Oral composition with reduced moisture content

Abstract

The present disclosure provides oral compositions that incorporate a relatively low water content while exhibiting the desired properties associated with wet products. Such compositions may include at least one releasable substance, at least one filler / carrier component, and at least one water substitute, such as a polyol. The water substitute may be present in an amount of about 25% by weight or more based on the total weight of the oral composition, and the compositions and products formed thereby may exhibit a relatively low water activity, such as in the range of about 0.85 or less. The present disclosure further provides a method for forming oral compositions that have a relatively low water activity but a mouthfeel comparable to that of wet products.

Description

Technical Field

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

Background Art

[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 compound in the user's mouth. Conventional forms of such smokeless tobacco products include moist snuff, snus, and chewing tobacco. These are usually formed almost entirely from particulate, granular, or shredded tobacco and are either portioned out by the user or provided to the user in disposable pouches or sachets. Other conventional forms of smokeless products include compressed or aggregated forms such as plugs, tablets, or pellets. Alternative product forms such as tobacco-containing gum and mixtures of tobacco and other plant materials are also known.For example, U.S. Patent No. 1,376,586 (Schwartz); U.S. Patent No. 4,513,756 (Pittman et al.); U.S. Patent No. 4,528,993 (Sensabaugh, Jr. et al.); U.S. Patent No. 4,624,269 (Story et al.); U.S. Patent No. 4,991,599 (Tibbetts); U.S. Patent No. 4,987,907 (Townsend); U.S. Patent No. 5,092,352 (Spr Inkle, III et al.); U.S. Patent No. 5,387,416 (White et al.); U.S. Patent No. 6,668,839 (Williams); U.S. Patent 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); U.S. Patent Application Publication No. 2 U.S. Patent Application Publication No. 005 / 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. 8 / 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 WO2004 / 095959 (Arnarp et al.).

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

[0004] All-white snus portions are gaining popularity, offering an aesthetically pleasing alternative to traditional snus. These modern "white" pouch products may or may not contain bleached tobacco. This type of product may have certain drawbacks, such as poor product stability, which can lead to product discoloration and / or undesirable sensory characteristics. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] U.S. Patent No. 1,376,586 [Patent Document 2] U.S. Patent No. 4513756 [Patent Document 3] U.S. Patent No. 4528993 [Patent Document 4] U.S. Patent No. 4624269 [Patent Document 5] U.S. Patent No. 4991599 [Patent Document 6] U.S. Patent No. 4987907 [Patent Document 7] U.S. Patent No. 5092352 [Patent Document 8] U.S. Patent No. 5387416 [Patent Document 9] U.S. Patent No. 6668839 [Patent Document 10] U.S. Patent No. 6,834,654 [Patent Document 11] U.S. Patent No. 6953040 [Patent Document 12] U.S. Patent No. 7032601 [Patent Document 13] U.S. Patent No. 7694686 [Patent Document 14] U.S. Patent Application Publication No. 2004 / 0020503 [Patent Document 15] U.S. Patent Application Publication No. 2005 / 0115580 [Patent Document 16] U.S. Patent Application Publication No. 2006 / 0191548 [Patent Document 17] U.S. Patent Application Publication No. 2007 / 0062549 [Patent Document 18] U.S. Patent Application Publication No. 2007 / 0186941 [Patent Document 19] U.S. Patent Application Publication No. 2007 / 0186942

Patent Document 20

Patent Document 21

Patent Document 22

Patent Document 23

Patent Document 24

Patent Document 25

Patent Document 26

Patent Document 27

Patent Document 28

Patent Document 29

Patent Document 30

Patent Document 31

Patent Document 32

Patent Document 33

Patent Document 34

Patent Document 35

Patent Document 36

Patent Document 37

Patent Document 38

Patent Document 39

Patent Document 40

Patent Document 41

Patent Document 42

Summary of the Invention

Problems to be Solved by the Invention

[0006] (Brief Summary) The present disclosure generally provides compositions and products configured for oral use. The compositions and products may include at least one releaseable component, at least one filler component, and a polyol component in an amount of about 25% by weight or more based on the total weight of the oral composition. The compositions and products may be configured to impart flavor upon oral use, and additionally or alternatively, may deliver an active ingredient such as nicotine to the consumer. The compositions, products, and methods of the present disclosure may particularly be adapted or configured to provide a desired mouthfeel and / or tactile sensation to the consumer while also having a low moisture content compared to known compositions exhibiting similar properties.

[0007] In certain embodiments, the polyol component is present in an amount of about 25% to about 40% by weight based on the total weight of the oral composition. In some embodiments, the oral composition contains less than 10% by weight of water based on the total weight of the oral composition. In other embodiments, the oral composition contains about 0.1% to 9% by weight of water based on the total weight of the oral composition. In certain embodiments, the oral composition contains about 0.5% to about 5% by weight of water based on the total weight of the oral composition. In some embodiments, the polyol comprises one or both of glycerin and propylene glycol. In other embodiments, the oral composition exhibits a mouthfeel equivalent to a moist product while having a water activity of about 0.85 or less. In some embodiments, the oral composition is contained in a pouch. In certain embodiments, the oral composition is in the form of lozenges, tablets, or extruded articles. In some embodiments, the releaseable component is the active ingredient. In certain embodiments, the active ingredient is selected from the group consisting of nicotine components, botanical substances, stimulants, amino acids, vitamins, cannabinoids, nutraceuticals, and combinations thereof. In some embodiments, the releaseable substance is a flavor component. In certain embodiments, the composition further comprises one or more components selected from the group consisting of sweeteners, gums, binders, or combinations thereof. In another embodiment, the oral composition further comprises a tobacco component.

[0008] In one or more embodiments, the Disclosure may provide a method for forming an oral composition having a mouthfeel equivalent to a moist product while having relatively low water activity. The method may include combining at least one releaseable substance and at least one filler component with a polyol such that the polyol constitutes about 25% by weight or more of the oral composition based on the total weight of the oral composition, and limiting the water content of the oral composition to a range where the water activity of the oral composition is about 0.85 or less. In some embodiments, the polyol may constitute about 25% to about 40% by weight of the oral composition based on the total weight of the oral composition. In another embodiment, the method may include limiting the water content of the oral composition to a range of about 10% by weight or less based on the total weight of the oral composition. In a particular embodiment, the method may include limiting the water content of the oral composition to a range of about 0.5% to about 5% by weight based on the total weight of the oral composition. In another embodiment, the method may include limiting the water content of the oral composition to a range where the water activity of the oral composition is about 0.80 or less.

[0009] This disclosure includes, but is not limited to, the following embodiments.

[0010] Embodiment 1: An oral composition having reduced water activity, comprising at least one releaseable component, at least one filler component, and a polyol component in an amount of about 25% by weight or more based on the total weight of the oral composition.

[0011] Embodiment 2: The oral composition according to Embodiment 1, wherein the polyol component may be present in an amount of about 25% to about 40% by weight based on the total weight of the oral composition.

[0012] Embodiment 3: The oral composition according to either Embodiment 1 or 2, wherein the oral composition may contain less than 10% by weight of water based on the total weight of the oral composition.

[0013] Embodiment 4: The oral composition according to any one of Embodiments 1 to 3, wherein the oral composition may contain about 0.1% to about 9% by weight of water based on the total weight of the oral composition.

[0014] Embodiment 5: The oral composition according to any one of Embodiments 1 to 4, wherein the oral composition may contain about 0.5% to about 5% by weight of water based on the total weight of the oral composition.

[0015] Embodiment 6: The oral composition according to any one of Embodiments 1 to 5, wherein the polyol may comprise one or both of glycerin and propylene glycol.

[0016] Embodiment 7: An oral composition according to any one of Embodiments 1 to 6, wherein the oral composition has a water activity of about 0.85 or less and exhibits a mouthfeel equivalent to that of a moist product.

[0017] Embodiment 8: An oral composition according to any one of Embodiments 1 to 7, wherein the water activity of the oral composition may be about 0.8 or less.

[0018] Embodiment 9: The oral composition according to any one of Embodiments 1 to 8, wherein the oral composition may be contained in a pouch.

[0019] Embodiment 10: The oral composition according to any one of Embodiments 1 to 9, wherein the oral composition may be in the form of a lozenge, a tablet, or an extruded article.

[0020] Embodiment 11: An oral composition according to any one of Embodiments 1 to 10, wherein the releaseable component may be an active ingredient.

[0021] Embodiment 12: An oral composition according to any one of Embodiments 1 to 11, wherein the active ingredient may be selected from the group consisting of nicotine components, botanical substances, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, and combinations thereof.

[0022] Embodiment 13: The oral composition according to any one of Embodiments 1 to 12, wherein the releaseable substance may be a flavor component.

[0023] Embodiment 14: An oral composition according to any one of Embodiments 1 to 13, which may contain one or more components selected from the group consisting of sweeteners, gums, binders, or combinations thereof.

[0024] Embodiment 15: An oral composition according to any one of Embodiments 1 to 14, which may contain tobacco components.

[0025] Embodiment 16: An oral composition according to any one of Embodiments 1 to 15, wherein the tobacco component may include bleached tobacco.

[0026] Embodiment 17: A method for forming an oral composition having a mouthfeel equivalent to a moist product while having relatively low water activity, comprising: combining at least one releaseable substance and at least one filler component with a polyol such that the polyol constitutes about 25% by weight or more of the oral composition based on the total weight of the oral composition; and limiting the water content of the oral composition to a range in which the water activity of the oral composition is about 0.85 or less.

[0027] Embodiment 18: The method according to Embodiment 17, wherein the polyol may constitute about 25% to about 40% by weight of the oral composition, based on the total weight of the oral composition.

[0028] Embodiment 19: The method according to any one of Embodiments 17 or 18, wherein the method may include limiting the moisture content of the oral composition to a range of about 10% by weight or less based on the total weight of the oral composition.

[0029] Embodiment 20: The method according to any one of Embodiments 17 to 19, which may include limiting the moisture content of the oral composition to a range of about 0.5% by weight to about 5% by weight based on the total weight of the oral composition.

[0030] Embodiment 21: The method according to any one of Embodiments 17 to 21, which may include limiting the water content of the oral composition to a range in which the water activity of the oral composition is about 0.80 or less.

[0031] Embodiment 22: Use of a polyol to reduce the water activity of an oral composition comprising a filler, at least one releaseable substance, and a polyol.

[0032] Embodiment 23: The use described in Embodiment 22, wherein the use of the polyol is effective in reducing the water activity of the oral composition to about 0.85 or less.

