Oral products and manufacturing methods

Abstract

The present disclosure provides a product adapted for oral use, the product comprising a filler, a sugar alcohol, a salt, an alginate, a sweetener, at least one flavoring agent or at least one active ingredient, or at least one of both a flavoring agent and an active ingredient, an optional mixture of natural gums, and water. The present disclosure also provides a method for producing a product adapted for oral use.

Description

Technical Field

[0001] The present disclosure relates to products intended for human consumption. The products are configured for oral use and deliver substances such as flavorants and / or active ingredients during use. Such products may contain tobacco or tobacco-derived components, or may be alternatives that do not contain tobacco.

Background Art

[0002] Tobacco can be enjoyed in so-called "smokeless" forms. In particular, common smokeless tobacco products are used by inserting some form of processed tobacco or tobacco-containing formulation into the user's mouth. Conventional forms of such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed from substantially whole particulate, granular, or shredded tobacco and are either divided by the user or presented to the user in individual portions such as disposable pouches or sachets. Other conventional forms of smokeless products include compressed or agglomerated forms such as plugs, tablets, or pellets. Alternative product forms such as tobacco-containing gums and mixtures of tobacco with other plant materials are also known.For example, see the types of smokeless tobacco blends, ingredients, and processing methods described in U.S. Patent No. 1,376,586 to Schwartz, No. 4,513,756 to Pittman et al., No. 4,528,993 to Sensabaugh, Jr. et al., No. 4,624,269 to Story et al., No. 4,991,599 to Tibbetts, No. 4,987,907 to Townsend, No. 5,092,352 to Sprinkle, III et al., No. 5,387,416 to White et al., No. 6,668,839 to Williams, No. 6,834,654 to Williams, No. 6,953,040 to Atchley et al., No. 7,032,601 to Atchley et al., No. 7,694,686 to Atchley et al., U.S. Patent Application Publication No. 2004 / 0020503 to Williams, No. 2005 / 0115580 to Quinter et al., No. 2006 / 0191548 to Strickland et al., No. 2007 / 0062549 to Holton, Jr. et al., No. 2007 / 0186941 to Holton, Jr. et al., No. 2007 / 0186942 to Strickland et al., No. 2008 / 0029110 to Dube et al., No. 2008 / 0029116 to Robinson et al., No. 2008 / 0173317 to Robinson et al., No. 2008 / 0209586 to Neilsen et al., No. 2009 / 0065013 to Essen et al., No. 2010 / 0282267 to Atchley, and International Publication No. 2004 / 095959 pamphlet to Arnarp et al. These are each incorporated herein by reference.

[0003] Configurations of smokeless tobacco products that combine tobacco materials with various binders and fillers have been proposed more recently and have exemplary product forms including lozenges, troches, gels, extruded shapes, etc. See, for example, U.S. Patent Application Publication Nos. 2008 / 0196730 to Engstrom et al., 2008 / 0305216 to Crawford et al., 2009 / 0293889 to Kumar et al., 2010 / 0291245 to Gao et al., 2011 / 0139164 to Mua et al., 2012 / 0037175 to Cantrell et al., 2012 / 0055494 to Hunt et al., 2012 / 0138073 to Cantrell et al., 2012 / 0138074 to Cantrell et al., 2013 / 0074855 to Holton, Jr., 2013 / 0074856 to Holton, Jr., 2013 / 0152953 to Mua et al., 2013 / 0274296 to Jackson et al., 2015 / 0068545 to Moldoveanu et al., 2015 / 0101627 to Marshall et al., and 2015 / 0230515 to Lampe et al. Each of these is hereby incorporated by reference into this specification.

[0004] All-white snus portions are growing in popularity and provide a distinct and aesthetically pleasing alternative to conventional snus. Such latest "white" pouch products may contain bleached tobacco or may be tobacco-free. This type of product has been criticized for certain drawbacks such as poor product stability that can lead to product discoloration and / or undesirable sensory irritation characteristics. Thus, in the art, it is desirable to provide products configured for oral use with improved stability to provide a more enjoyable experience to the user.

Prior Art Documents

Patent Documents

[0005] [Patent Document 1] U.S. Patent No. 1,376,586 [Patent Document 2] U.S. Patent No. 4,513,756 [Patent Document 3] U.S. Patent No. 4,528,993 [Patent Document 4] U.S. Patent No. 4,624,269 [Patent Document 5] U.S. Patent No. 4,991,599 [Patent Document 6] U.S. Patent No. 4,987,907 [Patent Document 7] U.S. Patent No. 5,092,352 [Patent Document 8] U.S. Patent No. 5,387,416 [Patent Document 9] U.S. Patent No. 6,668,839 [Patent Document 10] U.S. Patent No. 6,834,654 [Patent Document 11] U.S. Patent No. 6,953,040 [Patent Document 12] U.S. Patent No. 7,032,601 [Patent Document 13] U.S. Patent No. 7,694,686 [Patent Document 14] 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] U.S. Patent Application Publication No. 2008 / 0029110 [Patent Document 21] U.S. Patent Application Publication No. 2008 / 0029116 [Patent Document 22] U.S. Patent Application Publication No. 2008 / 0173317 [Patent Document 23] U.S. Patent Application Publication No. 2008 / 0209586 [Patent Document 24] U.S. Patent Application Publication No. 2009 / 0065013 [Patent Document 25] U.S. Patent Application Publication No. 2010 / 0282267 [Patent Document 26] International Publication No. 2004 / 095959 [Patent Document 27] U.S. Patent Application Publication No. 2008 / 0196730 [Patent Document 28] U.S. Patent Application Publication No. 2008 / 0305216 [Patent Document 29] U.S. Patent Application Publication No. 2009 / 0293889 [Patent Document 30] U.S. Patent Application Publication No. 2010 / 0291245 [Patent Document 31] U.S. Patent Application Publication No. 2011 / 0139164 [Patent Document 32] U.S. Patent Application Publication No. 2012 / 0037175 [Patent Document 33] U.S. Patent Application Publication No. 2012 / 0055494 [Patent Document 34] U.S. Patent Application Publication No. 2012 / 0138073 [Patent Document 35] U.S. Patent Application Publication No. 2012 / 0138074 [Patent Document 36] U.S. Patent Application Publication No. 2013 / 0074855 [Patent Document 37] U.S. Patent Application Publication No. 2013 / 0074856 [Patent Document 38] U.S. Patent Application Publication No. 2013 / 0152953 [Patent Document 39] U.S. Patent Application Publication No. 2013 / 0274296 [Patent Document 40] U.S. Patent Application Publication No. 2015 / 0068545 [Patent Document 41] U.S. Patent Application Publication No. 2015 / 0101627 [Patent Document 42] U.S. Patent Application Publication No. 2015 / 0230515 [Summary of the Invention] [Means for Solving the Problems]

[0006] The present disclosure generally provides products configured for oral use and methods of manufacturing such products. The products are intended to impart flavor when used orally and typically deliver one or more active ingredients, such as nicotine, to the consumer.

[0007] The present disclosure includes, without limitation, the following embodiments. When the method refers to an intermediate composition optionally further comprising one or more components selected from a list, such reference includes a composition comprising a single member of a single classification of components from the list (e.g., a single alginate), or two or more members of a single classification of components of the list (e.g., two sweeteners), or a combination of one or more members from each of two or more classifications of components of the list (e.g., a sweetener and an alginate).

[0008] Embodiment 1 A method of preparing an oral product, comprising Forming a dry mix by combining a filler and a salt, wherein the dry mix optionally further comprises one or more of alginate, bleached tobacco, sweetener, carbonate salt and natural gum; Forming an aqueous solution of a flavorant or an active ingredient or both a flavorant and an active ingredient (wherein the solution can contain a single flavorant, a plurality of flavorants, a single active ingredient, a plurality of active ingredients, or both one or more flavorants and one or more active ingredients), wherein the solution optionally further comprises one or more of a pH adjuster, a preservative, a wetting agent, and a sweetener; Adding the aqueous solution to the dry mix to form a mixture; and Optionally housing the mixture in a pouch A method comprising.

[0009] Embodiment 2 Forming a second aqueous solution of a sugar alcohol, a pH adjuster and an optional preservative; and further comprising adding the second solution to the mixture before housing the mixture in a pouch, the method of any of the preceding embodiments.

[0010] Embodiment 3 The dry mix does not contain alginate, and further comprising adding an aqueous solution of alginate and a sugar alcohol to the dry mix, the method of any of the preceding embodiments.

[0011] Embodiment 4 The dry mix does not contain a carbonate salt, and further comprising adding an aqueous solution of a carbonate salt to the dry mix, the method of any of the preceding embodiments.

[0012] Embodiment 5 Combining a filler, alginate and a salt to form a dry mix; Adding an aqueous solution of a carbonate salt to the dry mix; Forming an aqueous solution of both a flavoring agent and an active ingredient (meaning that the solution can contain one or more flavoring agents and one or more active ingredients), wherein the solution further contains a sugar alcohol, a pH adjuster, a preservative, a wetting agent, and a sweetener; Adding the aqueous solution to a dry mix to form a mixture; Forming a second aqueous solution of a sugar alcohol, a pH adjuster, a sweetener, and an optional preservative; and adding the second aqueous solution to the mixture to form a second mixture; and Optionally, housing the second mixture in a pouch The method of any of the preceding embodiments, comprising.

[0013] Embodiment 6 Combining a filler, an alginate, a bleached tobacco, and a salt to form a dry mix; Adding an aqueous solution of a carbonate salt to the dry mix; Forming an aqueous solution of both a flavoring agent and an active ingredient, wherein the solution further contains a sugar alcohol, a pH adjuster, a preservative, and a sweetener; Adding the aqueous solution to the dry mix to form a mixture; Forming a second aqueous solution of a sugar alcohol, a pH adjuster, a sweetener, and an optional preservative; and adding the second aqueous solution to the mixture to form a second mixture; and Optionally, housing the second mixture in a pouch The method of any of the preceding embodiments, comprising.

[0014] Embodiment 7 Combining a filler, an alginate, a bleached tobacco, a natural gum, and a salt to form a dry mix; Adding an aqueous solution of a carbonate salt to the dry mix; Forming an aqueous solution of both a flavoring agent and an active ingredient, wherein the solution further contains a sugar alcohol, a pH adjuster, a preservative, and a sweetener, Adding the aqueous solution to the dry mix to form a mixture; and Optionally, housing the mixture within a pouch The method of any of the preceding embodiments, comprising.

[0015] Embodiment 8 Forming a dry mix by combining a filler, bleached tobacco, natural gum, sweetener, carbonate salt, preservative, and salt; Adding an aqueous solution of alginate and sugar alcohol to the dry mix to form a mixture; Forming a second aqueous solution of both a flavoring agent and an active ingredient; Adding the second aqueous solution to the mixture; and Optionally, housing the mixture within a pouch The method of any of the preceding embodiments, comprising.

[0016] Embodiment 9 The method of any of the preceding embodiments, wherein the temperature of each aqueous solution is from about 30 to about 100 °C.

