Oral composition and method for production

Abstract

Products configured for oral use and methods for preparing such products are provided. In some embodiments, the oral products described herein may comprise at least one active ingredient, a sugar alcohol, and a gum in an amount of 10 weight percent or less, and the product is in the form of a pastille. In some embodiments, the oral products described herein may comprise at least one active ingredient, a sugar substitute, and a sugar alcohol syrup in an amount of about 10 weight percent or less, and the product is in the form of a lozenge.

Description

Technical Field

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

Background Art

[0002] Tobacco may be consumed in so-called "smokeless" forms. Particularly popular smokeless tobacco products are used by inserting some form of processed tobacco or tobacco-containing formulation into the user's mouth. Conventional formats for such smokeless tobacco products include snuff, snus, and chewing tobacco, which are typically formed of substantially completely particulate, granular, or shredded tobacco, which are portioned by the user, or provided 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.For example, U.S. Patent No. 1,376,586 to Schwartz, U.S. Patent No. 4,513,756 to Pittman et al., U.S. Patent No. 4,528,993 to Sensabaugh, Jr. et al., U.S. Patent No. 4,624,269 to Story et al., U.S. Patent No. 4,991,599 to Tibbetts, U.S. Patent No. 4,987,907 to Townsend, U.S. Patent No. 5,092,352 to Sprinkle, III et al., U.S. Patent No. 5,387,416 to White et al., U.S. Patent No. 6,668,839 to Williams, U.S. Patent No. 6,834,654 to Williams, U.S. Patent No. 6,953,040 to Atchley et al., U.S. Patent No. 7,032,601 to Atchley et al., and U.S. Patent No. 7,694,686 to Atchley et al., U.S. Patent Application Publication No. 2004 / 0020503 to Williams, U.S. Patent Application Publication No. 2005 / 0115580 to Quinter et al., U.S. Patent Application Publication No. 2006 / 0191548 to Strickland et al., U.S. Patent Application Publication No. 2007 / 0062549 to Holton, Jr. et al., U.S. Patent Application Publication No. 2007 / 0186941 to Holton, Jr. et al., U.S. Patent Application Publication No. 2007 / 0186942 to Strickland et al., U.S. Patent Application Publication No. 2008 / 0029110 to Dube et al., U.S. Patent Application Publication No. 2008 / 0029116 to Robinson et al., U.S. Patent Application Publication No. 2008 / 0173317 to Robinson et al., U.S. Patent Application Publication No. 2008 / 0209586 to Neilsen et al., U.S. Patent Application Publication No. 2009 / 0065013 to Essen et al., and U.S. Patent Application Publication No. 2010 / 0282267 to Atchley, each of which is incorporated herein by reference, and WO2004 / 095959 to Arnarp et al., see the types of formulations, components, and processing methodologies for smokeless tobacco.

[0003] Recently, more smokeless tobacco product configurations that combine tobacco materials with various binders and fillers have been proposed. Examples of product formats include lozenges, pastilles, gels, and extruded forms. For example, see the product types described in U.S. Patent Application Publication No. 2008 / 0196730 to Engstrom et al., No. 2008 / 0305216 to Crawford et al., No. 2009 / 0293889 to Kumar et al., No. 2010 / 0291245 to Gao et al., No. 2011 / 0139164 to Mua et al., No. 2012 / 0037175 to Cantrell et al., No. 2012 / 0055494 to Hunt et al., No. 2012 / 0138073 to Cantrell et al., No. 2012 / 0138074 to Cantrell et al., No. 2013 / 0074855 to Holton, Jr., No. 2013 / 0074856 to Holton, Jr., No. 2013 / 0152953 to Mua et al., No. 2013 / 0274296 to Jackson et al., No. 2015 / 0068545 to Moldoveanu et al., No. 2015 / 0101627 to Marshall et al., and No. 2015 / 0230515 to Lampe et al., each of which is incorporated herein by reference.

[0004] The all-white snus portion is gaining popularity and provides a distinct and aesthetically appealing alternative to traditional snus. Such modern "white" pouch-containing products may contain bleached tobacco or may be tobacco-free.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Patent Document 3

[0006] (Abstract of the Invention) The present disclosure generally provides oral products and processes for preparing such oral products. The products are intended to provide a taste when used orally and typically deliver an active ingredient such as nicotine to the consumer. Such products can also provide desirable sensory stimulation characteristics when inserted into the mouth of a user of these products. [Means for Solving the Problems]

[0007] Accordingly, in one aspect, the present disclosure provides an oral product that, based on the total weight of the product, contains at least one active ingredient in an amount of about 10 weight percent or less, at least one sugar alcohol in an amount of about 25 weight percent to about 45 weight percent, and gum in an amount of about 35 weight percent to about 55 weight percent, and is in the form of a lozenge. In some embodiments, the at least one active ingredient may be selected from the group consisting of nicotine components, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabinimimetics, terpenes, and combinations thereof. In certain embodiments, the at least one active ingredient may be selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12 (or other B vitamins), vitamin C, lemon balm extract, ginseng, choline, sunflower lecithin, and combinations thereof.

[0008] In certain other embodiments, the at least one active ingredient may include a combination of caffeine, taurine, and ascorbic acid. In such embodiments of the oral product, for example, based on the total weight of the product, caffeine may be present in an amount of about 2 weight percent to about 4 weight percent, taurine may be present in an amount of about 2 weight percent to about 4 weight percent, and ascorbic acid may be present in an amount of about 1 weight percent to about 3 weight percent. In some embodiments of the oral product, the at least one active ingredient may include theanine, gamma-aminobutyric acid, and lemon balm. In such embodiments, for example, based on the total weight of the product, theanine may be present in an amount of about 2 weight percent to about 4 weight percent, gamma-aminobutyric acid may be present in an amount of about 2 weight percent to about 4 weight percent, and lemon balm may be present in an amount of about 1 weight percent to about 3 weight percent. In still other embodiments of the oral product, the at least one active ingredient may include caffeine, theanine, and ginseng. In such embodiments, for example, based on the total weight of the product, caffeine may be present in an amount of about 2% to about 4%, theanine may be present in an amount of about 2% to about 4%, and ginseng may be present in an amount of about 0.1 weight percent to about 1 weight percent.

[0009] In some aspects of the present disclosure, the oral care product may include at least one active ingredient, including a combination of active ingredients present in an amount within the range of about 6 wt% to about 8 wt% based on the total weight of the product. In some embodiments, the oral care products described herein may be substantially free of tobacco materials. In some embodiments, the oral care products described herein may be substantially free of nicotine or nicotine-derived components.

[0010] In some embodiments of the oral care product, the at least one sugar alcohol may be selected from the group consisting of erythritol, arabinitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof. In certain embodiments, the at least one sugar alcohol may be selected from the group consisting of isomalt, maltitol, erythritol, and combinations thereof. In such embodiments, for example, the at least one sugar alcohol may include isomalt in an amount of about 20 wt% to about 35 wt%, maltitol in an amount of about 1 wt% to about 10 wt%, and erythritol in an amount of about 0.1 wt% to about 2 wt% based on the total weight of the product.

[0011] In some embodiments, the gum may be selected from the group consisting of gum arabic, xanthan gum, guar gum, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof. In some embodiments, the oral care products described herein may include an additive or combination of additives selected from the group consisting of flavoring agents, sweetening agents, additional binders, emulsifiers, disintegrating aids, wetting agents, salts, and mixtures thereof. In some embodiments, the oral care product may have an outer coating coated thereon. In some embodiments, the moisture content of the oral care product may be within the range of about 5 wt% to about 20 wt% based on the total weight of the oral care product. In certain embodiments, the moisture content of the oral care product may be within the range of about 5 wt% to about 10 wt% based on the total weight of the oral care product.

[0012] In one or more aspects, the present disclosure may provide an oral care product having various components included therein. For example, in some embodiments, the oral care product may include (i) a sugar alcohol in an amount in the range of 25 wt% to 45 wt% based on the total weight of the composition, (ii) a gum in an amount in the range of about 35 wt% to about 55 wt%, (iii) at least one active ingredient in an amount of about 10 wt% or less, (iv) a humectant in an amount in the range of about 0.1 wt% to about 5 wt%, (v) a salt in an amount in the range of about 0.1 wt% to about 5 wt%, (vi) a flavoring agent in an amount in the range of about 0.1 wt% to about 5 wt%, (vii) a moisture content in the range of about 5 wt% to about 10 wt% and (viii) a sweetening agent of at least about 0.01 wt%.

[0013] Some aspects of the present disclosure relate to methods of manufacturing an oral care product, such as a product in the form of, for example, a lozenge and / or a pastille. In some embodiments, for example, a method of manufacturing a pastille product may include mixing a gum and at least one active ingredient to obtain a combined mixture thereof, adding water, at least one additive and at least one flavoring agent to the combined mixture to obtain an aqueous mixture, separately adding at least one sugar alcohol to the aqueous mixture to obtain an oral care composition, heating the oral care composition, injecting the oral care composition into a mold and curing the oral care composition to obtain an oral care product in the form of a pastille. In some embodiments, such a method may include heating the gum to a temperature in the range of about 40°C to about 80°C. In some embodiments, the at least one sugar alcohol may be heated to a temperature in the range of about 160°C to about 190°C and then cooled to a temperature in the range of about 120°C to about 150°C before being added to the aqueous mixture. In some embodiments, the oral care composition is heated to a temperature in the range of about 60°C to about 80°C in the heating step.

[0014] Some aspects of the present disclosure relate to oral products having, based on the total weight of the product, at least one active ingredient, a sugar alcohol, and a gum in an amount of about 10 weight percent or less, and being in the form of a lozenge. In some embodiments, the active ingredient may be present in an amount of about 1 weight percent or less. In some embodiments, the sugar alcohol may include sorbitol. In some embodiments, the sugar alcohol may be selected from the group consisting of erythritol, arabinitol, ribitol, isomalt, maltitol, xylitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof. In some embodiments, the gum may be gum arabic. In some embodiments, the gum may be selected from the group consisting of gum arabic, xanthan gum, guar gum, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof.

[0015] In some embodiments, the at least one active ingredient may be selected from the group consisting of nicotine components, botanicals, nutraceuticals, stimulants, amino acids, vitamins, cannabinoids, cannabinomimetics, terpenes, and combinations thereof. In some embodiments, the oral product may include a tobacco material. In certain other embodiments, the oral product may be substantially free of tobacco material. In some embodiments, the oral products of the present disclosure may include additives selected from the group consisting of flavoring agents, sweetening agents, additional binders, emulsifiers, disintegrants, wetting agents, salts, and mixtures thereof.

[0016] In some embodiments, the oral product may have an outer coating coated thereon. In some embodiments, the oral product may contain a sufficient amount of buffer and / or pH adjuster to adjust the pH of the oral product to be within the range of about 5.0 to about 7.0. In some embodiments, the buffer and / or pH adjuster may be, for example, citric acid. In some embodiments, the moisture content of the oral product may be within the range of about 5 weight percent to about 20 weight percent based on the total weight of the oral product. In some embodiments, the oral product contains at least about 30 weight percent of at least one sugar alcohol, at least about 40 weight percent of at least one gum, at least about 2 weight percent of at least one wetting agent, at least about 0.05 weight percent of at least one sweetening agent, and at least about 0.1 weight percent of at least one flavoring agent based on the total weight of the composition.

[0017] In some aspects, the present disclosure provides an oral product that may be in the form of a lozenge. For example, in some embodiments, the present disclosure provides an oral product in the form of a lozenge that contains at least one active ingredient in an amount of 10 weight percent or less, at least about 80 weight percent of a sugar substitute and a sugar alcohol syrup. In some embodiments, the active ingredient may be present in an amount of 1 weight percent or less. In some embodiments, the sugar substitute may be a non-hygroscopic sugar alcohol capable of forming a vitreous matrix. In some embodiments, the sugar substitute may be, for example, isomalt. In some embodiments, the sugar substitute may be present in an amount of at least about 85 weight percent. In some embodiments, the sugar substitute may be present in an amount of at least about 90 weight percent. In some embodiments, the sugar substitute may be present in an amount of at least about 95 weight percent. In some embodiments, the sugar alcohol syrup is maltitol syrup.

