Moist Oral Composition

Abstract

The present disclosure provides oral compositions comprising at least one active ingredient, at least one filler ingredient, and a sufficient amount of water such that the oral composition has a total moisture content of about 15% to about 30% or more by weight, based on the total weight of the oral composition.

Description

[Technical field]

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

[0002] Tobacco can be enjoyed in so-called "smokeless" forms. Particularly popular smokeless tobacco products are used by placing some form of processed tobacco or tobacco-containing formulation in the user's mouth. Traditional forms of such smokeless tobacco products include moist snuff, snus and chewing tobacco. These are usually made almost entirely of particulate, granular or cut tobacco and are either dispensed by the user or provided to the user in portions such as disposable pouches or sachets. Other traditional forms of smokeless products include compressed or agglomerated forms such as plugs, tablets or pellets. Alternative product forms such as tobacco-containing gums and mixtures of tobacco with other plant materials are also known.See, for example, U.S. Pat. No. 1,376,586 (Schwartz); U.S. Pat. No. 4,513,756 (Pittman et al.); U.S. Pat. No. 4,528,993 (Sensabaugh, Jr. et al.); U.S. Pat. No. 4,624,269 (Story et al.); U.S. Pat. No. 4,991,599 (Tibbetts); U.S. Pat. No. 4,987,907 (Townsend); U.S. Pat. No. 5,092,352 (Spring, No. 6,834,654 (Williams); U.S. Patent No. 6,953,040 (Atchley et al.); U.S. Patent No. 7,032,601 (Atchley et al.); U.S. Patent No. 7,694,686 (Atchley et al.); U.S. Patent Application Publication No. 2004 / 0020503 (Williams ... No. 2005 / 0115580 (Quinter et al.); U.S. Patent Application Publication No. 2006 / 0191548 (Strickland et al.); U.S. Patent Application Publication No. 2007 / 0062549 (Holton, Jr. et al.); U.S. Patent Application Publication No. 2007 / 0186941 (Holton, Jr. et al.); U.S. Patent Application Publication No. 2007 / 0186942 (Strickland et al.); U.S. Patent Application Publication No. 2008 / 0029110 (Dube et al.); U.S. Patent Application Publication No. 200 See the types of smokeless tobacco formulations, ingredients and processing methods described in U.S. Patent Application Publication No. 2008 / 0029116 (Robinson et al.); U.S. Patent Application Publication No. 2008 / 0173317 (Robinson et al.); U.S. Patent Application Publication No. 2008 / 0209586 (Neilsen et al.); U.S. Patent Application Publication No. 2009 / 0065013 (Essen et al.); U.S. Patent Application Publication No. 2010 / 0282267 (Atchley); and WO 2004 / 095959 (Arnarp et al.).

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

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

[0005] [Patent Document 1] U.S. Pat. No. 1,376,586 [Patent Document 2] U.S. Pat. No. 4,513,756 [Patent Document 3] U.S. Pat. No. 4,528,993 [Patent Document 4] U.S. Pat. No. 4,624,269 [Patent Document 5] U.S. Pat. No. 4,991,599 [Patent Document 6] U.S. Pat. No. 4,987,907 [Patent Document 7] U.S. Patent No. 5,092,352 [Patent Document 8] U.S. Pat. No. 5,387,416 [Patent Document 9] U.S. 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. Pat. No. 7,694,686 [Patent Document 14] US Patent Application Publication No. 2004 / 0020503 [Patent Document 15] US Patent Application Publication No. 2005 / 0115580 [Patent Document 16] US Patent Application Publication No. 2006 / 0191548 [Patent Document 17] US Patent Application Publication No. 2007 / 0062549 [Patent Document 18] US Patent Application Publication No. 2007 / 0186941 [Patent Document 19] US Patent Application Publication No. 2007 / 0186942 [Patent Document 20] US Patent Application Publication No. 2008 / 0029110 [Patent Document 21] US Patent Application Publication No. 2008 / 0029116 [Patent Document 22] US Patent Application Publication No. 2008 / 0173317 [Patent Document 23] US Patent Application Publication No. 2008 / 0209586 [Patent Document 24] US Patent Application Publication No. 2009 / 0065013 [Patent Document 25] US Patent Application Publication No. 2010 / 0282267 [Patent Document 26] International Publication No. 2004 / 095959 [Patent Document 27] US Patent Application Publication No. 2008 / 0196730 [Patent Document 28] US Patent Application Publication No. 2008 / 0305216 [Patent Document 29] US Patent Application Publication No. 2009 / 0293889 [Patent Document 30] US Patent Application Publication No. 2010 / 0291245 [Patent Document 31] US Patent Application Publication No. 2011 / 0139164 [Patent Document 32] US Patent Application Publication No. 2012 / 0037175 [Patent Document 33] US Patent Application Publication No. 2012 / 0055494 [Patent Document 34] US Patent Application Publication No. 2012 / 0138073 [Patent Document 35] US Patent Application Publication No. 2012 / 0138074 [Patent Document 36] US Patent Application Publication No. 2013 / 0074855 [Patent Document 37] US Patent Application Publication No. 2013 / 0074856 [Patent Document 38] US Patent Application Publication No. 2013 / 0152953 [Patent Document 39] US Patent Application Publication No. 2013 / 0274296 [Patent Document 40] US Patent Application Publication No. 2015 / 0068545 [Patent Document 41] US Patent Application Publication No. 2015 / 0101627 [Patent Document 42] US Patent Application Publication No. 2015 / 0230515 Summary of the Invention

[0006] (Brief summary) The present disclosure generally provides compositions and products configured for use in the oral cavity. The products may be configured to impart a taste when used in the oral cavity, 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 be adapted or configured to deliver one or more substances to the consumer at a controlled release rate, such as sustained release.

[0007] In one or more embodiments, the present disclosure may provide, inter alia, an oral composition comprising an active ingredient and a desired moisture content. For example, a useful composition may comprise at least one active ingredient, at least one filler ingredient, and a sufficient amount of water such that the oral composition has a total moisture content of about 15% to about 30% or more by weight, based on the total weight of the oral composition.

[0008] The present disclosure includes, but is not limited to, the following embodiments.

[0009] Embodiment 1: An oral composition comprising at least one active ingredient, at least one filler ingredient, and a sufficient amount of water such that the oral composition has a total moisture content of about 15% to about 30% or more by weight, based on the total weight of the oral composition.

[0010] Embodiment 2: The oral composition of embodiment 1, wherein at least a portion of the at least one active ingredient is optionally bound to at least a portion of the at least one filler ingredient.

[0011] Embodiment 3: The oral composition of any one of embodiments 1 or 2, which may further comprise a binder.

[0012] Embodiment 4: An oral composition described in any one of embodiments 1 to 3, wherein the binder may be selected from the group consisting of povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, gums, and combinations thereof.

[0013] Embodiment 5: The oral composition of any one of embodiments 1 to 4, wherein at least one active ingredient may be selected from the group consisting of botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and combinations thereof.

[0014] Embodiment 6: The oral composition of any one of embodiments 1 to 5, wherein at least one active ingredient may be a nicotine ingredient.

[0015] Embodiment 7: The oral composition of any one of embodiments 1 to 6, wherein the nicotine component can be one or both of nicotine free base and a nicotine salt.

[0016] Embodiment 8: An oral composition according to any one of embodiments 1 to 7, wherein the nicotine component may be present in a substantially low amount, such as a weight ratio of the nicotine component to the total moisture content of about 0.01 to about 0.2, about 0.02 to about 0.1, or about 0.03 to about 0.08.

[0017] Embodiment 9: The oral composition of any one of embodiments 1-8, wherein the nicotine component may be present in an amount greater than 2% by weight based on the total weight of the oral composition.

[0018] Embodiment 10: An oral composition according to any one of embodiments 1 to 9, wherein the nicotine component may be present in an amount of about 3% by weight to about 10% by weight based on the total weight of the oral composition.

[0019] Embodiment 11: An oral composition according to any one of embodiments 1 to 10, wherein water may be present in an amount such that the oral composition has a total water content of greater than 20% by weight based on the total weight of the oral composition.

[0020] Embodiment 12: An oral composition according to any one of embodiments 1 to 1, wherein water may be present in an amount such that the oral composition has a total water content of about 20% by weight to about 45% by weight based on the total weight of the oral composition.

[0021] Embodiment 13: An oral composition according to any one of embodiments 1 to 12, wherein the oral composition may be substantially or completely free of tobacco.

[0022] Embodiment 14: An oral composition according to any one of embodiments 1 to 13, which may have a higher pH than embodiment 7.

[0023] Embodiment 15: An oral composition according to any one of embodiments 1 to 14, wherein the nicotine component may be present in an amount of less than 1% by weight based on the total weight of the oral composition.

[0024] Embodiment 16: An oral composition according to any one of embodiments 1 to 15, wherein the nicotine component may be present in an amount of about 0.01% by weight to about 0.9% by weight based on the total weight of the oral composition.

[0025] Embodiment 17: An oral composition according to any one of embodiments 1 to 16, wherein water may be present in an amount such that the oral composition has a total water content of about 15% by weight to about 30% by weight based on the total weight of the oral composition.

[0026] Embodiment 18: The oral composition according to any one of embodiments 1 to 17, which may further comprise a cyclodextrin.

[0027] Embodiment 19: An oral composition according to any one of embodiments 1 to 18, wherein at least a portion of at least one active ingredient is optionally bound to a cyclodextrin.

[0028] Embodiment 20: An oral composition according to any one of embodiments 1 to 19, wherein water may be present in an amount such that the oral composition has a total water content of about 15% by weight to about 30% by weight based on the total weight of the oral composition.

[0029] Embodiment 21: The oral composition according to any one of embodiments 1 to 20, optionally disposed in a pouch.

[0030] Embodiment 22: An oral composition according to any one of embodiments 1 to 21, wherein the oral composition may contain at least a trace amount, but less than 10% by weight, of white tobacco material, excluding any nicotine components present in the oral composition, based on the total weight of the oral composition.

