An oral composition

Abstract

An oral composition comprising a particulate material, an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0.

Description

[0001] An Oral Composition

[0002] Technical Field

[0003] The present disclosure relates to an oral composition, an oral pouched product comprising the oral composition and methods of preparing the oral composition.

[0004] Background

[0005] Oral compositions, such as smokeless tobacco products, have been known for many years and may include product formats such as moist snus, snuff, and chewing tobacco. Oral compositions also include nicotine replacement therapies (NRTs), which includes product formats such as lozenges, chewing gums, and tablets. More recently, there has been growing interest in the oral pouch category, whereby numerous actives including nicotine, caffeine, and cannabinoids, can be delivered to consumers, in a variety of formats, including pouches, tablets, chewing gums, chews, melts, and gummies.

[0006] Summary

[0007] According to a first aspect, there is described an oral composition comprising a particulate material, an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0.

[0008] According to a second aspect, there is described an oral composition comprising a bulk material; an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0.

[0009] According to a third aspect, there is described a method of preparing an oral composition according to the first and second aspects.

[0010] Detailed Description

[0011] 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 mixture including water. Unless otherwise indicated, reference to "weight percent" of a mixture reflects the total wet weight of the mixture (i.e., including water).

[0012] The present invention relates to an oral composition comprising a particulate material, an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0. Certain actives and / or flavourants which may be typically included in an oral composition suffer from lack of stability. For example, these components may be lost to the atmosphere during storage, prior to the product being consumed by a consumer. A consequence of this is that the amount of active and / or flavourant experienced by the consumer may be less than that which is listed on the product, or that may be anticipated by the consumer.

[0013] The loss of active and / or flavourant from an oral composition may also impact the shelf life of the composition, i.e. the shelf life of a product may be shortened in order to ensure that the consumer receives the advertised amount of active and / or that the consumer receives the intended flavour intensity.

[0014] It has been noticed that, for certain actives and / or flavourants, the protonated form thereof is more stable. There are various ways in which an active and / or flavourant could be protonated. In one example, the compound could be present as a salt. In another example, the compound could be combined with an acid. There may be considerations required for both of these methods for protonating a compound. For example, certain salts may impart an unwanted, sour flavour to the oral composition; and certain acids may be unsuitable for use in an oral composition.

[0015] An additional consideration for oral compositions is the method of absorption of the active, if present, into the bloodstream of a consumer. Certain oral compositions are configured to administer the active via the oral mucosa whereas other compositions are developed to deliver the active via the gastrointestinal (GI) tract. Some oral compositions are prepared in a manner to deliver active via the oral mucosa, oromucosal, and the GI tract.

[0016] As used herein, the term "oral composition" is intended to refer to a composition which delivers the majority of an active via the oral cavity. Such a composition can be described as an oromucosal composition. Such a composition is different, and distinct from, a composition which although administered via the oral cavity, is designed to deliver active via the GI tract.

[0017] By using an acid with a pKa of less than about 0, i.e. by using what may be considered a "strong" acid in the art, the oral composition may exhibit a longer shelf life due to increased stability of the active and / or flavourant present therein. The oral composition comprises a particulate material. Particulate materials are often included in oral composition for a variety of reasons, including modifying mouthfeel, modifying the compressibility of the composition, and may also enhance organoleptic properties of the composition.

[0018] In some embodiments, the particulate material is porous. In some embodiments, the particulate material is a cellulose-based material. In some embodiments, the particulate material is a porous cellulose-based material. Suitable particulate materials may include any non-tobacco plant material or derivative thereof, including cellulose materials derived from such sources. In some embodiments, the particulate material comprises a cellulosic non-tobacco plant material, such as cereal grains (e.g., maize, oat, barley, rye, buckwheat), sugar beet, bran fibre, citrus fibre, and mixtures thereof. In some embodiments, the particulate material comprises derivatives of non-tobacco plant material, such as starches (e.g., from potato, wheat, rice, corn), natural cellulose, and modified cellulosic materials. In some embodiments, the particulate material comprises alternative filler components, such as maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol, and sorbitol.

[0019] In some embodiments, the particulate material comprises an inorganic material, such as calcium carbonate, calcium phosphate, and bio-ceramic materials (e.g., porous hyd roxyapatite).

[0020] In some embodiments, the particulate material comprises a cellulose material or cellulose derivative and can, in some embodiments, comprise 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, VIVAPUR® grades 101, 103, 102, 112, 302, 12, 14, 200 and EMOCEL® grades 50M and 90M, and mixtures thereof.

[0021] In some embodiments, the particulate material is substantially spherical. Such materials can be defined by their sphericity, which is a measure of how closely an object resembles a perfect sphere. Sphericity (>4J) can be measuring using the equation below, wherein VPis the volume of the object and APis the surface area of the object.

[0022] 'P = (7i1 / 3(6Vp)%) / Ap

[0023] The sphericity of a sphere is unity by definition and any shape that is not a perfect sphere will have a sphericity less than 1. In some embodiments, the sphericity of the substantially spherical material is about 0.7 or higher, such as about 0.8 or higher or about 0.9 or higher (e.g., about 0.7 to 1 or about 0.75 to 1 or about 0.8 to 1 or about 0.85 to 1, or about 0.9 to 1).

