Classifications

• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/18—Treatment of tobacco products or tobacco substitutes
  • A24B15/186—Treatment of tobacco products or tobacco substitutes by coating with a coating composition, encapsulation of tobacco particles
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B13/00—Tobacco for pipes, for cigars, e.g. cigar inserts, or for cigarettes; Chewing tobacco; Snuff
  • A24B13/02—Flakes or shreds of tobacco
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/10—Chemical features of tobacco products or tobacco substitutes
  • A24B15/16—Chemical features of tobacco products or tobacco substitutes of tobacco substitutes
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/18—Treatment of tobacco products or tobacco substitutes
  • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
  • A24B15/281—Treatment of tobacco products or tobacco substitutes by chemical substances the action of the chemical substances being delayed
  • A24B15/283—Treatment of tobacco products or tobacco substitutes by chemical substances the action of the chemical substances being delayed by encapsulation of the chemical substances
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/18—Treatment of tobacco products or tobacco substitutes
  • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
  • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/18—Treatment of tobacco products or tobacco substitutes
  • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
  • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
  • A24B15/302—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances by natural substances obtained from animals or plants
  • A24B15/303—Plant extracts other than tobacco
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/18—Treatment of tobacco products or tobacco substitutes
  • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
  • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
  • A24B15/305—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances of undetermined constitution characterised by their preparation
• • A—HUMAN NECESSITIES
  • A24—TOBACCO; CIGARS; CIGARETTES; SIMULATED SMOKING DEVICES; SMOKERS' REQUISITES
  • A24B—MANUFACTURE OR PREPARATION OF TOBACCO FOR SMOKING OR CHEWING; TOBACCO; SNUFF
  • A24B15/00—Chemical features or treatment of tobacco; Tobacco substitutes, e.g. in liquid form
  • A24B15/18—Treatment of tobacco products or tobacco substitutes
  • A24B15/28—Treatment of tobacco products or tobacco substitutes by chemical substances
  • A24B15/30—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances
  • A24B15/308—Treatment of tobacco products or tobacco substitutes by chemical substances by organic substances vitamins

Definitions

• the present disclosure relates to products intended for human consumption.
• the products are configured for oral use and deliver substances such as flavors and/or active ingredients during use.
• Such products may include tobacco or a component derived from tobacco, or may be tobacco-free alternatives.
• Tobacco may be enjoyed in a so-called "smokeless” form.
• 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.
• 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 US Patent App. Pub. 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.
• 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.
• 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).
• 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.
• 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.
• the fillers are porous particulate materials and are cellulose-based.
• suitable particulate fillers are any non-tobacco plant material or derivative thereof, including cellulose materials derived from such sources.
• 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.
• starch major sources include cereal grains (e.g., rice, wheat, and maize) and root vegetables (e.g., potatoes and cassava).
• 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.
• modified 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.
• 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.
• modified starches are modified by heat treatments, such as pregelatinization, 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.
• 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-100, PH-102, PH-103, PH-105, PH-112, PH-113, PH-200, PH-300, PH-302, VIVACEL ® grades 101, 102, 12, 20 and EMOCEL ® grades 50M and 90M, and the like, and mixtures thereof.
• 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 75 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 about 10 to about 75 percent by total weight of the composition, for example, from about 10, about 15, about 20, about 25, or about 30, to about 35, about 40, about 45, or about 50 weight percent (e.g., about 20 to about 50 weight percent or about 25 to about 45 weight percent).
• the amount of particulate filler material is at least about 10 percent by weight, such as at least about 20 percent, or at least about 25 percent, or at least about 30 percent, or at least about 35 percent, or at least about 40 percent, based on the total weight of the composition.
• the particulate filler further comprises a cellulose derivative or a combination of such derivatives.
• the composition comprises from about 1 to about 10% of the cellulose derivative by weight, based on the total weight of the composition, with certain embodiments comprising about 1 to about 5% by weight of cellulose derivative.
• 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”).
• the cellulose derivative is one or more of methylcellulose, HPC, HPMC, hydroxyethyl cellulose, and CMC.
• the cellulose derivative is HPC.
• the composition comprises from about 1 to about 3% 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.
• the composition, as present within the product prior to insertion into the mouth of the user is less than about 60 percent by weight of water, and generally is from about 1 to about 60% by weight of water, for example, from about 5 to about 55, about 10 to about 50, about 20 to about 45, or about 25 to about 40 percent water by weight, including water amounts 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.