[0031] These and other features, aspects and advantages of the present disclosure will become apparent from the following detailed description read 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, including any combination of two, three, four or more features or elements described in this disclosure, whether or not such features or elements are expressly combined in the description of a particular embodiment herein. The present disclosure is intended to be read in its entirety such that any separable features or elements in any of the various aspects and embodiments of the disclosed invention should be considered as intended to be combinable unless the context clearly dictates otherwise.

[0032] Having thus described aspects of the disclosure in general terms above, reference is now made to the accompanying drawings, which are not necessarily drawn to scale, which are merely illustrative and should not be construed as limiting the disclosure. [Brief description of the drawings]

[0033] [Figure 1] FIG. 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 use in the oral cavity. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] The present disclosure provides compositions and products formed from said compositions, and the compositions and products are particularly configured for use in the oral cavity.The compositions and products may incorporate one or more active ingredients and one or more filler ingredients.Similarly, the compositions and products may provide desired sensory properties in the mouth of consumers, such as providing moisturizing sensation, and therefore the compositions and products may include at least a minimum content of water or other moisturizing agents.

[0035] The present disclosure will now be described more fully hereinafter with reference to exemplary embodiments thereof. These exemplary embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Indeed, the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but 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 %" or "dry weight basis" refer to weight based on dry ingredients (i.e., all ingredients except water). References to "wet weight" refer to the weight of the mixture, including water. Unless otherwise indicated, references to "weight %" of a mixture reflect the total wet weight of the mixture (i.e., including water).

[0036] The present disclosure provides compositions that may be included in products. More specifically, in some embodiments, the present disclosure provides oral compositions that include at least one active ingredient, at least one filler ingredient, and water. The water may be present in an amount sufficient that the oral composition has a total moisture content of about 15% or more by weight based on the total weight of the oral composition. As described, the composition may 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 may include the composition itself or may include the composition disposed within a unitizing structure, such as a pouch, fleece, and the like. In some embodiments, the products described herein include a mixture of ingredients that typically include at least one carrier and / or filler, and at least one flavoring agent and / or active ingredient. In some embodiments, the composition further includes one or more salts, one or more sweeteners, one or more binders, one or more humectants, one or more gums, organic acids, tobacco materials, tobacco-derived materials, or combinations thereof. The relative amounts of the various components in the composition may vary and are generally selected to provide the desired sensory and performance characteristics in the oral product. Exemplary individual components of the composition are described herein below.

[0037] Carrier / filler components The compositions described herein include at least one component that can be characterized as a carrier component and / or a filler component. In some embodiments, the composition may include both a carrier and a filler, and various materials can function as both a carrier and a filler. The carrier component according to the present disclosure may preferably be adapted or configured to hold at least one flavor component and / or active component described herein, and in some embodiments, may hold substantially all of the additional components of the composition. The filler component can serve multiple functions, such as enhancing certain organoleptic properties, such as texture and mouthfeel, and increasing the cohesiveness or compressibility of the product. Generally, the filler component is a porous particulate material. In some embodiments, the composition may include a carrier. In further embodiments, the composition may include a carrier and a filler.

[0038] In some embodiments, the carrier component and / or filler component may be cellulosic. For example, suitable particulate components may be any non-tobacco plant material or derivatives 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 beet (e.g., FIBREX® brand filler available from International Fiber Corporation), bran fiber, and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starch (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulosic materials. Further examples of possible 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.

[0039] As used herein, "starch" may refer to pure starch, modified starch, or starch derivatives from any source. Starch is present 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), usually in granular form. Starch may vary in composition as well as in granule shape and size. Starches from different sources often have different chemical and physical properties. Specific starches may be selected for inclusion in the mixture based on the ability of the starch material to impart specific organoleptic properties to the composition. Starches from various sources may be used. For example, major sources of starch include cereals (e.g., rice, wheat, and corn) and root vegetables (e.g., potato and cassava). Other examples of starch sources include acorn, arrowroot, arracachá, banana, barley, beans (e.g., broad bean, lentil, mung bean, pea, chickpea), breadfruit, buckwheat, canna, chestnut, taro, dogtooth violet, kudzu, malanga, millet, oats, ouca, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches have undergone one or more structural modifications, often designed to alter their high temperature properties. Some starches have been developed through genetic engineering and are considered "genetically modified" starches. Other starches are obtained and then modified by chemical, enzymatic, or physical means. For example, modified starch may be starch that has undergone chemical reactions such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, acetylation, hydroxypropylation and / or partial hydrolysis. Enzymatic treatments include subjecting native starch to enzyme isolates or concentrates, microbial enzymes and / or enzymes inherent to plant material, e.g., amylase present in corn kernels to modify corn starch.Other starches are modified by thermal treatments such as pregelatinization, dextrinization and / or cold water swelling. Specific modified starches include monostarch phosphate, distarch glycerol, distarch phosphate esterified with sodium trimetaphosphate, distarch phosphate, acetylated distarch phosphate, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated distarch adipate, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, and sodium starch octenyl succinate.

[0040] In some embodiments, the carrier component and / or filler component may be a cellulose material or a cellulose derivative. One particularly suitable material 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. 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 according to the desired properties. In some embodiments, cellulose derivatives or combinations of such derivatives may be used in combination with different carrier components, which may include cellulose derivatives such as cellulose ethers (including carboxyalkyl ethers). By cellulose derivatives, we mean 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.

[0041] The total amount of carrier and filler components present in the composition may vary, but is typically up to about 75% by weight of the composition, based on the total weight of the composition. A typical range for the total amount of carrier and / or filler components in the composition may be about 10 to about 75% by weight, e.g., about 10, about 15, about 20, about 25, or about 30 to about 35, about 40, about 45, or about 50% by weight (e.g., about 20 to about 50% by weight or about 25 to about 45% by weight) of the total weight of the composition. In certain embodiments, the total amount of carrier / filler components is at least about 10% by weight, e.g., at least about 20%, at least about 25%, at least about 30%, at least about 35%, or at least about 40% by weight, based on the total weight of the composition.

[0042] In one or more embodiments, the carrier component may be adapted or configured to substantially surround or encase the 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 as a general term for such structures, particularly herein, and should not be considered as limiting the nature of the structure.

[0043] A suitable fleece may be formed, for example, of a plurality of fibers. As used herein, the term "fiber" includes both fibers of finite length, such as conventional staple fibers and nanofibers, as well as substantially continuous structures, such as continuous filaments, unless otherwise indicated. The fibers may have a substantially round or circular cross-section or a non-circular cross-section (e.g., elliptical, rectangular, multilobal, etc.). The fibers may be provided in a variety of configurations, and the fibers may in particular include multicomponent fibers.

[0044] 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 a non-determined or random direction. 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.

[0045] Active ingredients In some embodiments, the compositions and products may include at least one active ingredient or ingredient. As used herein, "active ingredient" refers to one or more substances that belong to any of the following categories: APIs (active pharmaceutical ingredients), food additives, natural drugs, and naturally occurring substances that may have an effect on humans. Examples of active ingredients include any ingredient known to affect one or more biological functions in a living organism, such as ingredients that provide pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, prevention of disease, or ingredients that affect the structure or any function of the human body (e.g., stimulating effects on the central nervous system, enhancing arousal, antipyretic and analgesic effects, or other beneficial effects 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 may be defined in the art to encompass substances that are normally 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 medicinal effects), but that are not classified or regulated as pharmaceuticals. For example, the compositions and products may contain a single active ingredient or multiple active ingredients. Optionally, at least one active ingredient may be retained in at least a portion of at least one filler ingredient, and one or more active ingredients may be otherwise retained in the composition and / or product, such as being bound to additional fillers or being present in unitary form (e.g., pelleted active ingredients).

[0046] Non-limiting examples of active ingredients may include those belonging to the categories of botanical ingredients, stimulants, amino acids, nicotinic ingredients, and / or pharmaceutical, nutraceutical and medicinal ingredients (e.g., vitamins such as A, B3, B6, B12 and C, and / or cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these categories is further described herein below. The particular choice of active ingredient will vary depending on the desired flavor, texture and desired characteristics in a particular product.

[0047] In certain embodiments, the active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, vitamin C, B vitamins (e.g., vitamin B6 or B12), lemon balm extract, tryptophan, 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 a further embodiment, the active ingredient includes a combination of caffeine, taurine, and vitamin C.

[0048] The specific percentage of active ingredients present will vary depending on the desired properties in a particular product. Typically, the active ingredient or combinations thereof will be present at a total concentration of at least about 0.001% by weight of the composition, for example, in the range of about 0.001% to about 20%. In some embodiments, the active ingredient or combinations thereof will be present at a concentration of about 0.1% to about 10% by weight, such as, for example, about 0.5% to about 10% by weight, about 1% to about 10% by weight, about 1% to about 5% by weight, based on the total weight of the composition. In some embodiments, the active ingredient or combinations of active ingredients will be present at a concentration of about 0.001%, about 0.01%, about 0.1%, or about 1% to up to about 20% by weight. For example, based on the total weight of the composition, 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 0.08 wt.%, about 0.09 wt.%, about 0.1 wt.%, about 0.2 wt.%, 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 specific active ingredients are set forth herein below.

[0049] 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 and plant material derived from a natural plant material, such as an extract or isolate from the plant material, or treated plant material (e.g., plant material that has undergone heat treatment, fermentation, bleaching, or other treatment processes that can change the physical and / or chemical properties of the material). For purposes of this disclosure, "botanical" includes, but is not limited to, "herbal material." Herbal material refers to seed-producing plants that do not develop persistent woody tissue and are often valued for their medicinal or organoleptic properties (e.g., tea or tisane). Reference to a botanical material as "non-tobacco" is intended to exclude tobacco materials (i.e., does not include any Nicotiana species). In some embodiments, the compositions disclosed herein can be characterized as not including any tobacco materials (e.g., any embodiment disclosed herein may be completely or substantially free of any tobacco materials). By "substantially free" it is meant that no tobacco material has been intentionally added. For example, certain embodiments may be characterized as having less than 0.001% tobacco by weight, or less than 0.0001% tobacco by weight, or even 0% tobacco by weight.

[0050] 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.