[0017] Embodiment 10 The filler is a cellulose material; or The salt is sodium chloride; or The alginate is sodium alginate, calcium alginate, potassium alginate, magnesium alginate, ammonium alginate, or a mixture of two or more of the foregoing; or The sugar alcohol is xylitol; or The pH adjuster is ammonium chloride; or The carbonate salt is sodium bicarbonate; or The active ingredient is selected from the group consisting of nicotine components, plants, stimulants, amino acids, vitamins, and cannabinoids; or The natural gum is guar gum; or The preservative is potassium sorbate; or The sweetener is sucralose or acesulfame K; or The method of any of the preceding embodiments, which is one or more combinations of the above.

[0018] Embodiment 11 A method for preparing an oral product, comprising: forming a dry mix by combining a filler and a salt, wherein the dry mix optionally further comprises one or more of alginate, bleached tobacco, sweetener, carbonate salt, and natural gum; adding a flavoring agent and an active ingredient to the dry mix to form a mixture, wherein the active ingredient is applied before, after, or simultaneously with the flavoring agent; subsequently, applying water to the mixture to form a second mixture, wherein at least 50% by weight (e.g., at least about 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90%) of the water content of the second mixture is added after adding the active ingredient; and optionally, housing the second mixture in a pouch. A method comprising the above steps.

[0019] Embodiment 12 The method according to any of the preceding embodiments, further comprising introducing one or more capsules into the oral product, wherein the one or more capsules comprise an outer shell and an inner payload, the inner payload comprises at least one flavoring agent, and the one or more capsules optionally comprise a water-resistant outer coating.

[0020] Embodiment 13 A product configured for oral use, prepared by the method according to any of the preceding embodiments.

[0021] Embodiment 14 A method for preparing a nicotine-containing oral product, comprising premixing a nicotine component with a wetting agent to form a premix, and then combining the premix with a filler.

[0022] Embodiment 15 The method according to any of the preceding embodiments, wherein the wetting agent is propylene glycol or olive oil.

[0023] Embodiment 16 A composition comprising: a filler in an amount of at least 40 weight percent, based on the total weight of the composition (e.g., about 40 weight percent to about 60 weight percent or about 40% to about 50% of the composition); a sugar alcohol (e.g., about 1 weight percent to about 10 weight percent or about 2% to about 6% of the composition); a salt (e.g., about 1 weight percent to about 10 weight percent or about 2% to about 6% of the composition); an alginate (e.g., about 0.1 weight percent to about 10 weight percent or about 0.5% to about 1.5% of the composition); a sweetener such as an artificial sweetener (e.g., about 0.1 weight percent to about 10 weight percent or about 0.5% to about 1.5% of the composition); at least one flavoring agent or at least one active ingredient or at least one of both a flavoring agent and an active ingredient (e.g., a flavoring agent or an active ingredient in an amount of about 0.1 weight percent to about 10 weight percent or about 0.5% to about 1.5% of the composition); an optional natural gum (present in an amount of, e.g., about 0.1 weight percent to about 15 weight percent or about 1% to about 10% or about 2% to about 6% of the composition); and at least about 40% water content (e.g., about 40 weight percent to about 60 weight percent or about 40% to about 55% of the composition). A composition comprising the above ingredients.

[0024] Embodiment 17 The composition according to any of the preceding embodiments, further comprising a humectant (e.g., about 0.01 weight percent to about 10 weight percent or about 0.5% to about 6% of the composition).

[0025] Embodiment 18 The composition according to any of the preceding embodiments, wherein the humectant is propylene glycol or olive oil.

[0026] Embodiment 19 The composition according to any of the preceding embodiments, further comprising adding a nicotine component in an amount of about 0.001 to about 10 weight percent (e.g., about 0.5% to about 1.5%), calculated as the free base, based on the total weight of the composition.

[0027] A composition according to any preceding embodiment that, based on the total weight of the composition, substantially excludes tobacco materials, excluding any nicotine components present.

[0028] Embodiment 21 The filler is a cellulose material; or The salt is sodium chloride; or The alginate is sodium alginate, calcium alginate, potassium alginate, magnesium alginate, ammonium alginate, or a mixture of two or more of the foregoing; or The sugar alcohol is xylitol; or The active ingredient is selected from the group consisting of nicotine components, plants, stimulants, amino acids, vitamins, and cannabinoids; or The natural gum is guar gum; or A composition according to any preceding embodiment that is one or more combinations of the above.

[0029] Embodiment 22 A composition according to any preceding embodiment that further comprises one or more capsules comprising an outer shell and an inner payload, wherein the inner payload comprises at least one flavoring agent.

[0030] Embodiment 23 A composition according to any preceding embodiment, wherein one or more capsules comprise a water-resistant outer coating.

[0031] Embodiment 24 A composition according to any preceding embodiment, wherein the filler comprises a cellulose material.

[0032] Embodiment 25 A composition according to any preceding embodiment, wherein the cellulose material comprises microcrystalline cellulose.

[0033] Embodiment 26 A composition according to any preceding embodiment, comprising about 10 to about 50% of one or more particulate filler compositions and about 5 to about 60% water, based on the total weight of the composition.

[0034] Embodiment 27 A composition according to any preceding embodiment, wherein the composition contains tobacco material (e.g., about 0.01% to about 10% or about 0.5% to about 5% of the composition) of about 10% by weight or less, excluding any nicotine components present, based on the total weight of the composition.

[0035] Embodiment 28 A composition according to any preceding embodiment, wherein the composition is in the form of free-flowing microparticles.

[0036] These and other features, aspects, and advantages of the present disclosure will become apparent from the following detailed description read in conjunction with the accompanying drawings, which are briefly described below. The present invention encompasses any combination of two, three, four, or more of the above-described embodiments, as well as any combination of two, three, four, or more features or elements described in the present disclosure, regardless of whether such features or elements are explicitly combined in the description of a particular embodiment herein. The present disclosure is intended to be read as a whole such that, in any of its various aspects and embodiments, any separable feature or element of the disclosed invention should be considered combinable unless the context clearly indicates otherwise.

[0037] Having described aspects of the present disclosure under the foregoing general conditions, reference is now made to the accompanying drawings, which are not necessarily drawn to scale. The drawings are merely illustrative and should not be construed as limiting the present disclosure.

Brief Description of the Drawings

[0038]

Figure 1

Figure 2

Figure 3

Best Mode for Carrying Out the Invention

[0039] The present disclosure will now be described more fully hereinafter with reference to its exemplary embodiments. These exemplary embodiments are described so that the present disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. In fact, the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. References to “% dry weight” or “dry weight basis” refer to weights based on the dry components (i.e., all components excluding water). References to “wet weight” refer to the weight of a composition that includes water. Unless otherwise indicated, references to “% weight” of a composition reflect the total wet weight of the composition (i.e., including water).

[0040] The products described herein typically include a mixture of components including at least one filler and at least one flavoring agent and / or active ingredient. In some embodiments, the composition further includes one or more salts, one or more sweeteners, one or more binders, one or more wetting agents, one or more 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 the desired sensory and performance characteristics to the oral product. Exemplary individual components of the composition are described hereinbelow.

[0041] Components of the Filler The compositions described herein generally include a component of at least one filler. Such fillers can serve multiple functions, such as improving specific sensory stimulation characteristics like texture and mouthfeel, and improving the cohesiveness or compressibility of the product. Generally, the filler is a porous particulate material and is cellulose-based. For example, suitable particulate fillers are any non-tobacco plant material or derivatives thereof that contain cellulose materials derived from such sources. Examples of cellulose-based non-tobacco plant materials include grains (e.g., corn, wheat, barley, rye, buckwheat, etc.), sugar beet (e.g., FIBREX(R) brand filler available from International Fiber Corporation), bran fiber, and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starches (e.g., derived from potato, wheat, rice, corn), natural cellulose, and modified cellulose materials. Further examples of possible particulate fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Fillers can also be used in combination.

[0042] As used herein, "starch" can refer to pure starch, modified starch, or starch derivatives from any source. Starch is typically in granular form and is present in almost all green plants and various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains, and stems). Starch can vary in composition, as well as in granular shape and size. Often, starches from different sources have different chemical and physical properties. Specific starches can be selected for inclusion in a composition based on the ability of the starch material to impart specific sensory stimulus properties to the composition. Starches from various sources can be used. For example, the main sources of starch include cereals (e.g., rice, wheat, and corn) and root vegetables (e.g., potatoes and cassava). Other examples of starch sources include chestnuts, kudzu, peanuts, bananas, barley, beans (e.g., favas, lentils, mung beans, chickpeas, and fava beans), breadfruit, buckwheat, canna, chestnuts, cashews, katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potatoes, quinoa, rye, tapioca, taro, tobacco, water chestnuts, and yams. Certain starches are modified starches. Modified starches have undergone one or more structural modifications that are frequently designed to alter their high-temperature properties. Some starches have been developed by genetic modification and are considered "modified" starches. Other starches are obtained and subsequently modified.For example, the modified starch can be starch that has been subjected to chemical reactions such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of a base, bleaching, transglycosylation, and depolymerization (e.g., dextrinization in the presence of a catalyst), crosslinking, enzymatic treatment, acetylation, hydroxypropylation, and / or partial hydrolysis. Other starches are modified by heat treatment, such as gelatinization, dextrinization, and / or the cold water swelling process. Specific modified starches include monophosphate starch, didenpyl glycerol, diphosphate didenpyl esterified with sodium trimetaphosphate, diphosphate didenpyl phosphate, acetylated diphosphate didenpyl, acetate starch esterified with acetic anhydride, acetate starch esterified with vinyl acetate, acetylated adipic acid didenpyl, acetylated didenpyl glycerol, hydroxypropyl starch, hydroxypropyl didenpyl glycerol, and octenyl succinate sodium starch.

[0043] In some embodiments, the particulate filler is a cellulose material or a cellulose derivative. One particulate filler particularly suitable for use in the products described herein is microcrystalline cellulose (“mcc”). The mcc may be synthetic or semi-synthetic, or may be obtained entirely from natural cellulose. The mcc can be selected from the group consisting of AVICEL(R) grades PH-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-302, VIVACEL(R) grades 101, 102, 12, 20, and EMOCEL(R) grades 50M and 90M, and mixtures thereof. In one embodiment, the composition includes mcc as a component of the particulate filler. The amount of mcc present in the compositions described herein can vary depending on the desired properties.

[0044] The amount of the filler can vary and is typically up to about 75% by weight of the composition, based on the total weight of the composition. A typical range of particulate filler (e.g., MCC) in the composition is from about 10 to about 75% by weight of the total weight of the composition, such as from about 10, about 15, about 20, about 25, or about 30 to about 35, about 40, about 45, or about 50% by weight (e.g., about 20 to about 50% by weight or about 25 to about 45% by weight). In certain embodiments, the amount of the particulate filler material is at least about 10% by weight, such as at least about 20% by weight, or at least about 25% by weight, or at least about 30% by weight, or at least about 35% by weight, or at least about 40% by weight, based on the total weight of the composition.