[0024] In some embodiments, the substantially spherical particulate material comprises MCC. In some embodiments, the substantially spherical particulate material comprises solid (although porous) MCC spheres. In some embodiments, the substantially spherical particulate material comprises hollow MCC spheres. In some embodiments, the centre / core of such hollow MCC spheres may be unfilled; in other embodiments, the centre / core of such hollow MCC spheres may be filled with one or more additional components (e.g., flavourants, fillers, active ingredients, etc.). Examples of suitable MCC spheres include, but are not limited to, Vivapur® MCC spheres from JR.S Pharma, available, e.g., with particle sizes of 100-200 pm (Vivapur® 100), 200-355 pm (Vivapur® 200), 355-500 pm (Vivapur® 350), 500-710 pm (Vivapur® 500), 710- 1000 pm (Vivapur®700), and 1000-1400 pm (Vivapur® 1000). Further examples of suitable MCC spheres include, but are not limited to, Celphere™ MCC spheres from Asahi Kasei Corporation, available, e.g., with particle sizes of 75-212 pm (Celphere™ SCP-100), 106-212 pm (Celphere™ CP-102), 150-300 pm (Celphere™ CP-203), 300- 500 pm (Celphere™ CP-305), and 500-710 pm (Celphere™ CP-507).

[0025] In some embodiments, the oral composition comprises the particulate material in an amount of from about 5% to about 95%, by weight of the composition. For example, the particulate material may be included in an amount of from about 10% to about 95%; from about 15% to about 95%; from about 20% to about 95%; from about 25% to about 95%; from about 30% to about 95%; from about 35% to about 95%; from about 40% to about 95%; from about 45% to about 95%; from about 50% to about 95%; from about 55% to about 95%; from about 60% to about 95%; from about 65% to about 95%; from about 70% to about 95%; from about 75% to about 95%; from about 80% to about 95%; from about 85% to about 95%; from about 90% to about 95%, by weight of the oral composition. In some embodiments, the oral composition comprises the particulate material in an amount greater than about 60% by weight of the composition, such as greater than about 65%; greater than about 70%; greater than about 75%; greater than about 80%; greater than about 85%; greater than about 90%; greater than about 95%, by weight of the oral composition.

[0026] In some embodiments, the oral composition comprises the particulate material in an amount of from about 85% to about 98%, by weight of the composition, such as from about 86% to about 97%; from about 87% to about 96%; from about 87% to about 95%; from about 88% to about 95%; from about 89% to about 95%, by weight of the oral composition.

[0027] In some embodiments, the particulate material may comprise more than one component. For example, the particulate material may comprise a first particulate material and a second particulate material, wherein the first and second particulate materials are different. Where two particulate materials are present, the first particulate material may be present in an amount of up to about 10%, by weight of the oral composition, such as up to about 20%, up to about 30%, up to about 40%, up to about 50%, up to about 60%, up to about 70%, up to about 80%, up to about 90%, by weight of the oral composition. The second particulate material may be present in an amount of up to about 10%, by weight of the oral composition, such as up to about 20%, up to about 30%, up to about 40%, up to about 50%, up to about 60%, up to about 70%, up to about 80%, up to about 90%, by weight of the oral composition. Where the oral composition comprises different first and second particulate materials, the first material, or the second material may be selected from a cellulose based material, such as those discussed herein. The other material may be selected from a different source, such as a sugar alcohol, such as erythritol, xylitol, mannitol, sorbitol, isomalt, maltitol, and mixtures thereof.

[0028] In some embodiments, the oral composition comprises an active. The active, or active substance, as used herein may be a physiologically active material, which is a material intended to achieve or enhance a physiological response. The active substance may for example be selected from nutraceuticals, nootropics, psychoactives, active pharmaceutical ingredients, and medicinal ingredients. The active substance may be naturally occurring or synthetically obtained.

[0029] In some embodiments, the active comprises one or more stimulants, i.e. a material that increases activity of the central nervous system and / or the body, for example, enhancing focus, cognition, vigour, mood, alertness, and the like. In some embodiments, the active comprises caffeine, theacrine, theobromine, theophylline, and combinations thereof, including natural, naturally derived, or wholly synthetic versions thereof. Certain botanical materials (guarana, tea, coffee, cocoa, and the like) may possess a stimulant effect by virtue of the presence of e.g. caffeine or related alkaloids, and accordingly are "natural" stimulants. By "naturally derived" is meant the stimulant (e.g. caffeine, theacrine) is in a purified form, outside its natural (e.g. botanical) matrix. For example, caffeine can be obtained by extraction and purification from botanical sources (e.g. tea). By "wholly synthetic", it is meant that the stimulant has been obtained by chemical synthesis.