[0033] Embodiment 24: The use according to either Embodiment 22 or 23, wherein the polyol is present in the oral composition in an amount of about 25% by weight or more based on the total weight of the oral composition.

[0034] Embodiment 25: The use according to any one of Embodiments 22 to 24, wherein the use of the polyol is effective in providing a mouthfeel equivalent to that of a moist product, while the oral composition contains an amount of water of about 10% by weight or less based on the total weight of the oral composition.

[0035] Embodiment 26: An oral product having reduced water activity and a mouthfeel equivalent to a moist product, comprising an amount of polyol component of about 25% by weight or more based on the total weight of the oral product.

[0036] These, as well as other features, aspects, and advantages of the Disclosure, will become apparent upon reading the following detailed description together with the accompanying drawings, which are briefly described below. The Invention includes any combination of two, three, four, or more of the embodiments described above, and any combination of any two, three, four, or more features or elements described herein, whether such features or elements are expressly combined in the description of a particular embodiment herein. The Disclosure is intended to be read in whole so that any separable features or elements in any of the various aspects and embodiments of the Disclosed Invention should be considered to be intended to be combinable unless specifically indicated in the context.

[0037] Having described the aspects of this disclosure using the general terminology mentioned above, please now refer to the attached drawings (which are not necessarily drawn to scale). The drawings are illustrative and should not be construed as limiting the disclosure. [Brief explanation of the drawing]

[0038] [Figure 1] This is a perspective view of a pouch product according to an exemplary embodiment of the present disclosure, comprising a pouch or fleece in which a composition for oral use is at least partially filled. [Modes for carrying out the invention]

[0039] This disclosure provides compositions and products formed from such compositions, which are configured particularly for oral use. The compositions and products may incorporate one or more components that are effective in holding a releaseable component and then releasing the releaseable component at a desired time, such as when in contact with the oral cavity. The components for holding the releaseable component may be adapted or configured to result in controlled release in some embodiments.

[0040] The Disclosure is then described more fully below with reference to its exemplary embodiments. These exemplary embodiments are written to ensure that the Disclosure is sufficient and complete and to fully convey the scope of the Disclosure to those skilled in the art. In fact, the Disclosure can be implemented in many different forms and should not be construed as being limited to the embodiments described herein, but rather these embodiments are provided to satisfy the legal requirements to which the Disclosure applies. Where used herein and in the claims, the singular forms "a," "an," and "the" include the plural unless otherwise specified in the context. References to "dry weight %" or "on a dry weight basis" refer to the weight of the dry components (i.e., all components except water). References to "wet weight" refer to the weight of the mixture including water. Unless otherwise specified, references to "weight %" of a mixture reflect the total wet weight of the mixture (i.e., including water).

[0041] This disclosure provides compositions and products that may contain such compositions. As described herein, the compositions may be provided in various forms, and more specifically, in substantially solid forms such as aggregates of particles, fibers, etc., as further described herein. Accordingly, products may include the compositions themselves or the compositions arranged within a unitizing structure such as a pouch or fleece.

[0042] In some embodiments, the Disclosure provides oral compositions comprising at least one releaseable substance, at least one filler component, and a water substitute component in an amount of about 25% by weight or more based on the total weight of the oral composition. The water substitute component in exemplary embodiments includes polyols. The compositions and products may provide desired properties or a set of properties, particularly those expected in compositions typically having a relatively high water content, but which are exhibited by the compositions despite having a relatively low water content. Thus, the compositions may also exhibit preferably low water activity. In some embodiments, the products described herein typically comprise a mixture of components comprising at least one carrier and / or filler, and at least one releaseable substance (e.g., a flavoring substance and / or active ingredient). In some embodiments, the compositions may further comprise one or more additional components, such as salts, sweeteners, binders, wetting agents, gums, organic acids, tobacco materials, tobacco-derived materials, or combinations thereof. The relative amounts of the various components in the composition can vary and are typically selected to impart desired functional and performance characteristics to the oral product. Exemplary individual components of the composition are described further below.

[0043] 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 compositions may include both a carrier and a filler, and various materials may perform both the functions of a carrier and a filler. The carrier component according to this disclosure may preferably be adapted or configured to hold at least one releaseable substance described herein, and in some embodiments, may hold substantially all of the additional components of the composition. The filler component may perform multiple functions, such as enhancing certain sensory properties, such as tactile and mouthfeel, or enhancing the cohesiveness or compressibility of the product. Generally, the filler component is a porous particulate material. In some embodiments, the compositions may include a carrier. In further embodiments, the compositions may include both a carrier and a filler.

[0044] In some embodiments, the carrier and / or filler components may be cellulosic. For example, preferred particulate components are any non-tobacco plant material or its derivatives, including cellulosic materials derived from such sources. Examples of cellulosic non-tobacco plant materials include cereals (e.g., corn, oats, barley, rye, buckwheat, etc.), sugar beets (e.g., FIBREX® brand fillers available from International Fiber Corporation), bran fibers, and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starch (e.g., derived from potatoes, 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 can also be used.

[0045] As used herein, “starch” may refer to pure starch, modified starch, or starch derivatives of any source. Starch is usually present in granular form in almost all green plants and various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, buds, fruits, grains, and stems). Starch can vary not only in its composition but also in the shape and size of its granules. Often, starches from different sources have different chemical and physical properties. Specific starches may be selected for inclusion in a mixture based on their ability to impart specific functional properties to the composition. Starches from various sources can be used. For example, major sources of starch include grains (e.g., rice, wheat, and corn) and root vegetables (e.g., potatoes and cassava). Other examples of starch sources include acorns, arrowroot, arakacha, bananas, barley, beans (e.g., broad beans, lentils, yamen, peas, chickpeas), breadfruit, buckwheat, canna, chestnut, taro, dogtooth violet, kudzu, maranga, millet, oats, oak, Polynesian arrowroot, sago, sago maize, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnut, and yam. Certain starches are modified starches. Modified starches undergo one or more structural modifications, often designed to alter their high-temperature properties. Some starches are developed through genetic modification and are considered "genetically modified" starches. Other starches are obtained and then processed by chemical, enzymatic, or physical means. For example, modified starch may be starch that has undergone chemical reactions such as esterification, etherification, oxidation, depolymerization by acid-catalyzed or base-induced oxidation (reducing viscosity), bleaching, glycosyl group transfer and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, acetylation, hydroxypropylation and / or partial hydrolysis. Enzymatic treatments include subjecting natural starch to enzyme isolates or concentrates, microbial enzymes and / or enzymes specific to plant materials, for example, processing corn starch by subjecting it to amylase present in corn kernels.Other starches are processed by pregelatinization, dextrinization, and / or heat treatment such as cold water swelling. Specific processed 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 thipate, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, and sodium octenyl succinate starch.

[0046] In some embodiments, the carrier component and / or filler component may be 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 obtained 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, as well as mixtures thereof. In one embodiment, the compositions described herein may contain MCC as a particulate filler component and / or carrier component. The amount of MCC present in the compositions described herein may vary depending on the desired properties. In some embodiments, cellulose derivatives or combinations of such derivatives may be used in combination with different carrier components, which may include cellulose derivatives such as cellulose ethers (including carboxyalkyl ethers). A cellulose derivative means a cellulose polymer in which one or more hydrogens of hydroxyl groups in the cellulose structure are substituted with alkyl, hydroxyalkyl, or aryl groups. 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.

[0047] The total amount of carrier and / or filler components present in a composition can vary, but is typically at most 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 a composition is about 10 to about 75% by weight of the total weight of the composition, for example, about 10, about 15, about 20, about 25 or about 30 to about 35, about 40, about 45 or about 50% by weight (for example, about 20 to about 50% by weight or about 25 to about 45% by weight). In certain embodiments, the total amount of carrier / filler components is at least about 10% by weight, based on the total weight of the composition, for example, at least about 20%, at least about 25%, at least about 30%, at least about 35% or at least about 40%.

[0048] In one or more embodiments, the carrier component may be adapted or configured to substantially surround or enclose additional components of the composition. For example, the carrier may be configured as a packet, pouch, fleece, etc., 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 to limit the nature of the structure.

[0049] A suitable fleece may, for example, be formed of multiple fibers. As used herein, the term “fiber” includes, unless otherwise specified, both fibers of finite length, such as conventional staple fibers and nanofibers, and substantially continuous structures, such as continuous filaments. Fibers may have a substantially round or circular cross-section or a non-circular cross-section (e.g., elliptical, rectangular, multi-lobed, etc.). Fibers may be provided in a variety of configurations, and in particular, fibers may include multi-component fibers.

[0050] In some embodiments, the fleece may be in the form of a nonwoven material. The term “nonwoven” is used herein to refer to fibrous materials, webs, mats, bats, or sheets in which the fibers are aligned in an irregular or random direction. In some embodiments, the multiple fibers used to form the fleece may include heat-sealable and / or meltable binder fibers. Further embodiments of suitable pouches or fleeces are described below.

[0051] releasable substances As used herein, “releaseable substance” or “releaseable component” may refer to any substance or component that is held by a carrier component or filler component and can be released from the carrier component or filler component when in contact with the consumer’s mouth. The terms releaseable substance and releaseable component can be used interchangeably. In some embodiments, the releaseable substance may be adapted or configured to be absorbed, adsorbed or otherwise incorporated into a portion of the carrier component or filler component. In this way, the releaseable substance may be held with a desired level of stability and / or configured for controlled release from a porous structure.

[0052] A wide variety of releaseable substances may be used. In some embodiments, multiple releaseable substances may be used. In some embodiments, one or more releaseable substances may be adapted or configured to be released relatively rapidly from the carrier or filler component. Similarly, in some embodiments, one or more releaseable substances may be adapted or configured to be released relatively slowly from the carrier or filler component.

[0053] active ingredient In some embodiments, the releaseable substance may be an active ingredient. For example, the releaseable substance may consist of a single active ingredient or multiple active ingredients. If desired, one or more active ingredients may be retained as part of a filler, or one or more active ingredients may be retained in the composition and / or product in other ways, such as being bound to an additional filler or existing in a unit form (e.g., pelletized active ingredients). As used herein, “active ingredient” means one or more substances belonging to one of the following categories: APIs (pharmaceutical active ingredients), food additives, natural drugs, and naturally occurring substances that may affect humans. Examples of active ingredients include any ingredient known to affect one or more biological functions in the body, such as pharmacological activity or other direct effects in the diagnosis, treatment, mitigation, management, or prevention of disease, or ingredients that affect the structure or any function of the human body (e.g., stimulating the central nervous system, enhancing libido, antipyretic / analgesic effects, or other beneficial effects on the body). In some embodiments, the active ingredient may be of a type commonly referred to as a dietary supplement, nutraceutical, “phytochemical,” or “functional food.” These types of additives may be defined in the art as encompassing substances that are normally available from naturally occurring sources (e.g., botanical materials) that produce one or more beneficial biological effects (e.g., health promotion, disease prevention, or other medicinal effects) but are not classified or regulated as pharmaceuticals.