• organic acid refers to an organic (i.e., carbon-based) compound that is characterized by acidic properties.
• organic acids are relatively weak acids (i.e., they do not dissociate completely in the presence of water), such as carboxylic acids (-CO 2 H) or sulfonic acids (-SO 2 OH).
• reference to organic acid means an organic acid that is intentionally added.
• 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).
• 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.
• the organic acid is an alkyl carboxylic acid.
• 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.
• the organic acid is an alkyl sulfonic acid.
• alkyl sulfonic acids include propanesulfonic acid and octanesulfonic acid.
• 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.
• 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.
• suitable salts e.g., for nicotine, include formate, acetate, propionate, isobutyrate, butyrate, alpha-methylbutyate, isovalerate, beta-methylvalerate, caproate, 2-furoate, phenylacetate, heptanoate, octanoate, nonanoate, oxalate, malonate, glycolate, benzoate, tartrate, levulinate, ascorbate, fumarate, citrate, malate, lactate, aspartate, salicylate, tosylate, succinate, pyruvate, and the like.
• 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.
• organic acids having more than one acidic group such as a di- or-tri-carboxylic acid
• 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.
• 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.
• 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 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 comprises 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 by weight, based on the total weight of the composition.
• the composition comprises 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.
• the composition comprises from about 0.25 to about 0.35% by weight of organic acid, for example, from about 0.25, about 0.26, about 0.27, about 0.28, about 0.29, or 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.
• 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 7.0 or below, (typically about 6.8 or below, about 6.6 or below, or about 6.5 or below) of the composition. In certain embodiments the acid inclusion 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.
• the organic acid is provided in a quantity sufficient to provide a pH of the composition 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.
• flavoring agent or “flavorant” is any flavorful or aromatic substance capable of altering the sensory characteristics associated with the oral product.
• 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.
• 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, Leffingwell et al., Tobacco Flavoring for Smoking Products, R. J. Reynolds Tobacco Company (1972 ), which is incorporated herein by reference. Flavorings also may include components that are considered moistening, cooling or smoothening agents, such as eucalyptus.
• 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 US Pat. No. 5,387,416 to White et al. ; US Pat. App. Pub. No. 2005/0244521 to Strickland et al. ; and PCT Application Pub. No. WO 05/041699 to Quinter et al. , each of which is incorporated herein by reference.
• 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.
• 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).
• a volatile flavor component has a molecular weight below about 400 Da, and often include at least one carbon-carbon double bond, carbon-oxygen double bond, or both.
• 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 1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenone-1-one.
• Non-limiting examples of esters include allyl hexanoate, ethyl heptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate.
• Non-limiting examples of terpenes include sabinene, limonene, gamma-terpinene, beta-farnesene, nerolidol, thujone, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol.
• the at least one volatile flavor component comprises one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, or citral.
• 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 10 weight percent, and certain embodiments are characterized by a flavoring agent content of at least about 0.1 weight percent, such as about 0.5 to about 10 weight percent, about 1 to about 6 weight percent, or about 2 to about 5 weight percent, based on the total weight of the composition.
• the composition may further comprise a salt (e.g., alkali metal salts), typically employed in an amount sufficient to provide desired sensory attributes to the composition.
• a salt e.g., alkali metal salts
• suitable salts include sodium chloride, potassium chloride, ammonium chloride, flour salt, and the like.
• a representative amount of salt is about 0.5 percent by weight or more, about 1.0 percent by weight or more, or at about 1.5 percent by weight or more, but will typically make up about 10 percent or less of the total weight of the composition, or about 7.5 percent or less or about 5 percent or less (e.g., about 0.5 to about 5 percent by weight).
• the composition typically 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.
• natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, and the like.
• artificial sweeteners include sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame and the like.
• 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 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates).
• a representative amount of sweetener may make up from about 0.1 to about 20 percent or more of the of the composition by weight, for example, from about 0.1 to about 1%, from about 1 to about 5%, from about 5 to about 10%, or from about 10 to about 20% of the composition on a weight basis, based on the total weight of the composition.
• a binder (or combination of 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, sodium alginate, 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 30 weight percent, and certain embodiments are characterized by a binder content of at least about 0.1% by weight, such as about 1 to about 30% by weight, or about 5 to about 10% by weight, based on the total weight of the composition.
• the binder includes a gum, for example, a natural gum.