[0045] In one embodiment, the particulate filler further comprises a cellulose derivative or a combination of such derivatives. In some embodiments, the composition comprises from about 1 to about 10% by weight of a cellulose derivative, based on the total weight of the composition, and certain embodiments comprise from about 1 to about 5% by weight of a cellulose derivative. In certain embodiments, the cellulose derivative is a cellulose ether (including carboxyalkyl ethers), meaning a cellulose polymer in which the hydrogen of one or more hydroxyl groups in the cellulose structure is substituted with an alkyl, hydroxyalkyl, or aryl group. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethylcellulose, and carboxymethylcellulose ("CMC"). In one embodiment, the cellulose derivative is one or more of methylcellulose, HPC, HPMC, hydroxyethylcellulose, and CMC. In one embodiment, the cellulose derivative is HPC. In some embodiments, the composition comprises from about 1 to about 3% by weight of HPC, based on the total weight of the composition.

[0046] Water The water content of the composition can vary according to the desired properties before use of the product by the consumer. Typically, the composition is less than about 60% by weight of water when present inside the product, before insertion into the user's mouth, and generally is from about 1 to about 60% by weight of water, such as from about 5 to about 55, from about 10 to about 50, from about 20 to about 45, or from about 25 to about 40% by weight of water, and contains a water content of at least about 5% by weight, at least about 10% by weight, at least about 15% by weight, and at least about 20% by weight.

[0047] Organic acid As used herein, the term "organic acid" refers to an organic (i.e., carbon-based) compound characterized by acidic properties. Typically, organic acids are relatively weak acids such as carboxylic acids (-CO2H) or sulfonic acids (-SO2OH) (i.e., they do not dissociate completely in the presence of water). As used herein, reference to an organic acid means an intentionally added organic acid. In this regard, an organic acid is in contrast to being essentially present as a component of another composition component (e.g., a minor amount of an organic acid that may be essentially present in a composition component such as a tobacco material), and may be intentionally added as a specific composition component. In some embodiments, one or more organic acids are added neat (i.e., in their free acid, inherently solid or liquid form), or as a solution in, for example, water. In some embodiments, one or more organic acids are added in the form of salts, as described hereinbelow.

[0048] In some embodiments, the organic acid is an alkylcarboxylic acid. Non-limiting examples of alkylcarboxylic acids include formic acid, acetic acid, propionic acid, octanoic acid, nonanoic acid, decanoic acid, undecanoic acid, dodecanoic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, and the like. In some embodiments, the organic acid is an alkylsulfonic acid. Non-limiting examples of alkylsulfonic acids include propanesulfonic acid and octanesulfonic acid.

[0049] 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.

[0050] In alternative embodiments, some or even all of the organic acid may be added in the form of a salt with an alkaline component that may include, but is not limited to, nicotine. Non-limiting examples of salts suitable for nicotine include formate, acetate, propionate, isobutyrate, butyrate, alpha-methylbutyrate, isovalerate, beta-methylvalerate, caproate, 2-furoate, phenylacetate, heptanoate, octanoate, nonanoate, succinate, malonate, glycolate, benzoate, tartrate, levulinate, ascorbate, fumarate, citrate, malate, lactate, aspartate, salicylate, tosylate, succinate, pyruvate, and the like. In some embodiments, the organic acid or a portion thereof may be added in the form of a salt with an alkali metal such as sodium or potassium. In the case of an organic acid having more than one acidic group (such as a dicarboxylic acid or tricarboxylic acid), in some cases, one or more of these acid groups may be in the form of such a salt. Suitable non-limiting examples include monosodium citrate, disodium citrate, and the like. In some embodiments, the organic acid is a salt of 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 a monoester or diester of a dicarboxylic acid or tricarboxylic acid, respectively, such as a monomethyl ester of citric acid, malic acid, or tartaric acid, or a dimethyl ester of citric acid.

[0051] The amount of organic acid present in the composition can vary. Generally, the composition contains from about 0.1% to about 10% by weight of organic acid present as one or more organic acids, based on the total weight of the composition. In some embodiments, the composition contains, by weight, 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%, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9% or about 10% organic acid, based on the total weight of the composition. In some embodiments, the composition contains from about 0.1% to about 0.5% by weight of organic acid, for example, about 0.1, about 0.15, about 0.2, about 0.25, about 0.3, about 0.35, about 0.4, about 0.45 or about 0.5% by weight, based on the total weight of the composition. In some embodiments, the composition contains from about 0.25% to about 0.35% by weight of organic acid, for example, about 0.25, about 0.26, about 0.27, about 0.28, about 0.29, or from about 0.3 to about 0.31, about 0.32, about 0.33, about 0.34, or about 0.35% by weight, based on the total weight of the composition. When salts of organic acids are added, the weight % is calculated based on the weight of the free acid, excluding any counterions that may be present.

[0052] The amount of acid present varies based on the acidity and basicity of other components (such as nicotine, salts, buffers, etc.) that may be present in the composition. Thus, the organic acid is provided in an amount sufficient to provide a composition pH of 7.0 or less (typically about 6.8 or less, about 6.6 or less, or about 6.5 or less). In certain embodiments, the acid content is sufficient to provide a composition pH of from about 4.0 to about 7.0, for example, from about 4.5, about 5.0, about 5.5, or about 6.0 to about 6.5, or about 7.0. In some embodiments, the organic acid is provided in an amount sufficient to provide a composition pH of from about 5.5 to about 6.5, for example, from about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, or about 6.0 to about 6.1, about 6.2, about 6.3, about 6.4, or about 6.5.

[0053] Flavorant As used herein, "flavorant" or "flavor" is any flavored or aromatic substance capable of changing the sensory characteristics associated with an oral product. Examples of sensory characteristics that can be altered by a flavorant include taste, mouthfeel, moistness, coolness / warmth, and / or smell / aroma. The flavorant may be natural or synthetic, and the flavor characteristics imparted thereby may be described, but are not limited to, fresh, sweet, herbaceous, confectionery, floral, fruity, or spicy. Specific types of flavors include, but are not limited to, vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, and any combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, R.J. Reynolds Tobacco Company (1972), which is incorporated herein by reference. The flavor may also include components that may be considered wetting agents, coolants, or smoothing agents such as eucalyptus. These flavorants may be provided neat (i.e., alone) or in combination, and may be used as concentrates or flavorant packages (e.g., spearmint and menthol, orange and cinnamon, lime, pineapple, etc.). Representative types of components are also described in U.S. Patent No. 5,387,416 to White et al., U.S. Patent Application Publication No. 2005 / 0244521 to Strickland et al., and International Publication No. 05 / 041699 of the PCT application to Quinter et al., each of which is incorporated herein by reference. In some cases, the flavorant may be provided in spray-dried form or in liquid form.

[0054] A fragrance agent generally contains at least one volatile fragrance component. As used herein, "volatile" refers to a chemical substance that readily forms vapor at ambient temperature (i.e., a chemical substance having a high vapor pressure at a given temperature compared to a non-volatile substance). Typically, the volatile fragrance component has a molecular weight of less than about 400 Da and often contains at least one carbon-carbon double bond, carbon-oxygen double bond, or both. In one embodiment, the at least one volatile fragrance 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, cumin aldehyde, 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, cedrene, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, the at least one volatile fragrance component includes one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, γ-terpinene, β-farnesene, or citral. In one embodiment, the at least one volatile fragrance component includes ethyl vanillin.

[0055] The amount of fragrance agent utilized in the composition can vary, but is typically up to about 10 wt%, and certain embodiments feature a fragrance agent content of at least about 0.1 wt%, such as about 0.5 to about 10 wt%, about 1 to about 6 wt%, or about 2 to about 5 wt%, based on the total weight of the composition.

[0056] Salt In some embodiments, the composition may further comprise a salt (e.g., an alkali metal salt) typically used in an amount sufficient to impart the desired sensory properties to the composition. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, and salt of wheat flour. When present, representative amounts of the salt are about 0.5 wt% or more, about 1.0 wt% or more, or about 1.5 wt% or more, but typically constitute about 10% or less, or about 7.5% or less, or about 5% or less (e.g., about 0.5 to about 5 wt%) of the total weight of the composition.

[0057] Sweetener The composition typically further comprises one or more sweeteners. The sweetener can be any sweetener or combination of sweeteners, in natural or artificial form, or as a combination of natural and artificial sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, etc. Examples of artificial sweeteners include sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, etc. In some embodiments, the sweetener comprises one or more sugar alcohols. A sugar alcohol is a polyol derived from a monosaccharide or disaccharide having a partially or fully hydrogenated form. Sugar alcohols have, for example, about 4 to about 20 carbon atoms and include erythritol, arabinitol, ribitol, isomalt, maltitol, xylitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). When present, representative amounts of the sweetener can constitute, on a weight basis, about 0.1 to about 20% or more of the composition, e.g., on a weight basis, about 0.1 to about 1%, about 1 to about 5%, about 5 to about 10%, or about 10 to about 20% of the composition, based on the total weight of the composition.

[0058] Binder The binder (or combination of binders) can be used in an amount sufficient to impart the desired physical attributes and physical integrity to the composition in certain embodiments. Typical binders can be organic or inorganic, or combinations thereof. Representative binders include povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, zein, etc., and combinations thereof. The binder can be used in an amount sufficient to impart the desired physical attributes and physical integrity to the composition. The amount of binder utilized in the composition can vary, but is typically up to about 30% by weight, and certain embodiments feature a binder content of at least about 0.1% by weight, such as about 1 to about 30% by weight, or about 5 to about 10% by weight, based on the total weight of the composition.

[0059] In certain embodiments, the binder includes gums, such as natural gums. As used herein, natural gum refers to a polysaccharide material of natural origin that has binding properties and is also useful as a thickening or gelling agent. Representative natural gums of plant origin that are typically somewhat water-soluble include xanthan gum, guar gum, gum arabic, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof. When present, the natural gum binding material is typically present in an amount of up to about 5% by weight, such as about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9, or about 1% to about 2, about 3, about 4, or about 5% by weight, based on the total weight of the composition.

[0060] Humectant In certain embodiments, one or more humectants can be used in the composition. Examples of humectants include, but are not limited to, glycerin, propylene glycol, etc. Other examples include plant-based oils such as olive oil, almond oil, avocado seed oil, coconut oil, corn oil, cottonseed oil, linseed oil, grape seed oil, sesame oil, palm kernel oil, peanut oil, pumpkin seed oil, rice bran oil, safflower seed oil, sesame seed oil, sunflower seed oil, soybean oil, or walnut oil.

[0061] When present, the wetting agent is typically provided in an amount sufficient to impart the desired moisture attributes to the composition. Further, in some instances, the wetting agent may impart desirable flow characteristics to the composition for deposition on the mold.