[0018] In some embodiments, the oral products according to the present disclosure may contain additives selected from the group consisting of flavoring agents, sweetening agents, additional filler components, emulsifiers, disintegrating aids, wetting agents, salts, and mixtures thereof. In some embodiments, the oral products described herein may contain a sufficient amount of a buffering agent and / or a pH adjusting agent to adjust the pH of the oral product to be within the range of about 5.0 to about 7.0. In some embodiments, the buffering agent and / or the pH adjusting agent may be, for example, citric acid. In some embodiments, the moisture content of the oral lozenge product can be within the range of about 0.1 weight percent to about 5 weight percent based on the total weight of the oral product.

[0019] In some embodiments, the active ingredient can be selected from the group consisting of nicotine components, botanicals, dietary supplements, stimulants, amino acids, vitamins, cannabinoids, cannabinomimetics, terpenes, and combinations thereof. In some embodiments, the oral product may contain tobacco materials. In some embodiments, the tobacco material is in the form of an ultrafiltered tobacco extract. In certain other embodiments, the oral product may be substantially free of tobacco materials. In some embodiments, the oral products of the present disclosure contain at least one active ingredient in an amount of 2 weight percent or less, at least about 80 weight percent of a sugar substitute, at least about 2 weight percent of at least one wetting agent, at least about 0.1 weight percent of a sugar alcohol syrup, at least about 0.1 weight percent of at least one flavoring agent, and at least about 0.05 weight percent of at least one sweetening agent, based on the total weight of the composition.

[0020] The present disclosure includes, but is not limited to, the following embodiments.

[0021] Embodiment 1: An oral product in the form of a paste, containing at least one active ingredient, a sugar alcohol, and a gum in an amount of about 10 weight percent or less based on the total weight of the product.

[0022] Embodiment 2: The oral product of Embodiment 1, wherein at least one active ingredient is selected from the group consisting of nicotine components, botanicals, dietary supplements, stimulants, amino acids, vitamins, cannabinoids, cannabinomimetics, terpenes, and combinations thereof.

[0023] Embodiment 3: The oral product of any one of Embodiments 1 to 2, wherein the active ingredient contains a nicotine component in an amount of about 1 weight percent or less.

[0024] Embodiment 4: The oral product of any one of Embodiments 1 to 3, further comprising a tobacco material.

[0025] Embodiment 5: The oral product of any one of Embodiments 1 to 3, substantially free of tobacco material.

[0026] Embodiment 6: The oral product of any one of Embodiments 1 to 5, wherein the sugar alcohol is selected from the group consisting of erythritol, arabinitol, ribitol, isomalt, maltitol, xylitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof.

[0027] Embodiment 7: The oral product of any one of Embodiments 1 to 6, wherein the sugar alcohol contains sorbitol.

[0028] Embodiment 8: The oral product of any one of Embodiments 1 to 7, wherein the gum is selected from the group consisting of gum arabic, xanthan gum, guar gum, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof.

[0029] Embodiment 9: The oral product of any one of Embodiments 1 to 8, wherein the gum is gum arabic.

[0030] Embodiment 10: The oral product of any one of Embodiments 1 to 9, further comprising an additive selected from the group consisting of flavoring agents, sweetening agents, additional binders, emulsifiers, disintegrating aids, wetting agents, salts, and mixtures thereof.

[0031] Embodiment 11: An oral product according to any one of Embodiments 1 to 10, wherein the oral pastille product has an outer coating coated thereon.

[0032] Embodiment 12: An oral product according to any one of Embodiments 1 to 11, further comprising a buffer and / or a pH adjuster in an amount sufficient to adjust the pH of the oral product to be within the range of about 5.0 to about 7.0.

[0033] Embodiment 13: An oral product according to any one of Embodiments 1 to 12, wherein the buffer and / or the pH adjuster is citric acid.

[0034] Embodiment 14: An oral product according to any one of Embodiments 1 to 13, wherein the moisture content of the oral product is within the range of about 5% by weight to about 20% by weight based on the total weight of the oral product.

[0035] Embodiment 15: An oral product according to any one of Embodiments 1 to 14, comprising at least about 30% by weight of a sugar alcohol, at least about 40% by weight of at least one gum, at least about 2% by weight of at least one wetting agent, at least about 0.05% by weight of at least one sweetening agent, and at least about 0.1% by weight of at least one flavoring agent, based on the total weight of the composition.

[0036] Embodiment 16: An oral product configured for oral use, comprising at least one active ingredient in an amount of 10% by weight or less, at least about 80% by weight of a sugar substitute and a sugar alcohol syrup, and being in the form of a lozenge.

[0037] Embodiment 17: The oral product of Embodiment 16, wherein the at least one active ingredient is selected from the group consisting of a nicotine component, a botanical, a nutritional supplement, a stimulant, an amino acid, a vitamin, a cannabinoid, a cannabinimimetic, a terpene, and combinations thereof.

[0038] Embodiment 18: An oral product according to any one of Embodiments 16 to 17, wherein at least one active ingredient contains a nicotine component in an amount of about 1% by weight or less.

[0039] Embodiment 19: An oral product according to any one of Embodiments 16 to 18, further comprising a tobacco material.

[0040] Embodiment 20: An oral product according to any one of Embodiments 16 to 19, wherein the tobacco material is in the form of an ultrafiltered tobacco extract.

[0041] Embodiment 21: An oral product according to any one of Embodiments 16 to 18, substantially free of a tobacco material.

[0042] Embodiment 22: An oral product according to any one of Embodiments 16 to 21, wherein the sugar substitute is a non-hygroscopic sugar alcohol capable of forming a glassy matrix.

[0043] Embodiment 23: An oral product according to any one of Embodiments 16 to 22, wherein the sugar substitute is isomalt.

[0044] Embodiment 24: An oral product according to any one of Embodiments 16 to 23, wherein the sugar substitute is present in an amount of at least about 85% by weight.

[0045] Embodiment 25: An oral product according to any one of Embodiments 16 to 24, wherein the sugar substitute is present in an amount of at least about 90% by weight.

[0046] Embodiment 26: An oral product according to any one of Embodiments 16 to 25, wherein the sugar substitute is present in an amount of at least about 95% by weight.

[0047] Embodiment 27: An oral product according to any one of Embodiments 16 to 26, wherein the sugar alcohol syrup is maltitol syrup.

[0048] Embodiment 28: An oral product according to any one of Embodiments 16 to 27, further comprising an additive selected from the group consisting of a flavoring agent, a sweetening agent, an additional filler component, an emulsifier, a disintegrating aid, a wetting agent, a salt, and mixtures thereof.

[0049] Embodiment 29: An oral product according to any one of Embodiments 16 to 28, further comprising a buffer and / or a pH adjuster in an amount sufficient to adjust the pH of the oral product to be within the range of about 5.0 to about 7.0.

[0050] Embodiment 30: An oral product according to any one of Embodiments 16 to 29, wherein the buffer and / or the pH adjuster is citric acid.

[0051] Embodiment 31: An oral product according to any one of Embodiments 16 to 30, wherein the moisture content of the oral product is within the range of about 0.1 weight percent to about 5 weight percent based on the total weight of the oral product.

[0052] Embodiment 32: An oral product according to any one of Embodiments 16 to 31, comprising at least about 80 weight percent of a sugar substitute, at least about 2 weight percent of at least one wetting agent, at least about 0.1 weight percent of a sugar alcohol syrup, at least about 0.1 weight percent of at least one flavoring agent, and at least about 0.05 weight percent of at least one sweetening agent.

[0053] Embodiment 33: Use of at least one active ingredient in an oral product, wherein the active ingredient is present in an amount of 10 weight percent or less based on the total weight of the product.

[0054] Embodiment 34: Use of at least one active ingredient in an oral product according to Embodiment 33, wherein the oral product is substantially free of tobacco materials.

[0055] Embodiment 35: Use of at least one active ingredient in an oral product according to any one of Embodiments 33 to 34, wherein the oral product is in the form of a pastille or a lozenge.

[0056] Embodiment 36: Use of a nicotine component in an oral product, wherein the nicotine component is present in an amount of 1% by weight or less based on the total weight of the product.

[0057] Embodiment 37: Use of a nicotine component in the oral product of Embodiment 36, wherein the oral product is substantially free of tobacco materials.

[0058] Embodiment 38: Use of a nicotine component in any of the oral products of Embodiments 36 - 37, wherein the oral product is in the form of a lozenge or a pastille.

[0059] Embodiment 39: An oral product in the form of a pastille, comprising at least one active ingredient in an amount of about 10% by weight or less, at least one sugar alcohol in an amount of about 25% - about 45% by weight, and gum in an amount of about 35% - about 55% by weight, based on the total weight of the product.

[0060] Embodiment 40: The oral product of Embodiment 39, wherein the at least one active ingredient is selected from the group consisting of a nicotine component, botanicals, dietary supplements, stimulants, amino acids, vitamins, cannabinoids, cannabinomimetics, terpenes, and combinations thereof.

[0061] Embodiment 41: The oral product of any of Embodiments 39 - 40, wherein the at least one active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof.

[0062] Embodiment 42: The oral product of any of Embodiments 39 - 41, wherein the at least one active ingredient comprises a combination of caffeine, taurine, and ascorbic acid, and optionally further comprises trisodium citrate.

[0063] Embodiment 43: An oral product according to Embodiment 42, wherein caffeine is present in an amount of about 2% by weight to about 4% by weight, taurine is present in an amount of about 2% by weight to about 4% by weight, and ascorbic acid is present in an amount of about 1% by weight to about 3% by weight, based on the total weight of the product.

[0064] Embodiment 44: An oral product according to any one of Embodiments 39 to 41, wherein at least one active ingredient comprises theanine, gamma-aminobutyric acid and optionally lemon balm.

[0065] Embodiment 45: An oral product according to Embodiment 44, wherein theanine is present in an amount of about 2% by weight to about 4% by weight, gamma-aminobutyric acid is present in an amount of about 2% by weight to about 4% by weight, and lemon balm is present in an amount of about 1% by weight to about 3% by weight, based on the total weight of the product.

[0066] Embodiment 46: An oral product according to any one of Embodiments 39 to 41, wherein at least one active ingredient comprises caffeine, theanine and optionally ginseng.

[0067] Embodiment 47: An oral product according to Embodiment 46, wherein caffeine is present in an amount of about 2% to about 4%, theanine is present in an amount of about 2% to about 4%, and ginseng is present in an amount of about 0.1% by weight to about 1% by weight, based on the total weight of the product.

[0068] Embodiment 48: An oral product according to any one of Embodiments 39 to 47, wherein at least one active ingredient is present in an amount in the range of about 6% by weight to about 8% by weight based on the total weight of the product.

[0069] Embodiment 49: An oral product according to any one of Embodiments 39 to 48, which is substantially free of tobacco materials.

[0070] Embodiment 50: An oral product according to any one of Embodiments 39 to 49, which is substantially free of nicotine or nicotine-derived components.

[0071] Embodiment 51: An oral product according to any one of Embodiments 39 to 50, wherein at least one sugar alcohol is selected from the group consisting of erythritol, arabinitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof.

[0072] Embodiment 52: An oral product according to any one of Embodiments 39 to 51, wherein at least one sugar alcohol is selected from the group consisting of isomalt, maltitol, erythritol, and combinations thereof.

[0073] Embodiment 53: An oral product according to any one of Embodiments 39 to 52, wherein at least one sugar alcohol contains isomalt in an amount of about 20% to about 35% by weight, maltitol in an amount of about 1% to about 10% by weight, and erythritol in an amount of about 0.1% to about 2% by weight based on the total weight of the product.

[0074] Embodiment 54: An oral product according to any one of Embodiments 39 to 53, wherein the gum is selected from the group consisting of gum arabic, xanthan gum, guar gum, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof.

[0075] Embodiment 55: An oral product according to any one of Embodiments 39 to 54, further comprising an additive selected from the group consisting of flavoring agents, sweetening agents, additional binders, emulsifiers, disintegrating aids, wetting agents, salts, and mixtures thereof.

[0076] Embodiment 56: An oral product according to any one of Embodiments 39 to 55, wherein the oral lozenge product has an outer coating coated thereon.