• 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.
• natural gum binder materials are typically present in an amount of up to about 5% by weight, for example, from about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, 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.
• one or more humectants may be employed in the composition.
• humectants include, but are not limited to, glycerin, propylene glycol, and the like.
• 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.
• 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.
• a humectant When present, a humectant will typically make up about 5% or less of the weight of the composition (e.g., from about 0.5 to about 5% by weight). When present, a representative amount of humectant is about 0.1% to about 1% by weight, or about 1% to about 5% by weight, based on the total weight of the composition.
• the composition of the present disclosure can comprise pH adjusters or buffering agents.
• pH adjusters and buffering agents 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.
• the buffering agent is typically present in an amount less than about 5 percent based on the weight of the composition, for example, from about 0.5% to about 5%, such as, e.g., from about 0.75% to about 4%, from about 0.75% to about 3%, or about 0.5% to about 1.5%, or from about 1% to about 2% by weight, based on the total weight of the composition.
• 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.
• 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 3 weight percent, such as from about 0.1%, about 0.5%, or about 1%, to about 3% 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)).
• 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
• 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).
• a nicotine component may be included in the composition.
• 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.
• the nicotine component is selected from the group consisting of nicotine free base and a nicotine salt.
• 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 US Pat. Pub. No. 2004/0191322 to Hansson , which is incorporated herein by reference.
• 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 US Pat. No. 2,033,909 to Cox et al. and Perfetti, Beitrage Tabak Kauutz. Int., 12: 43-54 (1983 ), which are incorporated herein by reference. Additionally, salts of nicotine are available from sources such as Pfaltz and Bauer, Inc. and K&K Laboratories, Division of ICN Biochemicals, Inc.
• 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.
• 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.
• 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.
• an ion-exchange resin such as nicotine polacrilex
• a polymethacrilic acid such as Amberlite IRP64, Purolite C115HMR, or Doshion P551.
• a polymethacrilic acid such as Amberlite IRP64, Purolite C115HMR, or Doshion P551.
• a nicotine-polyacrylic carbomer complex such as with Carbopol 974P.
• nicotine may be present in the form of a nicotine polyacrylic complex.
• the nicotine component when present, is in a concentration of at least about 0.001% by weight of the composition, such as in a range from about 0.001% to about 10%.
• the nicotine component is present in a concentration from about 0.1% w/w to about 10% by weight, such as, e.g., from about from 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, calculated as the free base and based on the total weight of the composition.
• the nicotine component is present in a concentration from about 0.1% w/w to about 3% by weight, such as, e.g., from about from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, from about 0.1% to about 1.5%, or from about 0.1% to about 1% by weight, calculated as the free base and based on the total weight of the composition.
• concentration from about 0.1% w/w to about 3% by weight, such as, e.g., from about from about 0.1% w/w to about 2.5%, from about 0.1% to about 2.0%, from about 0.1% to about 1.5%, or from about 0.1% to about 1% by weight, calculated as the free base and based on the total weight of the composition.
• 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. alata, N. arentsii, N. excelsior, N. forgetiana, N. glauca, N. glutinosa, N. gossei, N. kawakamii, N. knightiana, N. langsdorffi, N. otophora, N. setchelli, N. sylvestris, N. tomentosa, N. tomentosiformis, N. undulata, N.
• 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 US Pat. Nos. 5,539,093 to Fitzmaurice et al. ; 5,668,295 to Wahab et al. ; 5,705,624 to Fitzmaurice et al. ; 5,844,119 to Weigl ; 6,730,832 to Dominguez et al. ; 7,173,170 to Liu et al. ; 7,208,659 to Colliver et al.
• 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 US Pat. Nos. 5,
• 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.
• plants of the Nicotiana species e.g., Galpao commun tobacco
• the plant of the Nicotiana species can be included within a composition as disclosed herein.
• virtually all of the plant e.g., the whole plant
• various parts or pieces of the plant can be harvested or separated for further use after harvest.
• the flower, leaves, stem, stalk, roots, seeds, and various combinations thereof, can be isolated for further use or treatment.
• the tobacco material comprises tobacco leaf (lamina).
• 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).
• 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)).
• DIET dry ice expanded tobacco
• the d composition optionally may incorporate tobacco that has been fermented. See, also, the types of tobacco processing techniques set forth in PCT WO2005/063060 to Atchley et al. , which is incorporated herein by reference.
• 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.
