112183 to Bjorkholm, as well as International Patent Application Publication No. WO 1996 / 031255 to Giolvas and International Patent Application Publication No. WO 2018 / 083114 to Bjorkholm, all of which are incorporated herein by reference.

[0120] In some embodiments, the whitened tobacco material may have an ISO brightness of at least about 50%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, or at least about 80%. In some embodiments, the whitened tobacco material may 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 may be measured according to ISO 3688:1999 or ISO 2470-1:2016.

[0121] In some embodiments, whitened tobacco materials may be characterized as being lighter in color (e.g., "whitened") compared to untreated tobacco materials. White is often defined with reference to the Commission Internationale de l'Eclairage (CIE) chromaticity diagram. In certain embodiments, whitened tobacco materials may be characterized as being closer to pure white on the chromaticity diagram than untreated tobacco materials.

[0122] In various embodiments, tobacco materials can be processed to extract soluble components of the tobacco material therefrom. As used herein, "tobacco extract" 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 tobacco material extraction techniques can be used to provide 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 are disclosed in U.S. Patent No. 4,144,895 to Fiore; U.S. Patent No. 4,150,677 to Osborne, Jr. et al.; U.S. Patent No. 4,267,847 to Reid; U.S. Patent No. 4,289,147 to Wildman et al.; U.S. Patent No. 4,351,346 to Brummer et al.; U.S. Patent No. 4,359,059 to Brummer et al.; U.S. Patent No. 4,506,682 to Muller; U.S. Patent No. 4,589,428 to Keritsis; U.S. Patent No. 4,605,016 to Soga et al.; U.S. Patent No. 4,605,016 to Poulo No. 4,716,911 to Se et al.; U.S. Patent No. 4,727,889 to Niven, Jr. et al.; U.S. Patent No. 4,887,618 to Bernasek 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. 5,065,775 to Fagg et al.; U.S. Patent No. 5,065,775 to White et al. No. 074,319; 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. 5,301,694 to Raymond et al.; Gonzalez-Parr No. 5,318,050 to Clapp et al.; U.S. Pat. No. 5,343,879 to Teague; U.S. Pat. No. 5,360,022 to Newton; U.S. Pat. No. 5,435,325 to Clapp et al.; U.S. Pat. No. 5,445,169 to Brinkley et al.; U.S. Pat. No. 6,131,584 to Lauterbach; U.S. Pat. No. 6,298,859 to Kierulff et al.; U.S. Pat. No. 6,772,767 to Mua et al.; and U.S. Pat. No. 7,337,782 to Thompson, all of which are incorporated herein by reference.

[0123] Typical content ranges of tobacco material can vary depending on the nature and type of tobacco material and the intended effect on the final blend, 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 blend (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 (except for purified nicotine as the active ingredient). For example, certain embodiments may be characterized as having less than 1% by weight, or less than 0.5% by weight, or less than 0.1% by weight, or even 0% by weight of tobacco material. In some embodiments, compositions or products according to the present disclosure may contain about 10% by weight or less of tobacco material, excluding any nicotine component present, based on the total weight of the blend.

[0124] Further additives In some embodiments, one or more additional additives may be included in the disclosed compositions and / or products. For example, the compositions may be processed, blended, compounded, combined, and / or mixed with other materials or ingredients. These additives may be artificial or obtained or derived from herbal or biological sources. Specific types of additional additives that may be included are further described below.

[0125] In some embodiments, the compositions and products may contain water content. The water content of the composition in the product prior to consumer use of the product may vary according to the desired properties. Typically, the composition present in the product prior to insertion into the user's mouth may contain less than 60%, less than 50%, less than 40%, less than 30%, less than 20%, less than 10%, or less than 5% water by weight. For example, the total water content in the composition and / or product may range from about 0.1% to about 60%, about 1% to about 50%, about 1.5% to about 40%, or about 2% to about 25% water by weight. In some embodiments, the compositions and products may contain at least 1%, at least 2%, at least 5%, at least 10%, or at least 20% water by weight.