[0077] Embodiment 57: An oral product according to any one of Embodiments 39 to 56, wherein the moisture content of the oral product is in the range of about 5% to about 20% by weight based on the total weight of the oral product.

[0078] Embodiment 58: An oral product according to any one of Embodiments 39 to 57, wherein the water content of the oral product is in the range of about 5% by weight to about 10% by weight based on the total weight of the oral product.

[0079] Embodiment 59: An oral product comprising, based on the total weight of the composition, an amount of sugar alcohol in the range of 25% by weight to 45% by weight, an amount of gum in the range of about 35% by weight to about 55% by weight, an amount of at least one active ingredient of about 10% by weight or less, an amount of wetting agent in the range of about 0.1% by weight to about 5% by weight, an amount of salt in the range of about 0.1% by weight to about 5% by weight, an amount of flavoring agent in the range of about 0.1% by weight to about 5% by weight, a water content in the range of about 5% by weight to about 10% by weight, and at least about 0.01% by weight of a sweetening agent.

[0080] Embodiment 60: A method for preparing an oral product, comprising mixing gum and at least one active ingredient to obtain a combined mixture thereof, adding water, at least one additive, and at least one flavoring agent to the combined mixture to obtain an aqueous mixture, adding at least one sugar alcohol separately to the aqueous mixture to obtain an oral composition, heating the oral composition, injecting the oral composition into a mold, and curing the oral composition to obtain an oral product in the form of a pastille.

[0081] Embodiment 61: The method of Embodiment 60, wherein the gum is heated to a temperature in the range of about 40°C to about 80°C.

[0082] Embodiment 62: The method according to any one of Embodiments 60 to 61, wherein at least one sugar alcohol is heated to a temperature in the range of about 160°C to about 190°C before being added to the aqueous mixture and then optionally cooled to a temperature in the range of about 120°C to about 150°C.

[0083] Embodiment 63: The method according to any one of Embodiments 60 to 62, wherein heating the oral composition comprises heating to a temperature in the range of about 60°C to about 80°C.

[0084] Embodiment 64: A method according to any one of Embodiments 60 to 63, wherein at least one active ingredient is selected from the group consisting of nicotine components, botanicals, dietary supplements, stimulants, amino acids, vitamins, cannabinoids, cannabinimimetics, terpenes, and combinations thereof.

[0085] Embodiment 65: A method according to any one of Embodiments 60 to 64, wherein at least one sugar alcohol is selected from the group consisting of erythritol, arabinitol, ribitol, isomalt, maltitol, xylitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof.

[0086] Embodiment 66: A method according to any one of Embodiments 60 to 65, wherein at least one additive is selected from the group consisting of flavoring agents, sweetening agents, additional binders, emulsifiers, disintegrating aids, wetting agents, salts, and mixtures thereof.

[0087] Embodiment 67: An oral product in the form of a lozenge, comprising an active ingredient in an amount of 10 weight percent or less, at least about 80 weight percent of a sugar substitute, and a sugar alcohol syrup.

[0088] Embodiment 68: An oral product according to Embodiment 67, wherein at least one active ingredient is selected from the group consisting of nicotine components, botanicals, dietary supplements, stimulants, amino acids, vitamins, cannabinoids, cannabinimimetics, terpenes, and combinations thereof.

[0089] Embodiment 69: An oral product according to any one of Embodiments 67 to 68, wherein at least one active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, choline, sunflower lecithin, and combinations thereof.

[0090] Embodiment 70: An oral product according to any one of Embodiments 67 to 69, wherein at least one active ingredient comprises a combination of caffeine, taurine, and ascorbic acid.

[0091] Embodiment 71: An oral product according to Embodiment 70, wherein caffeine is present in an amount of about 2% to about 4% by weight, taurine is present in an amount of about 2% to about 4% by weight, and ascorbic acid is present in an amount of about 1% to about 3% by weight, based on the total weight of the product.

[0092] Embodiment 72: An oral product according to any one of Embodiments 67 to 69, wherein at least one active ingredient includes theanine, gamma-aminobutyric acid, and optionally lemon balm.

[0093] Embodiment 73: An oral product according to Embodiment 72, wherein theanine is present in an amount of about 2% to about 4% by weight, gamma-aminobutyric acid is present in an amount of about 2% to about 4% by weight, and lemon balm is present in an amount of about 1% to about 3% by weight, based on the total weight of the product.

[0094] Embodiment 74: An oral product according to any one of Embodiments 67 to 69, wherein at least one active ingredient includes caffeine, theanine, and optionally ginseng.

[0095] Embodiment 75: An oral product according to Embodiment 74, wherein caffeine is present in an amount of about 2% to about 4% by weight, theanine is present in an amount of about 2% to about 4% by weight, and ginseng is present in an amount of about 0.1% to about 1% by weight, based on the total weight of the product.

[0096] Embodiment 76: An oral product according to any one of Embodiments 67 to 75, wherein at least one active ingredient is present in an amount in the range of about 6% to about 8% by weight, based on the total weight of the product.

[0097] Embodiment 77: An oral product according to any one of Embodiments 67 to 76, which does not contain tobacco materials.

[0098] Embodiment 78: An oral product according to any one of Embodiments 67 to 77, which does not contain nicotine or nicotine-derived components.

[0099] Embodiment 79: An oral product according to any one of Embodiments 67 to 78, further comprising a tobacco material.

[0100] Embodiment 80: An oral product according to any one of Embodiments 67 to 79, wherein the sugar substitute is a non-hygroscopic sugar alcohol capable of forming a glassy matrix.

[0101] Embodiment 81: An oral product according to any one of Embodiments 67 to 80, wherein the sugar substitute is isomalt.

[0102] Embodiment 82: An oral product according to any one of Embodiments 67 to 81, wherein the sugar substitute is present in an amount of at least about 85 weight percent.

[0103] Embodiment 83: An oral product according to any one of Embodiments 67 to 82, wherein the sugar substitute is present in an amount of at least about 90 weight percent.

[0104] Embodiment 84: An oral product according to any one of Embodiments 67 to 83, wherein the sugar substitute is present in an amount of at least about 95 weight percent.

[0105] Embodiment 85: An oral product according to any one of Embodiments 67 to 84, wherein the sugar alcohol syrup is maltitol syrup.

[0106] Embodiment 86: An oral product according to any one of Embodiments 67 to 85, further comprising an additive selected from the group consisting of a flavoring agent, a sweetening agent, an additional filler component, an emulsifier, a disintegrating aid, a wetting agent, a salt, and mixtures thereof.

[0107] Embodiment 87: An oral product according to any one of Embodiments 67 to 86, further comprising a sufficient amount of a buffering agent and / or a pH adjusting agent to adjust the pH of the oral product to be within the range of about 5.0 to about 7.0.

[0108] Embodiment 88: An oral care product according to any one of Embodiments 67 to 87, wherein the water content of the oral care product is in the range of about 0.1% by weight to about 5% by weight based on the total weight of the oral care product.

[0109] Embodiment 89: An oral care product according to any one of Embodiments 1 to 88, wherein at least one active ingredient is theanine, theanine and tryptophan or theanine and vitamin B6, vitamin B12 or both. An oral care product according to any one of Embodiments 1 to 88, which contains

[0110] Embodiment 90: An oral care product according to Embodiment 89, which contains theanine and one or both of vitamin B6 and vitamin B12.

[0111] Embodiment 91: An oral care product according to any one of Embodiments 1 to 90, further containing magnesium in an amount by weight of about 0.1% to about 2% or about 0.2 to about 1% based on elemental magnesium, for example.

[0112] These and other features, aspects, and advantages of the present disclosure will become apparent from reading the following detailed description in conjunction with the accompanying drawings described briefly below. The present invention includes any combination of two, three, four, or more of the above-described embodiments and any two, three, four, or more features or elements described in the present disclosure, whether or not such features or elements are explicitly combined in the description of a specific embodiment herein. This disclosure is intended to be read holistically such that any separable features or elements of the disclosed invention are combinable, unless the context clearly indicates otherwise, in any of its various aspects and embodiments.

Best Mode for Carrying Out the Invention

[0113] The present disclosure will be described more fully hereinafter with reference to example embodiments thereof. These example embodiments are described so that this disclosure will be thorough and complete and will fully convey the scope of the disclosure to those skilled in the art. Indeed, the present disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. As used in this specification and the claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. References to "percent dry weight" or "dry weight basis" refer to weight based on dry components (i.e., all components excluding water). References to "wet weight" refer to the weight of a mixture including water. Unless otherwise indicated, references to "percent weight" of a mixture represent the total wet weight of the mixture (i.e., including water).

[0114] The present disclosure provides products configured for oral use and processes for preparing such oral products. The oral products described herein may generally include a mixture of ingredients in the form of a composition. For example, in some embodiments, the compositions provided herein may include one or more active ingredients (e.g., tobacco materials and / or nicotine) and may include one or more additives (e.g., fillers, binder components, flavorants, etc.) that together form a product configured for oral use.

[0115] The oral products described herein can be provided in various different forms and by various combinations of ingredients. In particular, in preferred embodiments, the products of the present disclosure can be provided in one of two forms, for example, in the form of a lozenge-type product or a pastille-type product. The lozenge-type and pastille-type products according to embodiments of the present disclosure can be configured for oral use, but advantageously can provide different features and characteristics upon insertion of the product into the mouth of the user thereof. Certain products can exhibit, for example, one or more of the following features: crunchy, granular, chewy, syrupy, pasty, fluffy, smooth and / or creamy. In certain embodiments, the desired textural properties can be selected from the group consisting of adhesiveness, cohesiveness, density, dryness, brittleness, granulosity, gumminess, hardness, weight, water absorption, water release, mouthcoating, roughness, slipperiness, smoothness, tackiness, wetness and combinations thereof.

[0116] As used herein, the term "configured for oral use" means that the product is provided in a form such that, during use, one or more of the ingredients of the product (e.g., flavorants and / or nicotine) enter the mouth of the user by the saliva in the user's mouth. In one embodiment, the product is adapted to deliver the ingredient(s) to the user through the mucous membranes in the user's mouth, and in addition, the ingredient(s) 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. In some embodiments, the product may be adapted to deliver flavor components in addition to the active ingredient(s) to the user.

[0117] Products containing the compositions of the present disclosure may be dissolvable. As used herein, the terms "dissolve", "dissolubility", and "dissolvable" refer to compositions having water-soluble components that interact with the moisture in the oral cavity to form a solution, thereby causing the product to be gradually consumed. According to one aspect, a dissolvable product can last in the user's mouth for a given period of time until it is completely dissolved. The dissolution rate can vary over a wide range from about 1 minute or less to about 60 minutes. For example, a rapid release mixture typically dissolves and / or releases the active substance in about 2 minutes or less, often in about 1 minute or less (e.g., about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). Dissolution can occur by any means, such as melting, mechanical disruption (e.g., chewing), enzymatic or other chemical decomposition, or disruption of the interaction between the components of the mixture. In some embodiments, the product may be meltable, as discussed, for example, in U.S. Patent Application Publication No. 2012 / 0037175 to Cantrell et al. In other embodiments, the product does not dissolve while it is retained in the user's mouth.

[0118] In some embodiments, the products disclosed herein may be in the form of a lozenge product for oral use that is dissolvable and lightly chewable. As used herein, the term "lozenge" refers to a dissolvable oral product made by solidifying a liquid or gel composition, such as a composition containing a gelling or binding agent, so that the final product becomes a hardened solid gel. In certain embodiments, the lozenge products of the present disclosure are characterized by sufficient cohesiveness to withstand light chewing action in the oral cavity without rapid disintegration. The lozenge products of the present disclosure typically do not exhibit the highly deformable chewing characteristics found in conventional chewing gums. See, for example, the smokeless tobacco lozenges, lozenge formulations, lozenge configurations, lozenge characteristics, and techniques for formulating or manufacturing lozenges described in U.S. Patent Nos. 9,204,667 to Cantrell et al., 9,775,376 to Cantrell et al., and 10,357,054 to Marshall et al., which are incorporated herein by reference in their entireties.