[0030] In some embodiments, the active may comprise, or be derived from, one or more botanicals or constituents, derivatives or extracts thereof. As used herein, the term "botanical" includes any material derived from plants including, but not limited to, extracts, leaves, bark, fibres, stems, roots, seeds, flowers, fruits, pollen, husk, shells or the like. Alternatively, the material may comprise an active compound naturally existing in a botanical, obtained synthetically. The material may be in the form of liquid, gas, solid, powder, dust, crushed particles, granules, pellets, shreds, strips, sheets, or the like. Example botanicals are tobacco, eucalyptus, star anise, hemp, cocoa, cannabis, fennel, lemongrass, peppermint, spearmint, rooibos, chamomile, flax, ginger, ginkgo biloba, hazel, hibiscus, laurel, licorice (liquorice), matcha, mate, orange skin, papaya, rose, sage, tea such as green tea or black tea, thyme, clove, cinnamon, coffee, aniseed (anise), basil, bay leaves, cardamom, coriander, cumin, nutmeg, oregano, paprika, rosemary, saffron, lavender, lemon peel, mint, juniper, elderflower, vanilla, Wintergreen, beefsteak plant, curcuma, turmeric, sandalwood, cilantro, bergamot, orange blossom, myrtle, cassis, valerian, pimento, mace, damien, marjoram, olive, lemon balm, lemon basil, chive, carvi, verbena, tarragon, geranium, mulberry, ginseng, theanine, theacrine, maca, ashwagandha, damiana, guarana, chlorophyll, baobab or any combination thereof. The mint may be chosen from the following mint varieties: Mentha Arventis, Mentha c.v., Mentha niliaca, Mentha piperita, Mentha piperita citrata c.v., Mentha piperita c.v, Mentha spicata crispa, Mentha cardifolia, Memtha longifolia, Mentha suaveolens variegata, Mentha pulegium, Mentha spicata c.v. and Mentha suaveolens.

[0031] In some embodiments, the active comprises a vitamin or combination of vitamins selected from the list consisting of vitamin A (as all-trans-retinol, all-trans-retinyl- esters, as well as all-trans-beta-carotene and other provitamin A carotenoids), vitamin Bl (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin), vitamin B9 (folic acid or folate), vitamin B12 (cobalamins), vitamin C (ascorbic acid), vitamin D (calciferols), vitamin E (tocopherols and tocotrienols), and vitamin K (quinones), and combinations thereof.

[0032] In some embodiments, the active comprises one or more cannabinoids. As used herein, the term "cannabinoid" refers to a class of diverse chemical compounds that acts on cannabinoid receptors, also known as the endocannabinoid system, in cells that alter neurotransmitter release in the brain. Suitable cannabinoids include: cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A), and mixtures thereof.

[0033] In some embodiments, the active comprises a nicotine component. It is known that nicotine is a particularly volatile compound and may readily evaporate from oral compositions. Various techniques have been implemented in the art in order to reduce the loss of nicotine from oral compositions. Nicotine salts, such as nicotine bitartrate have been utilised to improve stability of nicotine; however, undesirable sour tastes have been detected when certain nicotine salts are present in oral compositions.

[0034] In some embodiments, the active comprises nicotine in free base form.

[0035] In some embodiments, the active comprises nicotine in its monoprotonated form.

[0036] In some embodiments, the active is included in the oral composition in an amount of at least about 0.01% by weight of the oral composition, optionally at least about 0.05%; at least about 0.1%; at least about 0.25%; at least about 0.5%; at least about 0.75%; at least about 1%; at least about 1.5%; at least about 2%; at least about 2.5%; at least about 3%; at least about 3.5%; at least about 4%; at least about 4.5%; at least about 5%; at least about 5.5%; at least about 6%; at least about 6.5%; at least about 7%; at least about 7.5%; at least about 8%, by weight of the oral composition.

[0037] In some embodiments, the oral composition comprises an active in an amount of from about 0.5% to about 10%, by weight of the oral composition, such as from about 0.5% to about 9.5%; from about 0.5% to about 9%; from about 1% to about 9%; from about 1% to about 8.5%; from about 1% to about 8%; from about 1% to about 7.5%; from about 1% to about 7%; from about 1% to about 6.5%; from about 1.5% to about 6.5%; from about 1.5% to about 6%; from about 1.5% to about 5.5%; from about 1.5% to about 5%; from about 1.5% to about 4.5%; from about 1.5% to about 4%; from about 2% to about 4%, by weight of the oral composition.

[0038] In some embodiments, the acid is included in the oral composition in an amount of at least about 0.01% by weight of the oral composition, optionally at least about 0.05%; at least about 0.1%; at least about 0.25%; at least about 0.5%; at least about 0.75%; at least about 1%; at least about 1.5%; at least about 2%; at least about 2.5%; at least about 3%; at least about 3.5%; at least about 4%; at least about

[0039] 4.5%; at least about 5%; at least about 5.5%; at least about 6%; at least about

[0040] 6.5%; at least about 7%; at least about 7.5%; at least about 8%, by weight of the oral composition.

[0041] In some embodiments, the oral composition comprises the acid in an amount of from about 0.5% to about 10%, by weight of the oral composition, such as from about 0.5% to about 9.5%; from about 0.5% to about 9%; from about 1% to about 9%; from about 1% to about 8.5%; from about 1% to about 8%; from about 1% to about 7.5%; from about 1% to about 7%; from about 1% to about 6.5%; from about 1.5% to about 6.5%; from about 1.5% to about 6%; from about 1.5% to about 5.5%; from about 1.5% to about 5%; from about 1.5% to about 4.5%; from about 1.5% to about 4%; from about 2% to about 4%, by weight of the oral composition.

[0042] In some embodiments, the oral composition comprises a flavourant.