[0062] When present, the wetting agent typically constitutes about 5% or less of the weight of the composition (e.g., from about 0.5% to about 5% by weight). When present, representative amounts of the wetting agent are from about 0.1% to about 1% by weight, or from about 1% to about 5% by weight, based on the total weight of the composition.

[0063] Buffering agent In certain embodiments, the compositions of the present disclosure can include a pH adjuster or a buffering agent. Examples of pH adjusters and buffering agents that can be used include metal hydroxides (e.g., alkali metal hydroxides such as sodium hydroxide and potassium hydroxide), and other alkali metal buffering agents such as metal carbonates (e.g., potassium carbonate or sodium carbonate), or metal bicarbonates such as sodium bicarbonate, but are not limited thereto. When present, the buffering agent is typically less than about 5% based on the weight of the composition, e.g., from about 0.5% to about 5% based on the total weight of the composition, e.g., from about 0.75% to about 4%, from about 0.75% to about 3%, or from about 0.5% to about 1.5%, or from about 1% to about 2% by weight. Non-limiting examples of suitable buffering agents include alkali metal acetates, glycine acetates, phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates, borates, or mixtures thereof.

[0064] Colorant The colorant can be used in an amount sufficient to impart the desired physical attributes to the composition. Examples of colorants include various dyes and pigments such as caramel colorants and titanium dioxide. The amount of colorant utilized in the composition can vary, but when present, it is typically up to about 3 weight percent, e.g., about 0.1%, about 0.5%, or from about 1% to about 3% by weight, based on the total weight of the composition.

[0065] Active ingredient The composition may additionally contain one or more active ingredients including, but not limited to, nicotine components, botanical components (e.g., lavender, peppermint, chamomile, basil, rosemary, ginger, cannabis, ginseng, maca and chisandra), stimulants (e.g., caffeine and guarana), amino acids (e.g., taurine, theanine, phenylalanine, tyrosine and tryptophan) and / or pharmaceutical, nutritional and medical components (e.g., vitamins such as B6, B12 and C, and / or cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). The specific proportions and selections of the ingredients vary depending on the desired flavor, texture and other properties. Exemplary active ingredients include components that produce a pharmacological activity or other direct effect in the diagnosis, cure, alleviation, treatment or prevention of diseases, or affect the structure or any function of the body of humans or other animals (e.g., those that exert a stimulating effect on the central nervous system, provide an energy supply effect, antipyretic or analgesic effect, or other useful effects to the body). Any component known to affect one or more biological functions in the body is included, such as those that affect one or more biological functions in the body.

[0066] In certain embodiments, a nicotine component may be included in the composition. The "nicotine component" means any suitable form of nicotine (e.g., free base or salt) to effect oral absorption of at least a portion of the nicotine present. Typically, the nicotine component is selected from the group consisting of nicotine free base and nicotine salts. In some embodiments, nicotine is in its free base form and can be readily adsorbed to, for example, a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, the discussion of nicotine in free base form in U.S. Patent Application Publication No. 2004 / 0191322 by Hansson, which is incorporated herein by reference.

[0067] In some embodiments, at least a portion of the nicotine may be used in the form of a salt. The salts of nicotine can be provided using the types of ingredients and techniques described in U.S. Patent No. 2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983). These are incorporated herein by reference. Additionally, salts of nicotine are available from suppliers such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically, the nicotine component is selected from the group consisting of nicotine free base, nicotine salts such as hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and zinc chloride nicotinate. In some embodiments, the nicotine component or a portion thereof is a nicotine salt having at least a portion of one or more of the organic acids disclosed above herein.

[0068] In some embodiments, at least a portion of the nicotine may be in the form of a resin complex of nicotine, where the nicotine is bound to an ion exchange resin such as nicotine polacrilex, which is nicotine bound to polymethacrylic acid such as Amberlite IRP64, Purolite C115HMR, or Doshion P551. See, for example, U.S. Patent No. 3,901,248 to Lichtneckert et al., which is incorporated herein by reference. Another example is a nicotine-polyacrylic carbomer complex including Carbopol 974P and the like. In some embodiments, the nicotine may exist in the form of a nicotine polyacrylic complex.

[0069] Typically, the nicotine component (calculated as the free base), when present, is 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%. In some embodiments, the nicotine component, calculated as the free base, is present at a concentration of about 0.1% w / w to about 10% by weight, for example about 0.1% w / w, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, or about 0.9% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9% or about 10% by weight, based on the total weight of the composition. In some embodiments, the nicotine component, calculated as the free base, is present at a concentration of about 0.1% w / w to about 3% by weight, for example about 0.1% w / w to about 2.5%, about 0.1% to about 2.0%, about 0.1% to about 1.5%, or about 0.1% to about 1% by weight, based on the total weight of the composition. These ranges can also be applied to other active ingredients described herein.

[0070] Materials for tobacco In some embodiments, the composition can include tobacco materials. The tobacco materials can differ in species, type, and form. Generally, the tobacco materials are obtained from harvested plants of the Nicotiana species. Examples of Nicotiana species include N. tabacum, N. rustica, N. alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei, N. knightiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata, N.× sanderae, N. africana, N. amplexicaulis, N. benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N. occidentalis, N. paniculata, N. plumbaginifolia, N. raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbratica, N. velutina, N. wigandioides, N. acaulis, N. acuminata, N. attenuata, N. benthamiana, N.benthamiana), N. cavicola, N. clevelandii, N. cordifolia, N. corymbosa, N. fragrans, N. goodspeedii, N. linearis, N. miersii, N. nudicaulis, N. obtusifolia, N. occidentalis subsp. Hersperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia, and N. spegazzinii. Various other representative types of plants from Nicotiana species are described in Goodspeed, The Genus Nicotiana, (Chonica Botanica) (1954), U.S. Patent No. 4,660,577 to Sensabaugh, Jr. et al., U.S. Patent No. 5,387,416 to White et al., U.S. Patent No. 7,025,066 to Lawson et al., U.S. Patent No. 7,798,153 to Lawrence, Jr. et al., and U.S. Patent No. 8,186,360 to Marshall et al. Each of these is incorporated herein by reference. Descriptions of various types of tobacco, cultivation practices, and harvesting practices are described in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999), which are incorporated herein by reference.

[0071] Nicotiana species from which suitable tobacco materials can be obtained can be derived using genetic modification or breeding techniques (e.g., tobacco plants can be genetically engineered or bred to increase or decrease the production of components, characteristics, or traits). See, for example, the types of genetic modification of plants described in U.S. Patent No. 5,539,093 to Fitzmaurice et al., No. 5,668,295 to Wahab et al., No. 5,705,624 to Fitzmaurice et al., No. 5,844,119 to Weigl et al., No. 6,730,832 to Dominguez et al., No. 7,173,170 to Liu et al., No. 7,208,659 to Colliver et al., No. 7,230,160 to Benning et al., U.S. Patent Application Publication No. 2006 / 0236434 to Conkling et al., and International Publication No. 2008 / 103935 pamphlet to Nielsen et al. Also see the types of genetic modification of plants described in U.S. Patent No. 4,660,577 to Sensabaugh, Jr. et al., No. 5,387,416 to White et al., and No. 6,730,832 to Dominguez et al. Each is hereby incorporated by reference into this specification.

[0072] In some embodiments, Nicotiana species can be selected for the content of various compounds present therein. For example, plants can be selected based on their producing relatively large amounts of one or more of the compounds from which it is desired to isolate them. In certain embodiments, plants of Nicotiana species (e.g., Galpao commun tobacco) are cultivated specifically for the compounds on the surface of their abundant leaves. Tobacco plants can be cultivated in a greenhouse, a growth chamber, or an outdoor field, or hydroponically.

[0073] Various parts of Nicotiana species plants can be included within the compositions disclosed herein. For example, substantially all of the plant (e.g., the whole plant) can be harvested and used as is. Alternatively, various parts or fragments of the plant can be harvested or separated after harvesting for further use. For example, flowers, leaves, stems, petioles, roots, seeds, and various combinations thereof can be isolated for further use or processing. In some embodiments, the tobacco material includes tobacco leaves (lamina). The compositions disclosed herein can include processed tobacco parts or fragments, cured and aged tobacco in essentially natural lamina and / or stem form, tobacco extracts, extracted tobacco pulp (e.g., using water as a solvent), or mixtures of the foregoing (e.g., a mixture combining extracted tobacco pulp with granulated aged natural tobacco lamina).

[0074] In certain embodiments, the tobacco material includes a solid tobacco material selected from the group consisting of lamina and stem. The tobacco used in the composition most preferably includes tobacco lamina, or a mixture of tobacco lamina and stem (at least a portion of which has been smoke treated). The tobacco portion within the composition may have a processed form such as a processed tobacco stem (e.g., a cut and rolled stem, a cut and rolled and expanded stem, or a cut and puffed stem) or a volume-expanded tobacco (e.g., a puffed tobacco such as dry ice expanded tobacco (DIET)). See, for example, U.S. Patent No. 4,340,073 to de la Burde, No. 5,259,403 to Guy, No. 5,908,032 to Poindexter, and No. 7,556,047 to Poindexter and the tobacco growing processes described therein. These are all incorporated by reference. Further, the composition may optionally incorporate fermented tobacco. See also the types of tobacco processing techniques described in International Publication No. 2005 / 063060 pamphlet by Atchley et al., which is incorporated herein by reference.

[0075] Tobacco materials are typically used in a form that can be described as particulate (i.e., fragmented, pulverized, granulated, or powdered). The methods by which tobacco materials are provided in a finely divided or powdered form can vary. Preferably, plant parts or fragments are subdivided, pulverized, or micronized using devices and techniques for micronization, milling, etc. Most preferably, the plant material is in a relatively dry form during pulverization or milling using devices such as hammer mills, cutter heads, air control mills, etc. For example, tobacco parts or fragments may be pulverized 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 between 1.4 millimeters and 250 microns. In some examples, the tobacco particles can be sized to pass through a screen mesh to obtain the required particle size range. If desired, an air classification device can be used to reliably collect small tobacco particles of the desired size or size range. If desired, granular tobacco pieces of different sizes may be mixed together.

[0076] There can be various ways in which tobacco is provided in a finely divided form or in powder form. Preferably, the tobacco parts or fragments are subdivided, pulverized or micronized into a powder-type form using devices and techniques for micronization, milling, etc. Most preferably, the tobacco is in a relatively dry form during pulverization or milling using devices such as hammer mills, cutter heads, air control mills, etc. For example, the tobacco parts or fragments may be pulverized or milled when their moisture content is less than about 15 wt% to less than about 5 wt%. For example, a tobacco plant or a part thereof can be separated into individual parts or fragments (e.g., the leaves can be removed from the stem, and / or the stem and leaves can be removed from the stem). The harvested plant or individual parts or fragments can be further subdivided into parts or fragments (e.g., the leaves can be fragmented, cut, subdivided, micronized, milled or pulverized into fragments or parts that can be characterized as filler-type fragments, granules, microparticles or fine powders). The plant or a part thereof can be subjected to an external force or pressure (e.g., by being subjected to a press or roll treatment). When carrying out such treatment conditions, the plant or a part thereof can have a water content close to its natural water content (e.g., the water content immediately after harvesting), a water content achieved by adding water to the plant or a part thereof, or a water content resulting from the drying of the plant or a part thereof. For example, the powdered, micronized, pulverized or milled fragments of the plant or a part thereof can have a water content of less than about 25 wt%, often less than about 20 wt%, frequently less than about 15 wt%.

