Patent Description:
Tobacco may be enjoyed in a so-called "smokeless" form. Particularly popular smokeless tobacco products are employed by inserting some form of processed tobacco or tobacco-containing formulation into the mouth of the user. Conventional formats for such smokeless tobacco products include moist snuff, snus, and chewing tobacco, which are typically formed almost entirely of particulate, granular, or shredded tobacco, and which are either portioned by the user or presented to the user in individual portions, such as in single-use pouches or sachets. Other traditional forms of smokeless products include compressed or agglomerated forms, such as plugs, tablets, or pellets. Alternative product formats, such as tobacco-containing gums and mixtures of tobacco with other plant materials, are also known. See for example, the types of smokeless tobacco formulations, ingredients, and processing methodologies set forth in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>, as well as <CIT>.

Smokeless tobacco product configurations that combine tobacco material with various binders and fillers have been proposed more recently, with example product formats including lozenges, pastilles, gels, extruded forms, and the like. See, for example, the types of products described in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

All-white snus portions are growing in popularity, and offer a discrete and aesthetically pleasing alternative to traditional snus. Such modern "white" pouched products may include a bleached tobacco or may be tobacco-free. Products of this type may suffer from certain drawbacks, such as poor product stability that could lead to discoloration of the product and/or undesirable organoleptic characteristics. Accordingly, it would be desirable in the art to provide products configured for oral use with enhanced stability to provide a more enjoyable user experience. <CIT> discloses cannabis moist snuff; <CIT> discloses smokeless tobacco; <CIT> discloses medicinal delivery systems; <CIT> discloses a whitened tobacco composition; <CIT> discloses methods and systems for incorporating nicotine into oral products; <CIT> discloses a smokeless tobacco composition; <CIT> discloses nebulizer formulations and methods of treating asthma; <CIT> discloses herbal chew and snuff compositions; <CIT> discloses an oral pouched product.

The present disclosure generally provides products configured for oral use and methods of making such products. The products are intended to impart a taste when used orally, and typically also deliver one or more active ingredients to the consumer, such as nicotine.

Where a method refers to an intermediate composition as optionally further including one or more components selected from a list, such a reference includes compositions that include a single member from a single classification of components from the list (e.g., a single alginate), or two or more members from a single classification of components from the list (e.g., two sweeteners), or combinations of one or more members from each of two or more classifications of components from the list (e.g., a sweetener and an alginate).

Having thus described aspects of the disclosure in the foregoing general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale. The drawings are exemplary only, and should not be construed as limiting the disclosure.

The present disclosure will now be described more fully hereinafter with reference to example embodiments thereof. These example embodiments are described so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art. Indeed, the disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. As used in this specification and the claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Reference to "dry weight percent" or "dry weight basis" refers to weight on the basis of dry ingredients (i.e., all ingredients except water). Reference to "wet weight" refers to the weight of the composition including water. Unless otherwise indicated, reference to "weight percent" of a composition reflects the total wet weight of the composition (i.e., including water).

The products as described herein comprise a mixture of components, typically including at least one filler and at least one flavoring agent and/or active ingredient. In some embodiments, the composition further comprises one or more salts, one or more sweeteners, one or more binding agents, one or more humectants, one or more gums, an organic acid, a tobacco material, a tobacco-derived material, or a combination thereof. The relative amounts of the various components within the composition may vary, and typically are selected so as to provide the desired sensory and performance characteristics to the oral product. The example individual components of the composition are described herein below.

Compositions as described herein generally include at least one filler component. Such fillers may fulfill multiple functions, such as enhancing certain organoleptic properties such as texture and mouthfeel, enhancing cohesiveness or compressibility of the product, and the like. Generally, the fillers are porous particulate materials and are cellulose-based. For example, suitable particulate fillers are any non-tobacco plant material or derivative thereof, including cellulose materials derived from such sources. Examples of cellulosic non-tobacco plant material include cereal grains (e.g., maize, oat, barley, rye, buckwheat, and the like), sugar beet (e.g., FIBREX® brand filler available from International Fiber Corporation), bran fiber, and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant material include starches (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulosic materials. Additional examples of potential particulate fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol. Combinations of fillers can also be used.

"Starch" as used herein may refer to pure starch from any source, modified starch, or starch derivatives. Starch is present, typically in granular form, in almost all green plants and in various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains, and stems). Starch can vary in composition, as well as in granular shape and size. Often, starch from different sources has different chemical and physical characteristics. A specific starch can be selected for inclusion in the composition based on the ability of the starch material to impart a specific organoleptic property to composition. Starches derived from various sources can be used. For example, major sources of starch include cereal grains (e.g., rice, wheat, and maize) and root vegetables (e.g., potatoes and cassava). Other examples of sources of starch include acorns, arrowroot, arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia, katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnuts, and yams. Certain starches are modified starches. A modified starch has undergone one or more structural modifications, often designed to alter its high heat properties. Some starches have been developed by genetic modifications, and are considered to be "modified" starches. Other starches are obtained and subsequently modified. For example, modified starches can be starches that have been subjected to chemical reactions, such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), cross-linking, enzyme treatment, acetylation, hydroxypropylation, and/or partial hydrolysis. Other starches are modified by heat treatments, such as pre gelatinization, dextrinization, and/or cold water swelling processes. Certain modified starches include monostarch phosphate, distarch glycerol, distarch phosphate esterified with sodium trimetaphosphate, phosphate distarch phosphate, acetylated distarch phosphate, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated distarch adipate, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, starch sodium octenyl succinate.

In some embodiments, the particulate filler is a cellulose material or cellulose derivative. One particularly suitable particulate filler for use in the products described herein is microcrystalline cellulose ("mcc"). The mcc may be synthetic or semi-synthetic, or it may be obtained entirely from natural celluloses. The mcc may be selected from the group consisting of AVICEL® grades PH-<NUM>, PH-<NUM>, PH-<NUM>, PH-<NUM>, PH-<NUM>, PH-<NUM>, PH-<NUM>, PH-<NUM>, PH-<NUM>, VIVACEL® grades <NUM>, <NUM>, <NUM>, <NUM> and EMOCEL® grades <NUM> and <NUM>, and the like, and mixtures thereof. In one embodiment, the composition comprises mcc as the particulate filler component. The quantity of mcc present in the composition as described herein may vary according to the desired properties.

The amount of filler can vary, but is typically up to about <NUM> percent of the composition by weight, based on the total weight of the composition. A typical range of particulate filler (e.g., mcc) within the composition can be from <NUM> to about <NUM> percent by total weight of the composition. The amount of particulate filler material is at least about <NUM> percent, based on the total weight of the composition.