• plant parts or pieces are comminuted, ground or pulverized into a particulate form using equipment and techniques for grinding, milling, or the like.
• 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.
• tobacco parts or pieces may be ground or milled when the moisture content thereof is less than about 15 weight percent or less than about 5 weight percent.
• the tobacco material is employed in the form of parts or pieces that have an average particle size between 1.4 millimeters and 250 microns.
• the tobacco particles may be sized to pass through a screen mesh to obtain the particle size range required.
• air classification equipment may be used to ensure that small sized tobacco particles of the desired sizes, or range of sizes, may be collected.
• differently sized pieces of granulated tobacco may be mixed together.
• 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.
• 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.
• tobacco parts or pieces may be ground or milled when the moisture content thereof is less than about 15 weight percent to less than about 5 weight percent.
• 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).
• 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.
• powdered, pulverized, ground or milled pieces of plants or portions thereof can have moisture contents of less than about 25 weight percent, often less than about 20 weight percent, and frequently less than about 15 weight percent.
• 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 Tobacco Production, Chemistry and Technology, Davis et al. (Eds.) (1999 ). Examples of techniques and conditions for curing flue-cured tobacco are set forth in Nestor et al., Beitrage Tabakforsch. Int., 20, 467-475 (2003 ) and US Pat. No. 6,895,974 to Peele , which are incorporated herein by reference. Representative techniques and conditions for air curing tobacco are set forth in US Pat.
• 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.
• flue-cured or Virginia e.g., K326)
• burley sun-cured
• Indian Kurnool and Oriental tobaccos including Katerini, Prelip, Komotini, Xanthi and Yambol tobaccos
• Maryland dark, dark-fired, dark air cured (e.g., Madole, Passand
• the tobacco material may also have a so-called "blended" form.
• 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).
• a representative blend may incorporate about 30 to about 70 parts burley tobacco (e.g., lamina, or lamina and stem), and about 30 to about 70 parts flue cured tobacco (e.g., stem, lamina, or lamina and stem) on a dry weight basis.
• example tobacco blends incorporate about 75 parts flue-cured tobacco, about 15 parts burley tobacco, and about 10 parts Oriental tobacco; or about 65 parts flue-cured tobacco, about 25 parts burley tobacco, and about 10 parts Oriental tobacco; or about 65 parts flue-cured tobacco, about 10 parts burley tobacco, and about 25 parts Oriental tobacco; on a dry weight basis.
• Other example tobacco blends incorporate about 20 to about 30 parts Oriental tobacco and about 70 to about 80 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.
• the tobacco materials can be, for example, irradiated, pasteurized, or otherwise subjected to controlled heat treatment.
• controlled heat treatment processes are detailed, for example, in US Pat. No. 8,061,362 to Mua et al. , which is incorporated herein by reference.
• 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.
• 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
• 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.
• 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.
• 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%. ISO brightness can be measured according to ISO 3688:1999 or ISO 2470-1:2016.
• 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.
• CIE's International Commission on Illumination's
• the whitened tobacco material can, in certain embodiments, be characterized as closer on the chromaticity diagram to pure white than an untreated tobacco material.
• the tobacco material can be treated to extract a soluble component of the tobacco material therefrom.
• tobacco extract 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.
• 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 US Pat. Appl. Pub. No. 2011/0247640 to Beeson et al. , which is incorporated herein by reference.
• Other example techniques for extracting components of tobacco are described in US Pat. Nos. 4,144,895 to Fiore ; 4,150,677 to Osborne, Jr. et al.
• 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 30% by weight (or up to about 20% by weight or up to about 10% by weight or up to about 5% by weight), based on total weight of the composition (e.g., about 0.1 to about 15% by weight).
• 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).
• 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 material, or 0% by weight of tobacco material.
• additives can be included in the disclosed composition.
• 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.
• 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 US Pat. No.
• 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).
• aforementioned types of additives may be encapsulated as provided in the final product or composition. Exemplary encapsulated additives are described, for example, in WO2010/132444 to Atchley , which has been previously incorporated by reference herein.
• any one or more of a filler, a tobacco material, and the overall oral product described herein can be described as a particulate material.
• 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 2:1, such as less than 1.5:1, such as about 1:1.
• 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.
• sieve analysis is a method used to measure the particle size distribution of a particulate material.
• 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.
• 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).
• 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.