[0077] For the preparation of oral products, harvested plants of Nicotiana species are typically subjected to a curing process. The tobacco materials incorporated into the composition for inclusion in the products disclosed herein are appropriately cured and / or aged. Descriptions of various types of curing processes for various types of tobacco are described in Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999). Examples of techniques and conditions for curing flue-cured tobacco are described in Nestor et al., Beitrage Tabakforsch.Int., 20, 467-475 (2003) and U.S. Patent No. 6,895,974 to Peele. These are incorporated herein by reference. Representative techniques and conditions for air-cured tobacco are described in U.S. Patent No. 7,650,892 to Groves et al., Roton et al., Beitrage Tabakforsch.Int., 21, 305-320 (2005) and Staaf et al., Beitrage Tabakforsch.Int., 21, 321-330 (2005), which are incorporated herein by reference. Certain types of tobacco can undergo alternative types of curing processes such as fire curing or sun drying curing.

[0078] In certain embodiments, tobacco materials that can be used include flue-cured or Virginia (e.g., K326), burley, sun-dried cured (e.g., Indian Kurnool and Oriental tobacco including Katerini, Prelip, Komotini, Xanthi and Yambol tobacco), Maryland, dark, dark fire, dark air-cured (e.g., Madole, Passanda, Cubano, Jatin and Bezuki tobacco), light air-cured (e.g., North Wisconsin and Galpao tobacco), Indian air-cured, Red Russian and Rustica tobacco, and various other rare or special tobaccos and various blends of any of the foregoing tobaccos.

[0079] The tobacco material may also have the form of a so-called "blend". For example, the tobacco material can include a mixture of parts or pieces of flue-cured, burley (e.g., burley tobacco from Malawi), and oriental tobacco (e.g., tobacco composed of or derived from tobacco lamina, or a mixture of tobacco lamina and tobacco stems). For example, a representative blend can incorporate from about 30 to about 70 parts of burley tobacco (e.g., lamina, or lamina and stems) and from about 30 to about 70 parts of flue-cured tobacco (e.g., stems, lamina, or lamina and stems) on a dry weight basis. Other examples of tobacco blends incorporate about 75 parts of flue-cured tobacco, about 15 parts of burley tobacco, and about 10 parts of oriental tobacco, or about 65 parts of flue-cured tobacco, about 25 parts of burley tobacco, and about 10 parts of oriental tobacco, or about 65 parts of flue-cured tobacco, about 10 parts of burley tobacco, and about 25 parts of oriental tobacco on a dry weight basis. Other examples of tobacco blends incorporate from about 20 to about 30 parts of oriental tobacco and from about 70 to about 80 parts of flue-cured tobacco on a dry weight basis.

[0080] The tobacco materials used in the present disclosure can be subjected to, for example, fermentation, bleaching, etc. If desired, the tobacco materials can be subjected to, for example, irradiation, pasteurization, or otherwise controlled heat treatment. Such treatment processes are detailed, for example, in U.S. Patent No. 8,061,362 to Mua et al., which is incorporated herein by reference. In certain embodiments, the tobacco materials are treated with water and an additive (e.g., lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, a composition 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 inhibit the reaction of asparagine upon heating of the tobacco materials to form acrylamide. See, for example, the types of treatment processes described in U.S. Patent Nos. 8,434,496, 8,944,072, and 8,991,403 to Chen et al., which are all incorporated herein by reference. In certain embodiments, this type of treatment is useful when the original tobacco materials are subjected to heat in the aforementioned processes.

[0081] In some embodiments, the type of tobacco material is initially selected to be somewhat visually brighter in color (e.g., whitened or bleached) than other tobacco materials. In certain embodiments, the tobacco pulp can be whitened according to any means known in the art. For example, whitened tobacco materials produced by various bleaching methods using various bleaching agents, oxidizing agents, and oxidation catalysts can be used. Examples of oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorites, chlorates, perchlorates, hypochlorites, ozone, ammonia, potassium permanganate, and combinations thereof. Examples of oxidation catalysts are titanium dioxide, manganese dioxide, and combinations thereof.Methods of treating tobacco with bleaching agents are described, for example, in U.S. Patent No. 787,611 to Daniels, Jr., No. 1,086,306 to Oelenheinz, No. 1,437,095 to Delling, No. 1,757,477 to Rosenhoch, No. 2,122,421 to Hawkinson, No. 2,148,147 to Baier, No. 2,170,107 to Baier, No. 2,274,649 to Baier, No. 2,770,239 to Prats et al., No. 3,612,065 to Rosen, No. 3,851,653 to Rosen, No. 3,889,689 to Rosen, No. 3,943,940 to Minami, No. 3,943,945 to Rosen, No. 4,143,666 to Rainer, No. 4,194,514 to Campbell, No. 4,366,823, No. 4,366,824, and No. 4,388,933 to Rainer et al., No. 4,641,667 to Schmekel et al., No. 5,713,376 to Berger, No. 9,339,058 to Byrd, Jr. et al., No. 9,420,825 to Beeson et al., and No. 9,950,858 to Byrd, Jr. et al., and in U.S. Patent Application Publication No. 2012 / 0067361 to Bjorkholm et al., No. 2016 / 0073686 to Crooks, No. 2017 / 0020183 to Bjorkholm, and No. 2017 / 0112183 to Bjorkholm, and in PCT Application International Publication No. 1996 / 031255 to Giolvas and International Publication No. 2018 / 083114 to Bjorkholm. All of these are hereby incorporated by reference into this specification.

[0082] In some embodiments, the whitened tobacco material can have an ISO brightness of at least about 50%, at least about 60%, at least about 65%, at least about 70%, at least about 75% or at least about 80%. In some embodiments, the whitened tobacco material can have an ISO brightness in the range of about 50% to about 90%, about 55% to about 75%, or about 60% to about 70%. The ISO brightness can be measured in accordance with ISO 3688:1999 or ISO 2470-1:2016.

[0083] In some embodiments, the whitened tobacco material can be characterized as being lighter in color (e.g., “whitened”) compared to the non-treated tobacco material. White is frequently defined with reference to the chromaticity diagram of the International Commission on Illumination (CIE). The whitened tobacco material can, in certain embodiments, be characterized as being closer to pure white in the chromaticity diagram than the non-treated tobacco material.

[0084] In various embodiments, the tobacco material can be processed to extract soluble components of the tobacco material therefrom. As used herein, "tobacco extract" refers to the isolated components of the tobacco material that are extracted from the solid tobacco pulp by a solvent that contacts the tobacco material in the extraction process. Various extraction techniques for the tobacco material can be used to provide the tobacco extract and the tobacco solid material. See, for example, the extraction process described in U.S. Patent Application Publication No. 2011 / 0247640 to Beeson et al., which is incorporated herein by reference. Other exemplary techniques for extracting components of tobacco are U.S. Patent No. 4,144,895 to Fiore, U.S. Patent No. 4,150,677 to Osborne, Jr. et al., U.S. Patent No. 4,267,847 to Reid, U.S. Patent No. 4,289,147 to Wildman et al., U.S. Patent No. 4,351,346 to Brummer et al., U.S. Patent No. 4,359,059 to Brummer et al., U.S. Patent No. 4,506,682 to Muller, U.S. Patent No. 4,589,428 to Keritsis, U.S. Patent No. 4,605,016 to Soga et al., U.S. Patent No. 4,716,911 to Poulose et al., Niven, Jr.U.S. Patent No. 4,727,889 to et al., U.S. Patent No. 4,887,618 to Bernasek et al., U.S. Patent No. 4,941,484 to Clapp et al., U.S. Patent No. 4,967,771 to Fagg et al., U.S. Patent No. 4,986,286 to Roberts et al., U.S. Patent No. 5,005,593 to Fagg et al., U.S. Patent No. 5,018,540 to Grubbs et al., U.S. Patent No. 5,060,669 to White et al., U.S. Patent No. 5,065,775 to Fagg, U.S. Patent No. 5,074,319 to White et al., U.S. Patent No. 5,099,862 to White et al., U.S. Patent No. 5,121,757 to White et al., U.S. Patent No. 5,131,414 to Fagg, U.S. Patent No. 5,131,415 to Munoz et al., U.S. Patent No. 5,148,819 to Fagg, U.S. Patent No. 5,197,494 to Kramer, U.S. Patent No. 5,230,354 to Smith et al., U.S. Patent No. 5,234,008 to Fagg, U.S. Patent No. 5,243,999 to Smith, U.S. Patent No. 5,301,694 to Raymond et al., U.S. Patent No. 5,318,050 to Gonzalez-Parra et al., U.S. Patent No. 5,343,879 to Teague, U.S. Patent No. 5,360,022 to Newton, U.S. Patent No. 5,435,325 to Clapp et al., U.S. Patent No. 5,445,169 to Brinkley et al., U.S. Patent No. 6,131,584 to Lauterbach, U.S. Patent No. 6,298,859 to Kierulff et al., U.S. Patent No. 6,772,767 to Mua et al., and U.S. Patent No. 7,337,782 to Thompson, all of which are hereby incorporated by reference into this specification.

[0085] Typical inclusion ranges for tobacco materials can vary depending on the nature and type of the tobacco material and the intended effect on the final composition, based on the total weight of the composition in an amount in the range of up to about 30 wt% (or up to about 20 wt% or up to about 10 wt% or up to about 5 wt%) (for example, from about 0.1 to about 15% by weight)is exemplified. In some embodiments, the products of the present disclosure can be characterized as containing no or substantially no tobacco materials (other than purified nicotine as an active ingredient). For example, certain embodiments can be characterized as having less than 1% by weight, or less than 0.5% by weight, or less than 0.1% by weight of tobacco materials, or 0% by weight of tobacco materials.

[0086] Other additives Other additives can be included in the disclosed compositions. For example, the compositions can be processed, blended, formulated, combined, and / or mixed with other materials or ingredients. The additives can be artificial, or can be obtained from or derived from herbs or biological sources. Examples of additional types of additives include thickening or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate, etc.), disintegrating aids, or combinations thereof. For example, representative components thereof, combinations of components, relative amounts of those components, and techniques and methods for using those components are described in U.S. Patent No. 9,237,769 to Mua et al., U.S. Patent No. 7,861,728 to Holton, Jr. et al., U.S. Patent Application Publication No. 2010 / 0291245 to Gao et al., and U.S. Patent Application Publication No. 2007 / 0062549 to Holton, Jr. et al. Each of which is incorporated herein by reference. Typical ranges of inclusion for such additional additives can vary depending on the nature and function of the additive and the intended effect on the final composition, and ranges up to about 10% by weight, based on the total weight of the composition, are exemplified (e.g., from about 0.1% to about 5% or from about 0.5% to about 1.5%).