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 <NUM> to about <NUM>% of the cellulose derivative by weight, based on the total weight of the composition, with certain embodiments comprising about <NUM> to about <NUM>% by weight of cellulose derivative. In certain embodiments, the cellulose derivative is a cellulose ether (including carboxyalkyl ethers), meaning a cellulose polymer with the hydrogen of one or more hydroxyl groups in the cellulose structure replaced with an alkyl, hydroxyalkyl, or aryl group. Non-limiting examples of such cellulose derivatives include methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethyl cellulose, and carboxymethylcellulose ("CMC"). In one embodiment, the cellulose derivative is one or more of methylcellulose, HPC, HPMC, hydroxyethyl cellulose, and CMC. In one embodiment, the cellulose derivative is HPC. In some embodiments, the composition comprises from about <NUM> to about <NUM>% HPC by weight, based on the total weight of the composition.

The water content of the composition, prior to use by a consumer of the product, may vary according to the desired properties. Typically, the composition, as present within the product prior to insertion into the mouth of the user, is less than about <NUM> percent by weight of water, and generally is from about <NUM> to about <NUM>% by weight of water, for example, from about <NUM> to about <NUM>, about <NUM> to about <NUM>, about <NUM> to about <NUM>, or about <NUM> to about <NUM> percent water by weight, including water amounts of at least about <NUM>% by weight, at least about <NUM>% by weight, at least about <NUM>% by weight, and at least about <NUM>% by weight.

As used herein, the term "organic acid" refers to an organic (i.e., carbon-based) compound that is characterized by acidic properties. Typically, organic acids are relatively weak acids (i.e., they do not dissociate completely in the presence of water), such as carboxylic acids (-CO<NUM>H) or sulfonic acids (-SO<NUM>OH). As used herein, reference to organic acid means an organic acid that is intentionally added. In this regard, an organic acid may be intentionally added as a specific composition ingredient as opposed to merely being inherently present as a component of another composition ingredient (e.g., the small amount of organic acid which may inherently be present in a composition ingredient such as a tobacco material). In some embodiments, the one or more organic acids are added neat (i.e., in their free acid, native solid or liquid form) or as a solution in, e.g., water. In some embodiments, the one or more organic acids are added in the form of a salt, as described herein below.

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

In some embodiments, the organic acid is citric acid, malic acid, tartaric acid, octanoic acid, benzoic acid, a toluic acid, salicylic acid, or a combination thereof. In some embodiments, the organic acid is benzoic acid. In some embodiments, the organic acid is citric acid.

In alternative embodiments, a portion, or even all, of the organic acid may be added in the form of a salt with an alkaline component, which may include, but is not limited to, nicotine. Non-limiting examples of suitable salts, e.g., for nicotine, include formate, acetate, propionate, isobutyrate, butyrate, alpha-methylbutyate, isovalerate, beta-methylvalerate, caproate, <NUM>-furoate, phenylacetate, heptanoate, octanoate, nonanoate, oxalate, 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, potassium, and the like. In organic acids having more than one acidic group (such as a di- or-tri-carboxylic acid), in some instances, 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, a toluic acid, salicylic acid, or a combination thereof. In some embodiments, the organic acid is a mono or di-ester of a di- or tri-carboxylic acid, respectively, such as a monomethyl ester of citric acid, malic acid, or tartaric acid, or a dimethyl ester of citric acid.

The amount of organic acid present in the composition may vary. Generally, the composition comprises from about <NUM> to about <NUM>% 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 comprises about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, or about <NUM>% organic acid by weight, based on the total weight of the composition. In some embodiments, the composition comprises from about <NUM> to about <NUM>% by weight of organic acid, for example, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>% by weight, based on the total weight of the composition. In some embodiments, the composition comprises from about <NUM> to about <NUM>% by weight of organic acid, for example, from about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>, to about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>% by weight, based on the total weight of the composition. In the case where a salt of an organic acid is added, the percent by weight is calculated based on the weight of the free acid, not including any counter-ion which may be present.

The quantity of acid present will vary based on the acidity and basicity of other components which may be present in the composition (e.g., nicotine, salts, buffers, and the like). Accordingly, the organic acid is provided in a quantity sufficient to provide a pH of <NUM> or below, (typically about <NUM> or below, about <NUM> or below, or about <NUM> or below) of the composition. In certain embodiments the acid inclusion is sufficient to provide a composition pH of from about <NUM> to about <NUM>; for example, from about <NUM>, about <NUM>, about <NUM>, or about <NUM>, to about <NUM>, or about <NUM>. In some embodiments, the organic acid is provided in a quantity sufficient to provide a pH of the composition of from about <NUM> to about <NUM>, for example, from about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>, to about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>.

As used herein, a "flavoring agent" or "flavorant" is any flavorful or aromatic substance capable of altering the sensory characteristics associated with the oral product. Examples of sensory characteristics that can be modified by the flavoring agent include taste, mouthfeel, moistness, coolness/heat, and/or fragrance/aroma. Flavoring agents may be natural or synthetic, and the character of the flavors imparted thereby may be described, without limitation, as fresh, sweet, herbal, confectionary, 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, cardamon, nutmeg, cinnamon, clove, cascarilla, sandalwood, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, and any combinations thereof. See also, <NPL>). Flavorings also may include components that are considered moistening, cooling or smoothening agents, such as eucalyptus. These flavors may be provided neat (i.e., alone) or in a composite, and may be employed as concentrates or flavor packages (e.g., spearmint and menthol, orange and cinnamon; lime, pineapple, and the like). Representative types of components also are set forth in <CIT>; <CIT>; and <CIT> In some instances, the flavoring agent may be provided in a spray-dried form or a liquid form.

The flavoring agent generally comprises at least one volatile flavor component. As used herein, "volatile" refers to a chemical substance that forms a vapor readily at ambient temperatures (i.e., a chemical substance that has a high vapor pressure at a given temperature relative to a nonvolatile substance). Typically, a volatile flavor component has a molecular weight below about <NUM> Da, and often include at least one carbon-carbon double bond, carbon-oxygen double bond, or both. In one embodiment, the at least one volatile flavor component comprises one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or a combination thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde, cuminaldehyde, benzaldehyde, and citronellal. Non-limiting examples of ketones include <NUM>-hydroxy-<NUM>-propanone and <NUM>-hydroxy-<NUM>-methyl-<NUM>-cyclopentenone-<NUM>-one. Non-limiting examples of esters include allyl hexanoate, ethyl heptanoate, ethyl hexanoate, isoamyl acetate, and <NUM>-methylbutyl acetate. Non-limiting examples of terpenes include sabinene, limonene, gamma-terpinene, beta-farnesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, the at least one volatile flavor component comprises one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, or citral. In one embodiment, the at least one volatile flavor component comprises ethyl vanillin.