[0119] Alternatively, in some embodiments, the products disclosed herein may be in the form of a dissolvable lozenge product configured for oral use. Exemplary lozenge-type products of the present invention have the form of lozenges, tablets, microtabs or other tablet-type products. For example, U.S. Patent No. 4,967,773 to Shaw, U.S. Patent No. 5,110,605 to Acharya, U.S. Patent No. 5,733,574 to Dam, U.S. Patent No. 6,280,761 to Santus, U.S. Patent No. 6,676,959 to Andersson et al., U.S. Patent Nos. 6,248,760 and 7,374,779 to Wilhelmsen, U.S. Patent Application Publication No. 2001 / 0016593 to Wilhelmsen, U.S. Patent Application Publication No. 2004 / 0101543 to Liu et al., U.S. Patent Application Publication No. 2006 / 0120974 to Mcneight, U.S. Patent Application Publication No. 2008 / 0020050 to Chau et al., U.S. Patent Application Publication No. 2009 / 0081291 to Gin et al., and U.S. Patent Application Publication No. 2010 / 0004294 to Axelsson et al., the contents of which are incorporated herein by reference, are referred to for the types of nicotine-containing lozenges, lozenge formulations, lozenge formats and configurations, lozenge characteristics, and techniques for formulating or manufacturing lozenges. Such lozenge-type products may exhibit translucency or transparency in some embodiments. The desired transparency or translucency of the product can be quantified by any known method. For example, optical methods such as turbidimetry (or nephelometry) and colorimetry can be used to quantify the haze (light scattering) and color (light absorption) of the product, respectively. Translucency can also be confirmed by visual inspection, simply by lifting the product up to a light source and determining whether light diffuses through the material or product.

[0120] The oral products of the present disclosure may be provided in the specific physical forms described above (e.g., in the form of pastilles or lozenges) by changing the moisture content. For example, the moisture content of the product may be provided within a specific range so as to define the final form of the product. The moisture content of the products described herein before use by the consumer of the product may vary within such a range in addition to defining the final form of the product, depending on the desired properties and characteristics. For example, a pastille-type product typically has a moisture content in the range of about 5 to about 20 weight percent, based on the total weight of the composition. Preferably, the moisture content of the pastille product present within a single unit of the product before insertion into the user's mouth is in the range of about 5 to about 25 weight percent, often about 8 to about 20 weight percent, and more often about 10 to about 15 weight percent, based on the total weight of the product unit. In some embodiments, the moisture content of the pastille product can be at least about 5 weight percent, at least about 10 weight percent, at least about 15 weight percent or at least about 20 weight percent, based on the total weight of the product.

[0121] Alternatively, a lozenge-type product typically has a moisture content in the range of about 0.1 to about 5 weight percent, based on the total weight of the composition. Preferably, the moisture content of the lozenge product present within a single unit of the product before insertion into the user's mouth is less than about 5 weight percent, less than about 3 weight percent, less than about 2 weight percent or less than about 1 weight percent, based on the total weight of the product unit. In some embodiments, the moisture content of the lozenge product described herein can be in the range of about 0.1 to about 5 weight percent, about 0.5 to about 3 weight percent or about 1 to about 2 weight percent, based on the total weight of the product.

[0122] As described above, the lozenge-type and pastille-type products of the present disclosure may incorporate various different additives in addition to at least one active ingredient and may be prepared by a variety of different methods generally known in the art for preparing lozenge-type and pastille-type products. Exemplary compositions, products, and methods of preparing such products are detailed below in this specification. Pastille product The pastille products of the present disclosure typically include a composition comprising at least one active ingredient (e.g., a nicotine compound) in an amount of less than about 10 weight percent, gum, and a sugar alcohol as a filler component. Any active ingredient (e.g., a tobacco material and / or an active ingredient) discussed below in this specification is meant to be suitable for use as an active ingredient in a pastille composition according to the present disclosure. Such an active ingredient may be added as the sole active ingredient or in combination with one or more other active ingredients. In some embodiments, the active ingredient may be provided in a liquid form or in the form of a dry powder or fine particles. As described above, the active ingredient is typically present in an amount from about 0.1 weight percent to about 10 weight percent, such as about 0.1 weight percent, about 0.5 weight percent, about 1 weight percent, about 1.5 weight percent, about 2 weight percent, about 2.5 weight percent, about 3 weight percent, about 3.5 weight percent, about 4 weight percent, or about 4.5 weight percent to about 5.5 weight percent, about 6 weight percent, about 6.5 weight percent, about 7 weight percent, about 7.5 weight percent, about 8 weight percent, about 8.5 weight percent, about 9 weight percent, about 9.5 weight percent, or about 10 weight percent, based on the total weight of the composition. In some embodiments, the active ingredient may be present in an amount of less than about 10 weight percent, less than about 9 weight percent, less than about 8 weight percent, less than about 7 weight percent, less than about 6 weight percent, less than about 5 weight percent, less than about 4 weight percent, less than about 3 weight percent, less than about 2 weight percent, or less than about 1 weight percent, based on the total weight of the composition.

[0123] Gum (or a combination of two or more gums) may be used in an amount sufficient to provide the physical properties and physical integrity desired for the lozenge product. In some embodiments, the gum can function as a binder component in the oral care product. Representative amounts of gum can account for at least about 5 percent or at least about 10 percent of the total weight of the lozenge composition. In certain embodiments, the gum in the composition is present in an amount of at least about 30 weight percent, at least about 35 weight percent, at least about 40 weight percent, at least about 45 weight percent or at least about 50 weight percent, based on the total weight of the composition. In some embodiments, the gum in the composition may be present in an amount of about 35 weight percent to about 55 weight percent, based on the total weight of the composition. Preferably, the total amount of gum in the lozenge product does not exceed about 55 percent of the total weight of the composition. Often, the amount of gum in the desired composition does not exceed about 65 percent of the total weight of the composition and often does not exceed about 60 percent.

[0124] In certain embodiments, the gum includes natural gum. In particular, natural gums (such as gum arabic, etc.) may be incorporated into the lozenge product as a softening agent. Advantageously, the use of natural gum as a softening agent provides the desired textural characteristics necessary to form the lozenge composition, particularly those described herein. In particular, it should be noted that as the amount of natural gum (such as gum arabic) increases while the amount of sugar alcohol subsequently decreases, the flexibility of the resulting lozenge product can advantageously be increased. As used herein, natural gum refers to a polysaccharide material of natural origin that is useful as a softening agent. Representative natural gums derived from plants, which are typically somewhat water-soluble, include xanthan gum, guar gum, gum arabic, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof. Preferably, gum arabic can be used as an exemplary natural gum that provides the softening characteristics described above when incorporated into the lozenge composition of the present disclosure.

[0125] In some embodiments, the gum can optionally include a tobacco-derived material in the form of a binder, which may be combined with one or more additional binder components. For example, in one particular embodiment, the gum component includes gum arabic in combination with the tobacco-derived binder described herein. In such embodiments, the amount of the tobacco-derived binder in the composition is at least about 0.5 percent or at least about 1 percent or at least about 1.5 percent, based on the weight of the composition. Exemplary weight ranges are from about 0.5 to about 10 weight percent, more often from about 1 to about 5 weight percent.

[0126] As described above, the lozenge products of the present disclosure may contain at least one sugar alcohol in the form of a filler component. Sugar alcohols are particularly advantageous as filler components in the lozenges of the present disclosure. This is because such materials provide some sweetness and do not destroy the chewable characteristic desired in the final product. Sugar alcohols are polyols derived from monosaccharides or disaccharides having a partially or fully hydrogenated form. Exemplary sugar alcohols have from 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). In some embodiments, isomalt may be incorporated as the sole filler component. Sugar alcohols are typically added to the compositions of the present disclosure in the form of an aqueous solution or suspension, e.g., a solution or suspension having a solids content of from about 50 to about 90 weight percent. Combinations of sugar alcohols with additional filler components can also be used. Filler components often serve multiple functions, such as enhancing certain sensory stimulation characteristics such as texture and mouthfeel, as well as enhancing the cohesiveness or compressibility of the product. When present, a representative amount of the filler, whether organic and / or inorganic, can account for at least about 10 percent, at least about 20 percent, or at least about 25 percent based on the total weight of the composition. Preferably, the amount of filler in the composition does not exceed about 50 percent of the total weight of the composition and often does not exceed about 40 percent. Typical filler ranges are from about 15 weight percent to about 50 weight percent, from about 25 weight percent to about 45 weight percent, or from about 30 weight percent to about 40 weight percent.

[0127] Lozenge product The lozenge products of the present disclosure typically include a composition comprising at least one active ingredient (e.g., a nicotine compound) in an amount of less than about 2 weight percent, at least about 80 weight percent of a sugar substitute, and a sugar alcohol syrup. Any active ingredient (e.g., tobacco material and / or active ingredient) discussed below herein is meant to be suitable for use as an active ingredient in the lozenge compositions provided herein. Such active ingredients can be added as the sole active ingredient or in combination with one or more other active ingredients. In some embodiments, the active ingredient can be provided in liquid form or in the form of a dry powder or fine particles. As described above, the active ingredient is typically present in an amount of about 0.1 weight percent to about 10 weight percent, such as about 0.1 weight percent to about 10 weight percent, etc., for example, about 0.1 weight percent, about 0.5 weight percent, about 1 weight percent, about 1.5 weight percent, about 2 weight percent, about 2.5 weight percent, about 3 weight percent, about 3.5 weight percent, about 4 weight percent or about 4.5 weight percent up to about 5.5 weight percent, about 6 weight percent, about 6.5 weight percent, about 7 weight percent, about 7.5 weight percent, about 8 weight percent, about 8.5 weight percent, about 9 weight percent, about 9.5 weight percent or about 10 weight percent, based on the total weight of the composition. In some embodiments, the active ingredient can be present in an amount of less than about 10 weight percent, less than about 9 weight percent, less than about 8 weight percent, less than about 7 weight percent, less than about 6 weight percent, less than about 5 weight percent, less than about 4 weight percent, less than about 3 weight percent, less than about 2 weight percent or less than about 1 weight percent, based on the total weight of the composition.

[0128] In some embodiments, the lozenge product includes a sugar substitute. The sugar substitute is typically provided in a pure, solid form (e.g., granular or powdered form). In certain embodiments, the sugar substitute is dry and contains a very low amount of moisture. For example, the sugar substitute can contain less than about 5 weight % water, less than about 3 weight % water, less than about 2 weight % water or less than about 1 weight % water.

[0129] The sugar substitute can be any sugar-free material (i.e., sucrose-free material), and can be natural or synthetically produced. The sugar substitute used in the products described herein may be a nutrient or a non-nutrient. For example, the sugar substitute is typically a sugar alcohol. Sugar alcohols that may be useful according to the present invention include, but are not limited to, erythritol, threitol, arabitol, xylitol, ribotol, mannitol, sorbitol, dulcitol, iditol, isomalt, maltitol, lactitol, polyglycitols, and mixtures thereof. For example, in certain embodiments, the sugar alcohol is selected from the group consisting of erythritol, sorbitol, and isomalt. The amount of sugar substitute in the lozenge composition can vary, but is typically at least about 75 wt%, at least about 80 wt%, at least about 85 wt%, or at least about 90 wt% or at least about 95 wt% of the composition.

[0130] In certain embodiments, the sugar substitute can form a glassy matrix. The formation of the glassy matrix is typically characterized by a translucent / transparent appearance. Typically, the sugar substitute is substantially non-hygroscopic. Non-hygroscopic materials typically do not absorb, adsorb, and / or retain significant amounts of moisture from the air. For example, in some embodiments, the sugar substitute exhibits a weight gain of less than about 50% water when exposed to conditions of 25°C and 80% relative humidity for two weeks. Typically, the sugar substitute exhibits a weight gain of less than about 30%, less than about 20%, less than about 10%, less than about 5%, less than about 2%, or less than about 1% when exposed to conditions of 25°C and 80% relative humidity for two weeks. Non-hygroscopic materials can provide the benefit of reducing the tendency of the lozenge product to become sticky when exposed to humidity.

[0131] In certain embodiments, the sugar substitute comprises one or more sugar alcohols. For example, in one embodiment, the sugar substitute is isomalt. Isomalt is typically a disaccharide produced by the hydrogenation of sucrose that gives an equimolar composition of 6-O-α-D-glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O-α-D-glucopyranosyl-D-mannitol dihydrate (1,1-GPM dihydrate) after enzymatic rearrangement to isomaltulose.