[0087] The foregoing additives can be used together (e.g., as an additive formulation) or separately (e.g., the individual additive components can be added at different stages involved in the preparation of the final composition). Further, additives of the foregoing types may be encapsulated so as to be supplied to the final product or composition. Exemplary encapsulated additives are described, for example, in International Publication No. WO 2010 / 132444 to Atchley, which is hereby incorporated by reference in its entirety.

[0088] In some embodiments, any one or more of the fillers, tobacco materials, and overall oral products described herein can be described as particulate materials. As used herein, the term "particulate" refers to a material in the form of a plurality of individual particles, some of which may be in the form of aggregates of multiple particles, and the particles have an average length-to-width ratio of less than 2:1, such as less than 1.5:1, such as about 1:1. In various embodiments, the particles of the particulate material can be described as being substantially spherical or granular.

[0089] The particle size of the particulate matter can be measured by sieve analysis. As will be readily understood by those skilled in the art, sieve analysis (otherwise known as a gradation test) is a method used to measure the particle size distribution of particulate materials. Typically, sieve analysis involves a nested column of sieves, preferably including a screen in the form of a wire mesh cloth. A pre-weighed sample can be introduced onto the top or uppermost sieve within the column, which has the largest sieve opening or mesh size (i.e., the largest pore diameter of the sieve). Each successive sieve within the column has a smaller screen opening or mesh size than the sieve above it. Typically, at the base of the column of sieves, there is a receiver portion for collecting any particles having a particle size smaller than the sieve opening size or mesh size of the bottom or lowermost sieve in the column (which has the smallest screen opening or mesh size).

[0090] In some embodiments, the sieve column can be placed on or in a mechanical stirrer. The stirrer causes vibration of each sieve within the column. The mechanical stirrer may be activated for a predetermined period to ensure that all particles are collected in the correct sieve. In some embodiments, the sieve column is stirred for a period of 0.5 minutes to 10 minutes, such as 1 minute to 10 minutes, such as 1 minute to 5 minutes, such as about 3 minutes. Once the stirring of the sieves within the column is complete, the material collected on each sieve is weighed. Then, the weight of each sample on each sieve can be divided by the total weight to obtain the percentage of the mass retained on each sieve. As will be readily understood by those skilled in the art, the sieve opening size or mesh size of each sieve of the column used for sieve analysis can 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 can be used for sieve analysis, and the column includes 2 to 20 sieves, such as 5 to 15 sieves. In some embodiments, a sieve column can be used for sieve analysis, and the column includes 10 sieves. In some embodiments, the maximum sieve opening or mesh size of the sieves used for sieve analysis can be 1000 μm, such as 500 μm, such as 400 μm, such as 300 μm.

[0091] In some embodiments, any particulate material referred to herein (e.g., filler components, tobacco materials, and oral products as a whole) can be characterized as having at least 50 weight % of particles with a particle size measured by sieve analysis of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less. In some embodiments, at least 60 weight % of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less when measured by sieve analysis. In some embodiments, at least 70 weight % of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less when measured by sieve analysis. In some embodiments, at least 80 weight % of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less when measured by sieve analysis. In some embodiments, at least 90 weight % of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less when measured by sieve analysis. In some embodiments, at least 95 weight % of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less when measured by sieve analysis. In some embodiments, at least 99 weight % of the particles of any particulate material referred to herein have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less when measured by sieve analysis.In some embodiments, for about 100% by weight of the particles of any particulate material referred to herein, when measured by sieve analysis, they have a particle size of about 1000 μm or less, such as about 500 μm or less, such as about 400 μm or less, such as about 350 μm or less, such as about 300 μm or less.

[0092] In some embodiments, at least 50% by weight, such as at least 60% by weight, such as at least 70% by weight, such as at least 80% by weight, such as at least 90% by weight, such as at least 95% by weight, such as at least 99% by weight of the particles of any particulate material referred to herein, when measured by sieve analysis, have a particle size of about 0.01 μm to about 1000 μm, such as about 0.05 μm to about 750 μm, such as about 0.1 μm to about 500 μm, such as about 0.25 μm to about 500 μm. In some embodiments, at least 50% by weight, such as at least 60% by weight, such as at least 70% by weight, such as at least 80% by weight, such as at least 90% by weight, such as at least 95% by weight, such as at least 99% by weight of the particles of any particulate material referred to herein, when measured by sieve analysis, have a particle size of about 10 μm to about 400 μm, such as about 50 μm to about 350 μm, such as about 100 μm to about 350 μm, such as about 200 μm to about 300 μm.

[0093] Preparation of the composition The ways of combining the various components of the composition can be diverse. In certain embodiments, typically various combinations of dry components, which typically include a filler component, are blended to form a dry mix. Thereafter, typically in multiple steps, the remaining liquid components are added to the dry mix to prepare the mixture of the final product. In certain embodiments, an active ingredient (e.g., nicotine) is mixed with a wetting agent (e.g., propylene glycol or olive oil) to form a premix before adding it to the remaining portion of the composition such as a dry mix containing a filler. By using a mixture of a specific active ingredient such as nicotine and a wetting agent, the irritation of the mouth or throat associated with the oral use of the resulting product can be reduced. If one or more capsules are included in the composition, the capsules can be added at various stages, such as adding them to the dry mix or to the product composition immediately before the final packaging (e.g., a pouch) or after putting the composition into the pouch (but before sealing the pouch).

[0094] In certain embodiments, the mixing efficiency and / or uniformity of the product can be enhanced by using a plurality of consecutive addition steps in the process for adding a liquid component (e.g., an aqueous solution or dispersion) to the dry mix. By separating the liquid component into a plurality of addition steps, smaller amounts of each liquid composition can be intimately mixed with the dry components, improving the mixing characteristics. In certain embodiments, the use of an aqueous composition at a high temperature between about 50 and about 100 °C, such as about 55 and about 80 °C or about 60 and about 70 °C, can also result in improved mixing efficiency and / or product uniformity.

[0095] In some embodiments, the aqueous composition used in the method is maintained at a temperature below room temperature, such as between about 10 and about 25 °C, for example about 20 and about 25 °C (room temperature). Surprisingly, in certain embodiments, using a lower temperature of the aqueous composition during mixing does not cause a significant loss of product uniformity or mixing efficiency, and can reduce the overall process cost, especially when room temperature water is used.

[0096] Still further, in certain embodiments, particularly after the addition of the active ingredient and / or flavorant, most of the total amount of water used in the product is added in the final water addition step. This type of process is particularly well-suited for use with cooler water, as described above. Surprisingly, applying most of the total amount of water after all or substantially all of the other ingredients have been added does not cause a significant loss of product uniformity or mixing efficiency, and without requiring a separate rinsing step that could result in an undesirable increase in water usage or loss of processing efficiency, additional advantages can be obtained in removing residual active ingredient and / or flavorant from the pipes in the mixing system. In certain embodiments, the amount of water added in the final water addition step is at least about 50 wt% (e.g., at least about 60% or at least about 65% or at least about 70% or at least about 75% or at least about 80% or at least about 85% or at least about 90%) of the total water content of the product mixture.

[0097] The various components of the composition can be brought into contact, combined, or mixed together using any mixing technique or apparatus known in the art. Any mixing method can be used that closely contacts the components of the mixture, such as a mixing apparatus featuring an impeller or other stirrable structure. Examples of mixing devices include casing drums, conditioning cylinders or drums, liquid spray devices, conical blenders, ribbon blenders, mixers available from Littleford Day, Inc. as FKM130, FKM600, FKM1200, FKM2000, and FKM3000, Plough Share type mixer cylinders, Hobart mixers, and the like. See, for example, the types of methods described in U.S. Patent No. 4,148,325 to Solomon et al., U.S. Patent No. 6,510,855 to Korte et al., and U.S. Patent No. 6,834,654 to Williams, U.S. Patent No. 4,725,440 to Ridgway et al., and U.S. Patent No. 6,077,524 to Bolder et al. Each of these is incorporated herein by reference.

[0098] Certain active ingredients, such as nicotine, present safety and handling challenges. Accordingly, the present disclosure includes an administration system that reduces the time spent handling the active ingredient. An embodiment of the administration system 20 is shown in FIG. 3. As shown, the system includes a storage tank 22 for the active ingredient, which is in fluid communication with an administration tank 30. In certain embodiments, the storage tank 22 can also be in fluid communication with an inert gas container 26 that contains an inert gas, such as nitrogen, whereby an inert gas blanket 24 can be generated over the headspace of the active ingredient stored in the storage tank 22.

[0099] A pump 28 is used to transport the liquid active ingredient from the storage tank 22 to the administration tank 30. One or more additional storage tanks are preferably in fluid communication with the administration tank 30, such as a storage tank 32 for flavoring agents and a storage tank 34 for wetting agents. In this way, additional components of the composition can be premixed with the active ingredient in the administration tank 30. From the administration tank 30, the active ingredient (optionally premixed with additional components) can be transported to one or more mixing tanks 36 that contain additional components of the desired composition, such as a dry mix as described above.

[0100] Oral Configuration Products configured for oral use are provided herein. As used herein, the term "configured for oral use" means that the product is provided in a form such that during use, saliva in the user's mouth causes one or more of the components of the composition (e.g., flavoring agents and / or nicotine) to pass into the user's mouth. In certain embodiments, the product is adapted to deliver the components to the user through the oral mucosa, and in some cases, the components can be active ingredients (e.g., including but not limited to nicotine) that can be absorbed through the oral mucosa when the product is used.

[0101] Products configured for oral use as described herein can take various forms including gels, lozenges, gums, tablets, powders, and pouches. The gels can be soft or hard. A particular product configured for oral use is in the form of a lozenge. As used herein, the term "lozenge" refers to a soluble oral product made by solidifying a liquid or gel composition such that the final product is a somewhat hardened solid gel. The rigidity of the gel is highly variable. The particular products of the present disclosure are in solid form. The particular products can exhibit one or more of, for example, crispy, granular, crunchy, syrupy, pasty, fluffy, smooth, and / or creamy characteristics. In certain embodiments, the desired texture characteristics can be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, friability, granulosity, rubberiness, hardness, weight, hygroscopicity, moisture release, mouth coating, coarseness, slipperiness, smoothness, viscosity, wettability, and combinations thereof.

[0102] Products containing the compositions of the present disclosure can be soluble. As used herein, the terms "dissolve", "dissolving", and "soluble" refer to compositions having water-soluble components that interact with the moisture in the oral cavity to enter into solution, thereby causing a slow consumption of the product. According to one aspect, the soluble product can persist in the user's mouth for a given period of time 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, an immediate-release composition typically dissolves and / or releases the 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 can occur by any means such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical decomposition, or disruption of the interaction between the components of the composition. In some embodiments, the product can be meltable as contemplated, for example, in U.S. Patent Application Publication No. 2012 / 0037175 to Cantrell et al. In other embodiments, the product does not dissolve while the product is present in the user's mouth.