[0043] As used herein, the terms "flavour" and "flavourant" refer to materials which, where local regulations permit, may be used to create a desired taste, aroma or other somatosensorial sensation in a product for adult consumers. They may include naturally occurring flavour materials, botanicals, extracts of botanicals, synthetically obtained materials, or combinations thereof (e.g., tobacco, cannabis, liquorice (liquorice), hydrangea, eugenol, Japanese white bark magnolia leaf, chamomile, fenugreek, clove, maple, matcha, menthol, Japanese mint, aniseed (anise), cinnamon, turmeric, Indian spices, Asian spices, herb, Wintergreen, cherry, berry, red berry, cranberry, peach, apple, orange, mango, clementine, lemon, lime, tropical fruit, papaya, rhubarb, grape, durian, dragon fruit, cucumber, blueberry, mulberry, citrus fruits, Drambuie, bourbon, scotch, whiskey, gin, tequila, rum, spearmint, peppermint, lavender, aloe vera, cardamom, celery, cascarilla, nutmeg, sandalwood, bergamot, geranium, khat, naswar, betel, shisha, pine, honey essence, rose oil, vanilla, lemon oil, orange oil, orange blossom, cherry blossom, cassia, caraway, cognac, jasmine, ylang-ylang, sage, fennel, wasabi, piment, ginger, coriander, coffee, hemp, a mint oil from any species of the genus Mentha, eucalyptus, star anise, cocoa, lemongrass, rooibos, flax, ginkgo biloba, hazel, hibiscus, laurel, mate, orange skin, rose, tea such as green tea or black tea, thyme, juniper, elderflower, basil, bay leaves, cumin, oregano, paprika, rosemary, saffron, lemon peel, mint, beefsteak plant, curcuma, cilantro, myrtle, cassis, valerian, pimento, mace, damien, marjoram, olive, lemon balm, lemon basil, chive, carvi, verbena, tarragon, limonene, thymol, camphene), flavour enhancers, bitterness receptor site blockers, sensorial receptor site activators or stimulators, sugars and / or sugar substitutes (e.g., sucralose, acesulfame potassium, aspartame, saccharine, cyclamates, lactose, sucrose, glucose, fructose, sorbitol, or mannitol), and other additives such as charcoal, chlorophyll, minerals, botanicals, or breath freshening agents. They may be imitation, synthetic or natural ingredients or blends thereof. They may be in any suitable form, for example, liquid such as an oil, solid such as a powder, or gas.

[0044] In some embodiments, the flavour comprises menthol, spearmint and / or peppermint.

[0045] In some embodiments, the flavour comprises flavour components of cucumber, blueberry, citrus fruits and / or redberry. In some embodiments, the flavour comprises eugenol. In some embodiments, the flavour comprises flavour components extracted from tobacco. In some embodiments, the flavour comprises flavour components extracted from cannabis.

[0046] In some embodiments, the flavour may comprise a sensate, which is intended to achieve a somatosensorial sensation which are usually chemically induced and perceived by the stimulation of the fifth cranial nerve (trigeminal nerve), in addition to or in place of aroma or taste nerves, and these may include agents providing heating, cooling, tingling, numbing effect. A suitable heat effect agent may be, but is not limited to, vanillyl ethyl ether and a suitable cooling agent may be, but not limited to eucalyptol, WS-3.

[0047] The oral composition comprises an acid which has a pKa of less than about 0.

[0048] Inclusion of an acid in the oral composition may facilitate protonation of an active and / or flavourant which is present in the oral composition. For example, in some embodiments the active comprises nicotine. When present in an oral composition as defined herein, the nicotine is protonated by the acid, which as discussed hereinabove, may improve its stability.

[0049] One additional consideration for oral compositions is the route of absorption, i.e. via the oral mucosa or via the GI tract. When seeking to provide an oral composition comprising nicotine, which is absorbed via the oral mucosa, the form of the nicotine is important because protonated nicotine does not readily pass through the oral mucosa. Nicotine must be in its free base, or unprotonated, form, in order to pass through the oral mucosa. Therefore, protonated nicotine must be converted to free base nicotine to facilitate absorption via the oral mucosa.

[0050] In some embodiments, the acid having a pKa of less than about 0 has a particularly low buffering capacity. Therefore, during use, the saliva of the consumer, which would typically naturally have a pH of about 7 is capable of buffering the nicotine from its protonated form to its free base form, such that it can be absorbed via the oral mucosa. Alternatively, or in addition, the inclusion of a buffering agent in the oral composition may facilitate deprotonation of the nicotine, forming free base nicotine and allowing absorption through the oral mucosa.

[0051] In some embodiments, the acid has a pKa of less than about -1, such as less than about -2, less than about -3, less than about -4, less than about -5, less than about - 6, less than about -7. In some embodiments, the acid has a pKa of about -7.

[0052] In some embodiments, the acid is an inorganic acid. In some embodiments, the acid is selected from hydrochloric acid, hydrobromic acid, hydroiodic acid, perchloric acid, sulfuric acid, nitric acid, and combinations thereof. In some embodiments, the acid is hydrochloric acid.

[0053] In some embodiments, the oral composition further comprises pH adjusters or buffering agents. For example, the pH adjuster or buffering agent may be selected form 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. Further examples of suitable buffering agents include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, hydrogen carbonates, borates, or mixtures thereof. In some embodiments, the buffering agent is trisodium phosphate. In some embodiments, the buffering agent is sodium carbonate. In some embodiments, the buffering agent is sodium bicarbonate. In some embodiments, the buffering agent is potassium dihydrogen phosphate.