• the column of sieves is agitated for a period of time from 0.5 minutes to 10 minutes, such as from 1 minute to 10 minutes, such as from 1 minute to 5 minutes, such as for approximately 3 minutes.
• 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.
• a column of sieves may be used for sieve analysis, wherein the column comprises from 2 to 20 sieves, such as from 5 to 15 sieves.
• a column of sieves may be used for sieve analysis, wherein the column comprises 10 sieves.
• the largest screen opening or mesh sizes of the sieves used for sieve analysis may be 1000 ⁇ m, such as 500 ⁇ m, such as 400 ⁇ m, such as 300 ⁇ m.
• any particulate material referenced herein can be characterized as having at least 50% by weight of particles with a particle size as measured by sieve analysis of no greater than about 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m.
• At least 60% 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 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m.
• at least 70% 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 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m.
• At least 80% 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 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m. In some embodiments, at least 90% 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 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m.
• At least 95% 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 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m. In some embodiments, at least 99% 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 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m.
• approximately 100% 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 1000 ⁇ m, such as no greater than about 500 ⁇ m, such as no greater than about 400 ⁇ m, such as no greater than about 350 ⁇ m, such as no greater than about 300 ⁇ m.
• 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 referenced herein have a particle size as measured by sieve analysis of from about 0.01 ⁇ m to about 1000 ⁇ m, such as from about 0.05 ⁇ m to about 750 ⁇ m, such as from about 0.1 ⁇ m to about 500 ⁇ m, such as from about 0.25 ⁇ m to about 500 ⁇ m.
• 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 referenced herein have a particle size as measured by sieve analysis of from about 10 ⁇ m to about 400 ⁇ m, such as from about 50 ⁇ m to about 350 ⁇ m, such as from about 100 ⁇ m to about 350 ⁇ m, such as from about 200 ⁇ m to about 300 ⁇ m.
• the various components of the composition may vary.
• various combinations of dry ingredients typically 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.
• the active ingredient e.g., nicotine
• a humectant e.g., propylene glycol or olive oil
• 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.
• 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).
• 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.
• liquid components e.g., aqueous solutions or dispersions
• 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 50 to about 100 °C, including about 55 to about 80 °C or about 60 to about 70 °C.
• aqueous compositions used in the process are maintained at room temperature or below, such as between about 10 to about 25°C, including about 20 to about 25 °C (room temperature).
• room temperature such as between about 10 to about 25°C, including about 20 to about 25 °C (room temperature).
• 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.
• a large percentage of the total amount of water used in the product is added in a final water addition step, particularly 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.
• 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.
• the amount of water added in the final water addition step is at least about 50% by weight of the total water content of the product mixture (such as 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%).
• 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.
• 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 US Pat. No. 4,148,325 to Solomon et al. ; US Pat. No.
• the present disclosure includes a dosing system that reduces the time spent handling active ingredients.
• An embodiment of the dosing system 20 is shown in Fig. 3 .
• the system includes a storage tank 22 for the active ingredient, the storage tank in fluid communication with a dosing tank 30.
• the storage tank 22 can also be in fluid communication with an inert gas container 26 containing an inert gas such as nitrogen, which enables the creation of an inert gas blanket 24 in the headspace over the active ingredient stored in the storage tank 22.
• a pump 28 is used to transport the liquid active ingredient from the storage tank 22 to the dosing tank 30.
• One or more additional storage tanks are advantageously in fluid communication with the dosing tank 30, such as a storage tank 32 for a flavoring agent and a storage tank 34 for a humectant.
• additional components of a composition can be premixed with the active ingredient in the dosing tank 30.
• the active ingredient (optionally premixed with additional components) can be transported to one or more mixing tanks 36, which contain additional components of the desired composition, such as a dry mix as described above.
• 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.
• 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.
• the products comprising the compositions of the present disclosure may be dissolvable.
• dissolve refers 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.
• 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 1 minute or less to about 60 minutes.
• the components of the composition therein e.g., flavoring agents and/or nicotine
• the pouch may be removed from the mouth of the human subject for disposal.
• a first embodiment of a pouched product 10 includes a moisture-permeable container in the form of a pouch 12, which contains a composition 14 as described herein.
• the pouched product 10 optionally includes one or more capsules 16 dispersed within the composition 14, the capsules containing an additive (e.g., a flavoring agent) such as described in greater detail below.
• an additive e.g., a flavoring agent
• 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.
• 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.