[0051] 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 may be referred to as dietary supplements, nutraceuticals, "phytochemicals" or "functional foods." Certain botanicals, as plant materials or extracts thereof, have found use in traditional Chinese medicine and are further described herein. Non-limiting examples of botanicals or botanical-derived materials include ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, chai fu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus, clove, cocoa, ectoderma, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata essential oil, eucalyptus, fennel, Galphimia glauca, ginger, ginkgo, ginseng (e.g., Panax ginseng), green tea, Griffonia simplicifolia, thyme, thyme leaves, thyme oil, thyme extract ... simplicifolia, guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha tea, Nardostachys chinensis, oily extract of sweet violet, peppermint, quercetin, resveratrol, Rhizoma gastrodiae, rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum, schisandra, skullcap, spearmint extract, spikenard, terpenes, tisane, turmeric, Turnera aphrodisiaca, valerian, white mulberry, and yerba mate.

[0052] In some embodiments, the active ingredient comprises lemon balm. Lemon balm (Melissa officinalis) is a mild lemon-scented herb in the same family (Lamiaceae) as mint. The herb is native to Europe, North Africa and Western Asia. Lemon balm teas and essential oils and extracts are used in traditional and alternative medicine. In some embodiments, the active ingredient comprises lemon balm extract. In some embodiments, the lemon balm extract is present in an amount of about 1 to about 4% by weight, based on the total weight of the composition.

[0053] In some embodiments, the active ingredient comprises ginseng. Ginseng is the root of a plant of the Panax genus and is characterized by the presence of unique steroidal saponin phytochemicals (ginsenosides) and gintonin. Ginseng is used as a dietary supplement in energy drinks or herbal teas and as a traditional medicine. Cultivated species include Korean ginseng (P. ginseng), South 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 ginseng is American ginseng or Korean ginseng. In certain embodiments, the active ingredient comprises Korean ginseng. In some embodiments, the ginseng is present in an amount of about 0.4 to about 0.6% by weight, based on the total weight of the composition.

[0054] Stimulants In some embodiments, the active ingredient comprises one or more stimulants. As used herein, the term "stimulant" refers to a material that increases the activity of the central nervous system and / or the body, e.g., enhances focus, cognition, energy, mood, alertness, etc. Non-limiting examples of stimulants include caffeine, theacrine, theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid structurally related to caffeine and has stimulant, analgesic, and anti-inflammatory properties. The stimulants of the present invention can be natural, naturally derived, or completely synthetic. For example, certain botanical materials (such as guarana, tea, coffee, cocoa, etc.) may have stimulant properties, e.g., 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. In some embodiments, the active ingredient comprises caffeine. In some embodiments, the caffeine is present in an encapsulated form. One example of encapsulated caffeine is Vitashure®, available from Balchem ​​Corp., 52 Sunrise Park Road, New Hampton, NY, 10958.

[0055] 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, such as 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. In some embodiments, the composition comprises caffeine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition.

[0056] amino acid In some embodiments, the active ingredient comprises an amino acid. As used herein, the term "amino acid" refers to an organic compound that contains 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. An amino acid may be a proteinogenic or non-proteinogenic amino acid. "Proteogenic" means that the amino acid is one of the 20 naturally occurring amino acids that are 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 the cellular machinery (e.g., is a product of post-translational modification). Non-limiting examples of non-proteinogenic amino acids include γ-aminobutyric acid (GABA), taurine (2-aminoethanesulfonic acid), theanine (L-γ-glutamylethylamide), hydroxyproline, and β-alanine. In some embodiments, the active ingredient comprises theanine. In some embodiments, the active ingredient comprises GABA. In some embodiments, the active ingredient comprises a combination of theanine and GABA. In some embodiments, the active ingredient is a combination of theanine, GABA, and lemon balm. In some embodiments, the active ingredient is a combination of caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises taurine. In some embodiments, the active ingredient is a combination of caffeine and taurine.

[0057] When present, the amino acid or combination of amino acids (e.g., theanine, GABA, and combinations thereof) are typically at a concentration of about 0.1% to about 15% by weight, for example, 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.

[0058] 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 a series of related molecules) that is an essential micronutrient required for the proper functioning of the metabolism in mammals. There are 13 vitamins required for human metabolism, including: Vitamin A (as all-trans retinol, all-trans retinyl esters, all-trans beta-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), Vitamin K (quinones). In some embodiments, the active ingredient comprises Vitamin C. In some embodiments, the active ingredient is a combination of Vitamin C, caffeine and taurine.

[0059] If present, the vitamin or combination of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or combinations thereof) will typically be at a concentration of about 0.01% to about 6% by weight, based on the total weight of the composition, for example, 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%, about 1%, about 2%, about 3%, about 4%, about 5% or about 6% by weight.

[0060] 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 terminating free radical reactions, slowing or preventing certain types of cell damage. Antioxidants can be naturally occurring or synthetic. Naturally occurring antioxidants include those found in foods and botanical materials. Non-limiting examples of antioxidants include certain botanical materials, vitamins, polyphenols, and phenol derivatives.

[0061] Examples of botanical ingredients with antioxidant properties include acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, bee balm, wild bergamot, black pepper, blueberry, borage seed oil, burdock, cacao, calamus root, catnip, catuaba, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato peel, grape seed, ginseng, and ginkgo biloba. biloba), St. John's wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, clove, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose, feverfew, ginger, goldenseal, hawthorn, hibiscus flower, gynostemma, kava, lavender, licorice, marjoram, milk thistle, mint, Botanical materials include, but are not limited to, oolong tea, beetroot, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rose hips, rosemary, sage, clary sage, savory, spearmint, spirulina, elm bark, high tannin sorghum bran, high tannin sorghum grain, sumac bran, comfrey leaf and root, goji berries, centella, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, bacopa monnieri, ashwagandha, yamabushitake mushroom, and silybum marianum. Such botanical materials may be provided in fresh or dried form, essential oils, or in the form of extracts. Botanical materials (and their extracts) often contain various classes of compounds known to provide antioxidant benefits, including minerals, vitamins, isoflavones, phytosterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles, lignans, flavonoids, polyphenols and carotenoids.Examples of compounds contained in botanical extracts or oils include ascorbic acid, peanut endocarb, resveratrol, sulforaphane, β-carotene, lycopene, lutein, coenzyme Q, carnitine, quercetin, kaempferol, etc. See, e.g., Santhosh et al., Phytomedicine, 12 (2005) 216-220, incorporated herein by reference.

[0062] Other non-limiting examples of suitable antioxidants include citric acid, vitamin E or a derivative thereof, tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperosides, polyphenols, catechol, resveratrol, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tert-butylhydroquinone (TBHQ), and combinations thereof.

[0063] When present, the antioxidant is typically at a concentration of about 0.001% to about 10% by weight, for example, 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.

[0064] Nicotine content In certain embodiments, the active ingredient comprises a nicotine component. By "nicotine component" is meant any suitable form of nicotine (e.g., free base or salt) to provide oral absorption of at least a portion of the nicotine present. Typically, the nicotine component is selected from the group consisting of nicotine free base and nicotine salt. In some embodiments, the nicotine component is a free base form of nicotine, which can be easily adsorbed, for example, to a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, the description of the free base form of nicotine in US Patent Application Publication No. 2004 / 0191322 (Hansson), which is incorporated herein by reference.

[0065] In some embodiments, at least a portion of the nicotine component can be used in the form of a salt. Nicotine salts can be obtained using the types of ingredients and techniques described in U.S. Pat. No. 2,033,909 (Cox et al.) and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983), which are incorporated herein by reference. Additionally, nicotine salts are available from sources such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically, the nicotine component is selected from the group consisting of nicotine salts such as nicotine free base, hydrochloride, dihydrochloride, tartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride.

[0066] In some embodiments, at least a portion of the nicotine may be in the form of a nicotine resin complex, in which the nicotine is bound to an ion exchange resin, such as nicotine polacrilex, which is nicotine bound to polymethacrylic acid, such as Amberlite IRP64, Purolite C115HMR, or Doshion P551. See, for example, U.S. Patent No. 3,901,248 (Lichtneckert et al.), which is incorporated herein by reference. Another example is a nicotine-polyacryl carbomer complex, such as Carbopol 974P. In some embodiments, the nicotine may be present in the form of a nicotine-polyacryl complex.

[0067] Typically, when present, the nicotine component (calculated as the free base) is at least about 0.001% by weight of the composition, e.g., in a concentration ranging from about 0.001% to about 10% by weight. In some embodiments, the nicotine component is present in 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, calculated as the free base, based on the total weight of the composition. 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 composition, 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.

[0068] In some embodiments, the products or compositions of the present disclosure can be characterized as being free of any nicotine components (e.g., any embodiment disclosed herein can be completely or substantially free of any nicotine components). By "substantially free" 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 can be characterized as having less than 0.001% nicotine by weight, or less than 0.0001% by weight, or even 0% nicotine by weight, calculated as the free base.

[0069] In some embodiments, the active ingredient comprises a nicotine component (e.g., any product or composition of the present disclosure, in addition to comprising any active ingredient or combination of active ingredients disclosed herein, can further comprise a nicotine component).

[0070] In one or more embodiments, the amount of nicotine component that may be present in the compositions and products may be at least partially related to the total moisture content of the compositions and products. Thus, it may be desirable for the nicotine component content and the total moisture content to be within a desired ratio. For example, in some embodiments, the weight ratio of the total nicotine content to the total moisture content may be substantially low, and thus may range from about 0.01 to about 0.2, from about 0.02 to about 0.1, or from about 0.03 to about 0.08.