[0054] These can be used as releaseable substances in this specification. Non-limiting examples of active ingredients that may be included in the composition and / or product by other means (e.g., not held by porous alumina) include botanical ingredients, stimulants, amino acids, nicotine ingredients and / or pharmaceutical, nutraceutical and medicinal ingredients (e.g., vitamins such as A, B3, B6, B12 and C and / or cannabinoids such as tetrahydrocannabinol (THC) and cannabidil (CBD)). Each of these categories is further described below herein. The specific selection of active ingredients varies depending on the desired flavor, texture and desired properties in a particular product.

[0055] 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, ginseng, tryptophan, 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 optionally lemon balm extract. In further embodiments, the active ingredient includes theanine, theanine, and tryptophan, or theanine, and one or more B vitamins (e.g., vitamin B6 or B12). In further embodiments, the active ingredient includes a combination of caffeine, taurine, and vitamin C.

[0056] The specific percentage of the active ingredient present varies depending on the desired properties in a particular product. Typically, the active ingredient or combination thereof is present at a total concentration of at least about 0.001% by weight of the composition, for example, ranging from about 0.001% to about 20%. In some embodiments, the active ingredient or combination thereof is present at a concentration of about 0.1% to about 10% by weight, based on the total weight of the composition, for example, about 0.5% to about 10% by weight, about 1% to about 10% by weight, or about 1% to about 5% by weight. In some embodiments, the active ingredient or combination thereof is present at a concentration of about 0.001% by weight, about 0.01% by weight, about 0.1% by weight, or about 1% to a maximum of about 20% by weight. For example, based on the total weight of the composition, approximately 0.001% by weight, approximately 0.002% by weight, approximately 0.003% by weight, approximately 0.004% by weight, approximately 0.005% by weight, approximately 0.006% by weight, approximately 0.007% by weight, approximately 0.008% by weight, approximately 0.009% by weight, approximately 0.01% by weight, approximately 0.02% by weight, approximately 0.03% by weight, approximately 0.04% by weight, approximately 0.05% by weight, approximately 0.06% by weight, approximately 0.07% by weight, approximately 0.08% by weight, approximately 0.09% by weight, approximately 0.1% by weight, approximately 0.2% by weight. It exists in concentrations of approximately 0.3% by weight, approximately 0.4% by weight, approximately 0.5% by weight, approximately 0.6% by weight, approximately 0.7% by weight, approximately 0.8% by weight, or approximately 0.9% by weight to approximately 1% by weight, approximately 2% by weight, approximately 3% by weight, approximately 4% by weight, approximately 5% by weight, approximately 6% by weight, approximately 7% by weight, approximately 8% by weight, approximately 9% by weight, approximately 10% by weight, approximately 11% by weight, approximately 12% by weight, approximately 13% by weight, approximately 14% by weight, approximately 15% by weight, approximately 16% by weight, approximately 17% by weight, approximately 18% by weight, approximately 19% by weight, or approximately 20% by weight. Further preferred ranges for specific active ingredients are shown below herein.

[0057] Botanical substances In some embodiments, the active ingredient includes a botanical component. As used herein, the terms “botanical component” or “botanical substance” refer to any plant material or fungal material, including plant materials in their natural forms and plant materials derived from natural plant materials, such as extracts or isolates from plant materials or processed plant materials (e.g., plant materials that have undergone heat treatment, fermentation, bleaching, or other processing processes that can alter the physical and / or chemical properties of the material). For the purposes of this disclosure, “botanical substance” 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 sensory properties (e.g., tea or chisan). The reference to botanical material as “non-tobacco” is intended to exclude tobacco material (i.e., not any Nicotiana species). In some embodiments, the compositions disclosed herein can be characterized as not containing any tobacco material (e.g., any embodiment disclosed herein may be completely or substantially free of any tobacco material). "Substantially free" means that tobacco material is not intentionally added. For example, a particular embodiment may be characterized as having less than 0.001% by weight of tobacco, less than 0.0001% by weight, or 0% by weight of tobacco.

[0058] If present, botanical substances are typically present in concentrations of about 0.01% by weight to about 10% by weight, based on the total weight of the composition, for example, about 0.01% by weight, about 0.05% by weight, about 0.1% by weight or about 0.5% by weight to about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight or about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight or about 15% by weight.

[0059] The botanical materials useful in this 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 botanical substances, as plant materials or extracts thereof, have been found to be used in traditional Chinese medicine and are further described herein. Non-exclusive examples of botanical substances or botanical-derived materials include ashwagandha, bacopa monniera, baobab, basil, Centella asiatica, chaifu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus, clove, cocoa, hyacinth mushrooms, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, fennel, Galphimia glauca, ginger, ginkgo, ginseng (e.g., Panax ginseng), green tea, and Griffonia simplicifolia. Examples include simplicifolia, guarana, cannabis, hemp, hops, jasmine, Kempferia parviflora (Thai ginseng), kawa, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, Nardostachys chinensis, sweet violet oil extract, peppermint, quercetin, resveratrol, Rhizoma gastrodiae, rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum, schistandra, skullcap, spearmint extract, spikenard, terpenes, chisan, turmeric, Turnera aphrodisiaca, valerian, toguar, and yerba mate.

[0060] In some embodiments, the active ingredient is lemon balm. Lemon balm (Melissa officinalis) is a mild lemon-scented herb belonging to the same family (Lamiaceae) as mint. This herb is native to Europe, North Africa, and West Asia. Lemon balm tea, essential oil, and extracts are used in traditional and alternative medicine. In some embodiments, the active ingredient is 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.

[0061] In some embodiments, the active ingredient is ginseng. Ginseng is the root of a plant of the genus Panax and is characterized by the presence of specific steroid saponin phytochemicals (ginsenosides) and gintonin. Ginseng is used as a nutritional supplement in energy drinks or herbal teas and as a traditional medicine. Cultivated varieties 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, ginseng is either American ginseng or Korean ginseng. In certain embodiments, the active ingredient is Korean ginseng. In some embodiments, ginseng is present in an amount of about 0.4 to about 0.6% by weight based on the total weight of the composition.

[0062] 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., a material that enhances focus, cognition, vitality, mood, arousal, etc. Non-limiting examples of stimulants include caffeine, theacrine, theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid structurally related to caffeine and has stimulant, analgesic, and anti-inflammatory effects. The stimulants of the present invention may be natural products, derived from natural products, or completely synthetic. For example, certain botanical materials (e.g., guarana, tea, coffee, cocoa) may have stimulant effects due to the presence of caffeine or related alkaloids, and are therefore “natural” stimulants. “Naturally derived” means that the stimulant (e.g., caffeine, theacrine) is in a purified form, outside of its natural (e.g., botanical) matrix. For example, caffeine can be obtained by extraction and purification from a botanical source (e.g., tea). "Complete synthesis" means that the stimulant was obtained by chemical synthesis. In some embodiments, the active ingredient contains caffeine. In some embodiments, caffeine exists in an encapsulated form. An example of encapsulated caffeine is Vitashure®, available from Balchem ​​Corp., 52 Sunrise Park Road, New Hampton, NY, 10958.

[0063] If present, stimulants or combinations of stimulants (e.g., caffeine, theacrin, and combinations thereof) are typically present in concentrations of about 0.1% to about 15% by weight, based on the total weight of the composition, 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. In some embodiments, the composition contains about 1.5% to about 6% by weight of caffeine, based on the total weight of the composition.

[0064] amino acid In some embodiments, the active ingredient comprises an amino acid. As used herein, the term “amino acid” refers to an organic compound containing an amine (-NH2) and a carboxyl (-COOH) or sulfonic acid (SO3H) functional group, along with a side chain (R group) specific to each amino acid. The amino acid may be a protein-constitutive amino acid or a non-protein-constitutive amino acid. “Protein-constitutive” means that the amino acid is one of the 20 naturally occurring amino acids found in proteins. Examples of protein-constitutive 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-protein-constitutive” means that the amino acid is not naturally found in proteins or is not directly produced by cellular mechanisms (e.g., it is a product of post-translational modification). Non-limiting examples of non-protein constituent 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.

[0065] If present, amino acids or combinations of amino acids (e.g., theanine, GABA, and combinations thereof) are typically concentrated at a concentration of about 0.1% to about 15% by weight, based on the total weight of the composition, 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.

[0066] 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 set of related molecules) that is an essential micronutrient necessary for the proper functioning of metabolism in mammals. There are 13 vitamins necessary for human metabolism, which are as follows: Vitamin A (as all-trans retinol, all-trans retinyl ester, all-trans β-carotene and other provitamin A carotenoids), Vitamin B1 (thiamine), Vitamin B2 (riboflavin), Vitamin B3 (niacin), Vitamin B5 (pantothenic acid), Vitamin B6 (pyridoxine), Vitamin B7 (biotin), Vitamin B9 (folic acid or folate), Vitamin B12 (cobalamin), Vitamin C (ascorbic acid), Vitamin D (calciferol), Vitamin E (tocopherol and tocotrienol), and Vitamin K (quinone). In some embodiments, the active ingredient comprises Vitamin C. In some embodiments, the active ingredient is a combination of Vitamin C, caffeine, and taurine.

[0067] If present, vitamins or combinations of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or combinations thereof) are typically present in concentrations 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.

[0068] Antioxidant In some embodiments, the active ingredient comprises one or more antioxidants. As used herein, the term “antioxidant” means a substance that can prevent or inhibit oxidation by terminating free radical reactions, thereby delaying or preventing certain types of cellular damage. Antioxidants may 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.