[0054] In some embodiments, the buffering system is made up of a mixture of buffering agents. For example, the oral composition may comprise two, or more buffering agents selected from trisodium phosphate, sodium carbonate, sodium bicarbonate, and potassium dihydrogen phosphate.

[0055] The presence of a pH adjuster or a buffering agent may help to increase the pH of the oral composition, which would naturally be low due to the presence of an acid with a pKa of less than about 0, during use. Increasing the pH of the oral composition during use may allow the form of the active and / or flavourant to change. For example, where the oral composition comprises nicotine, the buffering agent may increase the amount of nicotine present in its free base form. This is particularly relevant in view of the presence of the acid in the oral composition, which would cause the majority of the nicotine to be present in its protonated form. During use, the buffering agent would dissolve in saliva, increasing the pH which increases the amount of free base nicotine available for oromucosal absorption.

[0056] As is known in the art, the relative fraction of protonated nicotine, compared to free base or unprotonated nicotine, varies with pH and can be calculated using the Henderson-Hasselbalch equation. Furthermore, as well known in the art, nicotine has a pKa of 8.02; thus, as the pH of a composition falls below this, the relative fraction of mono-protonated nicotine increases and the relative fraction of unprotonated, free base, nicotine decreases. As the pH of a composition rises about 8.02, the relative fraction of unprotonated, free base, nicotine increases and the relative fraction of mono-protonated nicotine decreases.

[0057] Where present, the amount of buffering agent present in the oral formulation is not particularly limited. The main purpose of the buffering agent is to modify the pH of the oral composition during use and therefore the amount of buffering agent required in the oral composition typically depends on the form of the active. For example, an oral composition comprising a basic active may require less buffering agent compared to an oral composition comprising an active in its salt form. Where present, the buffering agent may be present in an amount less than about 5 percent based on the weight of the oral composition, such as less than about 4%, less than about 3%, less than about 2%, less than about 1% by weight of the composition. A buffering agent may be present in an amount of from about 0.2% to about 5%, by weight of the oral composition, such as from about 0.5% to about 5%; from about 0.5% to about 4.5%; from about 0.5% to about 4%; from about 0.5% to about 3.5%; from about 0.5% to about 3%; from about 0.5% to about 2.5%; from about 0.5% to about 2%; from about 0.5% to about 1.5%, by weight of the oral composition.

[0058] In some embodiments, the oral composition additionally comprises water. For example, the oral composition may comprise water in an amount of from about 0.5% to about 10% by weight of the oral composition, such as from about 0.5% to about 9%; from about 0.5% to about 8%; from about 0.5% to about 7%; from about 0.5% to about 6%; from about 0.5% to about 5%; from about 0.5% to about 4%; from about 0.5% to about 3%; from about 0.5% to about 2%; from about 0.5% to about 1%.

[0059] In some embodiments, the oral composition comprises water in an amount of less than about 5%, by weight of the oral composition, such as less than about 4%; less than about 3%, less than about 2%, less than about 1%, less than about 0.5%, less than about 0.25%, less than about 0.1%, less than about 0.05%, less than about 0.01%, by weight of the oral composition.

[0060] In some embodiments, the oral composition is substantially free, or entirely free, of water.

[0061] In some embodiments, the oral 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.

[0062] In some embodiments, the oral composition comprises sodium chloride, potassium chloride, ammonium chloride, and combinations thereof.

[0063] In some embodiments, the oral composition comprises an additional salt in an amount of about 0.5% by weight or more, about 1.0% by weight or more, or at about 1.5% by weight or more.

[0064] In some embodiments, the oral composition may further comprise one, or more, antioxidants. Suitable antioxidants include ascorbyl palmitate, citric acid, ascorbic acid, vitamin E, or any antioxidant considered a true antioxidant, i.e. compounds which block chain reactions by reacting with free radicals, including butylated hydroxytoluene; reducing agents, i.e. compounds having a lower redox potential than the active; and antioxidant synergists, i.e. compounds which enhance the effects of antioxidants, including sodium edetate.

[0065] In some embodiments, the oral composition further comprises a sweetener, in natural or artificial form, or as a combination of natural and artificial sweeteners. In some embodiments, the oral composition comprises a natural sweetener selected from the list consisting of: fructose, sucrose, glucose, maltose, mannose, galactose, lactose, stevia, honey, and combinations thereof. In some embodiments, the oral composition comprises an artificial sweetener selected from the list consisting of: sucralose, isomaltulose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, and the like.

[0066] In some embodiments, the sweetener comprises one or more sugar alcohols, such as erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates).

[0067] In some embodiments, the oral composition comprises acesulfame K.

[0068] When present, a sweetener may be included in an amount of from about 0.01% to about 2.5% by weight of the oral composition, such as from about 0.01% to about 2%, from about 0.01% to about 1.5%, from about 0.01% to about 1%, from about 0.01% to about 0.5%, from about 0.01% to about 0.25%, from about 0.01% to about 0.15%, from about 0.01% to about 0.1%, by weight of the oral composition.