[0126] In some embodiments, compositions and products may contain one or more organic acid contents. As used herein, the term "organic acid" refers to an organic (i.e., carbon-based) compound characterized by acidic properties. Typically, organic acids are relatively weak acids (i.e., they do not completely dissociate in the presence of water), such as carboxylic acids (-COH) or sulfonic acids (-SOOH). As used herein, reference to an organic acid refers to an organic acid that is intentionally added. In this regard, the organic acid may be intentionally added as a particular component, rather than being inherently present merely as a component of another component (e.g., a small amount of organic acid that may be inherently present in a component such as a tobacco material). In some embodiments, one or more organic acids are added neat (i.e., in their free acid, natural solid or liquid form) or as a solution, for example, in water. In some embodiments, one or more organic acids are added in the form of a salt, as described herein below.

[0127] In some embodiments, the organic acid is an alkyl carboxylic acid. Non-limiting examples of alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, etc. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propanesulfonic acid and octanesulfonic acid. In some embodiments, the alkyl carboxylic or sulfonic acid is substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4-hydroxybutyric acid, and lactic acid. In some embodiments, the organic acid can contain more than one carboxylic acid group or more than one sulfonic acid group (e.g., two, three, or more carboxylic acid groups). Non-limiting examples include oxalic acid, fumaric acid, maleic acid, and glutaric acid. In organic acids containing multiple carboxylic acids (e.g., 2 to 4 carboxylic acid groups), one or more carboxylic acid groups can be esterified. Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl or dimethyl citrate, and the like.

[0128] In some embodiments, the organic acid may 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. 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. In some embodiments, the organic acid is citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, toluic acid, salicylic acid, or a combination thereof. In some embodiments, the organic acid is benzoic acid. In some embodiments, the organic acid is citric acid. In alternative embodiments, some or even all of the organic acid may be added in the form of a salt with an alkaline component, which may include, but is not limited to, nicotine. Non-limiting examples of suitable salts, for example, for nicotine, include formate, acetate, propionate, isobutyrate, butyrate, α-methylbutyrate, isovalerate, β-methylvalerate, caproate, 2-furoate, phenylacetate, heptanoate, octanoate, nonanoate, oxalate, malonate, glycolate, benzoate, tartrate, levulinate, ascorbate, fumarate, citrate, malate, lactate, aspartate, salicylate, tosylate, succinate, pyruvate, and the like.

[0129] The amount of organic acid present in the composition can vary. Generally, the composition can contain from 0 to about 10% by weight of organic acid, present as one or more organic acids, based on the total weight of the mixture.

[0130] In some embodiments, the compositions may further comprise a salt (e.g., an alkali metal salt) typically used in an amount sufficient to provide the desired sensory attributes to the compositions and products. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, and the like. When present, a representative amount of salt is about 0.5 weight percent or more, about 1.0 weight percent or more, or about 1.5 weight percent or more, but typically comprises about 10 weight percent or less, or about 7.5 weight percent or less, or about 5 weight percent or less (e.g., about 0.5 to about 5 weight percent) of the total weight of the composition or product.

[0131] The compositions and products may also contain one or more sweeteners. The sweetener may be any sweetener or combination of sweeteners, whether natural or artificial, 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, which may be partially or completely hydrogenated. Sugar alcohols, for example, have from about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). When present, a representative amount of sweetener may comprise from about 0.1 to about 20 weight percent or more of the composition, based on the total weight of the composition or product, for example, from about 0.1 to about 1%, from about 1 to about 5%, from about 5 to about 10%, or from about 10 to about 20% of the composition or product by weight.

[0132] In some embodiments, compositions and products may include one or more binders. In certain embodiments, a binder (or combination of binders) may be used in an amount sufficient to provide the composition with desired physical attributes and physical integrity. Typical binders may be organic or inorganic, or a combination thereof. Representative binders include povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof. A binder may be used in an amount sufficient to provide the composition with desired physical attributes and physical integrity. The amount of binder utilized may vary but is typically up to about 30 weight percent, with certain embodiments characterized by a binder content of at least about 0.1 weight percent, e.g., from about 1 to about 30 weight percent, or from about 5 to about 10 weight percent, based on the total weight of the composition or product.