[0069] 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, purple bush clover, cacao, calamus root, chikuma mint, catuaba, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato peel, grapeseed, carrot, 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, hydrangea, hawthorn, hibiscus flower, Gynostemma pentaphyllum, riverweed, lavender, licorice, marjoram, milk thistle, mint (peppermint) Examples include, but are not limited to, oolong tea, beetroot, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rosehip, rosemary, sage, clary sage, savory, spearmint, spirulina, elm bark, high-tannin sorghum blanc, high-tannin sorghum gran, sumac blanc, comfrey leaves and roots, goji berries, centella asiatica, thyme, turmeric, uva ursi, valerian, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, dwarf cinnamon, ashwagandha, lion's mane mushroom, and silybum marianum. Such botanical materials may be provided in fresh or dried form, as essential oils, or as extracts. Botanical materials (and their extracts) often include various classes of compounds known to provide antioxidant effects, such as minerals, vitamins, isoflavones, phytosterols, allyl sulfide, dithiolthione, isothiocyanates, indole, lignans, flavonoids, polyphenols, and carotenoids.Examples of compounds contained in botanical extracts or oils include ascorbic acid, peanut endocarpone, resveratrol, sulforaphane, β-carotene, lycopene, lutein, coenzyme Q, carnitine, quercetin, and kaempferol. See, for example, Santhosh et al., Phytomedicine, 12(2005)216-220, incorporated herein by reference.

[0070] Other suitable antioxidants, though not limited to these, include citric acid, vitamin E or its derivatives, tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperoside, polyphenols, catechol, resveratrol, oleuropein, butylhydroxyanisole (BHA), butylhydroxytoluene (BHT), tert-butylhydroquinone (TBHQ), and combinations thereof.

[0071] If present, antioxidants are typically present in concentrations of about 0.001% by weight to about 10% by weight, based on the total weight of the composition, for example, about 0.001% by weight, about 0.005% by weight, about 0.01% by weight, about 0.05% by weight, about 0.1% by weight, or about 0.5% by weight to about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or about 10% by weight.

[0072] Nicotine In certain embodiments, the active ingredient includes a nicotine component. “Nicotine component” means any preferred form of nicotine (e.g., a free base or salt) for which at least a portion of the present nicotine is orally absorbed. Typically, the nicotine component is selected from the group consisting of nicotine free bases and nicotine salts. In some embodiments, the nicotine component is nicotine in the form of a free base, which can readily adsorb to, for example, a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier composite. See, for example, the description of nicotine in the form of a free base in U.S. Patent Application Publication No. 2004 / 0191322 (Hansson), incorporated herein by reference.

[0073] 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 components and techniques described in U.S. Patent No. 2,033,909 (Cox et al.) and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983), which are incorporated herein by reference. Furthermore, 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 free nicotine base, hydrochloride, dihydrochloride, tartrate, bicarbonate, sulfate, salicylate, and zinc nicotine chloride.

[0074] In some embodiments, at least a portion of the nicotine may be in the form of a nicotine resin composite, where nicotine is bonded to an ion exchange resin, such as nicotine polarilex, which is nicotine bonded 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.), incorporated herein by reference. Another example is a nicotine-polyacrylic carbomer composite, such as Carbopol 974P. In some embodiments, nicotine may exist in the form of a nicotine-polyacrylic composite.

[0075] Typically, if present, the nicotine component (calculated as free base) is present at a concentration of at least about 0.001% by weight of the composition, for example, in the range of about 0.001% to about 10% by weight. In some embodiments, the nicotine component is present at a concentration of about 0.1% to about 10% by weight, calculated as free base and based on the total weight of the composition, 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% by weight to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight. In some embodiments, the nicotine component is present at a concentration of about 0.1% to about 3% by weight, calculated as a free base and based on the total weight of the composition, for example, 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.

[0076] In some embodiments, the products or compositions of the Disclosure may be characterized as being free of any nicotine component (for example, any embodiment disclosed herein may be completely or substantially free of any nicotine component). "Substantially free" means that nicotine is not intentionally added beyond trace amounts that may naturally occur in, for example, botanical materials. For example, certain embodiments may be characterized as having less than 0.001% by weight of nicotine, less than 0.0001% by weight, or 0% by weight of nicotine, calculated as free base.

[0077] In some embodiments, the active ingredient includes a nicotine component (for example, any product or composition of this disclosure may further include a nicotine component in addition to any active ingredient or combination of active ingredients disclosed herein).

[0078] Cannabinoids In some embodiments, the active ingredient comprises one or more cannabinoids. As used herein, the term “cannabinoid” refers to a diverse group of compounds that act on intracellular cannabinoid receptors, also known as the endocannabinoid system, which alter neurotransmitter release in the brain. Ligands for these receptor proteins include endocannabinoids naturally produced in animals, phytocannabinoids found in cannabis, and synthetic cannabinoids produced artificially. 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), cannabiclomevalin (CBCV), cannabigerovalin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerol acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivaric acid (THCVA). In certain embodiments, the cannabinoids are selected from tetrahydrocannabinol (THC), the major psychoactive compound of 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 isolates from plant material or may be synthetically derived.

[0079] Alternatively, the active ingredient may be a cannabimimetic. Cannabimimetics are a group of compounds derived from plants other than cannabis that, like cannabinoids, have biological effects on the endocannabinoid system. Examples include yangonin, α-amyrin or β-amyrin (also classified as terpenes), cyanidin, curcumin (turmeric), catechin, quercetin, salvinorin A, N-acylethanolamine, and N-alkylamide lipids.

[0080] If present, cannabinoids (e.g., CBD) or cannabimimetes are 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, concentrations ranging from about 0.1% to about 30% by weight, such as about 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, or about 0.9% to about 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 15%, 20%, or 30% by weight.

[0081] Terpenes The active ingredients suitable for use in this disclosure may also be classified as terpenes, many of which have biological effects such as sedative effects. Terpenes are (C5H8) n Terpenes have the general formula and are understood to include monoterpenes, sesquiterpenes, and diterpenes. Terpenes can have acyclic, monocyclic, or bicyclic structures. Some terpenes produce an entourage effect when used in combination with cannabinoids or cannabimimetics. Examples include β-caryophyllene, linalool, limonene, β-citronellol, linalyl acetate, pinene (α or β), geraniol, carvone, eucalyptol, menthone, isomenthon, piperitone, myrcene, β-bulbonene, and germacrene, which may be used alone or in combination.

[0082] Pharmaceutical ingredients In some embodiments, the active ingredient comprises a pharmacokinetic agent (API). The API may be any known agent adapted for therapeutic, prophylactic, or diagnostic use. Examples of APIs include 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'-choline diphosphate), 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.

[0083] The amount of API can vary. For example, if present, API is typically concentrated at a concentration of about 0.001% by weight to about 10% by weight, based on the total weight of the composition, e.g., about 0.01% by weight, about 0.02% by weight, about 0.03% by weight, about 0.04% by weight, about 0.05% by weight, about 0.06% by weight, about 0.07% by weight, about 0.08% by weight, about 0.09% by weight, about 0.1% by weight, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, about 0.9% by weight, or about 1% by weight to about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or about 10% by weight.

[0084] In some embodiments, the compositions are substantially free of any APIs. "Substantially free of any APIs" means that the compositions do not contain and expressly exclude any APIs as defined herein, such as Food and Drug Administration (FDA) approved therapeutic agents intended to treat any medical condition.

[0085] Flavoring agent In some embodiments, the releaseable substance may be one or more flavoring agents. As used herein, “flavoring agent” or “flavoring agent” is any flavorful or aromatic substance that can alter the sensory characteristics associated with an oral product. Examples of sensory characteristics that can be altered by a flavoring agent include taste, mouthfeel, moistness, coldness / hotness, and / or aroma. Flavoring agents may be natural or synthetic, and the flavor characteristics imparted by a flavoring agent may be, but are not limited to, fresh, sweet, herbal, confectionery, floral, fruity, or spicy. In some embodiments, the releaseable substance may comprise a single flavoring agent or a plurality of flavoring agents. If desired, one or more flavoring agents may be retained in part with a carrier or filler, or one or more flavoring agents may be retained in the composition and / or product in other ways, such as by being bound to a further carrier or filler.

[0086] Non-limiting examples of flavorings that may be used as releaseable substances in this specification and / or that may be otherwise included in the Composition and / or Product (e.g., not held by porous alumina) 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, terpenes, and any combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, RJ Reynolds Tobacco Company (1972), incorporated herein by reference. As used herein, “trigeminal sensory agent” refers to a flavoring agent that affects the trigeminal nerve and produces sensations including warmth, coldness, and tingling. Non-limiting examples of trigeminal sensory flavoring agents include capsaicin, citric acid, menthol, Sichuan button, erythritol, and cuberol. Fragrances may also contain ingredients considered to be humectants, cooling agents, or smoothing agents, such as eucalyptus. These fragrances may be provided neat (i.e., individually) or in combination, or used as concentrates or fragrance packages (e.g., spearmint and menthol; orange and cinnamon; lime, pineapple, etc.). Typical 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. WO05 / 041699 (Quinter et al.), each incorporated herein by reference. In some cases, the flavoring agent may be provided in a spray-drying or liquid form.

[0087] Flavoring agents generally contain at least one volatile flavor component. As used herein, “volatile” refers to a chemical substance that readily forms vapor at ambient temperature (i.e., a chemical substance that has a higher vapor pressure at a given temperature compared to a non-volatile substance). Typically, volatile flavor components have a molecular weight of less than about 400 Da and often contain at least one carbon-carbon double bond, a carbon-oxygen double bond, or both. In one embodiment, the at least one volatile flavor component includes one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or combinations thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde, cuminaldehyde, benzaldehyde, and citronellal. Non-limiting examples of ketones include 1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-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, γ-terpinene, β-farnesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, at least one volatile flavor component comprises one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, γ-terpinene, β-farnesene, or citral. In one embodiment, at least one volatile flavor component comprises ethyl vanillin.

[0088] The amount of flavoring agent used in a mixture can vary, but is typically up to about 10% by weight based on the total weight of the mixture, and certain embodiments are characterized by a flavoring agent content of at least about 0.1% by weight, for example, about 0.5 to about 10% by weight, about 1 to about 6% by weight, or about 2 to about 5% by weight.

[0089] Tobacco materials In some embodiments, the composition and / or product may contain tobacco material. The species, type, and form of the tobacco material can vary. Generally, the tobacco material is obtained from harvested plants of the genus Nicotiana. Exemplary Nicotiana species include N. tabacum, N. rustica, N. alata, N. arentsi, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei, N. kawakamii, and N. kni N. 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. plumbaginfolia ifolia), N. raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbrella, 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 (subspecies hesperis) Examples include *N. subsp. Herperis*, *N. pauciflora*, *N. petunioides*, *N. quadrivalvis*, *N. repanda*, *N. rotundifolia*, *N. solanifolia*, and *N. spegazzinii*.