The amount of flavoring agent utilized in the composition can vary, but is typically up to about <NUM> weight percent, and certain embodiments are characterized by a flavoring agent content of at least about <NUM> weight percent, such as about <NUM> to about <NUM> weight percent, about <NUM> to about <NUM> weight percent, or about <NUM> to about <NUM> weight percent, based on the total weight of the composition.

The composition comprises a salt. This salt is (e.g., alkali metal salts), typically employed in an amount sufficient to provide desired sensory attributes to the composition. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, and the like. When present, a representative amount of salt is about <NUM> percent by weight or more, about <NUM> percent by weight or more, or at about <NUM> percent by weight or more, but will typically make up about <NUM> percent or less of the total weight of the composition, or about <NUM> percent or less or about <NUM> percent or less (e.g., about <NUM> to about <NUM> percent by weight).

The composition further comprises one or more sweeteners. The sweeteners 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, and the like. Examples of artificial sweeteners include sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame and the like. In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides that have a partially or fully hydrogenated form. Sugar alcohols have, for example, about <NUM> to about <NUM> carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). When present, a representative amount of sweetener may make up from about <NUM> to about <NUM> percent or more of the of the composition by weight, for example, from about <NUM> to about <NUM>%, from about <NUM> to about <NUM>%, from about <NUM> to about <NUM>%, or from about <NUM> to about <NUM>% of the composition on a weight basis, based on the total weight of the composition.

The composition according to the invention comprises alginate, e.g. sodium alginate, as binder. Binders may be employed in certain embodiments, in amounts sufficient to provide the desired physical attributes and physical integrity to the composition. Typical binders can be organic or inorganic, or a combination thereof. Representative binders include povidone, starch-based binders, pectin, carrageenan, pullulan, zein, and the like, and combinations thereof. A binder may be employed in amounts sufficient to provide 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 <NUM> weight percent, and certain embodiments are characterized by a binder content of at least about <NUM>% by weight, such as about <NUM> to about <NUM>% by weight, or about <NUM> to about <NUM>% by weight, based on the total weight of the composition.

In certain embodiments, the binder includes a gum, for example, a natural gum. As used herein, a natural gum refers to polysaccharide materials of natural origin that have binding properties, and which are also useful as a thickening or gelling agents. Representative natural gums derived from plants, which are typically water soluble to some degree, include xanthan gum, guar gum, gum arabic, ghatti gum, gum tragacanth, karaya gum, locust bean gum, gellan gum, and combinations thereof. When present, natural gum binder materials are typically present in an amount of up to about <NUM>% by weight, for example, from about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, about <NUM>, or about <NUM>%, to about <NUM>, about <NUM>, about <NUM>, or about <NUM>% by weight, based on the total weight of the composition.

In certain embodiments, one or more humectants may be employed in the composition. Examples of humectants include, but are not limited to, glycerin, propylene glycol, and the like. Other examples include plant-based oils, such as olive oil, almond oil, avocado seed oil, coconut oil, corn oil, cottonseed oil, flax seed oil, grapeseed oil, hemp 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.

Where included, the humectant is typically provided in an amount sufficient to provide desired moisture attributes to the composition. Further, in some instances, the humectant may impart desirable flow characteristics to the composition for depositing in a mold.

When present, a humectant will typically make up about <NUM>% or less of the weight of the composition (e.g., from about <NUM> to about <NUM>% by weight). When present, a representative amount of humectant is about <NUM>% to about <NUM>% by weight, or about <NUM>% to about <NUM>% by weight, based on the total weight of the composition.

In certain embodiments, the composition of the present disclosure can comprise pH adjusters or buffering agents. Examples of pH adjusters and buffering agents that can be used include, but are not limited to, metal hydroxides (e.g., alkali metal hydroxides such as sodium hydroxide and potassium hydroxide), and other alkali metal buffers such as metal carbonates (e.g., potassium carbonate or sodium carbonate), or metal bicarbonates such as sodium bicarbonate, and the like. Where present, the buffering agent is typically present in an amount less than about <NUM> percent based on the weight of the composition, for example, from about <NUM>% to about <NUM>%, such as, e.g., from about <NUM>% to about <NUM>%, from about <NUM>% to about <NUM>%, or about <NUM>% to about <NUM>%, or from about <NUM>% to about <NUM>% by weight, based on the total weight of the composition. Non-limiting examples of suitable buffers include alkali metals acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates, borates, or mixtures thereof.

A colorant may be employed in amounts sufficient to provide the desired physical attributes to the composition. Examples of colorants include various dyes and pigments, such as caramel coloring and titanium dioxide. The amount of colorant utilized in the composition can vary, but when present is typically up to about <NUM> weight percent, such as from about <NUM>%, about <NUM>%, or about <NUM>%, to about <NUM>% by weight, based on the total weight of the composition.

The composition may additionally include one or more active ingredients including, but not limited to, a nicotine component, botanical ingredients (e.g., lavender, peppermint, chamomile, basil, rosemary, ginger, cannabis, ginseng, maca, and tisanes), stimulants (e.g., caffeine and guarana), amino acids (e.g., taurine, theanine, phenylalanine, tyrosine, and tryptophan) and/or pharmaceutical, nutraceutical, and medicinal ingredients (e.g., vitamins, such as B6, B12, and C, and/or cannabinoids, such as tetrahydrocannabinol (THC) and cannabidiol (CBD)). The particular percentages and choice of ingredients will vary depending upon the desired flavor, texture, and other characteristics. Example active ingredients would include any ingredient known to impact one or more biological functions within the body, such as ingredients that furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or which affect the structure or any function of the body of humans or other animals (e.g., provide a stimulating action on the central nervous system, have an energizing effect, an antipyretic or analgesic action, or an otherwise useful effect on the body).

In certain embodiments, a nicotine component may be included in the composition. By "nicotine component" is meant any suitable form of nicotine (e.g., free base or salt) for providing 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 a nicotine salt. In some embodiments, nicotine is in its free base form, which easily can be adsorbed in 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 <CIT>.

In some embodiments, at least a portion of the nicotine can be employed in the form of a salt. Salts of nicotine can be provided using the types of ingredients and techniques set forth in <CIT> and <NPL>). Additionally, salts of nicotine are available from sources such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc. Typically, the nicotine component is selected from the group consisting of nicotine free base, a nicotine salt such as hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride. In some embodiments, the nicotine component or a protion thereof is a nicotine salt with at least a portion of the one or more organic acids as disclosed herein above.