[0069] In some embodiments, the oral composition further comprises a binder. Suitable binders may be selected from cellulose derivatives, such as cellulose ether (including carboxyalkyl ethers), i.e. a cellulose polymer with the hydrogen of one or more hydroxyl groups in the cellulose structure replaced with an alkyl, hydroxyalkyl, or aryl group. In some embodiments, the cellulose derivative may be selected from methylcellulose, hydroxypropylcellulose ("HPC"), hydroxypropylmethylcellulose ("HPMC"), hydroxyethyl cellulose, and carboxymethylcellulose ("CMC"). In some embodiments, the binder may be selected from N-vinylpyrrolidone derivatives, such as polyvinylpyrrolidone (PVP).

[0070] When present, a binder may be included in an amount of from about 0.5% to about 10% by weight of the oral composition, such as from about 0.5% to about 9%, from about 0.5% to about 8%, from about 0.5% to about 7%, from about 0.5% to about 6%, from about 0.5% to about 6%, from about 0.5% to about 5%, by weight of the oral composition.

[0071] In some embodiments, the oral composition further comprises a humectant. For example, the oral composition may comprise glycerin or propylene glycol.

[0072] When included in the oral composition, a humectant may be present in an amount of from 0.01% to about 5%, by weight of the oral composition, such as from about 0.1% to about 5%; from about 0.5% to about 5%; from about 0.5% to about 4.5%; from about 0.5% to about 4%; from about 0.5% to about 3.5%; from about 0.5% to about 3%; from about 0.5% to about 2.5%; from about 0.5% to about 2%, by weight of the oral composition.

[0073] In some embodiments, the oral composition further comprises one or more capsules. Capsules typically have an outer cover, shell, or coating which envelopes a liquid, gel, or solid core region, and in some embodiments, can have a generally spherical shape. By encapsulating a component within the core region of a capsule, the ability of this component to interact with other components of the oral composition prior to use can be reduced or eliminated. This may enhance the storage stability of the product. The core region, which typically releases the encapsulated component when the outer shell undergoes some type of physical destruction, breakage, or other loss of physical integrity (e.g., through dispersion, softening, crushing, application of pressure, or the like), thereby provides for altering the sensory properties of the pouched product.

[0074] In some embodiments, the outer shell of the capsule is designed to rupture during use or is water soluble under conditions of normal use.

[0075] In some embodiments, the capsule may have a diameter of less than about 1,000 microns, such as from about 1 to about 750 microns, about 10 microns to about 500 microns. In some embodiments, larger capsules may be utilized. For example, the capsule may have a size of about 0.5 mm to about 5 mm or about 0.6 mm to about 3 mm in diameter.

[0076] In some embodiments, the capsules described herein may comprise a flavourant, as described hereinabove. In some embodiments, the capsules may contain water, a buffering agent, or any other optional components described herein. When the capsule contains water, the oral composition may be rapidly hydrated by breaking / cracking the capsule upon placing the oral composition in the mouth of a user. Capsules can be formed using, for example, any encapsulating technology known in the art. For example, the capsules can be formed using any of various chemical encapsulation techniques such as solvent evaporation, solvent extraction, organic phase separation, interfacial polymerization, simple and complex coacervation, in-situ polymerization, liposome encapsulation, and nanoencapsulation. Alternatively, physical methods of encapsulation could be used, such as injection moulding, spheronisation, granulation, extrusion, microfluidics, spray coating, pan coating, fluid bed coating, annular jet coating, spinning disk atomization, spray cooling, spray drying, spray chilling, stationary nozzle coextrusion, centrifugal head coextrusion, or submerged nozzle coextrusion.

[0077] In some embodiments, the oral composition is contained within a pouch, i.e. a water permeable pouch. An oral pouched product is typically placed into the mouth of a user and positioned between the gum and the cheek / upper lip. Water soluble components of the oral composition are dissolved, pass through the water permeable pouch material, and subsequently can be absorbed through the oral mucosa.

[0078] In some embodiments, the pouched product comprises a pouch made from a fleece material. As used herein, a fleece material relates to a material made from fibres and includes materials such as nonwoven materials.

[0079] In some embodiments the fleece material is a nonwoven web comprising fibres wherein at least a portion of the fibres are selected from the group consisting of polyester fibres, viscose fibres (including tobacco-derived viscose fibres), sisal fibres, corn silk fibres, long wood fibres, MCC fibres, and combinations thereof.

[0080] In some embodiments, the fleece material comprises a nonwoven web comprising polyester fibres, such as cutin, polybutyrate, poly(ethylene terephthalate), polyglycolide, polylactic acid, polycaprolactone, polyhydroxyalkanoate, polyhydroxybutyrate, and copolymers and derivatives thereof.