[0090] Representative species of other various Nicotiana species are described in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954); U.S. Patent No. 4,660,577 (Sensabaugh, Jr. et al.); U.S. Patent No. 5,387,416 (White et al.); U.S. Patent No. 7,025,066 (Lawson et al.); U.S. Patent No. 7,798,153 (Lawrence, Jr.); and U.S. Patent No. 8,186,360 (Marshall et al.), respectively, which are incorporated herein by reference. Descriptions of various types of tobacco, cultivation methods, and harvesting methods are described in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999), which are incorporated herein by reference.

[0091] Nicotiana species from which suitable tobacco material can be obtained can be acquired using genetic modification or crossbreeding techniques (for example, tobacco plants can be genetically modified or crossbred to increase or decrease the expression of components, properties, or attributes). For example, see the types of plant genetic modification described in U.S. Patent No. 5,539,093 (Fitzmaurice et al.); U.S. Patent No. 5,668,295 (Wahab et al.); U.S. Patent No. 5,705,624 (Fitzmaurice et al.); U.S. Patent No. 5,844,119 (Weigl); U.S. Patent No. 6,730,832 (Dominguez et al.); U.S. Patent No. 7,173,170 (Liu et al.); U.S. Patent No. 7,208,659 (Colliver et al.); U.S. Patent 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 types of tobacco described in U.S. Patent No. 4,660,577 (Sensabaugh, Jr. et al.); U.S. Patent No. 5,387,416 (White et al.); and U.S. Patent No. 6,730,832 (Dominguez et al.), which are incorporated herein by reference.

[0092] In some embodiments, Nicotiana species may be selected for the content of various compounds present in the species. For example, a plant may be selected on the basis that it produces relatively large amounts of one or more desired compounds to be isolated from the plant. In certain embodiments, Nicotiana species (e.g., Galpao commun tobacco) are cultivated particularly for their abundant leaf surface compounds. Tobacco plants can be grown in greenhouses, growth chambers, or open fields, or hydroponically.

[0093] Various parts or portions of Nicotiana species plants may be included in the mixtures disclosed herein. For example, substantially the entire plant (e.g., the whole plant) can be harvested and used in this manner. Alternatively, various parts or fragments of the plant can be harvested or separated for further use after harvesting. 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 (laminae). The mixtures disclosed herein may include processed tobacco parts or fragments, hardened and aged tobacco in the form of essentially natural laminae and / or stems, tobacco extracts, extracted tobacco pulp (e.g., using water as a solvent), or the aforementioned mixtures (e.g., a mixture of extracted tobacco pulp and granular dried and aged natural tobacco laminae).

[0094] In certain embodiments, the tobacco material comprises a solid tobacco material selected from the group consisting of laminae and stems. The tobacco used in the mixture most preferably comprises tobacco laminae or a mixture of tobacco laminae and stems (at least a portion of which is smoke-treated). The portion of the tobacco in the mixture may have a processed form such as processed tobacco stems (e.g., cut-rolled stems, cut-rolled-expanded stems, or cut-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. Patent No. 4,340,073 (Burde et al.); U.S. Patent No. 5,259,403 (Guy et al.); U.S. Patent No. 5,908,032 (Poindexter et al.); and U.S. Patent No. 7,556,047 (Poindexter et al.), all of which are incorporated herein by reference. Furthermore, the mixture may optionally incorporate fermented tobacco. See also the types of tobacco processing techniques described in PCT WO2005 / 063060 (Atchley et al.), which are incorporated herein by reference.

[0095] Tobacco material is typically used in a form that can be described as particulate (i.e., chopped, powdered, granulated, or fine powder). The methods for providing tobacco material in particulate or powder form can vary. Preferably, parts or fragments of the plant are powdered, ground, or pulverized into particulate form using apparatus and techniques for grinding, milling, etc. Most preferably, the plant material is in a relatively dry form during grinding or milling using apparatus such as a hammer mill, cutter head, or air-controlled mill. For example, parts or fragments of tobacco can be ground or milled if their moisture content is less than about 15% by weight or less than about 5% by weight. Most preferably, the tobacco material is 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 may be of a size that passes through a sieve to obtain the desired particle size range. Optionally, an air classifier may be used to ensure the collection of small-sized tobacco particles of the desired size or size range. Optionally, granular tobacco of different sizes may be mixed together.

[0096] The methods by which tobacco is provided in particulate or powder form can vary. Preferably, parts or fragments of tobacco are powdered, ground, or pulverized into a powder form using apparatus and techniques for grinding, milling, etc. Most preferably, tobacco is in a relatively dry form during grinding or milling using apparatus such as a hammer mill, cutter head, or air-controlled mill. For example, parts or fragments of tobacco can be ground or milled if their moisture content is less than about 15% by weight and less than about 5% by weight. For example, a tobacco plant or a part thereof can be separated into individual parts or fragments (for example, leaves may be removed from the stem, and / or the stem and leaves may be removed from the axis). The harvested plant or individual parts or fragments can be further subdivided into parts or fragments (for example, leaves may be chopped, cut, powdered, pulverized, milled or ground into parts or fragments that can be characterized as filler-type fragments, granules, particles or fine powder). The plant or a part thereof may be subjected to external force or pressure (for example, by being pressed or rolled). When such processing conditions are implemented, the plant or a 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 water to the plant or a part thereof, or a moisture content obtained by drying the plant or a part thereof. For example, plant fragments or parts thereof obtained by powdering, pulverizing, grinding, or milling may have a moisture content of less than about 25% by weight, often less than about 20% by weight, and frequently less than about 15% by weight.

[0097] For the preparation of oral products, harvested Nicotiana species plants typically undergo a hardening process. Tobacco materials incorporated into mixtures for inclusion in the products disclosed herein are properly hardened and / or aged. Descriptions of various hardening 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 hardening yellow 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. Typical techniques and conditions for air-curing tobacco are described by reference herein by reference 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). Certain types of tobacco may undergo other curing treatments, such as heat curing or sun-drying curing.

[0098] In certain embodiments, tobacco materials that may be used include yellow varieties or Virginia (e.g., K326), burley, sun-dried (e.g., Indian Kurnool and Oriental tobaccos including Katerini, Prelip, Komotini, Xanthi and Yambol tobaccos), Maryland, dark, dark heat-dried, dark air-dried (e.g., Madole, Passanda, Cubano, Jatin and Bezuki tobaccos), light air-dried (e.g., North Wisconsin and Galpao tobaccos), Indian air-dried, Red Russian and Rustica tobaccos, as well as various other rare or specialty tobaccos and various blends of any of the aforementioned tobaccos.

[0099] The tobacco material may have a so-called "blended" form. For example, the tobacco material may include a mixture of parts or fragments of yellow tobacco, burley (e.g., Malawi burley tobacco), and Oriental tobacco (e.g., as tobacco composed of or derived from tobacco lamina, or as a mixture of tobacco lamina and tobacco stems). For example, a typical blend may incorporate, on a dry weight basis, about 30 to about 70 parts burley tobacco (e.g., lamina or lamina and stem) and about 30 to about 70 parts yellow tobacco (e.g., stem, lamina or lamina and stem). Other exemplary tobacco blends may incorporate, on a dry weight basis, about 75 parts yellow tobacco, about 15 parts burley tobacco and about 10 parts Oriental tobacco; or about 65 parts yellow tobacco, about 25 parts burley tobacco and about 10 parts Oriental tobacco; or about 65 parts yellow tobacco, about 10 parts burley tobacco and about 25 parts Oriental tobacco. Other exemplary tobacco blends incorporate approximately 20 to 30 parts Oriental tobacco and 70 to 80 parts yellow tobacco on a dry weight basis.

[0100] The tobacco material used in this disclosure may be subjected to, for example, fermentation, bleaching, etc. Optionally, the tobacco material may be subjected to, for example, irradiation, pasteurization, or other controlled heat treatment. Such treatment processes are described in detail, for example, U.S. Patent No. 8,061,362 (Mua et al.), which is incorporated herein by reference. In certain embodiments, the tobacco material may be treated with additives (selected from the group consisting of, for example, 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) that can suppress the reaction of asparagine with water to form acrylamide when the tobacco material is heated. For example, see the types of processing processes described in U.S. Patents 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 processing is useful when the original tobacco material is exposed to heat in the aforementioned processes.

[0101] In some embodiments, the type of tobacco material is selected such that it is visually lighter in color than other tobacco materials in its initial state (e.g., whitened or bleached). Tobacco pulp can be whitened in certain embodiments according to any means known in the art. For example, bleached tobacco material can be produced by various whitening methods using various bleaching or oxidizing agents and oxidation catalysts. Exemplary oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorites, chlorates, perchlorates, hypochlorites, ozone, ammonia, potassium permanganate, and combinations thereof. Exemplary oxidation catalysts include titanium dioxide, manganese dioxide, and combinations thereof.The process of treating tobacco with bleach is incorporated herein by reference, for example, in U.S. Patent Nos. 787,611 (Daniels, Jr.); 1,086,306 (Oelenheinz); 1,437,095 (Delling); 1,757,477 (Rosenhoch); 2,122,421 (Hawkinson); 2,148,147 (Baier); 2,170, 107 (Baier); US Patent No. 2,274,649 (Baier); US Patent No. 2,770,239 (Prats et al.); US Patent No. 3,612,065 (Rosen); US Patent No. 3,851,653 (Rosen); US Patent No. 3,889,689 (Rosen); US Patent No. 3,943,940 (Minami); US Patent No. 3,943,945 (Rosen); US Patent No. 4,143,666 (Rainer); US Patent No. 4,194, 514 (Campbell); US Patent No. 4,366,823 (Rainer et al.); US Patent No. 4,366,824 (Rainer et al.); US Patent No. 4,388,933 (Rainer et al.); US Patent No. 4,641,667 (Schmekel et al.); US Patent No. 5,713,376 (Berger); US Patent No. 9,339,0586 (Byrd Jr. et al.); US Patent No. 9,420,825 (Beeson et al.); US Patent No. 9,950,858 (By This is described in rdJr. et al., as well as U.S. Patent Publication No. 2012 / 0067361 (Bjorkholm et al.), U.S. Patent Publication No. 2016 / 0073686 (Crooks), U.S. Patent Publication No. 2017 / 0020183 (Bjorkholm), and U.S. Patent Publication No. 2017 / 0112183 (Bjorkholm), and International Publication Nos. WO1996 / 031255 (Giolvas) and WO2018 / 083114 (Bjorkholm).