[0071] In some embodiments, it may be desirable to provide compositions and products with a relatively high nicotine content. For example, in such embodiments, the nicotine component may be present in an amount of more than 2 wt%, more than 2.5 wt%, more than 3 wt%, or more than 3.5 wt%, based on the total weight of the composition or product. In other embodiments, the nicotine component may be present in an amount of about 2 wt% to about 10 wt%, about 3 wt% to about 10 wt%, or about 4 wt% to about 8 wt%, based on the total weight of the oral composition. When nicotine is present in a relatively high content, it may be desirable for the total moisture content of the compositions and products to be relatively high as well. For example, a suitable total moisture content may be a moisture content of more than 20 wt%, more than 25 wt%, more than 30 wt%, or more than 35 wt%, based on the total weight of the composition or product. Further, the total moisture content may range from about 20% to about 60%, about 25% to about 55%, about 30% to about 50%, or about 20% to about 45% by weight based on the total weight of the composition or product. In addition to the above, in some embodiments, it may be desirable for the compositions and products to be substantially or completely free of any tobacco material. This is particularly true in compositions having a relatively high nicotine content and / or a high moisture content. However, the explicit absence of any tobacco may apply to other embodiments of the present disclosure. As further described herein, it may be desirable in some embodiments for the composition or product to exhibit a defined pH. The defined pH may be achieved by the use of a suitable buffer or overall combination of materials, taking into account the inherent acidity (high or low) of the buffer or material. In some embodiments, such as when a high nicotine, high moisture content product is desired, it may be useful to control the overall composition (including the addition or elimination of any buffer) to result in a pH greater than 7, greater than 7.5, greater than 8, or greater than 8.5. In particular, the pH of such compositions may range from about 7.5 to about 11, from 7.5 to about 10, or from about 8 to about 9.5.Thus, in certain embodiments, it may be useful to provide a composition or product that has a relatively high nicotine content, a relatively high moisture content, explicitly excludes tobacco, and optionally has a pH within the ranges discussed above.

[0072] In some embodiments, it may be useful to provide compositions and products with a relatively low nicotine content. For example, in such embodiments, the nicotine component may be present in an amount of less than 1 wt%, less than 0.8 wt%, less than 0.7 wt%, or less than 0.5 wt%, based on the total weight of the composition or product. In another embodiment, the nicotine component may be present in an amount of about 0.01 wt% to about 0.9 wt%, about 0.05 wt% to about 0.8 wt%, about 0.1 wt% to about 0.7 wt%, or about 0.2 wt% to about 0.5 wt%, based on the total weight of the composition or product. When nicotine is present in a relatively low content, it may be desirable for the total moisture content of the compositions and products to be within a specified range. For example, a suitable total moisture content may be in the range of about 10 wt% to about 40 wt%, about 15 wt% to about 30 wt%, or about 20 wt% to about 30 wt%, based on the total weight of the composition or product.

[0073] Cannabinoids In some embodiments, the active ingredient comprises one or more cannabinoids.As used herein, the term "cannabinoid" refers to a group of diverse compounds that act on the cannabinoid receptors in cells, also known as the endocannabinoid system, to change neurotransmitter release in the brain.The ligands of the receptor proteins include endocannabinoids that are naturally produced in animals, phytocannabinoids that are found in cannabis, and synthetic cannabinoids that are artificially produced. 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 main psychoactive compound in cannabis, and cannabidiol (CBD), another major component of the plant that is not psychoactive. All of the above compounds may be used in the form of an isolate from the plant material or may be derived synthetically.

[0074] Alternatively, the active ingredient may be a cannabimimetic. Cannabimimetics are a group of compounds obtained from plants other than cannabis that have the same biological effects on the endocannabinoid system as 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.

[0075] When present, the cannabinoid (e.g., CBD) or cannabimimetic is typically present at a concentration of at least about 0.1% by weight of the composition, based on the total weight of the composition, for example, in the range of about 0.1% to about 30% by weight, such as 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.

[0076] Terpenes The active ingredients suitable for use in the present disclosure may also be classified as terpenes, many of which are associated with biological effects, such as sedative effects. Terpenes are the aryl group of the terpenes (C5H8) n It has the general formula: and is understood to include monoterpenes, sesquiterpenes and diterpenes. Terpenes can be acyclic, monocyclic, bicyclic structures. 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 may be used alone or in combination.

[0077] Pharmaceutical ingredients In some embodiments, the active ingredient comprises an active pharmaceutical ingredient (API). The API can be any known drug adapted for therapeutic, prophylactic or diagnostic use. APIs can include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrates), neurotransmitters or their precursors (e.g., serotonin, 5-hydroxytryptophan, oxytriptan, acetylcholine, dopamine, melatonin), and nucleic acid sequences having therapeutic, prophylactic or diagnostic activity. Non-limiting examples of APIs include analgesics and antipyretics (e.g., acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine, myo-inositol, docosahexaenoic acid (DHA, omega-3), arachidonic acid (AA, omega-6), S-adenosylmethionine (SAM), β-hydroxy-β-methylbutyrate (HMB), citicoline (cytidine-5′-diphosphate choline), and cotinine. In some embodiments, the active ingredient comprises citicoline. In some embodiments, the active ingredient is a combination of citicoline, caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises sunflower lecithin. In some embodiments, the active ingredient is a combination of sunflower lecithin, caffeine, theanine, and ginseng.

[0078] The amount of API may vary. For example, when present, the API is usually present at a concentration of about 0.001% to about 10% by weight, for example, about 0.01%, about 0.02%, about 0.03%, about 0.04%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9% or about 1% to 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.

[0079] In some embodiments, the composition is substantially free of any API. By "substantially free of any API" is meant that the composition does not contain and specifically excludes the presence of any API, as defined herein, such as a Food and Drug Administration (FDA) approved therapeutic agent intended to treat any medical condition.

[0080] Flavoring Agent In some embodiments, the releasable material may be one or more flavoring agents. As used herein, a "flavoring agent" or "flavoring agent" is any flavorful or aromatic substance that can change the sensory properties associated with an oral product. Examples of sensory properties that can be changed by a flavoring agent include taste, mouthfeel, moistness, cool / hot, and / or aroma / fragrance. Flavoring agents may be natural or synthetic, and the flavor characteristics imparted by the flavoring agent 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 as part of a carrier or filler, or one or more flavoring agents may be otherwise carried in the composition and / or product, such as being bound to an additional carrier or filler.

[0081] Non-limiting examples of flavoring agents that can be used as releasable materials herein and / or that can be otherwise included in the 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 sensate, terpene, and any combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, RJ Reynolds Tobacco Company (1972), which is incorporated herein by reference. Flavoring agents can include components such as terpenes, terpenoids, aldehydes, ketones, esters, and the like. In some embodiments, the flavoring agent is a trigeminal sensate. As used herein, "trigeminal sensate" refers to a flavoring agent that affects the trigeminal nerve and produces sensations including warmth, coldness, tingling, and the like. Non-limiting examples of trigeminal sensate flavoring agents include capsaicin, citric acid, menthol, Sichuan button, erythritol, and cubebal. The flavoring agent may also include ingredients that are considered moisturizing, cooling, or soothing agents, such as eucalyptus. These flavoring agents may be provided neat (i.e., alone) or in combination, and may be used as concentrates or flavoring packages (e.g., spearmint and menthol, orange and cinnamon; lime, pineapple, and the like). Representative types of ingredients are also described in U.S. Patent No. 5,387,416 (White et al.); U.S. Patent Application Publication No. 2005 / 0244521 (Strickland et al.); and International Publication No. WO 05 / 041699 (Quinter et al.), each of which is incorporated herein by reference. In some cases, the flavoring agent may be provided in a spray-dried or liquid form.

[0082] Flavoring agents generally include at least one volatile flavor ingredient. As used herein, "volatile" refers to a chemical that readily forms vapor at ambient temperature (i.e., has a high vapor pressure at a given temperature compared to non-volatile substances). Typically, volatile flavor ingredients have a molecular weight of less than about 400 Da and often contain at least one carbon-carbon double bond, carbon-oxygen double bond, or both. In one embodiment, the at least one volatile flavor ingredient includes one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or combinations thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde, cuminaldehyde, benzaldehyde, and citronellal. Non-limiting examples of ketones include 1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenone-1-one. Non-limiting examples of esters include allyl hexanoate, ethyl heptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate. Non-limiting examples of terpenes include sabinene, limonene, gamma-terpinene, beta-farnesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, the at least one volatile flavor component comprises one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, or citral. In one embodiment, the at least one volatile flavor component comprises ethyl vanillin.

[0083] The amount of flavoring utilized in the mixture can vary, but will typically be up to about 10% by weight, with certain embodiments being characterized by a flavoring content of at least about 0.1% by weight, such as from about 0.5 to about 10% by weight, from about 1 to about 6% by weight, or from about 2 to about 5% by weight, based on the total weight of the mixture.

[0084] Tobacco Materials In some embodiments, the compositions and / or products may include tobacco material. The species, type, and form of the tobacco material may vary. Generally, the tobacco material is obtained from harvested plants of Nicotiana species. Exemplary Nicotiana species include N. tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei, N. kawakamii, N. nightiana, N. niger ... ghtiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata, N. xsanderae, N. africana, N. amplexicauri N. amplexicaulis, N. benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N. occidentalis, N. paniculata, N. plumbaginifolia ifolia, 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. hesperis subsp. Hersperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia, and N. spegazzinii. Various other representative varieties of Nicotiana species plants are described in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); U.S. Pat. No. 4,660,577 (Sensabaugh, Jr. et al.); U.S. Pat. No. 5,387,416 (White et al.); U.S. Pat. No. 7,025,066 (Lawson et al.); U.S. Pat. No. 7,798,153 (Lawrence, Jr.) and U.S. Pat. No. 8,186,360 (Marshall et al.), each of which is incorporated herein by reference. Descriptions of various types of tobacco, growing and harvesting methods are found in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999), which is incorporated herein by reference.

[0085] Nicotiana species from which suitable tobacco material can be obtained may be obtained using genetic engineering or cross-breeding techniques (e.g., tobacco plants can be genetically engineered or cross-bred to increase or decrease the expression of a component, characteristic or attribute). See, for example, the types of genetically modified plants described in U.S. Pat. No. 5,539,093 (Fitzmaurice et al.); U.S. Pat. No. 5,668,295 (Wahab et al.); U.S. Pat. No. 5,705,624 (Fitzmaurice et al.); U.S. Pat. No. 5,844,119 (Weigl); U.S. Pat. No. 6,730,832 (Dominguez et al.); U.S. Pat. No. 7,173,170 (Liu et al.); U.S. Pat. No. 7,208,659 (Colliver et al.); U.S. Pat. No. 7,230,160 (Benning et al.); U.S. Patent Application Publication No. 2006 / 0236434 (Conkling et al.); and PCT WO2008 / 103935 (Nielsen et al.). See also the tobacco types described in U.S. Pat. No. 4,660,577 (Sensabaugh, Jr. et al.); U.S. Pat. No. 5,387,416 (White et al.); and U.S. Pat. No. 6,730,832 (Dominguez et al.), each of which is incorporated herein by reference.