[0081] In some embodiments, the fleece material can comprise at least about 10 wt.%, at least about 20 wt.%, at least about 25 wt.%, at least about 30 wt.%, at least about 40 wt.%, at least about 50 wt.%, at least about 60 wt.%, at least about 70 wt.%, at least about 80 wt.%, or at least about 90 wt.% viscose fibres, based on the total weight of the fibres within the fleece material. In some embodiments, the fleece material is 100% viscose. In some embodiments, the pouch is constructed of a single layer of the nonwoven web. In some embodiments, the pouch material comprises a multilayer composite made up of two or more nonwoven layers. In a multilayer structure, the pouched product may have a first layer which can be relatively hydrophilic and a second layer which can be relatively hydrophobic (compared to each other). In some embodiments, the pouched product may comprise an outer water-permeable pouch comprising an outer hydrophilic layer and an inner hydrophobic layer in contact with the oral composition. As such, the hydrophobic layer can, during storage of the pouched product, retain any moisture in the composition such that flavours in the composition are not lost due to moisture loss. However, capillaries in the hydrophobic layer can wick out moisture into the mouth of the user, such that composition components are released into the oral cavity when used. In this manner, the pouch material can enhance storage stability without significantly compromising the enjoyment of the product by the end user. In some embodiments, the relatively hydrophilic layer could be located on the interior of the multi-layer structure. The two layers can be formed into a multi-layer composite nonwoven material using any means known in the art, such as by attaching the two layers together using adhesive or stitching. The hydrophobicity of a textile material can be evaluated, for example, by measuring the contact angles between a drop of liquid and the surface of a textile material, as is known in the art.

[0082] Also described herein is a method of preparing an oral composition, comprising mixing a particulate material, an active and / or a flavourant, and an acid, to form the oral composition, wherein the acid has a pKa of less than about 0.

[0083] In some embodiments, the active and / or flavourant is dissolved in a solvent prior to mixing with the particulate material. Dissolving the active and / or flavourant in a solvent may ensure that the active and / or flavourant is more evenly distributed throughout the particulate material.

[0084] In some embodiments, the active and / or flavourant and the acid is dissolved in a solvent prior to mixing with the particulate material. Dissolving the active and / or flavourant in a solvent with the acid may ensure that substantially all of the active and / or flavourant is protonated. In some embodiments only a portion of the active is protonated, such as up to about 10%, up to about 20%, up to about 30%, up to about 40%, up to about 50%, up to about 60%, up to about 70%, up to about 80%, up to about 90%, up to about 95%. In some embodiments, the solvent is selected from ethanol, water, propylene glycol, and mixtures thereof.

[0085] In some embodiments, the solvent is removed from the mixture prior to forming the oral composition. For example, the solvent may be removed via vacuum in a high shear mixer. In some embodiments, the solvent is removed via evaporation.

[0086] In some embodiments, after removing the solvent from the mixture, additional optional components may be added. For example, if a flavourant is not already included one, or more may be added, a buffering agent, and / or a sweetener may be added to the mixture of the particulate material, the active / flavourant and the acid; and mixed further.

[0087] In an embodiment, the oral composition comprises a bulk material. For example, a bulk material may be a continuous system, such as a gel or polymer system.

[0088] Example Formulation

[0089] The various embodiments described herein are presented only to assist in understanding and teaching the claimed features. These embodiments are provided as a representative sample of embodiments only, and are not exhaustive and / or exclusive. It is to be understood that advantages, embodiments, examples, functions, features, structures, and / or other aspects described herein are not to be considered limitations on the scope of the invention as defined by the claims or limitations on equivalents to the claims, and that other embodiments may be utilised and modifications may be made without departing from the scope of the claimed invention. Various embodiments of the invention may suitably comprise, consist of, or consist essentially of, appropriate combinations of the disclosed elements, components, features, parts, steps, means, etc, other than those specifically described herein. In addition, this disclosure may include other inventions not presently claimed, but which may be claimed in future.

[0090] Clauses

[0091] The following clauses are not intended to represent claims but are included for information.

[0092] 1. An oral composition comprising : a particulate material, an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0.

[0093] 2. The oral composition according to clause 1, wherein the acid has a pKa of less than about -5.

[0094] 3. The oral composition according to clause 1 or clause 2, wherein the acid is an inorganic acid, such as an acid selected from the list consisting of: hydrochloric acid, sulfuric acid, and nitric acid, hydrobromic acid, hydroiodic acid, perchloric acid, and combinations thereof, in particular wherein the acid is hydrochloric acid.

[0095] 4. The oral composition according to any one of clauses 1 to 3, wherein the composition comprises the acid in an amount from about 0.01 to about 10%, by weight of the composition.

[0096] 5. The oral composition according to any one of clauses 1 to 4, wherein the active is selected from the list consisting of: a nicotine component, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, active pharmaceutical ingredients, and combinations thereof.

[0097] 6. The oral composition according to any one of clauses 1 to 5, wherein the composition comprises the active in an amount from about 0.1% to about 10%, by weight of the composition. 7. The oral composition according to any one of clauses 1 to 6, wherein the particulate material comprises cellulose, such as microcrystalline cellulose.

[0098] 8. The oral composition according to any one of clauses 1 to 7, wherein the composition comprises the particulate material in an amount from about 20% to about 95%, by weight of the composition.

[0099] 9. The oral composition according to any one of clauses 1 to 8, further comprising a buffering agent, wherein the buffering agent is selected from the list consisting of: carbonates, phosphates, bicarbonates, acetates, glycinates, citrates, borates, glycerophosphates, and combinations thereof, such as sodium carbonate, trisodium phosphate, sodium bicarbonate, potassium dihydrogen phosphate, and combinations thereof.

[0100] 10. The oral composition according to any one of clauses 1 to 9, wherein the flavourant is a liquid flavourant, dry powder flavourant, or a mixture thereof.