• pouch material manufactured from a mesh-like form of rice paper, or perforated rice paper may dissolve in the mouth of the user.
• 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.
• the amount of material contained within each product unit may vary.
• the weight of the composition within each pouch is at least about 50 mg, for example, from about 50 mg to about 1 gram, from about 100 to 800 about mg, or from about 200 to about 700 mg.
• the weight of the composition within each pouch may be from about 100 to about 300 mg.
• the weight of the material within each pouch may be from about 300 mg to about 700 mg.
• each pouch can contain 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.
• flavored water dispersible or water soluble material e.g., a breath-freshening edible film type of material
• 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 US Pat. Nos. 6,887,307 to Scott et al. and 6,923,981 to Leung et al. ; and The EFSA Journal (2004) 85, 1-32 ; which are incorporated herein by reference.
• 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.
• contact of the capsule with the raised temperature of the user's mouth 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 37°C or higher).
• 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 5.6 to 7.9).
• 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 0.5 to about 5 mm, as well as microcapsule size ranges such as diameters of less than about 100 microns, such as diameters in the range of about 1 to about 40 microns, or about 1 micron to about 20 microns.
• the total weight of the capsules within the product may vary, but is typically between about 10 mg to about 200 mg, such as about 20 mg to about 50 mg.
• 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 1 to about 500, more typically about 5 to about 100.
• 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 US Pat. Nos. 7,014,039 to Henson et al. ; 7,537,110 to Kutsch et al. ; 7,584,843 to Kutsch et al. ; 8,397,945 to Gelardi et al. , D592,956 to Thiellier ; D594,154 to Patel et al. ; and D625,178 to Bailey et al. ; US Pat. Pub. Nos. 2008/0173317 to Robinson et al. ; 2009/0014343 to Clark et al.
• Table 1 An oral composition comprising the ingredients set forth in Table 1 below is prepared. The actual ingredient percentages can be varied depending the desired final product.
• Table 1 Ingredient % by weight range Water 40-55 Microcrystalline cellulose (MCC) 40-50 Sodium chloride 2-6 Xylitol 2-6 Nicotine 0.5-1.5 Propylene glycol 0.5-6 Sodium alginate 0.5-1.5 Flavoring agent 0.5-1.5 Sodium bicarbonate 0.5-1.5 Artificial sweetener 0.5-1.5 Potassium sorbate 0.5-1.5
• composition is prepared using the following method:
• Table 3 An oral composition comprising the ingredients set forth in Table 3 below is prepared. The actual ingredient percentages can be varied depending the desired final product.
• Table 3 Ingredient % by weight range Water 40-55 Microcrystalline cellulose (MCC) 40-50 Sodium chloride 2-6 Xylitol 2-6 Guar gum 2-6 Nicotine 0.5-1.5 Bleached tobacco 0.5-5 Sodium alginate 0.5-1.5 Flavoring agent 0.5-1.5 Sodium bicarbonate 0.5-1.5 Artificial sweetener 0.5-1.5 Potassium sorbate 0.5-1.5
• composition is prepared using the following method:
• Table 4 An oral composition comprising the ingredients set forth in Table 4 below is prepared. The actual ingredient percentages can be varied depending the desired final product.
• Table 4 Ingredient % by weight range Water 40-55 Microcrystalline cellulose (MCC) 40-50 Sodium chloride 2-6 Xylitol 2-6 Guar gum 2-6 Nicotine 0.5-1.5 Bleached tobacco 0.5-5 Sodium alginate 0.5-1.5 Flavoring agent 0.5-1.5 Sodium bicarbonate 0.5-1.5 Artificial sweetener 0.5-1.5 Potassium sorbate 0.5-1.5
• composition is prepared using the following method:
• An oral composition comprising the ingredients set forth in Example 1 is prepared using the following method:
• An oral composition comprising the ingredients set forth in Example 2 is prepared using the following method:
• An oral composition comprising the ingredients set forth in Example 3 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: (1) pouches with 4 mg nicotine and 4 mg propylene glycol (PG) added; (2) pouches with 4 mg nicotine and 4 mg olive oil added; and (3) pouches with 4 mg nicotine only added (no propylene glycol or olive oil).
• PG propylene glycol
• the sensory evaluation was conducted by requesting panelists to choose the most irritating and the least irritating sample.
• the collected data was used to generate the data presented in Fig. 2 .
• the trend line indicates that there is lower irritation level for the samples containing either propylene glycol or olive oil.

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