[0132] In some embodiments, the lozenge product of the present disclosure may include a syrup, such as a sugar syrup or a sugar alcohol syrup. As used herein, "sugar alcohol syrup" is intended to refer to, for example, a concentrated aqueous solution of a sugar alcohol having greater than about 40% solids, preferably greater than about 50% solids, greater than about 60% solids, greater than about 70% solids or greater than about 80% solids. Typically, the solids of the sugar alcohol syrup mainly comprise the designated sugar alcohol (i.e., maltitol syrup typically comprises greater than about 80% by weight, greater than about 85% by weight or greater than about 90% by weight of maltitol on a dry basis). Sugar alcohol syrups are generally prepared by heating an aqueous solution of the sugar alcohol and cooling the mixture to give a viscous composition. The resulting syrup is typically characterized by a relatively high concentration of the sugar alcohol and relatively high stability (i.e., the sugar alcohol typically does not crystallize from the solution, for example at room temperature).

[0133] Syrups, such as sugar alcohol syrups, can desirably affect the recrystallization of the molten sugar substitute. An exemplary sugar alcohol syrup that is particularly useful according to the present disclosure is maltitol syrup. Other sugar alcohol syrups can also be used, including but not limited to, corn syrup, golden syrup, molasses, xylitol, mannitol, glycerol, erythritol, trehalose, arabitol, ribitol, mannitol, sorbitol, dulcitol, iditol, isomalt, lactitol, and polyglycitol syrup. Such sugar alcohol syrups can be prepared or obtained from commercial sources. For example, maltitol syrup is commercially available from suppliers such as Corn Products Specialty Ingredients. Although sugar alcohol syrups are sometimes preferred, in certain embodiments, sugar syrups can be used instead of or in combination with sugar alcohol syrups. For example, in some embodiments, corn syrup, golden syrup, and / or molasses can be used.

[0134] The amount of sugar alcohol syrup added to the lozenge composition mixture is typically the amount required to retard the recrystallization of the molten form of the sugar substitute. It should be noted that the amount of sugar alcohol syrup can be varied depending on the composition of the residual components to sufficiently retard recrystallization and ensure the desired characteristics (e.g., desired level of translucency / transparency) of the material. Thus, while the amount of sugar alcohol syrup can vary, it is typically in the range of about 0.1 wt% to about 2 wt% of the smokeless tobacco product mixture, often about 0.5 wt% to about 1.5 wt%, and more often about 1 wt%. In certain embodiments, the amount of sugar alcohol syrup is more, e.g., up to about 2 wt% of the mixture, up to about 5 wt% of the mixture, up to about 10 wt% of the mixture, or up to about 20 wt% of the mixture.

[0135] Active ingredient The compositions and products disclosed herein include one or more active ingredients. As used herein, "active ingredient" refers to one or more substances belonging to any of the following categories: API (active pharmaceutical ingredient), food additives, natural drugs, and naturally occurring substances that may have effects on humans. Exemplary active ingredients include any ingredient known to affect one or more biological functions in the body, such as an ingredient that provides a pharmacological activity or other direct effect in the diagnosis, cure, alleviation, treatment, or prevention of a disease, or an ingredient that affects the structure or any function of the human body (e.g., provides a stimulating effect on the central nervous system, has an energizing effect, has an antipyretic or analgesic effect, or otherwise has a useful effect on the body). In some embodiments, the active ingredient may generally be of the type commonly referred to as dietary supplements, nutritional supplements, "phytochemicals," or "functional foods." These types of additives include substances (e.g., botanical materials) typically obtainable from natural sources that provide one or more advantageous biological effects (e.g., health promotion, disease prevention, or other medicinal properties) in the art, but may be defined as not being classified or regulated as drugs.

[0136] Non-limiting examples of active ingredients include botanical components, stimulants, amino acids, nicotine components, and / or those included in the categories of pharmaceuticals, nutritional supplements, and medicinal ingredients (e.g., vitamins such as A, B3, B6, B12, and C and / or cannabinoids such as tetrahydrocannabinol (THC) and cannabidiol (CDB)). Each of these categories is further described below herein. The specific selection of the active ingredient will vary depending on the desired flavor, texture, and characteristics desired for a particular product.

[0137] In certain embodiments, the active ingredient is selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, choline, sunflower lecithin, and combinations thereof. For example, the active ingredient can include a combination of caffeine, theanine, and optionally ginseng. In another embodiment, the active ingredient includes a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract. In a further embodiment, the active ingredient includes theanine, theanine and tryptophan, one or more of theanine and B vitamins B6 and B12, or tryptophan, theanine, and one or more of B vitamins B6 and B12. In still further embodiments, the active ingredient includes a combination of caffeine, taurine, and vitamin C, optionally further including one or more additional B vitamins (such as vitamin B6 or B12). A magnesium salt (such as magnesium gluconate) may be added to any of the above combinations, particularly those that also include theanine.

[0138] The specific percentage of the active ingredient present varies according to the desired characteristics of the specific product. Typically, the active ingredient or combination thereof is present at a total concentration within at least about 0.001% by weight of the composition, for example in the range of about 0.001% to about 20%. In some embodiments, the active ingredient or combination of active ingredients is present at a concentration of about 0.1% w / w to about 10% by weight, for example, about 0.5% w / w to about 10% by weight, about 1% to about 10% by weight, about 1% to about 5% by weight, etc., based on the total weight of the composition. In some embodiments, the active ingredient or combination of active ingredients is about 0.001% by weight, about 0.01% by weight, about 0.1% by weight or about 1% to a maximum of about 20% by weight, for example, about 0.001% by weight, about 0.002% by weight, about 0.003% by weight, about 0.004% by weight, about 0.005% by weight, about 0.006% by weight, about 0.007% by weight, about 0.008% by weight, about 0.009% by weight, about 0.01% by weight, about 0.02% by weight, about 0.03% by weight, about 0.04% by weight, about 0.05% by weight, about 0.06% by weight, about 0.07% by weight, about 0.08% by weight, about 0.09% by weight, about 0.1% by weight, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight or about 0.9% to, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, about 15% by weight, about 16% by weight, about 17% by weight, about 18% by weight, about 19% by weight or about 20% by weight, etc., based on the total weight of the composition. Further preferred ranges for specific active ingredients are provided below herein.

[0139] Botanical In some embodiments, the active ingredient includes a botanical ingredient. As used herein, the term "botanical ingredient" or "botanical" refers to any plant material or fungus-derived material, including plant materials in their natural form and plant materials derived from natural plant materials, such as extracts or isolates from plant materials or processed plant materials (e.g., plant materials subjected to heat treatment, fermentation, bleaching, or other processing processes that can change the physical and / or chemical properties of the material). In the present disclosure, "botanical" includes, but is not limited to, "herbaceous materials", which refer to seed-producing plants that do not exhibit persistent woody tissue and are often highly valued for their medicinal or sensory characteristics (e.g., tea or thyme). Referring to a botanical material as "non-tobacco" is intended to exclude tobacco materials (i.e., not including any species of the genus Nicotiana). In some embodiments, the compositions disclosed herein can be characterized as being free of any tobacco materials (e.g., any of the embodiments disclosed herein may be completely or substantially free of any tobacco materials). "Substantially free" means that no tobacco material is intentionally added. For example, a particular embodiment can be characterized as having less than 0.001% by weight of tobacco, or less than 0.0001% by weight, or even 0% by weight of tobacco.

[0140] When present, the botanical is typically present at a concentration of about 0.01% w / w to about 10% by weight, based on the total weight of the composition, such as about 0.01% w / w, about 0.05% by weight, about 0.1% by weight, or about 0.5% by weight to, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, or about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, or about 15% by weight, etc.

[0141] Botanical materials useful in the present disclosure may include any of the compounds and sources described herein, including, but not limited to, mixtures thereof. Certain botanical materials of this type may be referred to as nutritional supplements, dietary supplements, "phytochemicals" or "functional foods". Certain botanicals have been found to be used in traditional herbal medicine as plant materials or extracts thereof and are further described herein.Non-limiting examples of botanical or botanically derived materials include ashwagandha, Bacopa monniera, baobab, basil, Centella asiatica, Chai-hu, chamomile, cherry blossom, chlorophyll, cinnamon, citrus fruits, clove, cocoa, Cordyceps, curcumin, damiana, Dorstenia arifolia, Dorstenia odorata, essential oils, eucalyptus, ginseng, Galphimia glauca, ginger, Ginkgo biloba, ginseng (e.g., Panax ginseng), green tea, Griffonia simplicifolia, guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), kava, lavender, lemon balm, lemongrass, licorice, lutein, maca, matcha, Nardostachys chinensis, oil-based extract of Viola odorata, peppermint, quercetin, resveratrol, Rhizoma gastrodiae, Rhodiola, rooibos, rose essential oil, rosemary, Sceletium tortuosum, Schisandra, skullcap, spearmint extract, spikenard, terpenes, turmeric, turmeric, Turnera aphrodisiaca, valerian, white mulberry, and Yerba mate.

[0142] In some embodiments, the active ingredient includes lemon balm. Lemon balm (Melissa officinalis) is a mild lemon-scented herb in the same family as mint (Lamiaceae). This herb is native to Europe, North Africa, and western Asia. Lemon balm tea, as well as essential oils and extracts, are used in traditional and alternative medicines. In some embodiments, the active ingredient includes a lemon balm extract. In some embodiments, the lemon balm extract is present in an amount of about 1% to about 4% by weight based on the total weight of the composition.

[0143] In some embodiments, the active ingredient includes ginseng. Ginseng is the root of plants in the genus Panax, which are characterized by the presence of unique steroid saponin phytochemicals (ginsenosides) and gintonin. Ginseng has been found to be used as a dietary supplement in energy drinks or as a herbal tea, and in traditional medicine. Cultivated species include Korean ginseng (P. ginseng), Southern Chinese ginseng (P. notoginseng), and American ginseng (P. quinquefolius). American ginseng and Korean ginseng vary in the types and amounts of ginsenosides present. In some embodiments, the ginseng is American ginseng or Korean ginseng. In certain embodiments, the active ingredient includes Korean ginseng. In some embodiments, the ginseng is present in an amount of about 0.4% to about 0.6% by weight based on the total weight of the composition.

[0144] Stimulant In some embodiments, the active ingredient includes one or more stimulants. As used herein, the term "stimulant" refers to a material that increases the activity of the central nervous system and / or the body, for example, enhancing concentration, cognition, physical strength, mood, alertness, etc. Non-limiting examples of stimulants include caffeine, theacrine, theobromine, and theophylline. Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid structurally related to caffeine and has stimulant, analgesic, and anti-inflammatory effects. The stimulants can be natural, natural-derived, or fully synthetic. For example, certain botanical materials (such as guarana, tea, coffee, and cocoa) may possess a stimulant effect due to the presence of, for example, caffeine or related alkaloids, and thus are "natural" stimulants. "Natural-derived" means that the stimulant (for example, caffeine, theacrine) is in a purified form outside of a natural (for example, botanical) matrix. For example, caffeine can be obtained by extraction and purification from a botanical source (tea). "Fully synthetic" means that the stimulant is obtained by chemical synthesis. In some embodiments, the active ingredient includes caffeine. In some embodiments, the caffeine exists in a encapsulated form. An example of encapsulated caffeine is Vitashure®, which is available from Balchem Corp., 52 Sunrise Park Road, New Hampton, NY, 10958.

[0145] If present, stimulants or combinations of stimulants (e.g., caffeine, theacrine, and combinations thereof) are typically present at concentrations of about 0.1% w / w to about 15% by weight, such as about 0.1% w / w, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, or about 0.9% by weight to, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, or about 15% by weight, based on the total weight of the composition. In some embodiments, the composition contains caffeine in an amount of about 1.5 to about 6% by weight based on the total weight of the composition.