[0102] In some embodiments, the whitened tobacco material may have an ISO whiteness 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 whiteness in the range of about 50% to about 90%, about 55% to about 75%, or about 60% to about 70%. The ISO whiteness can be measured according to ISO 3688:1999 or ISO 2470-1:2016.

[0103] In some embodiments, whitened tobacco material can be characterized as being lighter in color (e.g., "whitened") compared to untreated tobacco material. White is often defined by referring to the International Commission on Illumination (CIE) chromaticity diagram. In certain embodiments, whitened tobacco material can be characterized as being closer to pure white on the chromaticity diagram than untreated tobacco material.

[0104] In various embodiments, tobacco material may be treated to extract soluble components of the tobacco material from the material. As used herein, “tobacco extract” refers to isolated components of tobacco material extracted from solid tobacco pulp by a solvent that is contacted with the tobacco material in the extraction process. Various extraction techniques for tobacco material can be used to obtain tobacco extracts and tobacco solid material. 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 are all incorporated herein by reference: U.S. Patent No. 4,144,895 (Fiore); U.S. Patent No. 4,150,677 (Osborne, Jr. et al.); U.S. Patent No. 4,267,847 (Reid); U.S. Patent No. 4,289,147 (Wildman et al.); U.S. Patent No. 4,351,346 (Brummer et al.); U.S. Patent No. 4,359,059 (Brummer et al.); U.S. Patent No. 4,506,682 (Muller); U.S. Patent No. 4,589,428 (Keritsis); U.S. Patent No. 4,605,016 (Soga et al.); U.S. Patent No. 4,716,911 (Poulose et al.); U.S. Patent No. 4,727,889 (Niven, Jr. et al.).(et al.); US Patent No. 4,887,618 (Bernasek et al.); US Patent No. 4,941,484 (Clapp et al.); US Patent No. 4,967,771 (Fagg et al.); US Patent No. 4,986,286 (Roberts et al.); US Patent No. 5,005,593 (Fagg et al.); US Patent No. 5,018,540 (Grubbs et al.); US Patent No. 5,060,669 (White et al.); US Patent No. 5,065,775 (Fagg); US Patent No. 5,074,319 (White et al.); US Patent No. 5,099,862 (White et al.); US Patent No. 5,121,757 (White et al.); US Patent No. 5,131,414 (Fagg); US Patent No. 5,131,415 (Munoz et al.); US Patent No. 5,148,819 (Fagg); US Patent No. 5,197,4 It is described in U.S. Patent 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).

[0105] The typical range of tobacco material content can vary depending on the properties 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%), (e.g., about 0.1 to about 15%), based on the total weight of the mixture. In some embodiments, the products of the Disclosure can be characterized as being completely or substantially free of tobacco material (other than purified nicotine as the active ingredient). For example, certain embodiments can be characterized as having less than 1% by weight, less than 0.5% by weight, less than 0.1% by weight of tobacco material, or 0% by weight of tobacco material. In some embodiments, the compositions or products of the Disclosure may contain about 10% by weight or less of tobacco material, based on the total weight of the mixture, in addition to any nicotine component present.

[0106] Water and water substitutes Consumers of oral products often desire products that exhibit specific sensory properties and / or a particular type of mouthfeel. Often, it is desirable for oral products to exhibit properties such as a moist or hydrated feeling in the mouth. Therefore, in some embodiments, compositions and products can achieve such properties by containing water. The water content of the composition in a product before use by the consumer can vary depending on the desired properties. Typically, the composition present in a product before it enters the user's mouth 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 of water. For example, the total water content in a composition and / or product, based on the total weight of the composition, 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.

[0107] Even if certain properties are desired for an oral composition or product, materials with a relatively high moisture content may be unstable and more susceptible to mold and / or bacterial infiltration of the product. Therefore, there may be a need for compositions and products that provide a "moist" or "hydrated" feeling in the mouth but do not have a significant moisture content. In some embodiments, it may therefore be useful to provide compositions and products in which water is simply an optional component, or where water is present but the total amount of water is less than 10% by weight, less than 8% by weight, less than 5% by weight, less than 4% by weight, less than 3% by weight, less than 2% by weight, less than 1% by weight, or less than 0.5% by weight, based on the total weight of the composition. Furthermore, the moisture content may range from about 0.1% to about 9% by weight, about 0.2% to about 7% by weight, or about 0.5% to about 5% by weight, based on the total weight of the composition. Compositions having a moisture content within this range may be referred to as low-moisture compositions.

[0108] As described above, while such low-moisture compositions may be useful, they may not provide the sensory properties desired by consumers. Therefore, in some embodiments, the compositions and products may contain one or more water-alternative components. A suitable water-alternative may be any material that is not aqueous and therefore not a substantial source of water added to the composition, but nevertheless adapted or configured to impart a "moist" or "hydrating" sensation when the composition and product incorporating such a water-alternative is in the consumer's mouth. In some embodiments, non-limiting examples of further suitable water-alternatives include a variety of wetting agents, hygroscopic materials, and hydrophilic materials. For example, polydextrose, glycerol, polypropylene glycol, 1,3-propanediol, sorbitan esters (e.g., sorbitan monostearate), polysorbate, honey, sugar, molasses, glycerin triacetate, lactic acid, etc., may be used.

[0109] In one or more embodiments, the composition and product may incorporate one or more wetting agents as water substitutes. More specifically, one or more polyols may be used in the composition and product. Polyol components in particular may be beneficial in forming oral compositions and products that maintain a moist feeling in the mouth while having a low water content. In some embodiments, the polyol may include glycerin, propylene glycol, or a combination thereof. In some embodiments, the exemplary water substitute may also include one or more sugar alcohols. Advantageously, the water substitute, such as a polyol, may be present in the composition and product in an amount of about 25% by weight or more, about 30% by weight or more, or about 35% by weight or more (e.g., up to about 60% by weight) based on the total weight of the composition or product. In further embodiments, the water substitute, such as a polyol, may be present in an amount of about 25% to about 50% by weight, about 25% to about 45% by weight, about 25% to about 40% by weight, or about 25% to about 35% by weight based on the total weight of the composition. Surprisingly, this disclosure has found that by including a water substitute containing a polyol in a substantially high content, the desired functional / mouthfeel properties can be achieved without significantly reducing the processability of the composition. For example, while highly viscous additives such as polyols were expected to reduce the fluidity during processing of the product, this disclosure has found that even with a high polyol concentration of 40% by weight or more based on the total weight of the composition, there is no significant impact on the fluidity.

[0110] By providing compositions with substantially low moisture content, it is also possible to advantageously provide compositions with relatively low water activity. In some embodiments, oral compositions and products can thus exhibit a mouthfeel equivalent to that of a moist product while having a water activity of about 0.85 or less. Since water activity is the ratio of the vapor pressure of a composition or product to the water vapor pressure of pure water under identical conditions, the water activity of the compositions and products can be measured using any method known in the art. For example, water activity can be measured using an electrical resistance hygrometer, a volumetric hygrometer, or a dew point hygrometer. In further embodiments, the water activity of an oral composition or product may be about 0.8 or less. More specifically, the water activity may be about 0.5 to about 0.85, about 0.55 to about 0.8, or about 0.6 to about 0.75.

[0111] 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, formulated, combined and / or mixed with other materials or components. The additives may be artificial, obtained from or derived from herbs or biological sources. Specific types of additional additives that may be included are further described below.

[0112] In some embodiments, 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 its acidic nature. Typically, organic acids are relatively weak acids (i.e., those that do not completely dissociate in the presence of water), such as carboxylic acids (-CO2H) or sulfonic acids (-SO2OH). As used herein, references to organic acids mean organic acids that are intentionally added. In this respect, organic acids may be intentionally added as specific components, as opposed to simply being naturally present as components of another component (e.g., small amounts of organic acids that may naturally be present in components such as tobacco materials). In some embodiments, one or more organic acids are added neat (i.e., in the form of free acids, untreated (native) solids or liquids) or, for example, as aqueous solutions. In some embodiments, one or more organic acids are added in the form of salts, as described below herein.

[0113] 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, and linolenic acid. In some embodiments, the organic acid is an alkyl sulfonic acid. Non-limiting examples of alkyl sulfonic acids include propanesulfonic acid and octanesulfonic acid. In some embodiments, the alkyl carboxylic acid 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 an organic acid containing multiple carboxylic acids (e.g., two to four carboxylic acid groups), one or more carboxylic acid groups may be esterified. Non-limiting examples include monoethyl succinate, monomethyl fumarate, monomethyl citrate, or dimethyl citrate.

[0114] In some embodiments, the organic acid may comprise two or more carboxylic acid groups and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid and citric acid. In some embodiments, the organic acid is an aryl carboxylic acid or an aryl sulfonic acid. Non-limiting examples of aryl carboxylic acids 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 having an alkaline component, which may, 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-floate, phenylacetate, heptanoate, octanoate, nonanoate, oxalate, malonate, glycolate, benzoate, tartarate, levulinate, ascorbate, fumarate, citrate, malate, lactate, aspartate, salicylate, tosylate, succinate, and pirubate.

[0115] The amount of organic acid present in a composition can vary. Generally, a composition may contain one or more organic acids present as one or more organic acids in an amount of 0 to about 10% by weight based on the total weight of the mixture.

[0116] In some embodiments, the composition may further contain salts (e.g., alkali metal salts) used in amounts sufficient to impart the desired functional attributes to the composition and product. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, and flour salt. If present, typical amounts of salt 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 constitute about 10% or less, about 7.5% or less, or about 5% or less (e.g., about 0.5% to about 5% by weight) of the total weight of the composition or product.

[0117] The compositions and products may also contain one or more sweeteners. The sweeteners may be any sweetener or combination of sweeteners, either 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, and honey. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, and neotame. In some embodiments, the sweeteners may contain one or more sugar alcohols. The sugar alcohols are polyols derived from monosaccharides or disaccharides, having a partially or fully hydrogenated form. Sugar alcohols include, for example, erythritol, arabitol, ribitol, isomalt, maltitol, dalcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrolyzed hydrogenated starch), having about 4 to about 20 carbon atoms. If present, a typical amount of sweetener may be about 0.1 to about 20% by weight of the composition or product, based on the total weight of the composition or product, for example, about 0.1 to about 1% by weight, about 1 to about 5% by weight, about 5 to about 10% by weight, or about 10 to about 20% by weight of the composition or product.