[0133] In certain embodiments, the binder comprises a gum, such as a natural gum. As used herein, natural gum refers to a naturally occurring polysaccharide material that has binding properties and is also useful as a thickening or gelling agent. Representative natural gums derived from plants, which are typically somewhat water-soluble, include xanthan gum, guar gum, gum arabic, gum ghatti, gum tragacanth, gum karaya, locust bean gum, gellan gum, and combinations thereof. When present, natural gum binder materials are typically present in an amount of up to about 5% by weight, e.g., about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, or about 1% to about 2%, about 3%, about 4%, or about 5% by weight, based on the total weight of the composition or product.

[0134] In certain embodiments, one or more humectants may be used in the composition. Examples of humectants include, but are not limited to, glycerin, propylene glycol, and the like. When included, the humectant is typically provided in an amount sufficient to provide the composition with desired moisture attributes. Additionally, in some cases, the humectant can impart desirable flow properties to the composition for deposition in a mold. When present, the humectant typically accounts for about 5% by weight or less of the composition or product weight (e.g., about 0.5 to about 5% by weight). When present, a typical amount of humectant is about 0.1% to about 1% by weight, or about 1% to about 5% by weight, based on the total weight of the composition or product.

[0135] In certain embodiments, the compositions of the present disclosure may contain a pH adjuster or buffer. Examples of usable pH adjusters and buffers include, but are not limited to, metal hydroxides (e.g., alkali metal hydroxides such as sodium hydroxide and potassium hydroxide) and other alkali metal buffers, such as metal carbonates (e.g., potassium carbonate or sodium carbonate), or metal bicarbonates such as sodium bicarbonate. When present, the buffer is typically present in an amount of less than about 5 weight percent based on the weight of the composition or product, for example, about 0.5% to about 5% by weight, e.g., about 0.75% to about 4% by weight, about 0.75% to about 3% by weight, or about 1% to about 2% by weight based on the total weight of the composition or product. Non-limiting examples of suitable buffers include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof.

[0136] In some embodiments, the compositions and products may contain one or more colorants. The colorants may be used in an amount sufficient to provide the desired physical attributes to the composition or product. Examples of colorants include various dyes and pigments, such as caramel color and titanium dioxide. The amount of colorant utilized in the composition or product may vary, but, if present, is typically up to about 3 weight percent, e.g., about 0.1 weight percent, about 0.5 weight percent, or about 1 weight percent to about 3 weight percent, based on the total weight of the composition or product.

[0137] Examples of additional types of additives that can be used in the compositions and products include thickeners or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate, etc.), disintegration aids, zinc or magnesium salts selected to be relatively water-soluble for compositions with increased water solubility (e.g., magnesium gluconate or zinc gluconate), or zinc or magnesium salts selected to be relatively water-insoluble for compositions with reduced water solubility (e.g., magnesium oxide or zinc oxide), or combinations thereof. See, for example, 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. for representative ingredients, combinations of ingredients, relative amounts of ingredients, and techniques and methods for using the ingredients, each of which is incorporated herein by reference. Typical content ranges for such additional additives can vary depending on the nature and function of the additive and its intended effect on the final mixture, with exemplary ranges being up to about 10% by weight (e.g., about 0.1 to about 5% by weight) based on the total weight of the mixture.

[0138] The aforementioned 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 preparing the final mixture). Additionally, additives of the aforementioned types can be encapsulated as provided in the final product or mixture. Exemplary encapsulated additives are described, for example, in International Patent Application Publication No. WO 2010 / 132444 to Atchley, which has been previously incorporated by reference herein.