In some embodiments, at least a portion of the nicotine can be in the form of a resin complex of nicotine, where nicotine is bound in an ion-exchange resin, such as nicotine polacrilex, which is nicotine bound to, for example, a polymethacrilic acid, such as Amberlite IRP64, Purolite C115HMR, or Doshion P551. See, for example, <CIT>. Another example is a nicotine-polyacrylic carbomer complex, such as with Carbopol 974P. In some embodiments, nicotine may be present in the form of a nicotine polyacrylic complex.

Typically, the nicotine component (calculated as the free base) when present, is in a concentration of at least about <NUM>% by weight of the composition, such as in a range from about <NUM>% to about <NUM>%. In some embodiments, the nicotine component is present in a concentration from about <NUM>% w/w to about <NUM>% by weight, such as, e.g., from about from about <NUM>% w/w, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>% about <NUM>%, about <NUM>%, about <NUM>%, or about <NUM>%, to about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, about <NUM>%, or about <NUM>% by weight, calculated as the free base and based on the total weight of the composition. In some embodiments, the nicotine component is present in a concentration from about <NUM>% w/w to about <NUM>% by weight, such as, e.g., from about from about <NUM>% w/w to about <NUM>%, from about <NUM>% to about <NUM>%, from about <NUM>% to about <NUM>%, or from about <NUM>% to about <NUM>% by weight, calculated as the free base and based on the total weight of the composition. These ranges can also apply to other active ingredients noted herein.

In some embodiments, the composition may include a tobacco material. The tobacco material can vary in species, type, and form. Generally, the tobacco material is obtained from for a harvested plant of the Nicotiana species. Example Nicotiana species include N. tabacum, N. rustica, N. arentsii, N. excelsior, N. forgetiana, N. glutinosa, N. kawakamii, N. knightiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata, N. x 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. 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 representative other types of plants from the Nicotiana species are set forth in <NPL>); <CIT>; <CIT>, <CIT>; <CIT>and <CIT>. Descriptions of various types of tobaccos, growing practices and harvesting practices are set forth in <NPL>).

Nicotiana species from which suitable tobacco materials can be obtained can be derived using genetic-modification or crossbreeding techniques (e.g., tobacco plants can be genetically engineered or crossbred to increase or decrease production of components, characteristics or attributes). See, for example, the types of genetic modifications of plants set forth in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT> and <CIT>; <CIT>; and <CIT> See, also, the types of tobaccos that are set forth in <CIT>; <CIT>; and <CIT>.

The Nicotiana species can, in some embodiments, be selected for the content of various compounds that are present therein. For example, plants can be selected on the basis that those plants produce relatively high quantities of one or more of the compounds desired to be isolated therefrom. In certain embodiments, plants of the Nicotiana species (e.g., Galpao commun tobacco) are specifically grown for their abundance of leaf surface compounds. Tobacco plants can be grown in greenhouses, growth chambers, or outdoors in fields, or grown hydroponically.

Various parts or portions of the plant of the Nicotiana species can be included within a composition as disclosed herein. For example, virtually all of the plant (e.g., the whole plant) can be harvested, and employed as such. Alternatively, various parts or pieces of the plant can be harvested or separated for further use after harvest. For example, the flower, leaves, stem, stalk, roots, seeds, and various combinations thereof, can be isolated for further use or treatment. In some embodiments, the tobacco material comprises tobacco leaf (lamina). The composition disclosed herein can include processed tobacco parts or pieces, cured and aged tobacco in essentially natural lamina and/or stem form, a tobacco extract, extracted tobacco pulp (e.g., using water as a solvent), or a mixture of the foregoing (e.g., a mixture that combines extracted tobacco pulp with granulated cured and aged natural tobacco lamina).

In certain embodiments, the tobacco material comprises solid tobacco material selected from the group consisting of lamina and stems. The tobacco that is used for the composition most preferably includes tobacco lamina, or a tobacco lamina and stem mixture (of which at least a portion is smoke-treated). Portions of the tobaccos within the composition may have processed forms, such as processed tobacco stems (e.g., cut-rolled stems, cut-rolled-expanded stems or cut-puffed stems), or volume expanded tobacco (e.g., puffed tobacco, such as dry ice expanded tobacco (DIET)). See, for example, the tobacco expansion processes set forth in <CIT>; <CIT>; and <CIT>; and <CIT> In addition, the d composition optionally may incorporate tobacco that has been fermented. See, also, the types of tobacco processing techniques set forth in <CIT>.

The tobacco material is typically used in a form that can be described as particulate (i.e., shredded, ground, granulated, or powder form). The manner by which the tobacco material is provided in a finely divided or powder type of form may vary. Preferably, plant parts or pieces are comminuted, ground or pulverized into a particulate form using equipment and techniques for grinding, milling, or the like. Most preferably, the plant material is relatively dry in form during grinding or milling, using equipment such as hammer mills, cutter heads, air control mills, or the like. For example, tobacco parts or pieces may be ground or milled when the moisture content thereof is less than about <NUM> weight percent or less than about <NUM> weight percent. Most preferably, the tobacco material is employed in the form of parts or pieces that have an average particle size between <NUM> millimeters and <NUM> microns. In some instances, the tobacco particles may be sized to pass through a screen mesh to obtain the particle size range required. If desired, air classification equipment may be used to ensure that small sized tobacco particles of the desired sizes, or range of sizes, may be collected. If desired, differently sized pieces of granulated tobacco may be mixed together.

The manner by which the tobacco is provided in a finely divided or powder type of form may vary. Preferably, tobacco parts or pieces are comminuted, ground or pulverized into a powder type of form using equipment and techniques for grinding, milling, or the like. Most preferably, the tobacco is relatively dry in form during grinding or milling, using equipment such as hammer mills, cutter heads, air control mills, or the like. For example, tobacco parts or pieces may be ground or milled when the moisture content thereof is less than about <NUM> weight percent to less than about <NUM> weight percent. For example, the tobacco plant or portion thereof can be separated into individual parts or pieces (e.g., the leaves can be removed from the stems, and/or the stems and leaves can be removed from the stalk). The harvested plant or individual parts or pieces can be further subdivided into parts or pieces (e.g., the leaves can be shredded, cut, comminuted, pulverized, milled or ground into pieces or parts that can be characterized as filler-type pieces, granules, particulates or fine powders). The plant, or parts thereof, can be subjected to external forces or pressure (e.g., by being pressed or subjected to roll treatment). When carrying out such processing conditions, the plant or portion thereof can have a moisture content that approximates its natural moisture content (e.g., its moisture content immediately upon harvest), a moisture content achieved by adding moisture to the plant or portion thereof, or a moisture content that results from the drying of the plant or portion thereof. For example, powdered, pulverized, ground or milled pieces of plants or portions thereof can have moisture contents of less than about <NUM> weight percent, often less than about <NUM> weight percent, and frequently less than about <NUM> weight percent.