[0101] 11. The oral composition according to any one of clauses 1 to 10, further comprising an antioxidant selected from the list consisting of: ascorbyl palmitate, citric acid, ascorbic acid, vitamin E, butylated hydroxytoluene, sodium edetate, and mixtures thereof; and / or further comprising a sweetener selected from the list consisting of aspartame, acesulfame potassium, sucralose, saccharin, and combinations thereof; and / or further comprising a binder selected from the list consisting of: HPC, alginate, HPMC, maltodextrin, PVP, and combinations thereof.

[0102] 12. The oral composition according to any one of clauses 1 to 11, further comprising water in an amount of less than about 10 wt%, such as less than about 5%, such as less than about 2.5%, such as less than about 2%, such as less than about 1.5%, such as less than about 1%.

[0103] 13. An oral pouched product comprising the oral composition according to any one of clauses 1 to 12.

[0104] 14. A method of preparing an oral composition comprising : mixing a particulate material, an active, and an acid, to form the oral composition, wherein the acid has a pKa of less than about 0. oral composition comprising : a bulk material; an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0.

Claims

Claims1. An oral composition comprising : a particulate material, an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0.

2. The oral composition according to claim 1, wherein the acid has a pka of less than about -5.

3. The oral composition according to claim 1 or claim 2, wherein the acid is an inorganic acid.

4. The oral composition according to any one of claim 1 to 3, wherein the acid is selected from the list consisting of: hydrochloric acid, sulfuric acid, and nitric acid, hydrobromic acid, hydroiodic acid, perchloric acid, and combinations thereof.

5. The oral composition according to claim 4, wherein the acid is hydrochloric acid.

6. The oral composition according to any one of claims 1 to 5, wherein the composition comprises the acid in an amount from about 0.01 to about 10%, by weight of the composition.

7. The oral composition according to any one of claims 1 to 6, wherein the active is selected from the list consisting of: a nicotine component, botanicals, stimulants, amino acids, vitamins, cannabinoids, cannabimimetics, terpenes, nutraceuticals, active pharmaceutical ingredients, and combinations thereof.

8. The oral composition according to claim 7, wherein the active is a nicotine component.

9. The oral composition according to any one of claims 1 to 8, wherein the composition comprises the active in an amount from about 0.1% to about 10%, by weight of the composition.

10. The oral composition according to any one of claims 1 to 9, wherein the particulate material comprises cellulose.

11. The oral composition according to any one of claims 1 to 10, wherein the particulate material comprises microcrystalline cellulose.

12. The oral composition according to any one of claims 1 to 11, wherein the composition comprises the particulate material in an amount from about 20% to about 95%, by weight of the composition.

13. The oral composition according to any one of claims 1 to 12, further comprising a buffering agent.

14. The oral composition according to claim 13, wherein the buffering agent is selected from the list consisting of: carbonates, phosphates, bicarbonates, acetates, glycinates, citrates, borates, glycerophosphates, and combinations thereof.

15. The oral composition according to claim 13 or claim 14, wherein the buffering agent is selected from the list consisting of: sodium carbonate, trisodium phosphate, sodium bicarbonate, potassium dihydrogen phosphate, and combinations thereof.

16. The oral composition according to any one of claims 1 to 15, wherein the flavourant is a liquid flavourant, dry powder flavourant, or a mixture thereof.

17. The oral composition according to any one of claims 1 to 16, further comprising an antioxidant.

18. The oral composition according to claim 17, wherein the antioxidant is selected from the list consisting of: ascorbyl palmitate, citric acid, ascorbic acid, vitamin E, butylated hydroxytoluene, sodium edetate, and mixtures thereof.

19. The oral composition according to any one of claims 1 to 18, further comprising a sweetener.

20. The oral composition according to claim 19, wherein the sweetener is selected from the list consisting of aspartame, acesulfame potassium, sucralose, saccharin, and combinations thereof.

21. The oral composition according to any one of claims 1 to 20, further comprising a binder.

22. The oral composition according to claim 21, wherein the binder is selected from the list consisting of: HPC, alginate, HPMC, maltodextrin, PVP, and combinations thereof.

23. The oral composition according to any one of claims 1 to 22, further comprising water in an amount of less than about 10 wt%, such as less than about 5%, such as less than about 2.5%, such as less than about 2%, such as less than about 1.5%, such as less than about 1%.

24. The oral composition according to claim 23, wherein the oral composition is substantially free of water.

25. An oral pouched product comprising the oral composition according to any one of claims 1 to 24.

26. The oral pouched product according to claim 25, further comprising a capsule comprising an encapsulated component.

27. The oral pouched product according to claim 26, wherein the encapsulated component is selected from the list consisting of: water, flavourant, active, buffering agent, and combinations thereof.

28. A method of preparing an oral composition comprising : mixing a particulate material, an active, and an acid, to form the oral composition, wherein the acid has a pKa of less than about 0.

29. The method according to claim 28, wherein the active is dissolved in a solvent prior to mixing.

30. The method according to claim 29, wherein the solvent is ethanol.

31. The method according to claim 29 or claim 30, wherein the solvent is removed from the oral composition after mixing.

32. The method according to claim 31, wherein the solvent is removed by evaporation.

33. An oral composition comprising : a bulk material; an active and / or a flavourant, and an acid, wherein the acid has a pKa of less than about 0.

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