[0139] particle In some embodiments, any one or more of the filler components, tobacco materials, and overall oral products described herein may be described as particulate materials. As used herein, the term "particulate" refers to material in the form of a plurality of individual particles, some of which may be in the form of agglomerates of a plurality of particles, the particles having an average length-to-width ratio of less than 2:1, e.g., less than 1.5:1, e.g., about 1:1. In various embodiments, the particles of particulate material may be described as substantially spherical or granular.

[0140] The particle size of a particulate material can be measured by sieve analysis. As those skilled in the art will readily appreciate, sieve analysis (also known as gradient testing) is a method used to measure the particle size distribution of a particulate material. Typically, sieve analysis involves nested columns of sieves, each containing a screen, preferably in the form of a wire mesh cloth. A pre-weighed sample can be introduced into the top or uppermost sieve of the column, which has the largest screen opening or mesh size (i.e., the largest pore size of the sieve). Each lower sieve in the column has a screen opening or mesh size that is progressively smaller than the sieve above it. Typically, there is a receiver section at the base of the sieve column for collecting particles having a particle size smaller than the screen opening or mesh size of the bottom or lowest sieve in the column (which has the smallest screen opening or mesh size).

[0141] In some embodiments, the sieve column can be placed on or within a mechanical agitator. The agitator causes vibration of each sieve within the column. The mechanical agitator can be operated for a predetermined period of time to ensure that all particles are collected on the correct sieve. In some embodiments, the sieve column is agitated for 0.5 to 10 minutes, for example, 1 to 10 minutes, for example, 1 to 5 minutes, for example, about 3 minutes. Once agitation of the sieves within the column is complete, the material collected on each sieve is weighed. The weight of each sample on each sieve can then be divided by the total weight to obtain the percentage of mass retained on each sieve. As one skilled in the art would readily understand, the screen opening size or mesh size for each sieve within the column used for sieve analysis can be selected based on the particle size of the sample to be analyzed or the known maximum / minimum particle size. In some embodiments, a sieve column can be used for sieve analysis, where the column contains 2 to 20 sieves, for example, 5 to 15 sieves. In some embodiments, a column of sieves may be used for sieve analysis, where the column comprises 10 sieves. In some embodiments, the maximum screen opening or mesh size of the sieves used in the sieve analysis may be 1000 μm, e.g., 500 μm, e.g., 400 μm, e.g., 300 μm.

[0142] In some embodiments, any particulate material referred to herein (e.g., filler components, tobacco materials, and overall oral products) may be characterized as having at least 50% by weight of the particles having a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 60% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 70% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 80% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 90% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 95% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 99% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis.In some embodiments, about 100% by weight of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, for example about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis.

[0143] In some embodiments, at least 50% by weight, such as at least 60% by weight, for example at least 70% by weight, such as at least 80% by weight, for example at least 90% by weight, for example at least 95% by weight, for example at least 99% by weight, of the particles of any particulate material referred to herein have a particle size of from about 0.01 μm to about 1000 μm, such as from about 0.05 μm to about 750 μm, for example from about 0.1 μm to about 500 μm, such as from about 0.25 μm to about 500 μm, as measured by sieve analysis. In some embodiments, at least 50% by weight, such as at least 60% by weight, for example at least 70% by weight, such as at least 80% by weight, for example at least 90% by weight, for example at least 95% by weight, for example at least 99% by weight, of the particles of any particulate material referred to herein have a particle size of from about 10 μm to about 400 μm or less, such as from about 50 μm to about 350 μm, for example from about 100 μm to about 350 μm, for example from about 200 μm to about 300 μm, as measured by sieve analysis.

[0144] preparation The method for combining the various components of the composition can vary. Thus, the total mixture of the various components, including, for example, powdered blend components, can be relatively homogeneous in nature. The above components, which can be in liquid or dry solid form, can be mixed in a pre-processing step before mixing with the remaining components of the blend, or can simply be mixed together with all other liquid or dry ingredients. The various components can be contacted, combined, or mixed together using any mixing technique or device known in the art. Any mixing method that brings the blend components into intimate contact can be used, such as a mixing device featuring an impeller or other structure capable of agitation. 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. as FKM130, FKM600, FKM1200, FKM2000, and FKM3000, Plough Share-type mixer cylinders, Hobart mixers, etc. See also, 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, each of which is incorporated herein by reference. In some embodiments, the components forming the mixture are prepared so that the mixture can be used in a starch molding process to form the mixture. Techniques and methods for blending the mixture 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.