For the preparation of oral products, it is typical for a harvested plant of the Nicotiana species to be subjected to a curing process. The tobacco materials incorporated within the composition for inclusion within products as disclosed herein are those that have been appropriately cured and/or aged. Descriptions of various types of curing processes for various types of tobaccos are set forth in <NPL>). Examples of techniques and conditions for curing flue-cured tobacco are set forth in <NPL>) and <CIT>. Representative techniques and conditions for air curing tobacco are set forth in <CIT>; <NPL>) and <NPL>). Certain types of tobaccos can be subjected to alternative types of curing processes, such as fire curing or sun curing.

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

The tobacco material may also have a so-called "blended" form. For example, the tobacco material may include a mixture of parts or pieces of flue-cured, burley (e.g., Malawi burley tobacco) and Oriental tobaccos (e.g., as tobacco composed of, or derived from, tobacco lamina, or a mixture of tobacco lamina and tobacco stem). For example, a representative blend may incorporate about <NUM> to about <NUM> parts burley tobacco (e.g., lamina, or lamina and stem), and about <NUM> to about <NUM> parts flue cured tobacco (e.g., stem, lamina, or lamina and stem) on a dry weight basis. Other example tobacco blends incorporate about <NUM> parts flue-cured tobacco, about <NUM> parts burley tobacco, and about <NUM> parts Oriental tobacco; or about <NUM> parts flue-cured tobacco, about <NUM> parts burley tobacco, and about <NUM> parts Oriental tobacco; or about <NUM> parts flue-cured tobacco, about <NUM> parts burley tobacco, and about <NUM> parts Oriental tobacco; on a dry weight basis. Other example tobacco blends incorporate about <NUM> to about <NUM> parts Oriental tobacco and about <NUM> to about <NUM> parts flue-cured tobacco on a dry weight basis.

Tobacco materials used in the present disclosure can be subjected to, for example, fermentation, bleaching, and the like. If desired, the tobacco materials can be, for example, irradiated, pasteurized, or otherwise subjected to controlled heat treatment. Such treatment processes are detailed, for example, in <CIT> In certain embodiments, tobacco materials can be treated with water and an additive capable of inhibiting reaction of asparagine to form acrylamide upon heating of the tobacco material (e.g., an additive selected from the group consisting of lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, compositions incorporating di- and trivalent cations, asparaginase, certain non-reducing saccharides, certain reducing agents, phenolic compounds, certain compounds having at least one free thiol group or functionality, oxidizing agents, oxidation catalysts, natural plant extracts (e.g., rosemary extract), and combinations thereof. See, for example, the types of treatment processes described in <CIT>, <CIT>, and <CIT>. In certain embodiments, this type of treatment is useful where the original tobacco material is subjected to heat in the processes previously described.

In some embodiments, the type of tobacco material is selected such that it is initially visually lighter in color than other tobacco materials to some degree (e.g., whitened or bleached). Tobacco pulp can be whitened in certain embodiments according to any means known in the art. For example, bleached tobacco material produced by various whitening methods using various bleaching or oxidizing agents and oxidation catalysts can be used. Example oxidizing agents include peroxides (e.g., hydrogen peroxide), chlorite salts, chlorate salts, perchlorate salts, hypochlorite salts, ozone, ammonia, potassium permanganate, and combinations thereof. Example oxidation catalysts are titanium dioxide, manganese dioxide, and combinations thereof. Processes for treating tobacco with bleaching agents are discussed, for example, in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>, <CIT>, and <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; as well as in <CIT>; <CIT>; <CIT>; and <CIT>, and in <CIT>and <CIT>.

In some embodiments, the whitened tobacco material can have an ISO brightness of at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, at least about <NUM>%, or at least about <NUM>%. In some embodiments, the whitened tobacco material can have an ISO brightness in the range of about <NUM>% to about <NUM>%, about <NUM>% to about <NUM>%, or about <NUM>% to about <NUM>%. ISO brightness can be measured according to ISO <NUM>:<NUM> or ISO <NUM>-<NUM>:<NUM>.

In some embodiments, the whitened tobacco material can be characterized as lightened in color (e.g., "whitened") in comparison to an untreated tobacco material. White colors are often defined with reference to the International Commission on Illumination's (CIE's) chromaticity diagram. The whitened tobacco material can, in certain embodiments, be characterized as closer on the chromaticity diagram to pure white than an untreated tobacco material.

In various embodiments, the tobacco material can be treated to extract a soluble component of the tobacco material therefrom. "Tobacco extract" as used herein refers to the isolated components of a tobacco material that are extracted from solid tobacco pulp by a solvent that is brought into contact with the tobacco material in an extraction process. Various extraction techniques of tobacco materials can be used to provide a tobacco extract and tobacco solid material. See, for example, the extraction processes described in <CIT> Other example techniques for extracting components of tobacco are described in <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

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, with an example range of up to about <NUM>% by weight (or up to about <NUM>% by weight or up to about <NUM>% by weight or up to about <NUM>% by weight), based on total weight of the composition (e.g., about <NUM> to about <NUM>% by weight). In some embodiments, the products of the disclosure can be characterized as completely free or substantially free of tobacco material (other than purified nicotine as an active ingredient). For example, certain embodiments can be characterized as having less than <NUM>% by weight, or less than <NUM>% by weight, or less than <NUM>% by weight of tobacco material, or <NUM>% by weight of tobacco material. The composition according to the invention comprises less than <NUM>% by weight tobacco material, excluding any nicotine component present, based on the total weight of the composition.

Other additives can be included in the disclosed composition. For example, the composition can be processed, blended, formulated, combined and/or mixed with other materials or ingredients. The additives can be artificial, or can be obtained or derived from herbal or biological sources. Examples of further types of additives include thickening or gelling agents (e.g., fish gelatin), emulsifiers, oral care additives (e.g., thyme oil, eucalyptus oil, and zinc), preservatives (e.g., potassium sorbate and the like), disintegration aids, or combinations thereof. See, for example, those representative components, combination of components, relative amounts of those components, and manners and methods for employing those components, set forth in <CIT>, <CIT>, <CIT>, and <CIT>. Typical inclusion ranges for such additional additives can vary depending on the nature and function of the additive and the intended effect on the final composition, with an example range of up to about <NUM>% by weight, based on total weight of the composition (e.g., about <NUM> to about <NUM>% by weight or about <NUM>% to about <NUM>%).