[0103] In one embodiment, a product comprising the composition of the present disclosure is in the form of a composition disposed within a moisture-permeable container (e.g., a water-permeable pouch). Such a composition in the form of a water-permeable pouch is typically used by placing one pouch containing the composition into the mouth of a human subject / user. Generally, the pouch is placed somewhere in the user's oral cavity, such as under the lip, in the same manner as moist snuff is commonly used. The pouch is preferably not chewed or swallowed. Then, upon exposure to saliva, some of the components of the composition therein (e.g., flavorants and / or nicotine) pass through, for example, the water-permeable pouch, providing flavor and satisfaction to the user, and the user does not have to spit out any part of the composition. After about 10 minutes to about 60 minutes of use / enjoyment, typically about 15 minutes to about 45 minutes, a significant amount of the composition is absorbed by the human subject (either via gingival or sublingual absorption), and the pouch can be removed from the human subject's mouth for disposal.

[0104] Accordingly, in certain embodiments, the compositions disclosed herein and any of the other ingredients described above are combined within a moisture-permeable packet or pouch that functions as a container for use of the composition to provide a pouch product configured for oral use. Certain embodiments of the present disclosure are described with reference to FIG. 1 of the accompanying drawings, and these described embodiments include snus-type products having an outer pouch and containing the compositions described herein. As will be described in more detail below, such embodiments are provided by way of example only, and the pouch products of the present disclosure can include other forms of compositions.

[0105] The composition / structure of such a packet or pouch, such as container pouch 12 in the embodiment shown in FIG. 1, can vary. Referring to FIG. 1, a first embodiment of a pouch product 10 is shown. The pouch product 10 includes a moisture-permeable container in the form of a pouch 12 containing the composition 14 described herein. The pouch product 10 optionally includes one or more capsules 16 dispersed within the composition 14, and the capsules contain additives (e.g., flavorants) as described in more detail below.

[0106] Suitable types of packets, pouches or containers for use in the manufacture of smokeless tobacco products are available under the trade names CatchDry, Ettan, General, Granit, Goteborgs Rape, Grovsnus White, Metropol Kaktus, Mocca Anis, Mocca Mint, Mocca Wintergreen, Kicks, Probe, Prince, Skruf and TreAnkrare. The composition may be contained and packaged in a pouch in the manner of and using components of the type used in the manufacture of conventional snus-type products. The pouch comprises a liquid-permeable container of a type that may be considered to be similar in characteristics to the mesh-type materials used in the construction of tea bags. The components of the composition diffuse easily through the pouch into the user's mouth.

[0107] Non-limiting examples of suitable types of pouches are described, for example, in U.S. Patent No. 5,167,244 to Kjerstad and U.S. Patent No. 8,931,493 to Sebastian et al., U.S. Patent Application Publication No. 2016 / 0000140 by Sebastian et al., U.S. Patent Application Publication No. 2016 / 0073689 to Sebastian et al., U.S. Patent Application Publication No. 2016 / 0157515 to Chapman et al. and U.S. Patent Application Publication No. 2016 / 0192703 to Sebastian et al. These are hereby incorporated by reference into this specification. The pouches can be provided as individual pouches or multiple pouches (e.g., 2, 4, 5, 10, 12, 15, 20, 25 or 30 pouches) can be connected or linked to each other (e.g., in an end-to-end manner) such that an individual pouch or individual portion can be easily removed from a one-piece strand or parent material of the pouch for use.

[0108] Exemplary pouches can be manufactured from materials in such a way that the pouch undergoes controlled dispersion or dissolution during use by the user. Such pouch materials can have forms such as mesh, screen, perforated paper, permeable cloth, etc. For example, a pouch material made from rice paper in mesh form or perforated rice paper can dissolve in the user's mouth. As a result, the pouch and the composition can each be completely dispersed in the user's mouth during normal use conditions, and thus both the pouch and the composition can be ingested or absorbed by the user. Other examples of pouch materials can be manufactured using water-dispersible film-forming materials (such as binders like alginate, carboxymethyl cellulose, xanthan gum, pullulan, etc.), and materials combined with materials such as ground cellulose (such as particulate-sized wood pulp). Preferred pouch materials are water-dispersible or soluble, but may be designed and manufactured such that a significant amount of the composition contents permeate the pouch material before the pouch loses 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.

[0109] The amount of material contained within each product unit, such as a pouch, can vary. In some embodiments, the weight of the composition within each pouch is at least about 50 mg, such as from about 50 mg to about 1 g, from about 100 to about 800 mg, or from about 200 to about 700 mg. In some smaller-scale embodiments, the weight of the composition within each pouch can be from about 100 to about 300 mg. In larger-scale embodiments, the weight of the material within each pouch may be from about 300 mg to about 700 mg.

[0110] Optionally, other ingredients can be incorporated within each pouch. For example, strips, pieces or sheets of at least one flavored water-dispersible or water-soluble material (such as a fresh edible film type material) may be placed within each pouch, with or without at least one capsule. Such strips or sheets may be folded or crinkled to facilitate incorporation within the pouch. See, for example, the types of materials and techniques described in U.S. Patent No. 6,887,307 to Scott et al., and U.S. Patent No. 6,923,981 to Leung et al. and The EFSA Journal (2004) 85, 1-32. These are hereby incorporated by reference into this specification.

[0111] As described above, in some embodiments, the composition components of any of the above types can be added in encapsulated form (e.g., in the form of capsules including microcapsules), the encapsulated form including a wall or barrier structure that defines an inner region and permanently or temporarily isolates the inner region from the remainder of the product composition. The inner region contains a payload of additives adapted to enhance one or more sensory properties of the product such as taste, mouthfeel, moisture, coldness / heat, and / or aroma, or to add additional functional properties to the product such as the addition of antioxidants or immune system enhancing functions. See, for example, the subject matter of U.S. Patent Application Publication No. 2009 / 0025738 to Mua et al. This is hereby incorporated by reference into this specification.

[0112] The use of capsules physically separates or isolates the additives to some extent from one or more other ingredients of the product. The functional advantages of such separation can vary, but typically include minimizing or eliminating chemical interactions between the additives and the other ingredients of the product under normal storage and / or use conditions. Thus, separation of specific additives can enhance the storage stability of the resulting product and / or maintain the desired sensory properties of the product.

[0113] The outer shell of the capsule functions as a barrier between the payload (i.e., the additive) and the remainder of the product composition. The additive in the core region of the capsule is released under specific product use conditions. For example, the outer shell may undergo some kind of physical destruction, breakage, or other loss of physical integrity (e.g., by disintegration, softening, crushing, application of pressure, etc.) in response to a trigger condition associated with the product. Release of such an additive can change or enhance the flavor or other sensory properties of the product, extend the period during which the user can enjoy the product, or provide other functional benefits. The trigger conditions associated with the release of the additive can be varied and can include, for example, changes in the temperature or pH of the product, contact with digestive enzymes, or physical rupture or breakage caused, for example, by the chewing action of the product user.

[0114] In some embodiments, contact of the capsule with the high temperature of the user's mouth (e.g., the user's saliva) can soften the capsule, cause it to lose its physical integrity, and allow the additive to be released into the user's mouth (e.g., at a temperature of about 37 °C or higher). In some embodiments, the capsule is configured to release the additive in response to a change in pH, for example, a capsule configured to release the additive when the pH of the capsule is typical of or near (e.g., higher) the pH of the user's mouth (e.g., from about 5.6 to 7.9). Still further, in certain embodiments, the capsule is configured to release the additive in response to digestive enzymes (e.g., amylase) commonly found in the user's mouth.

[0115] The capsules may be uniform or variable in size, weight, and shape, and such characteristics of the capsules depend on the desired characteristics of the product. The capsules may be of various shapes including generally spherical, linear, oblong, oval, or ovoid. The size of the capsules can vary, including diameter ranges such as about 0.5 to about 5 mm, as well as microcapsule size ranges such as a diameter of less than about 100 microns, for example, a diameter in the range of about 1 to about 40 microns, or about 1 micron to about 20 microns. The total weight of the capsules in the product can vary, but is typically about 10 mg to about 200 mg, for example, about 20 mg to about 50 mg.

[0116] The number of capsules utilized in each product can vary depending on factors such as the size of the capsules, the characteristics or properties of the additives in the payload, and the desired attributes of the product. The number of capsules is typically in the range of 1 to about 500, more typically about 5 to about 100.

[0117] The materials of the outer wall or shell used to form the capsules can be different. The types of materials typically used as the wall or shell material include proteins, polysaccharides, starches, waxes, fats, natural and synthetic polymers, and resins. Examples of materials include gelatin, natural gums, polyvinyl acetate, potassium or sodium alginate, carrageenan, dextrin, polyvinyl alcohol, povidone, dimethyl polysiloxane, paraffin wax, shellac, cellulose derivatives (e.g., ethyl cellulose, carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, methyl cellulose, methyl ethyl cellulose), microcrystalline wax, terpene resin, tragacanth, polyethylene, and polyethylene glycol.

[0118] In certain embodiments, the capsule can include an additional outer coating, such as a coating adapted to enhance water resistance, on the outer shell. Exemplary coating materials include various polymer materials such as cellulose derivatives (e.g., HPMC), polyvinyl alcohol, and acrylate or methacrylate polymers.

[0119] The pouch products described herein can be packaged inside any suitable inner packaging material and / or outer container. For example, see U.S. Patent No. 7,014,039 to Henson et al., No. 7,537,110 to Kutsch et al., No. 7,584,843 to Kutsch et al., No. 8,397,945 to Gelardi et al., D592,956 to Thiellier, D594,154 to Patel et al., and D625,178 to Bailey et al., U.S. Patent Application Publication No. 2008 / 0173317 to Robinson et al., No. 2009 / 0014343 to Clark et al., No. 2009 / 0014450 to Bjorkholm, No. 2009 / 0250360 to Bellamah et al., No. 2009 / 0266837 to Gelardi et al., No. 2009 / 0223989 to Gelardi, No. 2009 / 0230003 to Thiellier, No. 2010 / 0084424 to Gelardi, and No. 2010 / 0133140 to Bailey et al., No. 2010 / 0264157 to Bailey et al., and No. 2011 / 0168712 to Bailey et al. for various types of containers for smokeless type products. These are hereby incorporated by reference into this specification.

[0120] Many modifications and other embodiments of the present invention will come to mind to those skilled in the art having the benefit of the teachings presented in the foregoing description. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed herein and that modified forms and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

[0121] Experiment Aspects of the present invention are more fully described by the following examples which are set forth to illustrate specific aspects of the invention and are not to be construed as limiting thereof.

Example

[0122] [Example 1] Prepare an oral composition containing the components shown in Table 1 below. The actual percentage of the components can be varied according to the desired final product.