[0145] In some embodiments, preparing a composition or product as described herein may be useful for improving the binding of an active ingredient therein. Thus, the preparation method may be useful for preparing a product configured for oral use. In an exemplary embodiment, such a method may include mixing an active ingredient containing a charged group with a carrier / filler component containing an oppositely charged group, such that the active ingredient is retained by the carrier / filler via a bond between the charged group on the active ingredient and the oppositely charged group on the carrier / filler component. The bond between the active ingredient and the carrier / filler may be configured such that at least a portion of the retained active ingredient is released from the product when the product is present in the oral cavity. In some embodiments, the method may include functionalizing one or both of the active ingredient and the carrier / filler material so that the active ingredient and / or the carrier / filler have oppositely charged groups.

[0146] Configured for oral use Provided herein are products configured for oral use. As used herein, the term "configured for oral use" means that the product is provided in a form such that one or more components of the mixture (e.g., flavoring agent and / or nicotine) are delivered to the user's mouth by saliva in the user's mouth during use. In certain embodiments, the product is adapted to deliver a releasable component to the user through the mucous membrane of the user's mouth, and in some cases, the releasable component is an active ingredient (e.g., including, but not limited to, nicotine) that can be absorbed through the mucous membrane of the mouth when the product is used.

[0147] Products configured for oral use as described herein may take a variety of forms, including gels, pastilles, gums, lozenges, powders, and pouches. Gels may be soft or hard. Certain products configured for oral use are in the form of pastilles. As used herein, the term "pastel" refers to a dissolvable oral product made by solidifying a liquid or gel mixture, such that the final product is a somewhat hardened, solid gel. The stiffness of the gel may vary widely. Certain products of the present disclosure are in solid form. Certain products may exhibit, for example, one or more of the following characteristics: crispiness, granularity, chewiness, syrupy texture, pasty texture, fluffy texture, smoothness, and / or creaminess. In certain embodiments, the desired textural properties may be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, friability, granularity, stickiness, hardness, weight, moisture absorption, moisture release, mouthcoating, roughness, slipperiness, smoothness, viscosity, wetness, and combinations thereof.

[0148] Products containing the mixtures of the present disclosure may be dissolvable. As used herein, the terms "dissolve," "dissolvable," and "dissolvable" refer to mixtures having water-soluble components that interact with the moisture in the oral cavity to go into solution, thereby causing the product to be gradually consumed. According to one aspect, a dissolvable product can persist in the user's mouth for a given period of time until it completely dissolves. Dissolution rates can vary widely, from about 1 minute or less to about 60 minutes. For example, rapid-release mixtures typically dissolve and / or release the active agent in about 2 minutes or less, often about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). Dissolution can occur by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical degradation, or by disruption of interactions between the components of the mixture. In some embodiments, the product may be dissolvable, as discussed, for example, in U.S. Patent Application Publication No. 2012 / 0037175 to Cantrell et al. In other embodiments, the product does not dissolve while the product remains in the user's mouth.

[0149] In one embodiment, a product containing a composition of the present disclosure is in the form of a mixture disposed in a moisture-permeable container (e.g., a water-permeable pouch). Such mixtures in the form of water-permeable pouches are typically used by placing one pouch containing the mixture in the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's oral cavity, for example, under the lips, in the same manner as moist snuff products are commonly used. The pouch is preferably not chewed or swallowed. Then, upon exposure to saliva, some components of the mixture therein (e.g., active ingredients such as flavoring agents and / or nicotine) pass through, for example, the water-permeable pouch, providing flavor and a satisfying sensation to the user, without the user having to expectorate any portion of the mixture. After about 10 to about 60 minutes, typically about 15 to about 45 minutes of use / enjoyment, a substantial amount of the mixture is ingested by the human subject, and the pouch can be removed from the human subject's mouth for disposal.