The aforementioned additives can be employed together (e.g., as additive formulations) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final composition). Furthermore, the aforementioned types of additives may be encapsulated as provided in the final product or composition. Exemplary encapsulated additives are described, for example, in <CIT>.

In some embodiments, any one or more of a filler, a tobacco material, and the overall oral product described herein can be described as a particulate material. As used herein, the term "particulate" refers to a material in the form of a plurality of individual particles, some of which can be in the form of an agglomerate of multiple particles, wherein the particles have an average length to width ratio less than <NUM>:<NUM>, such as less than <NUM>:<NUM>, such as about <NUM>:<NUM>. In various embodiments, the particles of a particulate material can be described as substantially spherical or granular.

The particle size of a particulate material may be measured by sieve analysis. As the skilled person will readily appreciate, sieve analysis (otherwise known as a gradation test) is a method used to measure the particle size distribution of a particulate material. Typically, sieve analysis involves a nested column of sieves which comprise screens, preferably in the form of wire mesh cloths. A pre-weighed sample may be introduced into the top or uppermost sieve in the column, which has the largest screen openings or mesh size (i.e. the largest pore diameter of the sieve). Each lower sieve in the column has progressively smaller screen openings or mesh sizes than the sieve above. Typically, at the base of the column of sieves is a receiver portion to collect any particles having a particle size smaller than the screen opening size or mesh size of the bottom or lowermost sieve in the column (which has the smallest screen opening or mesh size).

In some embodiments, the column of sieves may be placed on or in a mechanical agitator. The agitator causes the vibration of each of the sieves in the column. The mechanical agitator may be activated for a pre-determined period of time in order to ensure that all particles are collected in the correct sieve. In some embodiments, the column of sieves is agitated for a period of time from <NUM> minutes to <NUM> minutes, such as from <NUM> minute to <NUM> minutes, such as from <NUM> minute to <NUM> minutes, such as for approximately <NUM> minutes. Once the agitation of the sieves in the column is complete, the material collected on each sieve is weighed. The weight of each sample on each sieve may then be divided by the total weight in order to obtain a percentage of the mass retained on each sieve. As the skilled person will readily appreciate, the screen opening sizes or mesh sizes for each sieve in the column used for sieve analysis may be selected based on the granularity or known maximum/minimum particle sizes of the sample to be analysed. In some embodiments, a column of sieves may be used for sieve analysis, wherein the column comprises from <NUM> to <NUM> sieves, such as from <NUM> to <NUM> sieves. In some embodiments, a column of sieves may be used for sieve analysis, wherein the column comprises <NUM> sieves. In some embodiments, the largest screen opening or mesh sizes of the sieves used for sieve analysis may be <NUM>, such as <NUM>, such as <NUM>, such as <NUM>.

In some embodiments, any particulate material referenced herein (e.g., filler component, tobacco material, and the overall oral product) can be characterized as having at least <NUM>% by weight of particles with a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>. In some embodiments, at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>. In some embodiments, at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>. In some embodiments, at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>. In some embodiments, at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>. In some embodiments, at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>. In some embodiments, at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>. In some embodiments, approximately <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>, such as no greater than about <NUM>.

In some embodiments, at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>. In some embodiments, at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight, such as at least <NUM>% by weight of the particles of any particulate material referenced herein have a particle size as measured by sieve analysis of from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>, such as from about <NUM> to about <NUM>.

The manner by which the various components of the composition are combined may vary. According to the method of the present invention, various combinations of dry ingredients, including the filler component, will be blended to form a dry mix. Thereafter, typically in multiple steps, the remaining liquid ingredients are added to the dry mix to prepare the final product mixture. In certain embodiments, the active ingredient (e.g., nicotine) is mixed with a humectant (e.g., propylene glycol or olive oil) to form a premix before adding to the remainder of the composition, such as the dry mix containing a filler. The use of a mixture of certain active ingredients, such as nicotine, with a humectant can reduce mouth or throat irritation associated with oral use of the resulting product. If one or more capsules are included in the composition, the capsules can be added at various stages, such as addition to the dry mix or addition to the product composition immediately before final packaging (e.g., pouching) or after placement of the composition in a pouch (but before pouch sealing).

In certain embodiments, mixing efficiency and/or uniformity of the product can be enhanced by using multiple, successive addition steps in the process to add liquid components (e.g., aqueous solutions or dispersions) to the dry mix. By separating the liquid components into multiple addition steps, smaller amounts of each liquid composition are intimately mixed with the dry ingredients, which can result in improved mixing characteristics. Improved mixing efficiency and/or product uniformity can also be provided, in certain embodiments, through use of aqueous compositions at elevated temperature, such as between about <NUM> to about <NUM>, including about <NUM> to about <NUM> or about <NUM> to about <NUM>.

In some embodiments, aqueous compositions used in the process are maintained at room temperature or below, such as between about <NUM> to about <NUM>, including about <NUM> to about <NUM> (room temperature). Surprisingly, in certain embodiments, use of lower aqueous composition temperatures during mixing does not cause significant loss in product uniformity or mixing efficiency, and can reduce overall process cost, particularly where room temperature water is used.

According to the method of the present invention, a large percentage, at least <NUM>% by weight content, of the total amount of water used in the product is added in a final water addition step, after active ingredients and/or flavoring agents are added. This type of process is particularly well-suited for use with lower temperature water as noted above. Surprisingly, applying a large percentage of the total amount of water after addition of all, or virtually all, other ingredients does not cause significant loss in product uniformity or mixing efficiency, and can provide the added benefit of removing residual active ingredient and/or flavoring agent from the pipes in the mixing system without the need for a separate rinsing step that could lead to an undesirable increase in water use or loss in process efficiency. In certain embodiments, the amount of water added in the final water addition step is at least about <NUM>% or at least about <NUM>% or at least about <NUM>% or at least about <NUM>% or at least about <NUM>% or at least about <NUM>% or at least about <NUM>%.

The various components of the composition may be contacted, combined, or mixed together using any mixing technique or equipment known in the art. Any mixing method that brings the mixture ingredients into intimate contact can be used, such as a mixing apparatus featuring an impeller or other structure capable of agitation. Examples of mixing equipment include casing drums, conditioning cylinders or drums, liquid spray apparatus, conical-type blenders, ribbon blenders, mixers available as FKM130, FKM600, FKM1200, FKM2000 and FKM3000 from Littleford Day, Inc. , Plough Share types of mixer cylinders, Hobart mixers, and the like. See, for example, the types of methodologies set forth in <CIT>; <CIT>; and <CIT>, <CIT>, and <CIT>.