[0086] Nicotiana species may be selected in some embodiments for the content of various compounds present in the species. For example, a plant may be selected based on the plant producing relatively high amounts of one or more compounds of interest isolated from the plant. In certain embodiments, Nicotiana species plants (e.g., Galpao commun tobacco) are grown specifically for their abundance of leaf surface compounds. Tobacco plants can be grown in greenhouses, growth chambers, or outdoor fields, or grown hydroponically.

[0087] Various parts or portions of the Nicotiana species plant can be included in the mixtures disclosed herein. For example, substantially all of the plant (e.g., the whole plant) can be harvested and used as such. Alternatively, various parts or pieces of the plant can be harvested or harvested and then separated for further use. For example, flowers, leaves, stems, stalks, roots, seeds, and various combinations thereof can be separated for further use or processing. In some embodiments, the tobacco material includes tobacco leaves (lamina). The mixtures disclosed herein can include processed tobacco parts or pieces, cured and aged tobacco in the form of essentially natural lamina and / or stems, tobacco extracts, extracted tobacco pulp (e.g., using water as a solvent) or mixtures of the foregoing (e.g., a mixture combining extracted tobacco pulp and granular cured and aged natural tobacco lamina).

[0088] In certain embodiments, the tobacco material comprises a solid tobacco material selected from the group consisting of lamina and stems. The tobacco used in the mixture most preferably comprises tobacco lamina or a mixture of tobacco lamina and stems, at least a portion of which is smoke-treated. A portion of the tobacco in the mixture may have a processed form, such as processed tobacco stems (e.g., cut-rolled stems or cut-rolled-expanded stems or cut-puffed stems), volume-expanded tobacco (e.g., puffed tobacco, such as dry ice expanded tobacco (DIET)). See, for example, the tobacco expansion processes described in U.S. Pat. No. 4,340,073 (Burde et al.); U.S. Pat. No. 5,259,403 (Guy et al.); U.S. Pat. No. 5,908,032 (Poindexter et al.); and U.S. Pat. No. 7,556,047 (Poindexter et al.), all of which are incorporated herein by reference. Additionally, the mixture may optionally incorporate fermented tobacco. See also the types of tobacco processing techniques described in PCT WO2005 / 063060 (Atchley et al.), which is incorporated herein by reference.

[0089] Tobacco materials are typically used in a form that can be described as particulate (i.e., shredded, powdered, granulated, or powdered). The manner in which tobacco materials are provided in particulate or powdered form can vary. Preferably, plant parts or fragments are pulverized, crushed, or pulverized into particulate form using equipment and techniques for crushing, milling, and the like. Most preferably, the plant material is in a relatively dry form during crushing or milling using equipment such as hammer mills, cutter heads, air control mills, and the like. For example, tobacco parts or fragments can be crushed or milled when their moisture content is less than about 15% by weight, or less than about 5% by weight. Most preferably, tobacco materials are used in the form of parts or fragments having an average particle size of 1.4 mm to 250 μm. In some cases, the tobacco particles can be sized to pass through a sieve to obtain the required particle size range. If desired, an air classifier can be used to ensure that small sized tobacco particles are collected, which are of a desired size or range of sizes. If desired, granulated tobacco of different sizes can be mixed together.

[0090] The manner in which tobacco is provided in particulate or powdered form can vary. Preferably, tobacco parts or pieces are pulverized, crushed or pulverized into a powdered form using equipment and techniques for crushing, milling, and the like. Most preferably, the tobacco is in a relatively dry form during crushing or milling using equipment such as hammer mills, cutter heads, air controlled mills, and the like. For example, tobacco parts or pieces can be crushed or milled when their moisture content is less than about 15% to less than about 5% by weight. For example, a tobacco plant or part 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 cobs). The harvested plant or individual parts or pieces can be further subdivided into parts or pieces (e.g., leaves can be chopped, cut, powdered, pulverized, milled or crushed into parts or pieces that can be characterized as filler-type pieces, granules, particles, or fine powders). The plant or part thereof can be subjected to an external force or pressure (e.g., by being pressed or subjected to a rolling process). When such processing conditions are practiced, the plant or part thereof may have a moisture content that approximates its natural moisture content (e.g., moisture content immediately after harvest), a moisture content obtained by adding moisture to the plant or part thereof, or a moisture content obtained by drying the plant or part thereof. For example, a powdered, pulverized, crushed, or milled fragment of a plant or part thereof may have a moisture content of less than about 25% by weight, often less than about 20% by weight, and often less than about 15% by weight.

[0091] For the preparation of oral products, harvested Nicotiana species plants are usually subjected to a drying process. The tobacco materials incorporated into the mixture for inclusion in the products disclosed herein are appropriately dried and / or aged. Descriptions of different types of drying processes for different types of tobacco are found in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999). Examples of techniques and conditions for drying flue-cured tobacco are found in Nestor et al., Beitrage Tabakforsch. Int., 20, 467-475 (2003) and U.S. Patent No. 6,895,974 (Peele), which are incorporated herein by reference. Exemplary techniques and conditions for air-curing tobacco are described in U.S. Patent No. 7,650,892 (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 may be subjected to different types of curing treatments, such as flue-curing or sun-curing.

[0092] In certain embodiments, tobacco materials that may be used include flue-cured or Virginia (e.g., K326), burley, sun-cured (e.g., Indian Kurnool and Oriental tobaccos, including Katerini, Prelip, Komotini, Xanthi and Yambol tobaccos), Maryland, dark, dark flue-cured, dark air-cured (e.g., Madole, Passanda, Cubano, Jatin and Bezuki tobaccos), light air-cured (e.g., North Wisconsin and Galpao tobaccos), Indian air-cured, Red Russian and Rustica tobaccos, as well as various other rare or specialty tobaccos and various blends of any of the foregoing tobaccos.

[0093] The tobacco material may have a so-called "blended" form. For example, the tobacco material may include a mixture of flue-cured, burley (e.g., Malawi burley tobacco) and Oriental tobacco parts or pieces (e.g., as a mixture of tobacco composed of or derived from tobacco lamina or tobacco lamina and tobacco stems). For example, a representative blend may incorporate, on a dry weight basis, about 30 to about 70 parts burley tobacco (e.g., lamina or lamina and stems) and about 30 to about 70 parts flue-cured tobacco (e.g., stem, lamina or lamina and stems). Other exemplary tobacco blends incorporate, on a dry weight basis, about 75 parts flue-cured tobacco, about 15 parts burley tobacco and about 10 parts Oriental tobacco; or about 65 parts flue-cured tobacco, about 25 parts burley tobacco and about 10 parts Oriental tobacco; or about 65 parts flue-cured tobacco, about 10 parts burley tobacco and about 25 parts Oriental tobacco. Other exemplary tobacco blends incorporate, on a dry weight basis, from about 20 to about 30 parts Oriental tobacco and from about 70 to about 80 parts flue-cured tobacco.

[0094] The tobacco material used in the present disclosure may be subjected to, for example, fermentation, bleaching, etc. Optionally, the tobacco material may be subjected to, for example, irradiation, pasteurization, or otherwise controlled heat treatment. Such treatment processes are detailed, for example, in U.S. Pat. No. 8,061,362 (Mua et al.), which is incorporated herein by reference. In certain embodiments, the tobacco material may be treated with an additive capable of inhibiting the reaction of asparagine to form acrylamide upon heating of water and the tobacco material (e.g., an additive selected from the group consisting of lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, compositions incorporating divalent and trivalent cations, asparaginase, certain non-reducing sugars, certain reducing agents, phenolic compounds, certain compounds having at least one free thiol group or functional group, oxidizing agents, oxidation catalysts, natural plant extracts (e.g., rosemary extract), and combinations thereof). See, for example, the types of treatment processes described in U.S. Patent Nos. 8,434,496, 8,944,072, and 8,991,403 (Chen et al.), all of which are incorporated herein by reference. In certain embodiments, this type of treatment is useful when the original tobacco material is exposed to heat in the aforementioned processes.

[0095] In some embodiments, the type of tobacco material is selected to be somewhat visually lighter in color than other tobacco materials in their initial state (e.g., whitened or bleached). The tobacco pulp can be whitened in certain embodiments according to any means known in the art. For example, bleached tobacco materials produced by various whitening methods using various bleaching or oxidizing agents and oxidation catalysts can be used. Exemplary oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorites, chlorates, perchlorates, hypochlorites, ozone, ammonia, potassium permanganate, and combinations thereof. Exemplary oxidation catalysts are titanium dioxide, manganese dioxide, and combinations thereof.Processes for treating tobacco with bleaching agents are described, for example, in U.S. Pat. No. 787,611 (Daniels, Jr.); U.S. Pat. No. 1,086,306 (Oelenheinz); U.S. Pat. No. 1,437,095 (Delling); U.S. Pat. No. 1,757,477 (Rosenhoch); U.S. Pat. No. 2,122,421 (Hawkinson); U.S. Pat. No. 2,148,147 (Baier); U.S. Pat. No. 2,170,107 (Baier); U.S. Pat. No. 2,274,649 (Baier); U.S. Pat. No. 2,770,239 (Prats et al.); U.S. Pat. No. 3,612,065 (Rosen); No. 3,851,653 (Rosen); U.S. Patent No. 3,889,689 (Rosen); U.S. Patent No. 3,943,940 (Minami); U.S. Patent No. 3,943,945 (Rosen); U.S. Patent No. 4,143,666 (Rainer); U.S. Patent No. 4,194,514 (Campbell); U.S. Patent No. 4,366,823 (Rainer et al.); U.S. Patent No. 4,366,824 (Rainer et al.); U.S. Patent No. 4,388,933 (Rainer et al.); U.S. Patent No. 4,641,667 (Schmekel et al.); U.S. Patent No. 5,713,376 (Berger); U.S. Patent No. 9,339,0586 (Byrd Jr. et al.); U.S. Patent No. 9,420,825 (Beeson et al.); U.S. Patent No. 9,950,858 (Byrd Jr. et al.); and U.S. Patent Application Publication No. 2012 / 0067361 (Bjorkholm et al.); U.S. Patent Application Publication No. 2016 / 0073686 (Crooks); U.S. Patent Application Publication No. 2017 / 0020183 (Bjorkholm); and U.S. Patent Application Publication No. 2017 / 0112183 (Bjorkholm); and International Publication Nos. WO1996 / 031255 (Giolvas) and WO2018 / 083114 (Bjorkholm).