[0150] Thus, in certain embodiments, a mixture as disclosed herein and any other ingredients described above are combined in a moisture-permeable packet or pouch that serves as a container for use of the mixture to provide a pouch product configured for oral use. Certain embodiments of the present disclosure are described with reference to FIG. 1 , and these described embodiments involve a snus-type product having an outer pouch and containing a mixture as described herein. As described in more detail below, such embodiments are provided by way of example only, and pouch products of the present disclosure may contain compositions in other forms. The blending / construction of such packets or pouches, such as the container pouch 102 in the embodiment illustrated in FIG. 1 , may vary. Referring to FIG. 1 , a first embodiment of a pouch product 100 is shown. The pouch product 100 includes a moisture-permeable container in the form of a pouch 102, which contains a material 104 that includes a composition as described herein. The pouch product 100 may be an example of a product as described herein formed at least in part from the composition described.

[0151] Suitable packets, pouches, or containers of the type used in the manufacture of smokeless tobacco products are available under the trademarks CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf, and TreAnkrare. The mixture can be contained in the pouch and packaged in a manner that uses ingredients of the type used in the manufacture of traditional snus-type products. The pouch provides a liquid-permeable container of the type that can be considered similar in characteristics to the mesh-type material used in the construction of tea bags. The ingredients of the mixture easily diffuse through the pouch into the user's mouth.

[0152] Non-limiting examples of suitable types of pouches are described, for example, in U.S. Patent No. 5,167,244 to Kjerstad and U.S. Patent No. 8,931,493 to Sebastian et al., and 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 can be provided as individual pouches, or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25, or 30 pouches) can be connected or bonded together (e.g., end-to-end) so that single pouches or individual portions can be easily removed for use from a one-piece strand or matrix of pouches.

[0153] Exemplary pouches can be manufactured from materials and in a manner that allows the pouch to undergo controlled dispersion or dissolution during use by the user. Such pouch materials can have the form of mesh, screen, perforated paper, permeable fabric, etc. For example, a pouch material manufactured from mesh-like rice paper or perforated rice paper can dissolve in the user's mouth. As a result, the pouch and the mixture can each completely disperse in the user's mouth during normal use, and thus both the pouch and the mixture can be ingested by the user. Other examples of pouch materials can be manufactured using water-dispersible film-forming materials (e.g., binders such as alginate, carboxymethylcellulose, xanthan gum, pullulan, etc.) and those materials in combination with materials such as ground cellulose (e.g., fine-particle-sized wood pulp). Preferred pouch materials are water-dispersible or water-soluble, but can be designed and manufactured so that under normal use conditions, a significant amount of the mixture contents will permeate the pouch material before the pouch loses its physical integrity. If desired, flavoring ingredients, disintegration aids and other desired ingredients can be incorporated into or applied to the pouch material.

[0154] The amount of material contained in each product unit, e.g., pouch, can vary. In some embodiments, the weight of the mixture in each pouch is at least about 50 mg, e.g., about 50 mg to about 2 grams, about 100 mg to about 1.5 grams, or about 200 mg to about 700 mg. In some relatively smaller embodiments, the weight of the mixture in each pouch can be about 100 mg to about 300 mg. In relatively larger embodiments, the weight of the material in each pouch can be about 300 mg to about 700 mg. If desired, other ingredients can be included in each pouch. For example, at least one flavored strip, piece, or sheet of flavored water-dispersible or water-soluble material (e.g., a breath-freshening edible film-type material) can be disposed in each pouch, with or without at least one capsule. Such strips or sheets can be folded or rolled for easy incorporation into the pouch. 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.; and materials and techniques of the type described in The EFSA Journal (2004) 85, 1-32, which are incorporated herein by reference.