Certain active ingredients, such as nicotine, present safety and handling challenges. Accordingly, the present disclosure includes a dosing system that reduces the time spent handling active ingredients. An embodiment of the dosing system <NUM> is shown in <FIG>. As shown, the system includes a storage tank <NUM> for the active ingredient, the storage tank in fluid communication with a dosing tank <NUM>. In certain embodiments, the storage tank <NUM> can also be in fluid communication with an inert gas container <NUM> containing an inert gas such as nitrogen, which enables the creation of an inert gas blanket <NUM> in the headspace over the active ingredient stored in the storage tank <NUM>.

A pump <NUM> is used to transport the liquid active ingredient from the storage tank <NUM> to the dosing tank <NUM>. One or more additional storage tanks are advantageously in fluid communication with the dosing tank <NUM>, such as a storage tank <NUM> for a flavoring agent and a storage tank <NUM> for a humectant. In this manner, additional components of a composition can be premixed with the active ingredient in the dosing tank <NUM>. From the dosing tank <NUM>, the active ingredient (optionally premixed with additional components) can be transported to one or more mixing tanks <NUM>, which contain additional components of the desired composition, such as a dry mix as described above.

Provided herein is a product configured for oral use. The term "configured for oral use" as used herein means that the product is provided in a form such that during use, saliva in the mouth of the user causes one or more of the components of the composition (e.g., flavoring agents and/or nicotine) to pass into the mouth of the user. In certain embodiments, the product is adapted to deliver components to a user through mucous membranes in the user's mouth and, in some instances, said component is an active ingredient (including, but not limited to, for example, nicotine) that can be absorbed through the mucous membranes in the mouth when the product is used.

Products configured for oral use as described herein may take various forms, including gels, pastilles, gums, lozenges, powders, and pouches. Gels can be soft or hard. Certain products configured for oral use are in the form of pastilles. As used herein, the term "pastille" refers to a dissolvable oral product made by solidifying a liquid or gel composition so that the final product is a somewhat hardened solid gel. The rigidity of the gel is highly variable. Certain products of the disclosure are in the form of solids. Certain products can exhibit, for example, one or more of the following characteristics: crispy, granular, chewy, syrupy, pasty, fluffy, smooth, and/or creamy. In certain embodiments, the desired textural property can be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, fracturability, graininess, gumminess, hardness, heaviness, moisture absorption, moisture release, mouthcoating, roughness, slipperiness, smoothness, viscosity, wetness, and combinations thereof.

The products comprising the compositions of the present disclosure may be dissolvable. As used herein, the terms "dissolve," "dissolving," and "dissolvable" refer to compositions having aqueous-soluble components that interact with moisture in the oral cavity and enter into solution, thereby causing gradual consumption of the product. According to one aspect, the dissolvable product is capable of lasting in the user's mouth for a given period of time until it completely dissolves. Dissolution rates can vary over a wide range, from about <NUM> minute or less to about <NUM> minutes. For example, fast release compositions typically dissolve and/or release the active substance in about <NUM> minutes or less, often about <NUM> minute or less (e.g., about <NUM> seconds or less, about <NUM> seconds or less, about <NUM> seconds or less, or about <NUM> seconds or less). Dissolution can occur by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical degradation, or by disruption of the interaction between the components of the composition. In some embodiments, the product can be meltable as discussed, for example, in <CIT> In other embodiments, the products do not dissolve during the product's residence in the user's mouth.

In one embodiment, the 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 compositions in the water-permeable pouch format are typically used by placing one pouch containing the composition in the mouth of a human subject/user. Generally, the pouch is placed somewhere in the oral cavity of the user, for example under the lips, in the same way as moist snuff products are generally used. The pouch preferably is not chewed or swallowed. Exposure to saliva then causes some of the components of the composition therein (e.g., flavoring agents and/or nicotine) to pass through e.g., the water-permeable pouch and provide the user with flavor and satisfaction, and the user is not required to spit out any portion of the composition. After about <NUM> minutes to about <NUM> minutes, typically about <NUM> minutes to about <NUM> minutes, of use/enjoyment, substantial amounts of the composition have been absorbed (via either gingival or buccal absorption) by the human subject, and the pouch may be removed from the mouth of the human subject for disposal.

Accordingly, in certain embodiments, the composition as disclosed herein and any other components noted above are combined within a moisture-permeable packet or pouch that acts as a container for use of the composition to provide a pouched product configured for oral use. Certain embodiments of the disclosure will be described with reference to <FIG> of the accompanying drawings, and these described embodiments involve snus-type products having an outer pouch and containing a composition as described herein. As explained in greater detail below, such embodiments are provided by way of example only, and the pouched products of the present disclosure can include the composition in other forms.

The composition/construction of such packets or pouches, such as the container pouch <NUM> in the embodiment illustrated in <FIG>, may be varied. Referring to <FIG>, there is shown a first embodiment of a pouched product <NUM>. The pouched product <NUM> includes a moisture-permeable container in the form of a pouch <NUM>, which contains a composition <NUM> as described herein. The pouched product <NUM> optionally includes one or more capsules <NUM> dispersed within the composition <NUM>, the capsules containing an additive (e.g., a flavoring agent) such as described in greater detail below.

Suitable packets, pouches or containers of the type used for the manufacture of smokeless tobacco products are available under the tradenames 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 in pouches and packaged, in a manner and using the types of components used for the manufacture of conventional snus types of products. The pouch provides a liquid-permeable container of a type that may be considered to be similar in character to the mesh-like type of material that is used for the construction of a tea bag. Components of the composition readily diffuse through the pouch and into the mouth of the user.

Non-limiting examples of suitable types of pouches are set forth in, for example, <CIT>and <CIT>; as well as <CIT>; <CIT>; <CIT>; and <CIT>. Pouches can be provided as individual pouches, or a plurality of pouches (e.g., <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM> pouches) can be connected or linked together (e.g., in an end-to-end manner) such that a single pouch or individual portion can be readily removed for use from a one-piece strand or matrix of pouches.

An example pouch may be manufactured from materials, and in such a manner, such that during use by the user, the pouch undergoes a controlled dispersion or dissolution. Such pouch materials may have the form of a mesh, screen, perforated paper, permeable fabric, or the like. For example, pouch material manufactured from a mesh-like form of rice paper, or perforated rice paper, may dissolve in the mouth of the user. As a result, the pouch and composition each may undergo complete dispersion within the mouth of the user during normal conditions of use, and hence the pouch and composition both may be ingested or absorbed by the user. Other examples of pouch materials may be manufactured using water dispersible film forming materials (e.g., binding agents such as alginates, carboxymethylcellulose, xanthan gum, pullulan, and the like), as well as those materials in combination with materials such as ground cellulosics (e.g., fine particle size wood pulp). Preferred pouch materials, though water dispersible or dissolvable, may be designed and manufactured such that under conditions of normal use, a significant amount of the composition contents permeate through the pouch material prior to the time that the pouch undergoes loss of its physical integrity. If desired, flavoring ingredients, disintegration aids, and other desired components, may be incorporated within, or applied to, the pouch material.