[0096] 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.

[0097] In some embodiments, whitened tobacco materials can be characterized as 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. Whitened tobacco materials can, in certain embodiments, be characterized as closer to pure white on the chromaticity diagram than untreated tobacco materials.

[0098] In various embodiments, the tobacco material may be processed to extract soluble components of the tobacco material from the material. As used herein, "tobacco extract" refers to an isolated component of the tobacco material that is extracted from the solid tobacco pulp by a solvent that is contacted with the tobacco material in an extraction process. Various extraction techniques of tobacco materials can be used to produce tobacco extracts and tobacco solid materials. See, for example, the extraction process described in U.S. Patent Application Publication No. 2011 / 0247640 (Beeson et al.), which is incorporated herein by reference. Other exemplary techniques for extracting tobacco components include those described in U.S. Pat. No. 4,144,895 (Fiore); U.S. Pat. No. 4,150,677 (Osborne, Jr. et al.); U.S. Pat. No. 4,267,847 (Reid); U.S. Pat. No. 4,289,147 (Wildman et al.); U.S. Pat. No. 4,351,346 (Brummer et al.); U.S. Pat. No. 4,359,059 (Brummer et al.); U.S. Pat. No. 4,506,682 (Muller); U.S. Pat. No. 4,589,428 (Keritsis); U.S. Pat. No. 4,605,016 (Soga et al.); U.S. Pat. No. 4,716,911 (Poulose et al.); U.S. Pat. No. 4,727,889 (Niven, Jr.), all of which are incorporated herein by reference.No. 4,887,618 (Bernasek et al.); U.S. Patent No. 4,941,484 (Clapp et al.); U.S. Patent No. 4,967,771 (Fagg et al.); U.S. Patent No. 4,986,286 (Roberts et al.); U.S. Patent No. 5,005,593 (Fagg et al.); U.S. Patent No. 5,018,540 (Grubbs et al.); U.S. Patent No. 5,060,669 (White et al.); U.S. Patent No. 5,065,775 (Fagg); U.S. Patent No. 5,074,319 (White et al.); U.S. Patent No. 5,099,862 (White et al.); U.S. Patent No. 5,121,757 (White et al.); U.S. Patent No. 5,131,414 (Fagg); U.S. Patent No. 5,131,415 (Munoz et al.); U.S. Patent No. 5,148,819 (Fagg); U.S. Patent No. 5,197,4 No. 94 (Kramer); U.S. Patent No. 5,230,354 (Smith et al.); U.S. Patent No. 5,234,008 (Fagg); U.S. Patent No. 5,243,999 (Smith); U.S. Patent No. 5,301,694 (Raymond et al.); U.S. Patent No. 5,318,050 (Gonzalez-Parra et al.); U.S. Patent No. 5,343,879 (Teague); U.S. Patent No. 5,360,022 (Newton); U.S. Patent No. 5,435,325 (Clapp et al.); U.S. Patent No. 5,445,169 (Brinkley et al.); U.S. Patent No. 6,131,584 (Lauterbach); U.S. Patent No. 6,298,859 (Kierulff et al.); U.S. Patent No. 6,772,767 (Mua et al.); and U.S. Patent No. 7,337,782 (Thompson).

[0099] Typical content ranges of tobacco material may vary depending on the nature and type of tobacco material and the intended effect on the final mixture, with exemplary ranges being up to about 30% by weight (or up to about 20% by weight, up to about 10% by weight, or up to about 5% by weight), (e.g., about 0.1 to about 15% by weight), based on the total weight of the mixture. In some embodiments, products of the present disclosure may be characterized as being completely free or substantially free of tobacco material (other than purified nicotine as an active ingredient). For example, certain embodiments may be characterized as having less than 1% by weight, less than 0.5% by weight, or less than 0.1% by weight of tobacco material, or having 0% by weight of tobacco material. In some embodiments, compositions or products of the present disclosure may include about 10% by weight or less of tobacco material, based on the total weight of the mixture, excluding any nicotine components present.

[0100] Additional 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. The additives may be artificial, obtained or derived from herbal or biological sources. The specific types of additional additives that may be included are further described below.

[0101] In some embodiments, the composition and product may contain water. The moisture content (or total moisture content) of the composition in the product before the product is used by the consumer may vary according to the desired properties. Typically, the composition present in the product before being placed in the mouth of the user may contain less than 60% by weight, less than 50% by weight, less than 40% by weight, less than 30% by weight, less than 20% by weight, less than 10% by weight, or less than 5% by weight. For example, the total moisture content in the composition and / or product may range from about 0.1% to about 60% by weight, about 1% to about 50% by weight, about 1.5% to about 40% by weight, or about 2% to about 25% by weight of water. In some embodiments, the composition and product may contain at least 1% by weight, at least 2% by weight, at least 5% by weight, at least 10% by weight, or at least 20% by weight of water. As previously mentioned, the moisture content in some embodiments may be at least partially related to the content of other ingredients in the composition, such as the nicotine content or the content of another active ingredient. Similarly, the moisture content (or total moisture content) can vary in conjunction with the use of a binder component, as described separately below. For example, the moisture content or total moisture content can range from about 10% to about 40% by weight, from about 15% to about 35% by weight, or from about 15% to about 30% by weight, based on the total weight of the composition or product.

[0102] In some embodiments, the compositions and products may contain one or more organic acids. 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., do not completely dissociate in the presence of water), such as carboxylic acids (-CO2H) or sulfonic acids (-SO2OH). As used herein, reference to an organic acid refers to an organic acid that is intentionally added. In this regard, an organic acid may be intentionally added as a particular ingredient, as opposed to simply being naturally present as a constituent of another ingredient (e.g., a small amount of organic acid that may be naturally present in an ingredient such as a tobacco material). In some embodiments, the one or more organic acids are added neat (i.e., in free acid, native solid or liquid form) or as, for example, an aqueous solution. In some embodiments, the one or more organic acids are added in the form of a salt, as described herein below.

[0103] In some embodiments, the organic acid is an alkyl carboxylic acid. Non-limiting examples of alkyl carboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, and the like. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propane sulfonic acid and octane sulfonic 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 may contain two or more carboxylic acid groups or two or more sulfonic acid groups (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., 2-4 carboxylic acid groups), one or more carboxylic acid groups may be esterified. Non-limiting examples include succinic acid monoethyl ester, monomethyl fumarate, monomethyl citrate or dimethyl citrate.

[0104] In some embodiments, the organic acid may contain two or more carboxylic acid groups and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid, citric acid, and the like. In some embodiments, the organic acid is an aryl carboxylic acid or an aryl sulfonic acid. Non-limiting examples of aryl carboxylic and sulfonic acids include benzoic acid, toluic 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 another embodiment, some or 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. For example, non-limiting examples of suitable salts of 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.

[0105] 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, based on the total weight of the mixture, of one or more organic acids.

[0106] In some embodiments, the composition may further comprise a salt (e.g., an alkali metal salt), typically used in an amount sufficient to provide the composition and product with the desired sensory attributes. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, and the like. When present, representative amounts of salts are about 0.5% by weight or more, about 1.0% by weight or more, or about 1.5% by weight or more, but typically comprise about 10% by weight or less, about 7.5% by weight or less, or about 5% by weight or less (e.g., about 0.5 to about 5% by weight) of the total weight of the composition or product.

[0107] The compositions and products may also include one or more sweeteners. The sweetener may be any sweetener or combination of sweeteners, in natural or artificial form or as a combination of natural and artificial sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, isomaltulose, stevia, honey, etc. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, etc. In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides, with partial or complete hydrogenation. Sugar alcohols, for example, have from about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). If present, a representative amount of sweetener may comprise from about 0.1 to about 20% or more by weight of the composition by weight, for example, from about 0.1 to about 1%, from about 1 to about 5%, from about 5 to about 10% or from about 10 to about 20% by weight of the composition or product by weight, based on the total weight of the composition or product.

[0108] In some embodiments, the compositions and products may include one or more binders. In certain embodiments, a sufficient amount of binder (or combination of binders) may be used to provide the composition with the desired physical attributes and physical integrity, and the binder often also functions as a thickening or gelling agent. Typical binders may be organic or inorganic or combinations thereof. Representative binders include povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof. In some embodiments, the binder includes pectin or carrageenan, or combinations thereof.

[0109] The amount of binder utilized may vary, but is typically up to about 30% by weight based on the total weight of the composition or product, with certain embodiments characterized by a binder content of at least about 0.1% by weight, such as about 1 to about 30% by weight or about 5 to about 10% by weight. As noted above, one or more binders may be particularly useful in compositions having a relatively moderate amount of moisture, such as in the range of about 15% to about 30% by weight, based on the total weight of the composition or product. Such compositions may be particularly suitable for use with certain active ingredients that have improved stability and / or improved release when contained in products having an overall moderate moisture content.

[0110] 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 of plant origin, which are usually water soluble to some extent, include xanthan gum, guar gum, gum arabic, gum ghatti, gum tragacanth, gum karaya, locust bean gum, gellan gum, and combinations thereof. When present, the natural gum binder material is typically present in an amount of up to about 5% by weight, such as 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% by weight to about 2, about 3, about 4, or about 5% by weight, based on the total weight of the composition or product.