[0146] Amino acid In some embodiments, the active ingredient comprises an amino acid. As used herein, the term "amino acid" refers to an organic compound containing an amine functional group (-NH2) and a carboxyl (-COOH) or sulfonic acid (SO3H) functional group, along with a side chain (R group), where the side chain is specific to each amino acid. The amino acid may be proteinogenic or non-proteinogenic. "Proteinogenic" means that the amino acid is one of the 20 naturally occurring amino acids found in proteins. Examples of proteinogenic amino acids include alanine, arginine, asparagine, aspartic acid, cysteine, glutamine, glutamic acid, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine, threonine, tryptophan, tyrosine, and valine. "Non-proteinogenic" means that the amino acid is either not found naturally in proteins or is not directly produced by cellular machinery (e.g., is a product of post-translational modification). Non-limiting examples of non-proteinogenic amino acids include gamma-aminobutyric acid (GABA), taurine (2-aminoethanesulfonic acid), theanine (L-γ-glutamylethylamide), hydroxyproline, and beta-alanine. In some embodiments, the active ingredient comprises theanine. In some embodiments, the active ingredient comprises GABA. In some embodiments, the active ingredient comprises a combination of theanine and GABA. In some embodiments, the active ingredient is a combination of theanine, GABA, and lemon balm. In some embodiments, the active ingredient is a combination of caffeine, theanine, and ginseng. In some embodiments, the active ingredient comprises taurine. In some embodiments, the active ingredient is a combination of caffeine and taurine.

[0147] Without being bound by any theory of operation, it is thought that certain amino acids, such as theanine, tryptophan, GABA, or taurine, can have a beneficial effect on mood, anxiety levels, concentration, or cognitive function, particularly when combined with other active ingredients such as caffeine or certain botanicals.

[0148] When present, amino acids or combinations of amino acids (e.g., theanine, taurine, GABA, tryptophan, and combinations thereof) are typically present at concentrations of about 0.01% w / w to about 15% by weight, based on the total weight of the composition, such as about 0.1% w / w, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, or about 0.9% by weight to, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight, about 10% by weight, about 11% by weight, about 12% by weight, about 13% by weight, about 14% by weight, or about 15% by weight.

[0149] In one embodiment, at least one active ingredient comprises tryptophan in an amount by weight of about 0.03 to about 1% or about 0.05% to about 0.5%.

[0150] Vitamin In some embodiments, the active ingredient comprises a vitamin or combination of vitamins. As used herein, the term "vitamin" refers to an organic molecule (or set of related molecules) that is an essential micronutrient required for the proper functioning of metabolism in mammals. There are 13 vitamins required for human metabolism, which are vitamin A (as all-trans retinol, all-trans retinyl esters, and all-trans-beta-carotene and other provitamin A carotenoids), vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B7 (biotin), vitamin B9 (folic acid or folate), vitamin B12 (cobalamin), vitamin C (ascorbic acid), vitamin D (cholecalciferol), vitamin E (tocopherols and tocotrienols), and vitamin K (quinone). In some embodiments, the active ingredient comprises vitamin C. In some embodiments, the active ingredient is a combination of vitamin C, caffeine, and taurine.

[0151] When present, vitamins or combinations of vitamins (e.g., vitamin B6, vitamin B12, vitamin E, vitamin C, or combinations thereof) are typically present at concentrations of about 0.0001 wt% to about 6 wt%, such as about 0.0001, about 0.001, about 0.01 wt%, about 0.02 wt%, about 0.03 wt%, about 0.04 wt%, about 0.05 wt%, about 0.06 wt%, about 0.07 wt%, about 0.08 wt%, about 0.09 wt% or about 0.1% w / w to, about 0.2 wt%, about 0.3 wt%, about 0.4 wt%, about 0.5 wt%, about 0.6 wt%, about 0.7 wt%, about 0.8 wt%, about 0.9 wt%, about 1 wt%, about 2 wt%, about 3 wt%, about 4 wt%, about 5 wt% or about 6 wt% etc., based on the total weight of the composition.

[0152] In some embodiments, the active ingredient comprises vitamin B6 in an amount of about 0.008 wt% to about 0.06 wt% or about 0.01 wt% to about 0.04 wt%.

[0153] In some embodiments, the active ingredient comprises vitamin B12 in an amount of about 0.0001 wt% to about 0.007 wt% or about 0.0005 wt% to about 0.001 wt%.

[0154] In some embodiments, the active ingredient comprises a combination of vitamin B6 and vitamin B12 in a total amount by weight of about 0.008% to about 0.07%.

[0155] Antioxidant In some embodiments, the active ingredient comprises one or more antioxidants. As used herein, the term "antioxidant" refers to a substance that prevents or inhibits oxidation by terminating free radical reactions and can delay or prevent some types of cell damage. Antioxidants may be naturally occurring or synthetic. Naturally occurring antioxidants include those found in foods and botanical materials. Non-limiting examples of antioxidants include certain botanical materials, vitamins, polyphenols, and phenolic derivatives.

[0156] Examples of botanical materials with antioxidant characteristics include, but are not limited to, acai berry, alfalfa, allspice, annatto seed, apricot oil, basil, beavermint, wild bergamot, black pepper, blueberry, borage seed oil, bugleweed, cocoa, calamus root, catnip, cattail, cayenne pepper, chaga mushroom, chervil, cinnamon, dark chocolate, potato peel, grape seed, ginseng, Ginkgo biloba, St. John's wort, saw palmetto, green tea, black tea, black cohosh, cayenne, chamomile, clove, cocoa powder, cranberry, dandelion, grapefruit, honeybush, echinacea, garlic, evening primrose, Japanese aster, ginger, goldenseal, horsetail, hibiscus flower, amacha tsuru, kava, lavender, licorice, marjoram, great burdock, mint (peppermint), oolong tea, beet root, orange, oregano, papaya, pennyroyal, peppermint, red clover, rooibos (red or green), rose hip, rosemary, sage, clary sage, savory, spearmint, spirulina, acanthus bark, sorghum bran high tannin, sorghum grain high tannin, smack bran, comfrey leaf and root, goji berry, gutu kola, thyme, turmeric, Japanese star anise, valerian, wild yam root, wintergreen, yacon root, yellow dock, yerba mate, yerba santa, Bacopa monnieri, Withania somnifera, Houttuynia cordata, and Silybum marianum. Such botanical materials may be provided in fresh or dried form, in essential oils, or in the form of extracts. Botanical materials (and their extracts) often contain various classes of compounds known to provide antioxidant effects, such as minerals, vitamins, isoflavones, phytosterols, allyl sulfides, dithiolthiones, isothiocyanates, indoles, lignans, flavonoids, polyphenols, and carotenoids.Examples of compounds found in botanical extracts or oils include ascorbic acid, peanut endocarb, resveratrol, sulforaphane, beta-carotene, lycopene, lutein, coenzyme Q, carnitine, quercetin, and kempferol, among others. See, for example, Santhosh et al., Phytomedicine, 12(2005)216-220, which is incorporated herein by reference in its entirety.

[0157] Non-limiting examples of other suitable antioxidants include citric acid, vitamin E or its derivatives, tocopherol, epicatechol, epigallocatechol, epigallocatechin gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin, theaflavin monogallate A or B, theaflavin digallate, phenolic acids, glycosides, quercitrin, isoquercitrin, hyperoside, polyphenols, catechol, resveratrol, oleuropein, butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), tertiary butylhydroquinone (TBHQ), and combinations thereof.

[0158] When present, the antioxidant is typically present at a concentration of about 0.001% w / w to about 10% by weight, based on the total weight of the composition, such as about 0.001%, about 0.005%, about 0.01% w / w, about 0.05%, about 0.1%, or about 0.5% to, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10%.

[0159] Nicotine component In certain embodiments, the active ingredient comprises a nicotine component. The "nicotine component" means any form of nicotine (e.g., free base or salt) suitable for providing oral absorption of at least a portion of the nicotine present. Typically, the nicotine component is selected from the group consisting of nicotine free base and nicotine salts. In some embodiments, the nicotine component is nicotine in free base form, which can be readily absorbed, for example, in a microcrystalline cellulose material to form a microcrystalline cellulose-nicotine carrier complex. See, for example, the discussion of nicotine in free base form in U.S. Patent Application Publication No. 2004 / 0191322 to Hansson, which is hereby incorporated by reference in its entirety.

[0160] In some embodiments, at least a portion of the nicotine component can be used in the form of a salt. Salts of nicotine can be provided using the types and techniques of components described in U.S. Patent No. 2,033,909 to Cox et al. and Perfetti, Beitrage Tabakforschung Int., 12:43-54 (1983), which are hereby incorporated by reference in their entirety. In addition, salts of nicotine are available from sources such as Pfaltz and Bauer, Inc. and K&K Laboratories, a division of ICN Biochemicals, Inc. Typically, the nicotine component is selected from the group consisting of nicotine free base, nicotine salts, for example, hydrochloride, dihydrochloride, monotartrate, bitartrate, sulfate, salicylate, and nicotine zinc chloride.

[0161] In some embodiments, at least a portion of the nicotine may be in the form of a resin complex of nicotine, such as nicotine polacrillex, in which the nicotine is bound in an ion exchange resin, for example, nicotine polacrillex is nicotine bound to polymethacrylic acid such as Amberlite IRP64, Purolite C115HMR or Doshion P551. See, for example, U.S. Patent No. 3,901,248 to Lichtneckert et al., which is incorporated herein by reference in its entirety. Another example is, for example, a nicotine polyacrylic carbomer complex with Carbopol 974P. In some embodiments, the nicotine may be present in the form of a nicotine polyacrylic complex.

[0162] Typically, the nicotine component (calculated as the free base), if present, is present at a concentration of at least about 0.001% by weight of the composition, for example, in the range of about 0.001% to about 10%. In some embodiments, the nicotine component, calculated as the free base and based on the total weight of the composition, is from about 0.1% w / w to about 10% by weight, for example, about 0.1% w / w, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight or about 0.9% by weight to, about 1% by weight, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight or about 10% by weight and the like. In some embodiments, the nicotine component, calculated as the free base and based on the total weight of the composition, is from about 0.1% w / w to about 3% by weight, for example, from about 0.1% w / w to about 2.5% by weight, from about 0.1% w / w to about 2.0% by weight, from about 0.1% w / w to about 1.5% by weight or from about 0.1% w / w to about 1% by weight and the like.

[0163] In some embodiments, the products or compositions of the present disclosure can be characterized as being free of any nicotine components (e.g., any of the embodiments disclosed herein may be completely or substantially free of any nicotine components). "Substantially free" means that nicotine is not intentionally added, for example, in excess of trace amounts that may naturally occur in botanical materials. For example, a particular embodiment can be characterized as having less than 0.001% by weight of nicotine or less than 0.0001% by weight or even 0% by weight of nicotine, calculated as the free base.

[0164] In some embodiments, the active ingredient includes a nicotine component (e.g., any product or composition of the present disclosure may further include a nicotine component in addition to including any active ingredient or combination of active ingredients disclosed herein).

[0165] Cannabinoid In some embodiments, the active ingredient comprises one or more cannabinoids. As used herein, the term "cannabinoid" refers to a class of various chemical compounds that act on cannabinoid receptors, also known as the endocannabinoid system, and in cells, cannabinoids alter neurotransmitter release in the brain. Ligands for these receptor proteins include endogenous cannabinoids that are naturally produced in the body by animals, phytocannabinoids found in cannabis, and synthetic cannabinoids that are artificially manufactured. Cannabinoids found in cannabis include, but are not limited to, cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabidiorol (CBDL), cannabicyclol (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidiovalerate (CBDV), cannabichromevarin (CBCV), cannabigerovalerate (CBGV), cannabigerol monomethyl ether (CBGM), cannabinerolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabinotriol (CBO), tetrahydrocannabinolic acid (THCA), and tetrahydrocannabivarinic acid (THCV A). In certain embodiments, the cannabinoid is selected from tetrahydrocannabinol (THC), which is the main psychoactive compound in cannabis, and cannabidiol (CBD), which is another main component of the plant but lacks psychoactivity. All of the above compounds can be used in isolated form from plant material or in synthetically derived form.

[0166] Alternatively, the active ingredient can be a cannabinimetic, which is a class of compounds derived from plants other than cannabis that have a biological effect similar to cannabinoids on the endogenous cannabinoid system. Examples include yangonin, alpha-amyrin, beta-amyrin (also classified as a terpene), cyanidin, curcumin (turmeric), catechin, quercetin, salvianolin A, N-acylethanolamine, and N-alkylamide lipids.