[0118] In some embodiments, compositions and products may contain one or more binders. In certain embodiments, a sufficient amount of binder (or combination of binders) may be used to give the composition the desired physical attributes and physical coherence, and the binder may also often function as a thickener or gelling agent. Typical binders may be organic, inorganic, or a combination thereof. Representative binders include povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, and combinations thereof. In some embodiments, the binder may include pectin or carrageenan or a combination thereof. The binder may be used in an amount sufficient to give the composition the desired physical attributes and physical coherence. The amount of binder used may vary, but is usually up to about 30% by weight based on the total weight of the composition or product, and certain embodiments are characterized by a binder content of at least about 0.1% by weight, for example, about 1 to about 30% by weight or about 5 to about 10% by weight.

[0119] In certain embodiments, the binder includes gum, such as natural gum. As used herein, natural gum refers to naturally occurring polysaccharide materials that are binding and also useful as thickeners or gelling agents. Typical plant-derived natural gums that are usually somewhat water-soluble include xanthan gum, guar gum, gum arabic, ghati gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof. If present, the natural gum binder material is usually present in amounts up to about 5% by weight, based on the total weight of the composition or product, 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, about 0.9 or about 1% to about 2, about 3, about 4 or about 5% by weight.

[0120] In certain embodiments, the compositions of the present disclosure may include pH adjusters or buffers. Examples of usable pH adjusters and buffers include, but are not limited to, metal hydroxides (e.g., alkali metal hydroxides such as sodium hydroxide and potassium hydroxide) and other alkali metal buffers such as metal carbonates (e.g., potassium carbonate or sodium carbonate) or metal bicarbonates such as sodium bicarbonate. If present, buffers are usually present in amounts 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 buffers include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, bicarbonates, borates, or mixtures thereof.

[0121] In some embodiments, compositions and products may contain one or more colorants. The colorants may be used in an amount sufficient to impart the desired physical attributes to the composition or product. Examples of colorants include various dyes and pigments, such as caramel color and titanium dioxide. The amount of colorant used in a composition or product can vary, but if present, it is typically at most about 3% by weight, for example, about 0.1% by weight, about 0.5% by weight, or about 1% to about 3% by weight, based on the total weight of the composition or product.

[0122] Further examples of additives that may be used in the present composition and product include thickeners or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate), disintegrants, zinc or magnesium salts selected to be relatively water-soluble for highly water-soluble compositions (e.g., magnesium gluconate or zinc gluconate), or zinc or magnesium salts selected to be relatively water-insoluble for less water-soluble compositions (e.g., magnesium oxide or zinc oxide), or combinations thereof. For example, see the representative components, combinations of components, relative amounts of each component, and methods and techniques for 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.), respectively, which are incorporated herein by reference. The typical range of such additional additives can vary depending on the nature and function of the additive and the intended effect on the final mixture, with exemplary ranges being up to about 10% by weight (e.g., about 0.1 to about 5%) based on the total weight of the mixture.

[0123] The aforementioned additives may be used together (e.g., as an additive formulation) or separately (e.g., individual additive components may be added at different stages involved in the preparation of the final mixture). Furthermore, the aforementioned types of additives may be encapsulated so as to be supplied into the final product or mixture. Exemplary encapsulated additives are described, for example, in WO2010 / 132444 (Atchley), which has already been incorporated herein by reference.

[0124] particle In some embodiments, any one or more of the filler components, tobacco materials, and oral products described herein may be described as particulate matter. As used herein, the term “particle” refers to a material in which there are multiple individual particles, some of which may be in the form of aggregates of multiple particles, and the ratio of the average length to width of the particles is less than 2:1, for example less than 1.5:1, for example about 1:1. In various embodiments, the particles of particulate matter may be described as substantially spherical or granular.

[0125] The particle size of particulate matter can be measured by sieve analysis. As will be readily apparent to those skilled in the art, sieve analysis (also known as gradation testing) is a method used to measure the particle size distribution of particulate matter. Typically, sieve analysis uses a nested column of sieves, which comprises sieves, preferably in the form of wire mesh. A pre-weighed sample may be placed in the top or uppermost sieve of the column, which has the largest sieve opening or mesh size (i.e., the largest pore size of the sieve). Each sieve at the bottom of the column has a progressively smaller sieve opening or mesh size than the sieves above it. Typically, the bottom of the sieve column has a receiving section for collecting any particles with a particle size smaller than the sieve opening or mesh size of the bottom or lowermost sieve (which has the smallest sieve opening or mesh size).

[0126] In some embodiments, the sieve column may be placed on or in a mechanical stirrer. The stirrer vibrates each sieve in the column. The mechanical stirrer 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 stirred for 0.5 to 10 minutes, e.g., 1 to 10 minutes, e.g., 1 to 5 minutes, e.g., about 3 minutes. Once the stirring 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 held on each sieve. As will be readily apparent to those skilled in the art, 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 being analyzed or the known maximum / minimum particle size. In some embodiments, a sieve column having 2 to 20 sieves, for example 5 to 15 sieves, may be used for sieve analysis. In some embodiments, a sieve column having 10 sieves may be used for sieve analysis. In some embodiments, the largest sieve opening or mesh size of the sieves used for sieve analysis may be 1,000 μm, for example 500 μm, for example 400 μm, for example 300 μm.

[0127] In some embodiments, any particulate matter referred to herein (e.g., filler components, tobacco materials, and entire oral products) can be characterized as having at least 50% by weight of particles with a particle size of about 1,000 μm or less, e.g., about 500 μm or less, e.g., about 400 μm or less, e.g., about 350 μm or less, e.g., about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 60% by weight of particles in any particulate matter referred to herein have a particle size of about 1,000 μm or less, e.g., about 500 μm or less, e.g., about 400 μm or less, e.g., about 350 μm or less, e.g., about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 70% by weight of the particles in any particulate matter referred to herein have a particle diameter of about 1,000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 80% by weight of the particles in any particulate matter referred to herein have a particle diameter of about 1,000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 90% by weight of the particles in any particulate matter referred to herein have a particle diameter of about 1,000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 95% by weight of the particles in any particulate matter referred to herein have a particle diameter of about 1,000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis. In some embodiments, at least 99% by weight of the particles in any particulate matter referred to herein have a particle diameter of about 1,000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis.In some embodiments, about 100% by weight of the particles in any particulate matter referred to herein have a particle diameter of about 1,000 μm or less, for example, about 500 μm or less, for example, about 400 μm or less, for example, about 350 μm or less, for example, about 300 μm or less, as measured by sieve analysis.

[0128] In some embodiments, at least 50% by weight, e.g., at least 60% by weight, e.g., at least 70% by weight, e.g., at least 80% by weight, e.g., at least 90% by weight, e.g., at least 95% by weight, e.g., at least 99% by weight, of the particles in any particulate matter referred to herein have particle diameters of about 0.01 μm to about 1,000 μm, e.g., about 0.05 μm to about 750 μm, e.g., about 0.1 μm to about 500 μm, e.g., about 0.25 μm to about 500 μm, as measured by sieve analysis. In some embodiments, at least 50% by weight, e.g., at least 60% by weight, e.g., at least 70% by weight, e.g., at least 80% by weight, e.g., at least 90% by weight, e.g., at least 95% by weight, e.g., at least 99% by weight, of the particles in any particulate matter referred to herein have particle diameters of about 10 μm to about 400 μm, e.g., about 50 μm to about 350 μm, e.g., about 100 μm to about 350 μm, e.g., about 200 μm to about 300 μm, as measured by sieve analysis.

[0129] preparation The various components of this composition can be combined in a variety of ways. Thus, a mixture of various components, for example, having powdered components, may have relatively uniform properties. The components, which may be in liquid or dry solid form, may be mixed in a pretreatment step before mixing with any components in the remainder of the mixture, or they may simply be mixed together with all the other liquid or dry components. The various components may be brought into contact, combined, or mixed together using any mixing technique or apparatus known in the art. Any mixing method that brings the mixed components into close contact can be used, for example, a mixing apparatus featuring an impeller or other agitable structure can be used. Examples of mixing apparatuses include casing drums, conditioning cylinders or drums, liquid spray devices, conical blenders, ribbon blenders, Littleford Day, Inc.'s FKM130, FKM600, FKM1200, FKM2000, FKM3000, Plough Share type mixer cylinders, and Hobart mixers, among other available mixers. See also, for example, the types of methods described in U.S. Patent No. 4,148,325 (Solomon et al.); U.S. Patent No. 6,510,855 (Korte et al.); and U.S. Patent No. 6,834,654 (Williams), which are each incorporated herein by reference. In some embodiments, the components forming the mixture are prepared so that the mixture can be used in a starch molding process for forming the mixture. Techniques and methods for formulating the mixture will be obvious to those skilled in the art. See, for example, the types of methods described in U.S. Patent No. 4,148,325 (Solomon et al.); U.S. Patent No. 6,510,855 (Korte et al.); U.S. Patent No. 6,834,654 (Williams), U.S. Patent No. 4,725,440 (Ridgway et al.) and U.S. Patent No. 6,077,524 (Bolder et al.), which are each incorporated herein by reference.

[0130] In one or more embodiments, the Disclosure may provide a method for forming an oral composition having a mouthfeel equivalent to that of a wet product while having relatively low water activity. In non-limiting examples, such a method may include combining at least one releaseable substance and at least one filler / carrier component with a polyol and / or other water substitute such that the polyol and / or other water substitute constitutes at least about 25% by weight of the oral composition based on the total weight of the oral composition. The method may further include limiting the water content of the oral composition to a range where the water activity of the oral composition is about 0.85 or less. In one embodiment, the polyol or other water substitute may be added in such an amount that the component constitutes about 25% to about 40% by weight based on the total weight of the oral composition. In other embodiments, the method may include limiting the water content of the oral composition to a range of about 10% by weight or less based on the total weight of the oral composition, for example, limiting the water content of the oral composition to a range of about 0.5% to about 5% by weight based on the total weight of the oral composition. In a further embodiment, the method includes limiting the water content of the oral composition to a range in which the water activity of the oral composition is about 0.80 or less.

[0131] Designed for oral use Provided herein are products configured for oral use. As used herein, the term “configured for oral use” means that the product is provided in such a form that, during use, one or more components of the mixture (e.g., flavoring agents and / or nicotine) pass through the user’s mouth by saliva. In certain embodiments, the product is adapted to deliver releaseable components to the user through the mucous membranes of the user’s mouth. In some cases, the releaseable components are active ingredients (e.g., including, but not limited to, nicotine) that can be absorbed through the mucous membranes of the mouth when the product is used.