[0111] 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 the desired moisture attributes. Additionally, in some cases, the humectant may impart desirable flow properties to the composition for depositing into a mold. When present, the humectant typically comprises about 5% or less (e.g., about 0.5 to about 5% by weight) of the composition or product. When present, a representative amount of the humectant is about 0.1% to about 1% by weight, or about 1% to about 5% by weight, based on the total weight of the composition or product.

[0112] In certain embodiments, the compositions of the present disclosure may include a pH adjusting agent or buffering agent. Examples of pH adjusting agents and buffering agents that can be used include, but are not limited to, metal hydroxides (e.g., alkali metal hydroxides 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. If present, the buffering agent is usually present in an amount of less than about 5% by weight based on the weight of the composition or product, for example, about 0.5% to about 5% by weight, for example, 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 buffering agents include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof. As noted above, in certain embodiments, it may be desirable to provide a pH within a specified range, and the materials described above may be suitable for use in providing compositions and products having the desired pH range.

[0113] In some embodiments, the compositions and products may include one or more colorants. Colorants may be used in an amount sufficient to provide the composition or product with the desired physical attributes. 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 when present, is typically up to about 3% by weight, such as about 0.1%, about 0.5%, or about 1% to about 3% by weight, based on the total weight of the composition or product.

[0114] Further examples of types of additives that can be used in the present compositions and products include thickening or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil and zinc), preservatives (e.g., potassium sorbate, etc.), disintegration aids, zinc or magnesium salts selected to be relatively water soluble for compositions with higher water solubility (e.g., magnesium gluconate or zinc gluconate), or zinc or magnesium salts selected to be relatively water insoluble for compositions with lower water solubility (e.g., magnesium oxide or zinc oxide), or combinations thereof. See, for example, the representative components, combinations of components, relative amounts of each component, and procedures and methods of using these components described in U.S. Patent No. 9,237,769 (Mua et al.), U.S. Patent No. 7,861,728 (Holton, Jr. et al.), U.S. Patent Application Publication No. 2010 / 0291245 (Gao et al.), and U.S. Patent Application Publication No. 2007 / 0062549 (Holton, Jr. et al.), each of which is incorporated herein by reference. Typical inclusion ranges of 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.

[0115] In one or more embodiments, the compositions and products may include one or more complexing agents, such as cyclodextrin. Non-limiting examples of suitable cyclodextrins for use in the compositions include gamma-cyclodextrin and hydroxypropylcyclodextrin. Cyclodextrins, due to their cyclic structure, can function as hosts to incorporate flavorings and / or active ingredients in the composition, for example, in the form of inclusion complexes. Without wishing to be bound by theory, when the composition is placed in the mouth of a user, which is moist, the incorporated flavorings and / or active ingredients may be released as a result of thermal degradation and / or migration to saliva. In one embodiment of the present disclosure, at least a portion of at least one active ingredient is bound to the cyclodextrin. In some embodiments, when cyclodextrin or similar complexing agents are utilized, it may be beneficial to limit the total moisture content of the entire composition or product. Reduced moisture may improve product stability, and therefore the total moisture content of compositions and products containing cyclodextrin or other complexing agents may usefully be in the range of about 5% to about 30% by weight, about 10% to about 30% by weight, or about 15% to about 30% by weight, based on the total weight of the composition or product.

[0116] The aforementioned additives may be used together (e.g., as an additive blend) or separately (e.g., individual additive components may be added at different stages involved in the preparation of the final mixture). Additionally, additives of the aforementioned types may be encapsulated so as to be provided in the final product or mixture. Exemplary encapsulated additives are described, for example, in WO2010 / 132444 (Atchley), already incorporated herein by reference.

[0117] 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 matter. As used herein, the term "particle" 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 average length to width ratio of the particles being less than 2:1, such as less than 1.5:1, for example about 1:1. In various embodiments, the particles of the particulate matter may be described as substantially spherical or granular.

[0118] The particle size of particulate matter can be measured by sieve analysis. As one skilled in the art can easily appreciate, sieve analysis (also known as gradient test) is a method used to measure the particle size distribution of particulate matter. Typically, sieve analysis uses a nested column of sieves, which preferably comprises sieves in the form of wire mesh fabric. A pre-weighed sample can be placed on the top or uppermost sieve in the column, which has the largest sieve opening or mesh size (i.e., the largest sieve hole size). Each sieve in the lower part of the column has an increasingly smaller sieve opening or mesh size than the sieve above it. Typically, the bottom of the sieve column has a receiver that collects any particles that have a particle size smaller than the sieve opening or mesh size of the bottom or lowest sieve in the column (having the smallest sieve opening or mesh size).

[0119] In some embodiments, the sieve column may be placed on or in a mechanical agitator. The agitator vibrates each sieve in the column. The mechanical agitator may be operated for a predetermined time to ensure that all particles are collected on the correct sieve. In some embodiments, the sieve column is agitated for 0.5 minutes to 10 minutes, such as 1 minute to 10 minutes, such as 1 minute to 5 minutes, such as about 3 minutes. Once the agitation of the sieves in the column is complete, the weight of the material collected on each sieve is measured. The weight of each sample on each sieve may then be divided by the total weight to obtain the percentage of the amount retained on each sieve. As one of ordinary skill in the art will readily appreciate, the sieve opening size or mesh size of each sieve in the column used for sieve analysis may be selected based on the particle size of the sample to be analyzed or the known maximum / minimum particle size. In some embodiments, a sieve column may be used for the sieve analysis, the column comprising 2-20 sieves, for example 5-15 sieves. In some embodiments, a sieve column may be used for the sieve analysis, the column comprising 10 sieves. In some embodiments, the largest sieve opening or mesh size of the sieve used for the sieve analysis may be 1,000 μm, for example 500 μm, for example 400 μm, for example 300 μm.

[0120] 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 particles having a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 60% by weight of the particles in any particulate material referred to herein have a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 70% by weight of the particles in any particulate material referred to herein have a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 80% by weight of the particles in any particulate material referred to herein have a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 90% by weight of the particles in any particulate material referred to herein have a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 95% by weight of the particles in any particulate material referred to herein have a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 99% by weight of the particles in any particulate material referred to herein have a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less, as measured by sieve analysis.In some embodiments, about 100% by weight of the particles in any particulate material referred to herein have a particle size of about 1,000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, for example about 300 μm or less, as measured by sieve analysis.

[0121] 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 in any particulate material referred to herein have a particle size of from about 0.01 μm to about 1,000 μm, such as from about 0.05 μm to about 750 μm, for example from about 0.1 μm to about 500 μm, for example from about 0.25 μm to about 500 μm, as measured by sieve analysis. In some embodiments, at least 50% by weight, such as at least 60% by weight, 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 in any particulate material referred to herein have a particle size of from about 10 μm to about 400 μm, such as from about 50 μm to about 350 μm, for example from about 100 μm to about 350 μm, for example from about 200 μm to about 300 μm, as measured by sieve analysis.

[0122] preparation The manner in which the various components of the composition are combined may vary. Thus, the overall mixture of the various components, for example with powdered mixed components, may have a relatively homogeneous nature. The components, which may be in the form of liquid or dry solids, may be blended in a pre-treatment step before being mixed with any components in the remainder of the mixture, or may simply be mixed together with all other liquid or dry components. The various components may be contacted, combined or mixed together using any mixing technique or device known in the art. Any mixing method that brings the mixed components into intimate contact may be used, for example, a mixing device characterized by an impeller or other structure capable of stirring. Examples of mixing devices include available mixers such as casing drums, conditioning cylinders or drums, liquid spray devices, cone-type blenders, ribbon blenders, Littleford Day, Inc. FKM130, FKM600, FKM1200, FKM2000, FKM3000, Plough Share type mixer cylinders, Hobart mixers, etc. See also, for example, the types of methods described in U.S. Pat. No. 4,148,325 (Solomon et al.); U.S. Pat. No. 6,510,855 (Korte et al.); U.S. Pat. No. 6,834,654 (Williams), each of which is incorporated herein by reference. In some embodiments, the ingredients 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. Pat. No. 4,148,325 (Solomon et al.); U.S. Pat. No. 6,510,855 (Korte et al.); U.S. Pat. No. 6,834,654 (Williams), U.S. Pat. No. 4,725,440 (Ridgway et al.), and U.S. Pat. No. 6,077,524 (Bolder et al.), each of which is incorporated herein by reference.

[0123] Constructed for oral use Provided herein are products configured for use in the oral cavity. As used herein, the term "configured for use in the oral cavity" means that the product is provided in a form such that, during use, one or more components of the mixture (e.g., flavoring agent and / or nicotine) are passed through the mouth of the user by the saliva in the mouth of the user. In certain embodiments, the product is adapted to deliver a releasable component to the user through the mucous membrane in the mouth of the user. 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 in the mouth when the product is used.

[0124] The products described herein that are configured for use in the oral cavity can take a variety of forms, including gels, pastilles, gums, lozenges, powders, and pouches. Gels can be soft or hard. A particular product that is configured for use in the oral cavity is in the form of a pastille. 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 solidified solid gel. Gels vary greatly in stiffness. A particular product of the present disclosure is in solid form. A particular product may exhibit, for example, one or more of the following characteristics: crispy, granular, chewy, syrupy, pasty, fluffy, smooth, and / or creamy. In certain embodiments, the desired texture property may be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, friability, granularity, gummyness, hardness, weight, hygroscopicity, hygroscopicity, mouthfeel, roughness, slipperiness, smoothness, viscosity, moisture, and combinations thereof.

[0125] Products containing the mixtures of the present disclosure may be dissolvable. As used herein, the terms "dissolve", "dissolving" and "dissolvable" refer to a mixture having water-soluble components that interact with the moisture in the oral cavity to go into solution, thereby allowing for gradual consumption of the product. According to one aspect, a dissolvable product can persist in the user's mouth for a period of time until completely dissolved. The dissolution rate can vary over a wide range, from about 1 minute or less to about 60 minutes. For example, a fast-release mixture will usually dissolve and / or release the active 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 disruption of interactions between the components of the mixture. In some embodiments, the product may be dissolvable, for example, as described in U.S. Patent Application Publication No. 2012 / 0037175 (Cantrell et al.). In other embodiments, the product does not dissolve during the time the product remains in the user's mouth.