[0167] When present, the cannabinoid (e.g., CBD) or cannabinimetic is typically present in the composition at a concentration of at least about 0.1% by weight, e.g., in the range of about 0.1% to about 30% by weight, based on the total weight of the composition, such as about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8% or about 0.9% to, about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 15%, about 20% or about 30% by weight, etc.

[0168] Terpene Active ingredients suitable for use in the present disclosure can also be classified as terpenes, and many terpenes are associated with biological effects such as a sedative effect. Terpenes are understood to have the general formula of (C5H8) n and include monoterpenes, sesquiterpenes, and diterpenes. Terpenes can be acyclic, monocyclic, or bicyclic in structure. Some terpenes provide an entourage effect when used in combination with cannabinoids or cannabinimetics. Examples include beta-caryophyllene, linalool, limonene, beta-citronellol, linalyl acetate, pinene (alpha or beta), geraniol, carvone, eucalyptol, menthone, isomenthone, piperitone, myrcene, beta-bulbonene, and germacrene, which can be used singly or in combination.

[0169] Pharmaceutical ingredient In some embodiments, the active ingredient comprises an active pharmaceutical ingredient (API). The API can be any known drug suitable for use in treatment, prevention or diagnosis. These include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g., magnesium, selenium, zinc, nitrates), neurotransmitters or their precursors (e.g., serotonin, 5-hydroxytryptophan, oxytryptan, acetylcholine, dopamine, melatonin), and nucleic acid sequences having activity for treatment, prevention or diagnosis. Non-limiting examples of APIs include analgesics and antipyretics (e.g., acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine, myo-inositol, docosahexaenoic acid (DHA, omega-3), arachidonic acid (AA, omega-6), S-adenosylmethionine (SAM), beta-hydroxy-beta-methylbutyrate (HMB), cytidine (cytidine-5'-diphosphate-choline), and cotinine. In some embodiments, the active ingredient comprises cytidine. In some embodiments, the active ingredient is a combination of cytidine, caffeine, theanine and ginseng. In some embodiments, the active ingredient comprises sunflower lecithin. In some embodiments, the active ingredient is a combination of sunflower lecithin, caffeine, theanine and ginseng.

[0170] The amount of the API can vary. For example, when present, the API is typically present at a concentration of about 0.001% w / w to about 10% by weight, such as about 0.01% by weight, about 0.02% by weight, about 0.03% by weight, about 0.04% by weight, about 0.05% by weight, about 0.06% by weight, about 0.07% by weight, about 0.08% by weight, about 0.09% by weight, about 0.1% w / w, about 0.2% by weight, about 0.3% by weight, about 0.4% by weight, about 0.5% by weight, about 0.6% by weight, about 0.7% by weight, about 0.8% by weight, about 0.9% by weight or about 1% by weight to, about 2% by weight, about 3% by weight, about 4% by weight, about 5% by weight, about 6% by weight, about 7% by weight, about 8% by weight, about 9% by weight or about 10% by weight, etc., based on the total weight of the composition.

[0171] In some embodiments, the composition is substantially free of any API. "Substantially free of any API" means that the composition does not contain the presence of any API as defined herein, for example, any therapeutic agent approved by the US Food and Drug Administration (FDA) intended to treat any medical condition, and specifically excludes it.

[0172] Advantageously, in some embodiments, the compositions and products of the present disclosure (regardless of the physical form, e.g., a pastille-type product or a lozenge-type product) can provide the active ingredient (e.g., nicotine) contained therein in a relatively small amount compared to traditional smokeless tobacco products generally known in the art. In particular, embodiments containing a relatively small amount of nicotine, it should be noted that when these products are inserted into the mouth of a user of these products, they advantageously provide compositions and products having a more desirable delivery profile of active nicotine and improved sensory stimulation properties. For example, the oral products of the present disclosure can exhibit improved flavor characteristics, improved appearance (e.g., translucency or transparency), and improved mouthfeel compared to traditional smokeless tobacco products having a greater amount of nicotine or tobacco material incorporated therein. Such improvements are achieved by providing oral products having a relatively small amount of active ingredient therein. For example, the compositions and products described herein may contain the active ingredient in the form of a nicotine component in an amount of less than about 2 weight percent based on the total weight of the composition. In some embodiments, the oral product may contain the nicotine component in an amount of less than about 2 weight percent, less than about 1.75 weight percent, less than about 1.5 weight percent, less than about 1.25 weight percent, less than about 1.0 weight percent, less than about 0.75 weight percent, less than about 0.50 weight percent, or less than about 0.25 weight percent based on the total weight of the composition.

[0173] Tobacco material In some embodiments, the oral care product according to the present disclosure may further contain tobacco material. The tobacco material may vary in genus, type, and form. Generally, the tobacco material is obtained from harvested plants of the Nicotiana genus. Examples of Nicotiana genus 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. x sanderae, N. africana, N. amplexicaulis, N. benavidesii, N. bonariensis, N. debneyi, N. longiflora, N. maritina, N. megalosiphon, N. occidentalis, N. paniculata, N. plumbaginifolia, N. raimondii, N. rosulata, N. simulans, N. stocktonii, N. suaveolens, N. umbratica, N. velutina, N. wigandioides, N. acaulis, N. acuminata (N.Nicotiana acuminata, N. attenuata, N. benthamiana, N. cavicola, N. clevelandii, N. cordifolia, N. corymbosa, N. fragrans, N. goodspeedii, N. linearis, N. miersii, N. nudicaulis, N. obtusifolia, N. occidentalis subsp. Hersperis, N. pauciflora, N. petunioides, N. quadrivalvis, N. repanda, N. rotundifolia, N. solanifolia, and N. spegazzinii. Various other representative types of Nicotiana species are described in Goodspeed, The Genus Nicotiana, (Chonica Botanica)(1954), which is hereby incorporated by reference in its entirety; U.S. Patent Nos. 4,660,577 to Sensabaugh, Jr. et al., 5,387,416 to White et al., 7,025,066 to Lawson et al., 7,798,153 to Lawrence, Jr. et al., and 8,186,360 to Marshall et al., each of which is hereby incorporated by reference in its entirety. Descriptions of various types of tobacco, cultivation operations, and harvesting operations are described in Tabacco Production, Chemistry and Technology, Davis et al. (eds.)(1999), which is hereby incorporated by reference in its entirety.

[0174] Nicotiana species that can provide suitable tobacco materials can be induced using recombinant or cross-breeding techniques (e.g., genetically engineering or cross-breeding tobacco plants to increase or decrease the production, characteristics, or traits of components). See, for example, U.S. Patent 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., 7,230,160 to Benning et al., U.S. Patent Application Publication No. 2006 / 0236434 to Conkling et al., and the types of plant recombinants described in PCT WO2008 / 103935 to Nielsen et al. Also see the types of tobacco described in U.S. Patent Nos. 4,660,577 to Sensabaugh, Jr. et al., 5,387,416 to White et al., and 6,730,832 to Dominguez et al., each of which is incorporated herein by reference.

[0175] In some embodiments, Nicotiana species can be selected based on the content of various compounds present therein. For example, a plant can be selected based on the plant producing a relatively large amount of one or more compounds that are desired to be isolated therefrom. In certain embodiments, plants of the Nicotiana species (e.g., Galpao commun tobacco) are cultivated particularly because the compounds on the leaf surface are abundant. Tobacco plants can be cultivated in a greenhouse, a cultivation chamber, or an outdoor plot or can be hydroponically cultivated.

[0176] Various parts or portions of plants of the genus Nicotiana can be included within the compositions disclosed herein. For example, virtually all of the plant (e.g., the whole plant) can be harvested and used as such. Alternatively, various parts or pieces of the plant can be harvested or sorted for further use after harvest. For example, flowers, leaves, leaf stalks, stems, roots, seeds, and various combinations thereof can be isolated for further use or processing. In some embodiments, the tobacco material includes tobacco leaves (leaf blades). The compositions disclosed herein can include processed tobacco parts or pieces, tobacco dried and aged in essentially natural leaf blade and / or leaf stalk form, tobacco extracts, extracted tobacco pulp (e.g., using water as a solvent), or mixtures of the foregoing (e.g., a mixture combining extracted tobacco pulp and dried and aged granulated natural tobacco leaf blades).

[0177] In certain embodiments, the tobacco material includes a solid tobacco material selected from the group consisting of leaf blades and leaf stalks. The tobacco used for the mixtures is most preferably tobacco leaf blades or a mixture of tobacco leaf blades and leaf stalks, at least a portion of which has been cased. A portion of the tobacco in the mixture may have a processed form such as processed tobacco leaf stalks (e.g., cut-rolled leaf blades, cut-rolled expanded leaf blades, or cut-puffed leaf blades) or volume-expanded tobacco (e.g., expanded tobacco such as dry ice expanded tobacco (DIET)). See, for example, the tobacco expansion processes described in U.S. Patent Nos. 4,340,073 to de la Burde et al., 5,259,403 to Guy et al., 5,908,032 to Poindexter et al., and 7,556,047 to Poindexter et al., all of which are incorporated herein by reference in their entirety. Additionally, the d mixture may optionally incorporate fermented tobacco. See also the types of tobacco processing techniques described in PCT WO2005 / 063060 to Atchley et al., the contents of which are incorporated herein by reference.

[0178] Tobacco materials are typically used in a form that can be described as particulate (i.e., shredded, milled, granulated, or powdered). The methods for providing the tobacco material in a finely divided or powdered type form may vary. Preferably, the plant parts or pieces are micronized, milled, or pulverized using equipment and techniques for milling or grinding, such as a hammer mill, cutter head, or air-controlled mill, to obtain a particulate form. Most preferably, the plant material is relatively dry during milling or grinding using equipment such as a hammer mill, cutter head, or air-controlled mill. For example, the tobacco parts or pieces can be milled or ground when their moisture content is less than about 15 weight percent or less than about 5 weight percent. Most preferably, the tobacco material is used in the form of parts or pieces having an average particle size of 1.4 millimeters to 250 microns. In some examples, the tobacco particles may be sized to pass through a screen mesh to obtain the required particle size range. If desired, air classification equipment may be used to ensure that the smaller-sized tobacco particles of the desired size or size range are collected. If desired, pieces of granulated tobacco of different sizes may be mixed together.

[0179] Methods of providing tobacco in a finely divided form or in a powder type form may vary. Preferably, the tobacco parts or pieces are micronized, milled or pulverized using equipment and techniques for grinding or pulverizing, etc. to form a powder type form. Most preferably, the tobacco is relatively dry in the form during grinding or pulverizing using equipment such as a hammer mill, cutter head or air control mill, etc. For example, the tobacco parts or pieces can be ground or pulverized when their moisture content is less than about 15 weight percent to less than about 5 weight percent. For example, the tobacco plant or its parts can be separated into individual parts or pieces (for example, the leaves may be removed from the leaf stalks, and / or the leaf stalks and leaves may be removed from the stems). The harvested plant or individual parts or pieces can be further subdivided into parts or pieces (for example, the leaves can be shredded, cut, micronized, pulverized, ground or milled into pieces or parts that can be characterized as filler type pieces, granules, microparticles or fine powders). The plant or its parts can also be subjected to an external force or pressure (for example, by pressing or subjecting to a rolling process). When performing such processing conditions, the plant or its parts can have a moisture content approximated to the natural moisture content (for example, the moisture content immediately after harvesting), the moisture content achieved by adding moisture to the plant or its parts, or the moisture content obtained by drying the plant or its parts. For example, the powdered, micronized, milled or pulverized pieces of the plant or its parts can have a moisture content of less than about 25 weight percent, often less than about 20 weight percent, and frequently less than about 15 weight percent.

[0180] For the preparation of oral products, harvested Nicotiana species plants are typically subjected to a drying process. The tobacco material incorporated into the composition for inclusion within the products disclosed herein is appropriately dried and / or aged. Descriptions of various types of drying processes for various types of tobacco are set forth in Tobacco Production, Chemistry and Technology, Davis et al. (eds.) (1999). Examples of techniques and conditions for drying hot air duct dried tobacco are described in Nestor et al., Beitrage Tabakforsch.Int., 20, 467-475 (2003) and U.S. Patent No. 6,895,974 to Peele, the contents of which are incorporated herein by reference. Representative techniques and conditions for air drying tobacco are described in U.S. Patent No. 7,650,892 to Groves et al., Roton et al., Beitrage Tabakforsch.Int., 21, 305-320 (2005) and Staaf et al., Beitrage Tabakforsch.Int., 21, 321-330 (2005), the contents of which are incorporated herein by reference. Certain types of tobacco can be subjected to alternative types of drying processes such as fire drying or sun drying.