[0155] Pouch products as described herein can be packaged in any suitable inner packaging material and / or outer container, as well as in any of the other pouches described in, 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.; U.S. Patent No. D592,956 to Thiellier et al.; U.S. Patent No. D594,154 to Patel et al.; and U.S. Patent No. D625,178 to Bailey et al.; U.S. Patent Application Publication No. 2008 / 0173317 to Robinson et al.; U.S. Patent Application Publication No. 2009 / 0014343 to Clark et al.; U.S. Patent Application Publication No. 2009 / 0014450 to Bjorkholm; U.S. Patent Application Publication No. 2009 / 0014450 to Bellamah et al. Reference is also made to various types of containers for smokeless-type products described in U.S. Patent Publication Nos. 2009 / 0250360; Gelardi et al., U.S. Patent Publication No. 2009 / 0266837; Gelardi, U.S. Patent Publication No. 2009 / 0223989; Thiellier, U.S. Patent Publication No. 2009 / 0230003; Gelardi, U.S. Patent Publication No. 2010 / 0084424; and Bailey et al., U.S. Patent Publication Nos. 2010 / 0133140; Bailey et al., U.S. Patent Publication No. 2010 / 0264157; and Bailey et al., U.S. Patent Publication No. 2011 / 0168712, which are incorporated herein by reference.

[0156] Many modifications and other embodiments of the invention will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing description. Therefore, it is to be understood that the invention is not limited to the specific embodiments disclosed, and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. an active ingredient containing a positively charged amino group, and A filler that is a cellulose material or cellulose derivative that contains negatively charged groups that are carboxyl groups. wherein an active ingredient is retained by the filler through bonding between each positively charged amino group and a negatively charged group of the cellulose material or cellulose derivative, and the active ingredient is configured to be released when the product is present in the oral cavity.

2. 10. The oral product of claim 1, wherein the active ingredient is selected from the group consisting of nicotine components, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and combinations thereof.

3. 3. The oral product of claim 1 or 2, wherein the active ingredient comprises protonated nicotine.

4. An oral product according to any one of claims 1 to 3, further comprising one or more flavouring agents.

5. 5. The oral product of claim 4, wherein the one or more flavoring agents comprise a compound having a carbon-carbon double bond, a carbon-oxygen double bond, or both.

6. 6. The oral product of claim 5, wherein the one or more flavoring agents comprise one or more aldehydes, ketones, esters, terpenes, terpenoids, trigeminal sensory elicitors, or combinations thereof.

7. 6. The oral product of claim 5, wherein the one or more flavoring agents include one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, and citral.

8. An oral product according to any one of claims 1 to 7, wherein the filler is in particulate form.

9. An oral product according to any one of claims 1 to 8, wherein the filler is carboxylated microcrystalline cellulose.

10. 10. An oral product according to any one of claims 1 to 9, comprising no more than 10% by weight of tobacco material, excluding any nicotine component present, based on the total weight of the mixture.

11. 11. The oral product of any one of claims 1 to 10, wherein at least the active ingredient and filler are combined as a mixture that is enclosed within a pouch to form the pouch product, the mixture optionally being in free-flowing particulate form.

12. 12. The oral product of any one of claims 1 to 11, further comprising one or more salts, one or more sweeteners, one or more binders, one or more humectants, one or more gums, tobacco materials, buffers or combinations thereof.

13. 1. A method for improving binding of an active ingredient in an oral product, comprising: mixing an active ingredient containing a positively charged amino group with a filler which is a cellulose material or cellulose derivative containing negatively charged groups which are carboxyl groups, such that the active ingredient is retained by the filler through bonds between each positively charged amino group and the negatively charged groups which are carboxyl groups, and such that the active ingredient so retained is configured to be released from the filler when the product is present in the oral cavity; A method comprising:

14. 14. The method of claim 13, wherein the active ingredient is selected from the group consisting of nicotine components, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and combinations thereof.

15. 15. The method of claim 13 or 14, wherein the active ingredient comprises protonated nicotine.

16. The method of any one of claims 13 to 15, wherein the filler is carboxylated microcrystalline cellulose.

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