[0126] In one embodiment, the product containing the 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 a water-permeable pouch-format mixture is 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, e.g., under the lips, in the same manner that moist snuff products are typically used. The pouch is preferably not chewed or swallowed. Thereafter, upon exposure to saliva, some of the mixture ingredients therein (e.g., active ingredients such as flavoring agents and / or nicotine) pass through, e.g., the water-permeable pouch, providing flavor and satisfaction to the user. The user does not need to spit out any part of the mixture. After about 10 to about 60 minutes, usually about 15 to about 45 minutes, of use / enjoyment, a substantial amount of the mixture has been ingested by the human subject, and the pouch may be removed from the human subject's mouth for disposal.

[0127] Thus, in certain embodiments, the mixture disclosed herein and any other ingredients described above are combined in a moisture-permeable packet or pouch that serves as a container for using the mixture to provide a pouch product configured for use in the oral cavity. Certain embodiments of the disclosure are described with reference to the figures, and these described embodiments include a snus-type product having an outer pouch and containing the mixture described herein. As will be described in more detail below, such embodiments are shown by way of example only, and the pouch product of the present disclosure may contain the composition in other forms. The mixture / configuration of such a packet or pouch, such as the container pouch 102 in the embodiment shown in the figures, may vary. Referring to the figures, 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 that contains a material 104 that includes the composition described herein. The pouch product 100 may be an example of a product described herein that is formed at least in part from the composition described.

[0128] Suitable packets, pouches or containers of the type used in the manufacture of smokeless tobacco products are available under the trade names CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare. The mixture can be pouched and packaged using techniques and types of ingredients used in the manufacture of traditional snus-type products. The pouch provides a type of liquid-permeable container that can be considered to have similar properties to the mesh-type materials used in the construction of tea bags. The ingredients of the mixture easily diffuse through the pouch into the mouth of the user.

[0129] Non-limiting examples of suitable types of pouches are described, for example, in U.S. Pat. No. 5,167,244 (Kjerstad) and U.S. Pat. No. 8,931,493 (Sebastian et al.); and U.S. Patent Application Publication No. 2016 / 0000140 (Sebastian et al.); U.S. Patent Application Publication No. 2016 / 0073689 (Sebastian et al.); U.S. Patent Application Publication No. 2016 / 0157515 (Chapman et al.); and U.S. Patent Application Publication No. 2016 / 0192703 (Sebastian et al.), each of which is incorporated herein by reference. The pouches may be provided as individual pouches or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches) may be connected or bonded together (e.g., in an end-to-end manner) such that single pouches or individual portions can be easily removed for use from the integral strand or matrix of pouches.

[0130] Exemplary pouches can be manufactured in such a manner from materials such that the pouch undergoes controlled dispersion or dissolution during use by the user. Such pouch materials may have the form of mesh, screen, perforated paper, breathable fabric, and the like. For example, a pouch material manufactured from a mesh-like form of rice paper or rice paper with holes may dissolve in the mouth of the user. As a result, each of the pouch and the mixture may undergo complete dispersion in the mouth of the user under normal use conditions, and thus both the pouch and the mixture may be ingested by the user. Other examples of pouch materials may be manufactured using water-dispersible film-forming materials (e.g., binders such as alginates, carboxymethylcellulose, xanthan gum, pullulan, and the like) and combinations of these materials and materials such as comminuted cellulose compounds (e.g., fine grain wood pulp). Preferred pouch materials are water-dispersible or soluble, but may be designed and manufactured such that a significant amount of the mixed contents will permeate the pouch material under normal use conditions before the time at which the pouch undergoes loss of its physical integrity. Flavoring ingredients, disintegration aids and other desired ingredients may be incorporated into or applied to the pouch material, if desired.

[0131] The amount of material contained in each product unit (e.g., pouch) may 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 g, about 100 mg to about 1.5 g, or about 200 to about 700 mg. In some smaller embodiments, the weight of the mixture in each pouch may be about 100 mg to about 300 mg. For larger embodiments, the weight of the material in each pouch may be about 300 mg to about 700 mg. Other ingredients may be contained in each pouch, as desired. For example, at least one flavored strip, piece, or sheet of flavored water-dispersible or water-soluble material (e.g., a breath-proof edible film-type material) may be placed in each pouch, with or without at least one capsule. Such strips or sheets may be folded or crumpled for easy incorporation into the pouch. See, for example, the types of materials and techniques described in U.S. Pat. No. 6,887,307 (Scott et al.), U.S. Pat. No. 6,923,981 (Leung et al.); and EFSA Journal (2004) 85, 1-32, which are incorporated herein by reference.

[0132] The pouch products described herein can be packaged in any suitable inner packaging material and / or outer container. See, for example, U.S. Pat. No. 7,014,039 (Henson et al.); U.S. Pat. No. 7,537,110 (Kutsch et al.); U.S. Pat. No. 7,584,843 (Kutsch et al.); U.S. Pat. No. 8,397,945 (Gelardi et al.); U.S. Pat. No. D592,956 (Thiellier); U.S. Pat. No. D594,154 (Patel et al.); U.S. Pat. No. D625,178 (Bailey et al.); U.S. Pat. App. Pub. No. 2008 / 0173317 (Robinson et al.); U.S. Pat. App. Pub. No. 2009 / 0014343 (Clark et al.); U.S. Pat. App. Pub. No. 2009 / 0014450 (Bjorkholm), all of which are incorporated herein by reference. ; see also the various types of containers for smokeless type products described in U.S. Patent Application Publication No. 2009 / 0250360 (Bellamah et al.); U.S. Patent Application Publication No. 2009 / 0266837 (Gelardi et al.); U.S. Patent Application Publication No. 2009 / 0223989 (Gelardi); U.S. Patent Application Publication No. 2009 / 0230003 (Thiellier); U.S. Patent Application Publication No. 2010 / 0084424 (Gelardi); U.S. Patent Application Publication No. 2010 / 0133140 (Bailey et al.); U.S. Patent Application Publication No. 2010 / 0264157 (Bailey et al.); and U.S. Patent Application Publication No. 2011 / 0168712 (Bailey et al.).

[0133] The compositions and products according to the present disclosure may be adapted or configured to provide a desired release characteristic associated with one or more of the releasable substances contained in the compositions and products. In some embodiments, the desired release rate may be associated specifically with a flavor substance. In other embodiments, the desired release rate may be associated specifically with an active ingredient.

[0134] 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. It is to be understood, therefore, 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 have been employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

1. An oral pouch product comprising an oral composition within a water-permeable pouch, the oral composition comprising: At least one active ingredient, At least one filler component, and a sufficient amount of water such that the oral composition has a total moisture content of about 15% to about 30% or more by weight based on the total weight of the oral composition; Including, An oral pouch product, wherein said oral composition is completely free of tobacco material or contains less than 1% by weight of tobacco material excluding any nicotine components present.

2. 10. The oral pouch product of claim 1, wherein at least a portion of the at least one active ingredient is bound to at least a portion of the at least one filler ingredient.

3. 10. The oral pouch product of claim 1 further comprising a binder.

4. 4. The oral pouch product of claim 3, wherein the binder is selected from the group consisting of povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, gums, and combinations thereof.

5. 10. The oral pouch product of claim 1, wherein the at least one active ingredient is selected from the group consisting of botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and combinations thereof.

6. 10. The oral pouch product of claim 1, wherein at least one active ingredient is a nicotine ingredient.

7. 7. The oral pouch product of claim 6, wherein the nicotine component is one or both of nicotine free base and a nicotine salt.

8. 7. The oral pouch product of claim 6, wherein the nicotine component is present in an amount having a weight ratio of nicotine component to total moisture content of from about 0.01 to about 0.

2.

9. 7. The oral pouch product of claim 6, wherein the nicotine component is present in an amount having a weight ratio of nicotine component to total moisture content of about 0.01 to about 0.

1.

10. 7. The oral pouch product of claim 6, wherein the nicotine component is present in an amount having a weight ratio of nicotine component to total moisture content of from about 0.03 to about 0.

08.

11. 7. The oral pouch product of claim 6, wherein the nicotine component is present in an amount greater than 2% by weight based on the total weight of the oral composition.

12. 12. The oral pouch product of claim 11, wherein the nicotine component is present in an amount of about 3% to about 10% by weight based on the total weight of the oral composition.

13. 12. The oral pouch product of claim 11, wherein the water is present in an amount such that the oral composition has a total moisture content of greater than 20% by weight, based on the total weight of the oral composition.

14. 14. The oral pouch product of claim 13, wherein the water is present in an amount such that the oral composition has a total moisture content of about 20% to about 45% by weight, based on the total weight of the oral composition.

15. 12. The oral pouch product of claim 11 having a pH greater than 7.

16. 7. The oral pouch product of claim 6, wherein the nicotine component is present in an amount of less than 1% by weight based on the total weight of the oral composition.

17. 17. The oral pouch product of claim 16, wherein the nicotine component is present in an amount of about 0.01% to about 0.9% by weight based on the total weight of the oral composition.

18. 17. The oral pouch product of claim 16, wherein the water is present in an amount such that the oral composition has a total moisture content of about 15% to about 30% by weight, based on the total weight of the oral composition.

19. 10. The oral pouch product of claim 1 further comprising a cyclodextrin.

20. 20. The oral pouch product of claim 19, wherein at least a portion of the at least one active ingredient is bound to the cyclodextrin.

21. 21. The oral pouch product of claim 20, wherein the water is present in an amount such that the oral composition has a total moisture content of about 15% to about 30% by weight, based on the total weight of the oral composition.

22. 22. The oral pouch product of any of claims 1 to 21, comprising at least a trace amount of white tobacco material, but less than 1% by weight, excluding any nicotine components present in the oral composition, based on the total weight of the oral composition.

23. The oral pouch product of claim 1, wherein the water is present in an amount such that the oral composition has a total moisture content of about 20% by weight to about 45% by weight based on the total weight of the oral composition.

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