The amount of material contained within each product unit, for example, a pouch, may vary. In some embodiments, the weight of the composition within each pouch is at least about <NUM>, for example, from about <NUM> to about <NUM> gram, from about <NUM> to <NUM> about mg, or from about <NUM> to about <NUM>. In some smaller embodiments, the weight of the composition within each pouch may be from about <NUM> to about <NUM>. For a larger embodiment, the weight of the material within each pouch may be from about <NUM> to about <NUM>.

If desired, other components can be contained within each pouch. For example, at least one flavored strip, piece or sheet of flavored water dispersible or water soluble material (e.g., a breath-freshening edible film type of material) may be disposed within each pouch along with or without at least one capsule. Such strips or sheets may be folded or crumpled in order to be readily incorporated within the pouch. See, for example, the types of materials and technologies set forth in <CIT> and <CIT>; and <NPL>.

As noted above, in some embodiments, any of the types of composition components described above can be added in an encapsulated form (e.g., in the form of capsules including microcapsules), the encapsulated form including a wall or barrier structure defining an inner region and isolating the inner region permanently or temporarily from the remainder of the product composition. The inner region includes a payload of an additive either adapted for enhancing one or more sensory characteristics of the product, such as taste, mouthfeel, moistness, coolness/heat, and/or fragrance, or adapted for adding an additional functional quality to the product, such as addition of an antioxidant or immune system enhancing function. See, for example, the subject matter of <CIT>.

The use of a capsule physically separates or segregates, to a certain extent, an additive from one or more other components of the product. The functional advantage of such a separation can vary, but typically involves the minimization or elimination of chemical interaction between the additive and other components of the product during conditions of normal storage and/or use. Separation of certain additives can thus enhance storage stability of the resulting product and/or preserve the desirable sensory characteristics of the product.

The outer shell of the capsule serves as a barrier between the payload (i.e., the additive) and the remainder of the composition of the product. The additive in the core region of the capsule is released under certain conditions of product use. For instance, the outer shell may undergo some type of physical destruction, breakage, or other loss of physical integrity (e.g., through disintegration, softening, crushing, application of pressure, or the like) in response to a trigger condition associated with the product. Such a release of the additive may alter or enhance the flavor or other sensory characteristics of the product, extend the period of time that a user may enjoy the product, or provide other functional advantages. The trigger conditions associated with release of the additive may vary, and can include for example, a change in temperature or pH of the product, contact with a digestive enzyme, or physical rupture or breakage caused, for example, by chewing action of the product user.

In some embodiments, contact of the capsule with the raised temperature of the user's mouth (e.g., the user's saliva) may cause the capsule to soften, lose its physical integrity, and release the additive within the user's mouth (e.g., at a temperature of about <NUM> or higher). In some embodiments, the capsule is configured to release the additive in response to a change in pH, such as a capsule configured to release the additive when the pH of the capsule is at or near (e.g., greater than) a pH typical of a user's mouth (e.g., approximately <NUM> to <NUM>). Still further, in certain embodiments, the capsule is configured to release the additive in response to a digestive enzyme typically found in the mouth of a user (e.g., amylase).

The capsules may be uniform or varied in size, weight, and shape, and such properties of the capsules will depend upon the desired properties of the product. The capsules may be of various shape, including being generally spherical, rectilinear, oblong, elliptical, or oval. The size of the capsules can vary, and will include diameter ranges such as about <NUM> to about <NUM>, as well as microcapsule size ranges such as diameters of less than about <NUM> microns, such as diameters in the range of about <NUM> to about <NUM> microns, or about <NUM> micron to about <NUM> microns. The total weight of the capsules within the product may vary, but is typically between about <NUM> to about <NUM>, such as about <NUM> to about <NUM>.

The number of the capsules utilized in each product can vary, depending upon factors such as the size of the capsules, the character or nature of the additive in the payload, the desired attributes of the product, and the like. The number of capsules will typically range from <NUM> to about <NUM>, more typically about <NUM> to about <NUM>.

The outer wall or shell material used to form the capsules can vary. Classes of materials that are typically used as wall or shell materials include proteins, polysaccharides, starches, waxes, fats, natural and synthetic polymers, and resins. Example materials include gelatin, natural gums, polyvinyl acetate, potassium or sodium alginate, carrageenan, dextrin, polyvinyl alcohol, povidone, dimethylpolysiloxane, paraffin wax, shellac, cellulose derivatives (e.g., ethylcellulose, carboxymethylcellulose, hydroxypropyl cellulose, hydroxypropylmethylcellulose, methylcellulose, methyl ethyl cellulose), microcrystalline wax, terpene resin, tragacanth, polyethylene, and polyethylene glycol.

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

A pouched product as described herein can be packaged within any suitable inner packaging material and/or outer container. See also, for example, the various types of containers for smokeless types of products that are set forth in <CIT>; <CIT>; <CIT>; <CIT>,<CIT>;<CIT><CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; <CIT>; and <CIT>.

Many modifications and other embodiments of the invention will come to mind to one skilled in the art to which this invention pertains having the benefit of the teachings presented in the foregoing description. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed.

Aspects of the present invention are more fully illustrated by the following examples, which are set forth to illustrate certain aspects of the present invention and are not to be construed as limiting thereof.

An oral composition comprising the ingredients set forth in Table <NUM> below is prepared. The actual ingredient percentages can be varied depending the desired final product.

The composition is prepared using the following reference method:.

An oral composition comprising the ingredients set forth in Example <NUM> is prepared using the following method:.

Pouched product samples were made containing the same amounts of microcrystalline cellulose, sodium chloride, alginate, and acesulfame K. Three sets of samples were prepared using this same base formulation, including: (<NUM>) pouches with <NUM> nicotine and <NUM> propylene glycol (PG) added; (<NUM>) pouches with <NUM> nicotine and <NUM> olive oil added; and (<NUM>) pouches with <NUM> nicotine only added (no propylene glycol or olive oil).

Claim 1:
A method of preparing an oral product, comprising:
combining a filler and a salt to form a dry mix, the dry mix optionally further including one or more of an alginate, a bleached tobacco, a sweetener, a carbonate salt, and a 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 either before, after, or simultaneously with the flavoring agent;
thereafter, applying water to the mixture to form a second mixture, wherein at least <NUM>% by weight of the water content of the second mixture is added after adding the active ingredient; and
encasing the second mixture within a pouch.