[0123]

Table 1

[0124] The composition is prepared using the following method.

[0125] 1. Put MCC, sodium alginate, and sodium chloride into a paddle blender and blend to form a dry mix. 2. In a separate container, mix sodium bicarbonate with about half of the total water used in the recipe (e.g., hot water at about 65 °C). Stir the mixture until the sodium bicarbonate is completely dissolved to form an aqueous solution. 3. Then, spray the sodium bicarbonate solution from a pressure vessel onto the dry mix in the blender and blend the resulting mixture for about 5 minutes. 4. In another container, mix xylitol, ammonium chloride as a pH adjuster, potassium sorbate as a preservative, and an artificial sweetener (e.g., sucralose or acesulfame K) with approximately 2 / 3 of the remaining water (e.g., hot water at about 65 °C), and stir until dissolved to form an aqueous solution. 5. In another container, mix a flavoring agent, propylene glycol, and nicotine together, and then add them to the solution from Step 4. 6. Then, spray the mixture from Step 5 from the pressure container into the mixture obtained in Step 3 in the blender, and blend the resulting mixture for about 10 minutes. 7. In another container, mix xylitol, ammonium chloride as a pH adjuster, potassium sorbate as a preservative, and an artificial sweetener (e.g., sucralose or acesulfame K) with the remaining 1 / 3 of the water (e.g., hot water at about 65 °C), and stir until dissolved to form an aqueous solution. 8. Then, spray the mixture from Step 7 from the pressure container into the mixture obtained in Step 6 in the blender, and blend the resulting mixture for about 10 minutes. 9. Then, take out the resulting mixture from the blender and put it into a storage container for future pouches.

[0126] [Example 2] Prepare an oral composition containing the components shown in Table 2 below. The actual percentages of the components can be varied according to the desired final product.

[0127]

Table 2

[0128] The composition is prepared using the following method.

[0129] 1. Put MCC, sodium alginate, bleached tobacco, and sodium chloride into a paddle blender and blend to form a dry mix 2. In another container, mix sodium bicarbonate with approximately half of the total water used in the recipe (e.g., hot water at about 65 °C). Stir the mixture until the sodium bicarbonate is completely dissolved and an aqueous solution is formed. 3. Next, spray the sodium bicarbonate solution from the pressure vessel onto the dry mix in the blender and blend the resulting mixture for about 5 minutes. 4. In another container, mix xylitol, ammonium chloride as a pH adjuster, potassium sorbate as a preservative, and an artificial sweetener (e.g., sucralose or acesulfame K) with approximately 2 / 3 of the remaining water (e.g., hot water at about 65 °C), and stir until dissolved to form an aqueous solution. 5. Add a flavoring agent and nicotine to the solution from Step 4. 6. Next, spray the mixture from Step 5 from the pressure vessel onto the mixture obtained in Step 3 in the blender and blend the resulting mixture for about 10 minutes. 7. In another container, mix xylitol, ammonium chloride as a pH adjuster, potassium sorbate as a preservative, and an artificial sweetener (e.g., sucralose or acesulfame K) with the remaining 1 / 3 of the water (e.g., hot water at about 65 °C), and stir until dissolved to form an aqueous solution. 8. Next, spray the mixture from Step 7 from the pressure vessel onto the mixture obtained in Step 6 in the blender and blend the resulting mixture for about 10 minutes. 9. Next, remove the resulting mixture from the blender and place it in a storage container for future pouches.

[0130] [Example 3] Prepare an oral composition containing the components shown in Table 3 below. The actual percentages of the components can be varied according to the desired final product.

[0131]

Table 3

[0132] The composition is prepared using the following method. 1. Put MCC, sodium alginate, bleached tobacco, guar gum, and sodium chloride into a paddle blender and blend to form a dry mix. 2. In a separate container, mix sodium bicarbonate with approximately half of the total water used in the recipe (e.g., hot water at about 65 °C). Stir the mixture until the sodium bicarbonate is completely dissolved to form an aqueous solution. 3. Then, spray the sodium bicarbonate solution from the pressure vessel onto the dry mix in the blender and blend the resulting mixture for about 5 minutes. 4. In a separate container, mix xylitol, ammonium chloride as a pH adjuster, potassium sorbate as a preservative, and an artificial sweetener (e.g., sucralose or acesulfame K) with the remaining water (e.g., hot water at about 65 °C) and stir until dissolved to form an aqueous solution. 5. Add a flavoring agent and nicotine to the solution from Step 4. 6. Then, spray the mixture from Step 5 from the pressure vessel onto the mixture obtained in Step 3 in the blender and blend the resulting mixture for about 10 minutes. 7. Then, take the resulting mixture out of the blender and put it into a storage container for future pouches.

[0133] [Example 4] Prepare an oral composition containing the components shown in Table 4 below. The actual percentages of the components can be varied according to the desired final product.

[0134]

Table 4

[0135] The composition is prepared using the following method.

[0136] 1. Put MCC, bleached tobacco, guar gum, an artificial sweetener (e.g., sucralose or acesulfame K), sodium bicarbonate, potassium sorbate, and sodium chloride into a paddle blender and blend to form a dry mix. 2. In a separate container, mix sodium alginate with water (e.g., hot water at about 65 °C). Stir the mixture until the sodium alginate is completely dissolved to form an aqueous solution. Then, add xylitol and mix until dissolved. 3. Next, spray the solution obtained in step 2 from the pressure vessel into the dry mix in the blender and blend the resulting mixture for about 5 minutes. 4. In a separate container, mix the flavoring agent and nicotine. 5. Next, spray the mixture from step 4 from the pressure vessel into the mixture obtained in step 3 in the blender and blend the resulting mixture for about 10 minutes. 6. Then, remove the resulting mixture from the blender and place it in a storage container for future pouches.

[0137] [Example 5] An oral composition containing the components described in Example 1 is prepared using the following method.

[0138] 1. Put MCC, sodium chloride, xylitol, sodium alginate, sodium bicarbonate, artificial sweetener, and potassium sorbate into a paddle blender and blend to form a dry mix. 2. Mix the nicotine solution with propylene glycol, then spray it from the pressure vessel into the dry mix in the blender and blend the resulting mixture for about 5 minutes. 3. Next, spray the flavoring agent from the pressure vessel into the mixture in the blender and blend the resulting mixture for about 5 minutes. 4. Then, spray all the water used in the composition from the pressure vessel into the mixture in the blender and blend the resulting mixture for about 10 minutes. The water is not heated and is typically at or below room temperature. 5. Then, remove the resulting mixture from the blender and place it in a storage container for future pouches.

[0139] [Example 6] An oral composition containing the components described in Example 2 is prepared using the following method.

[0140] 1. Put MCC, sodium chloride, xylitol, bleached tobacco, sodium alginate, sodium bicarbonate, artificial sweetener and potassium sorbate into a paddle blender and blend to form a dry mix. 2. Then, spray the nicotine solution from the pressure vessel onto the dry mix in the blender and blend the resulting mixture for about 5 minutes. 3. Next, spray the flavoring agent from the pressure vessel onto the mixture in the blender and blend the resulting mixture for about 5 minutes. 4. Then, spray all the remaining water used in the composition from the pressure vessel onto the mixture in the blender and blend the resulting mixture for about 10 minutes. The water is not heated and is typically at or below room temperature. 5. Then, remove the resulting mixture from the blender and place it in a storage container for future pouches.

[0141] [Example 7] An oral composition containing the components described in Example 3 is prepared using the following method.

[0142] 1. Put MCC, sodium chloride, xylitol, guar gum, bleached tobacco, sodium alginate, sodium bicarbonate, artificial sweetener and potassium sorbate into a paddle blender and blend to form a dry mix. 2. Then, spray the nicotine solution from the pressure vessel onto the dry mix in the blender and blend the resulting mixture for about 5 minutes. 3. Next, spray the flavoring agent from the pressure vessel onto the mixture in the blender and blend the resulting mixture for about 5 minutes. 4. Then, spray all the remaining water used in the composition from the pressure vessel onto the mixture in the blender and blend the resulting mixture for about 10 minutes. The water is not heated and is typically at or below room temperature. 5. Then, remove the resulting mixture from the blender and place it in a storage container for future pouches.

[0143] [Example 8] The oral composition containing the components described in Example 4 is prepared using the following method.

[0144] 1. Put MCC, sodium chloride, xylitol, guar gum, bleached tobacco, sodium alginate, sodium bicarbonate, artificial sweetener and potassium sorbate into a paddle blender and blend to form a dry mix. 2. Mix the nicotine solution with propylene glycol, then spray it from a pressure vessel into the dry mix in the blender and blend the resulting mixture for about 5 minutes. 3. Then spray the flavoring agent from a pressure vessel into the mixture in the blender and blend the resulting mixture for about 5 minutes. 4. Then spray all the remaining water used in the composition from a pressure vessel into the mixture in the blender and blend the resulting mixture for about 10 minutes. The water is not heated and is typically at or below room temperature. 5. Then take the resulting mixture out of the blender and put it into a storage container for future pouches.

[0145] [Example 9] Reduction of Irritation Pouch product samples containing the same amounts of microcrystalline cellulose, sodium chloride, alginate, and acesulfame K were prepared. Using this same base formulation, three sets of samples were prepared. (1) Pouches with 4 mg of nicotine and 4 mg of propylene glycol (PG) added, (2) pouches with 4 mg of nicotine and 4 mg of olive oil added, and (3) pouches with 4 mg of nicotine only (without propylene glycol or olive oil).

[0146] The sensory evaluation was conducted by asking the panelists to select the most irritating sample and the least irritating sample. Using the data collected, the data shown in Figure 2 was generated. The trend line indicates that the irritation level of the samples containing either propylene glycol or olive oil is low.

Claims

1. A method of preparing an oral product, comprising: forming a dry mix by combining a filler comprising microcrystalline cellulose and a salt, wherein the dry mix further comprises one or more of alginate, bleached tobacco, sweetener, carbonate salt, and natural gum; adding a flavoring agent and an active ingredient to the dry mix to form a mixture, wherein the active ingredient is applied in liquid form before, after, or simultaneously with the flavoring agent; and subsequently applying water to the mixture to form a second mixture, wherein at least 50% by weight of the water content of the second mixture is added after adding the active ingredient. A method comprising the above steps.

2. The method according to claim 1, further comprising containing the second mixture in a pouch.

3. The method according to claim 1, wherein the salt is sodium chloride.

4. The method according to claim 1, wherein at least 60% by weight of the water content of the second mixture is added after adding the active ingredient.

5. The method according to claim 1, wherein at least 70% by weight of the water content of the second mixture is added after adding the active ingredient.

6. The method according to claim 1, wherein the active ingredient is a nicotine solution.

7. The method according to claim 1, wherein the water applied to the mixture to form the second mixture is at room temperature.

8. The method according to claim 1, further comprising introducing one or more capsules into the oral product, wherein the one or more capsules comprise an outer shell and an inner payload, and the inner payload comprises at least one flavoring agent.

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