[0132] Products or compositions configured for oral use as described herein can take various forms, including gels, tablets, gums, lozenges, extruded articles, powders, and pouches. Gels can be soft or hard. A particular product configured for oral use is in the form of a tablet. As used herein, the term "tablet" refers to a soluble oral product prepared by solidifying a liquid or gel mixture so that the final product is a partially solidified solid gel. The stiffness of gels varies greatly. A particular product of this disclosure is in solid form. A particular product may exhibit one or more of the following properties, for example, crispy, granular, chewy, syrup-like, paste-like, fluffy, smooth, and / or creamy. In a particular embodiment, the desired tactile property can be selected from the group consisting of stickiness, cohesiveness, density, dryness, crumbleability, granularity, gumminess, hardness, weight, hygroscopicity, hygroscopicity, mouthfeel, roughness, slipperiness, smoothness, viscosity, humidity, and combinations thereof.

[0133] Products containing the mixtures of this disclosure may be soluble. As used herein, the terms “dissolve,” “dissolving,” and “soluble” refer to mixtures having water-soluble components that interact with oral moisture to enter a solution, thereby causing gradual consumption of the product. In one embodiment, a soluble product may remain in the user’s mouth for a predetermined period until it is 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 typically dissolves and / or releases its active substance in about 2 minutes or less, often about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). Dissolution may occur by any means, including melting, mechanical destruction (e.g., chewing), enzymatic or other chemical decomposition, or interruption of interactions between components of the mixture. In some embodiments, the product may be soluble, as described, for example, in U.S. Patent Application Publication No. 2012 / 0037175 (Cantrell et al.). In other embodiments, the product does not dissolve while it remains in the user's mouth.

[0134] In one embodiment, a product comprising the composition of the present disclosure is in the form of a mixture placed in a moisture-permeable container (e.g., a permeable pouch). Such a permeable pouch-form mixture is typically used by placing one pouch containing the mixture into the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's mouth, for example, under the lips, in the same manner as moist snuff products are generally used. The pouch is preferably not chewed or swallowed. Thereafter, by exposure to saliva, some of the mixture components inside (e.g., flavoring agents and / or active ingredients such as nicotine) pass through, for example, the permeable pouch, providing the user with flavor and satisfaction. The user is not required to spit out any portion of the mixture. About 10 to 60 minutes after use / enjoyment, usually about 15 to 45 minutes, 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.

[0135] Accordingly, in certain embodiments, the mixtures disclosed herein and any other components described herein are combined in a breathable packet or pouch that serves as a container for using the composition, providing a pouch product configured for oral use. 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 mixtures described herein. As will be described in more detail below, such embodiments are shown only as examples, and the pouch products of this disclosure may contain the composition in other forms. The mixtures / compositions of such packets or pouches, such as container pouch 102 in the embodiments shown in the figures, can be diverse. Referring to the figures, a first embodiment of pouch product 100 is shown. Pouch product 100 includes a breathable container in the form of pouch 102 containing material 104 containing the composition described herein. Pouch product 100 may be an example of a product described herein, formed at least in part from the composition described herein.

[0136] Suitable packets, pouches, or containers of the type used in the manufacture of smokeless tobacco products are available under the brand 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 placed in pouches and packaged using the methods and types of ingredients used in the manufacture of conventional snus-type products. The pouches provide 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 components of the mixture readily diffuse into the user's mouth through the pouch.

[0137] Non-limiting examples of preferred types of pouches are described, for example, in U.S. Patent No. 5,167,244 (Kjerstad) and U.S. Patent No. 8,931,493 (Sebastian et al.), which are each incorporated herein by reference; and U.S. Patent Publication No. 2016 / 0000140 (Sebastian et al.), U.S. Patent Publication No. 2016 / 0073689 (Sebastian et al.), U.S. Patent Publication No. 2016 / 0157515 (Chapman et al.), and U.S. Patent Publication No. 2016 / 0192703 (Sebastian et al.). The pouches may be supplied as individual pouches, or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25, or 30 pouches) may be joined or connected together (e.g., by end-to-end methods) so that a single pouch or individual portion can be easily removed from the integrated strand or matrix of the pouch for use.

[0138] 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 take the form of mesh, screen, perforated paper, breathable cloth, etc. For example, a pouch material made from a mesh form of rice paper or perforated rice paper may dissolve in the user's mouth. As a result, both the pouch and the mixture may undergo complete dispersion in the user's mouth under normal use conditions, and thus both the pouch and the mixture may be ingested by the user. Other examples of pouch materials can be manufactured using water-dispersible film-forming materials (e.g., binders such as alginates, carboxymethylcellulose, xanthan gum, and pullulan) and combinations of these materials with pulverized cellulose compounds (e.g., fine-particle wood pulp). Preferred pouch materials are water-dispersible or soluble, but may be designed and manufactured so that a substantial amount of the mixed contents permeates the pouch material before the time it takes for the pouch to lose its physical integrity under normal use conditions. If desired, flavor components, disintegration aids, and other desired components may be incorporated into or applied to the pouch material.

[0139] The amount of material contained in each product unit (e.g., pouch) can vary. In some embodiments, the weight of the mixture in each pouch is at least about 50 mg, for example, 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. In larger embodiments, the weight of the material in each pouch may be about 300 mg to about 700 mg, about 700 mg to about 1.5 g, or about 1 g to about 2 g. Other ingredients may be contained in each pouch as desired. For example, at least one flavored strip, piece, or sheet of a flavored, water-dispersible or water-soluble material (e.g., an edible film-type material for bad breath prevention) may be placed in each pouch together with or without at least one capsule. Such strips or sheets may be folded or crumpled so as to be easily incorporated into the pouch. For example, see the types of materials and technologies described in U.S. Patent No. 6,887,307 (Scott et al.), U.S. Patent No. 6,923,981 (Leung et al.), and EFSA Journal (2004) 85, 1-32, which are incorporated herein by reference.

[0140] The pouch products described herein may be packaged in any suitable inner packaging material and / or outer container. Also, for example, incorporated herein by reference, U.S. Patent No. 7,014,039 (Henson et al.); U.S. Patent No. 7,537,110 (Kutsch et al.); U.S. Patent No. 7,584,843 (Kutsch et al.); U.S. Patent No. 8,397,945 (Gelardi et al.); U.S. Patent No. D592,956 (Thiellier); U.S. Patent No. D594,154 (Patel et al.); U.S. Patent No. D625,178 (Bailey et al.); U.S. Patent Application Publication No. 2008 / 0173317 (Robinson et al.); U.S. Patent Application Publication No. 2009 / 0014343 (Clark et al.); U.S. Patent Application Publication No. 2009 / 0014450 (Bjorkholm). See also the various types of containers for smokeless products described in U.S. Patent Publication No. 2009 / 0250360 (Bellamah et al.); U.S. Patent Publication No. 2009 / 0266837 (Gelardi et al.); U.S. Patent Publication No. 2009 / 0223989 (Gelardi); U.S. Patent Publication No. 2009 / 0230003 (Thiellier); U.S. Patent Publication No. 2010 / 0084424 (Gelardi); U.S. Patent Publication No. 2010 / 0133140 (Bailey et al.); U.S. Patent Publication No. 2010 / 0264157 (Bailey et al.); and U.S. Patent Publication No. 2011 / 0168712 (Bailey et al.).

[0141] Those skilled in the art in which the present invention belongs, who benefit from the teachings presented in the foregoing description, will likely envision many modifications and other embodiments of the present invention. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, and modifications and other embodiments are intended to be included within the scope of the appended claims. Certain terms are used herein, but these are used in a general and descriptive sense only and are not intended to be limiting.

Claims

1. Oral composition, At least one type of releaseable substance; At least one filler component; and The oral composition contains a polyol component in an amount of 25% by weight or more, based on the total weight of the composition. The releaseable substance contains at least one active ingredient selected from the group consisting of nicotine components, stimulants, cannabinoids, cannabimimetics, terpenes, and combinations thereof. The oral composition contains less than 10% by weight of water based on the total weight of the oral composition. A non-tobacco material in which at least one filler component is present in an amount of 40% by weight or more based on the total weight of the oral composition, The oral composition is contained within the pouch. Oral composition.

2. The oral composition according to claim 1, wherein the polyol component is present in an amount of 25% to 40% by weight based on the total weight of the oral composition.

3. The oral composition according to claim 1, wherein the oral composition contains 0.1% to 9% by weight of water based on the total weight of the oral composition.

4. The oral composition according to claim 1, wherein the oral composition contains 0.5% to 5% by weight of water based on the total weight of the oral composition.

5. The oral composition according to claim 1, wherein the polyol comprises one or both of glycerin and propylene glycol.

6. The oral composition according to claim 1, wherein the oral composition has a water activity of 0.85 or less and exhibits a mouthfeel equivalent to that of a moist product.

7. The oral composition according to claim 6, wherein the oral composition has a water activity of 0.8 or less.

8. The oral composition according to any one of claims 1 to 7, wherein the releaseable substance further comprises a flavor component.

9. The oral composition according to any one of claims 1 to 7, further comprising one or more components selected from the group consisting of sweeteners, gums, binders, or combinations thereof.

10. An oral composition according to any one of claims 1 to 7, further comprising tobacco components.

11. The oral composition according to claim 10, wherein the tobacco component includes bleached tobacco.

12. A method for forming an oral composition having a water activity of 0.85 or less while having a mouthfeel equivalent to that of a moist product, Combining at least one releaseable substance and at least one filler component with a polyol such that the polyol constitutes 25% by weight or more of the oral composition based on the total weight of the oral composition, and The water content of the oral composition is limited to a range in which the oral composition has a water activity of 0.85 or less, and the water content of the oral composition is limited to a range of 10% by weight or less based on the total weight of the oral composition. Includes, The releaseable substance contains at least one active ingredient selected from the group consisting of nicotine components, stimulants, cannabinoids, cannabimimetics, terpenes, and combinations thereof. A non-tobacco material in which at least one filler component is present in an amount of 40% by weight or more based on the total weight of the oral composition, The oral composition is contained within the pouch. method.

13. The method according to claim 12, wherein the polyol constitutes 25% to 40% by weight of the oral composition based on the total weight of the oral composition.

14. The method according to claim 12, comprising limiting the water content of the oral composition to a range of 0.5% to 5% by weight based on the total weight of the oral composition.

15. The method according to claim 12, comprising limiting the water content of the oral composition to a range in which the oral composition has a water activity of 0.80 or less.

Images