[0181] In certain embodiments, tobacco materials that can be used include flue-cured varieties or Virginia (e.g., K326), burley, sun-cured varieties (e.g., Indian Kurnool and Oriental tobacco including Katerini, Prelip, Komotini, Xanthi, and Yambol tobacco), Maryland, dark varieties, dark fire-cured varieties, dark air-cured varieties (e.g., Madole, Passanda, Cubano, Jatin, and Bezuki tobacco), light air-cured varieties (e.g., North Wisconsin and Galpao tobacco), Indian air-cured varieties, Red Russian and Rustica tobacco, and various other rare or special tobaccos, as well as various blends of any of the foregoing tobaccos.

[0182] The tobacco material may also have a so-called "blended" form. For example, the tobacco material may include a mixture of portions or pieces of flue-cured varieties, burley (e.g., Malawi burley tobacco), and Oriental tobacco (e.g., as tobacco consisting of or derived from a mixture of tobacco leaf blades or a mixture of tobacco leaf blades and tobacco leaf stalks). For example, a representative blend may incorporate, on a weight basis, about 30 to about 70 parts of burley tobacco (e.g., leaf blades or leaf blades and leaf stalks) and about 30 to about 70 parts of flue-cured tobacco (e.g., leaf stalks, leaf blades, or leaf blades and leaf stalks). Other example tobacco blends may incorporate, on a weight basis, about 75 parts of flue-cured tobacco, about 15 parts of burley tobacco, and about 10 parts of Oriental tobacco; or about 65 parts of flue-cured tobacco, about 25 parts of burley tobacco, and about 10 parts of Oriental tobacco; or about 65 parts of flue-cured tobacco, about 10 parts of burley tobacco, and about 25 parts of Oriental tobacco. Other example tobacco blends may incorporate, on a weight basis, about 20 to about 30 parts of Oriental tobacco and about 70 to about 80 parts of flue-cured tobacco.

[0183] The tobacco materials used in the present disclosure can be subjected to, for example, fermentation and bleaching. If desired, the tobacco materials can be subjected to, for example, radiation irradiation, pasteurization or controlled heat treatment by other methods. Such treatment processes are detailed in, for example, U.S. Patent No. 8,061,362 to Mua et al., which is incorporated herein by reference in its entirety. In certain embodiments, the tobacco material can be treated with water and an additive (e.g., lysine, glycine, histidine, alanine, methionine, cysteine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, a composition incorporating divalent and trivalent cations, asparaginase, certain non-reducing polysaccharides, certain reducing agents, phenolic compounds, certain compounds having at least one free thiol group or functional group, oxidants, oxidation catalysts, natural plant extracts (e.g., rosemary extract)) that can inhibit the reaction of asparagine that forms acrylamide when the tobacco material is heated, and combinations thereof. See, for example, the types of treatment processes described in U.S. Patent Application Publication Nos. 8,434,496, 8,944,072 and 8,991,403 to Chen et al., which are incorporated herein by reference in their entirety. In certain embodiments, this type of treatment, where the initial tobacco material is subjected to heating in the processes already described, is useful.

[0184] At least a part of the tobacco material used in the tobacco composition or product can be in the form of an extract. In some embodiments, all of the tobacco material used in the tobacco composition or product may be in the form of an extract, such as a tobacco-derived nicotine extract. The tobacco extract can be obtained by extracting tobacco using a solvent having an aqueous character, such as distilled water or tap water. As described above, the aqueous tobacco extract can be provided by extracting tobacco with water such that the water-insoluble pulp material is separated from the aqueous solvent and the water-soluble and water-dispersible tobacco components are dissolved and dispersed in water. The tobacco extract can be used in various forms. For example, the aqueous tobacco extract can also be isolated in an essentially solvent-free form that can be obtained as a result of the use of, for example, a spray drying or freeze drying process or other similar types of processing steps. Alternatively, the aqueous tobacco extract can also be used in liquid form, and thus the content of tobacco solubles in the liquid solvent can be controlled by, for example, the selection of the amount of solvent used for extraction, concentration of the liquid tobacco extract by removal of the solvent, or dilution of the liquid tobacco extract by addition of a solvent.Exemplary techniques for extracting tobacco components are described in U.S. Patent No. 4,144,895 to Fiore, U.S. Patent No. 4,150,677 to Osborne, Jr. et al., U.S. Patent No. 4,267,847 to Reid, U.S. Patent No. 4,289,147 to Wildman et al., U.S. Patent No. 4,351,346 to Brummer et al., U.S. Patent No. 4,359,059 to Brummer et al., U.S. Patent No. 4,506,682 to Muller, U.S. Patent No. 4,589,428 to Keritsis, U.S. Patent No. 4,605,016 to Soga et al., U.S. Patent No. 4,716,911 to Poulose et al., U.S. Patent No. 4,727,889 to Niven, Jr. et al., U.S. Patent No. 4,887,618 to Bernasek et al., U.S. Patent No. 4,941,484 to Clapp et al., U.S. Patent No. 4,967,771 to Fagg et al., U.S. Patent No. 4,986,286 to Roberts et al., U.S. Patent No. 5,005,593 to Fagg et al., U.S. Patent No. 5,018,540 to Grubbs et al., U.S. Patent No. 5,060,669 to White et al., U.S. Patent No. 5,065,775 to Fagg, U.S. Patent No. 5,074,319 to White et al., U.S. Patent No. 5,099,862 to White et al., U.S. Patent No. 5,121,757 to White et al., U.S. Patent No. 5,131,414 to Fagg, U.S. Patent No. 5,131,415 to Munoz et al., U.S. Patent No. 5,148,819 to Fagg, U.S. Patent No. 5,197,494 to Kramer, U.S. Patent No. 5,230,354 to Smith et al., U.S. Patent No. 5,234,008 to Fagg, U.S. Patent No. 5,243,999 to Smith, U.S. Patent No. 5,301,694 to Raymond et al., U.S. Patent No. 5,318,050 to Gonzalez-Parra et al., U.S. Patent No. 5,343,879 to Teague, U.S. Patent No. 5,360,022 to Newton, U.S. Patent No. 5,435,325 to Clapp et al., U.S. Patent No. 5,445,169 to Brinkley et al., U.S. Patent No. 6,131,584 to Lauterbach, U.S. Patent No. 6,284,875 to Turpen et al., U.S. Patent No. 6,298,859 to Kierulff et al., U.S. Patent No. 6,772,767 to Mua, U.S. Patent No. 6,817,970 to Berit, U.S. Patent No. 6,906,172 to Bratcher, U.S. Patent No. 7,034,128 to Turpen et al., U.S. Patent No. 7,048,211 to Bratcher, and U.S. Patent No. 7,337,782 to Thompson, all of which are incorporated herein by reference in their entirety for all purposes.

[0185] According to the present disclosure, Nicotiana plants or parts thereof (described above herein) are typically subjected to a process intended to provide improved clarity of tobacco materials. In certain embodiments, the tobacco material used in the products of the present invention is in the form of an extract of the tobacco material, such as an aqueous extract. The improved clarity of the tobacco extract can be obtained, for example, by removing high molecular weight components from the tobacco extract. In certain embodiments, the high molecular weight components beneficially removed by the present invention include, but are not limited to, high molecular weight Maillard browning polymers, proteins, polysaccharides, certain pigments, and bacteria. For this purpose, various methods can be used, including size exclusion chromatography, microfiltration, ultrafiltration, nanofiltration, reverse osmosis, and combinations thereof. Ideally, the tobacco extract may be subjected to an ultrafiltration process to provide an ultrafiltered tobacco extract. Examples of filter media, methods, and processes for ultrafiltration of tobacco materials are described in U.S. Patent No. 9,084,439 to Holton Jr. and U.S. Patent No. 9,901,113 to Holton Jr., which are hereby incorporated by reference in their entirety.

[0186] According to the present disclosure, the ultrafiltration process is designed such that the tobacco extract achieves having a reduced level of suspended solids and thus an increased level of clarity. For example, depending on the molecular weight cut-off of the filter media, the ultrafiltered extract can contain only compounds having a molecular weight of less than about 50,000, less than about 25,000, less than about 10,000 Da, less than about 7,500 Da, less than about 5,000 Da, less than about 2,500 Da, or less than about 1,000 Da. The ultrafiltered extract typically mainly contains sugars, nicotine, and amino acids.

[0187] The ultrafiltration extract exhibits an improved level of clarity compared to the non-ultrafiltration extract. The clarity of the extract and the oral products according to the present disclosure incorporating such extracts is typically defined in terms of translucency. As used herein, "translucent" or "translucency" refers to a material transmitting a certain level of light by diffusion through the material. In certain embodiments, certain materials of the present invention (e.g., certain tobacco extracts or final smokeless tobacco products made from tobacco extracts) can have a high level of clarity such that the material can be classified as "transparent" or exhibiting "transparency", where transparency is defined as the material allowing light to pass freely without significant diffusion. The clarity of the ultrafiltration extract is such that there is a level of translucency, which is the opposite of opacity (which refers to a material through which light cannot pass).

[0188] The improvement in the clarity of the ultrafiltration extract compared to the non-ultrafiltration extract can be quantified by any known method. For example, optical methods such as turbidimetry (or nephelometry) and colorimetry can be used to quantify the haze (light scattering) and color (light absorption), respectively, of the ultrafiltration extract or a product made from the ultrafiltration extract. Translucency can also be confirmed by visual inspection, simply by holding the material (e.g., the extract) or product up to a light source and determining whether the light diffuses and passes through the material or product.

[0189] In certain embodiments, the ultrafiltration extract is analyzed by contacting the extract with light and measuring the percentage of light that is not absorbed and / or scattered by the extract. The measurement can be performed, for example, at a given wavelength using a standard spectrophotometer. The spectrophotometer is typically calibrated with deionized water, which is assigned a transparency value of 100%. In the ultrafiltration extract, the acceptable level of translucency / transparency at a given wavelength can vary. Typically, the ultrafiltration extract has a translucency of greater than about 5%, greater than about 10%, greater than about 15%, greater than about 20%, greater than about 25%, greater than about 30%, greater than about 40%, greater than about 50%, greater than about 60%, greater than about 60%, greater than about 70%, greater than about 80% or greater than about 90%. Typically, the ultrafiltration extract is not colorless and has some distinguishable brown / black coloration. Following ultrafiltration, prior to use in the products of the present invention, the extract can be stored in a refrigerator or freezer, or the extract can be lyophilized or spray dried. In certain embodiments, the extract is provided in syrup form.

[0190] In some embodiments, the tobacco extract is used directly, although it may be desirable to heat-treat the extract. This heat treatment can be carried out before ultrafiltration, after ultrafiltration, or both before and after ultrafiltration. For example, the tobacco material can be thermally processed by mixing the tobacco material, water, and an additive selected from the group consisting of lysine, glycine, histidine, alanine, methionine, glutamic acid, aspartic acid, proline, phenylalanine, valine, arginine, divalent and trivalent cations, asparaginase, sugars, phenolic compounds, reducing agents, compounds having free thiol groups, oxidizing agents (e.g., hydrogen peroxide), oxidation catalysts, plant extracts, and combinations thereof to form a hydrated tobacco mixture; and heating the hydrated tobacco mixture at a temperature of at least about 60° C. to form a heat-treated tobacco mixture. In one embodiment, the treated tobacco extract is heat-treated at about 88° C. for about 60 minutes in the presence of water, NaOH, and an additive (e.g., lysine). Such heat treatment may help prevent acrylamide formation resulting from the reaction of asparagine and reducing sugars in the tobacco material and can provide some degree of pasteurization. See, for example, U.S. Patent Application Publication No. 2010 / 0300463 to Chen, which is incorporated herein by reference. In certain embodiments where the heat-treated tobacco extract is used in the smokeless tobacco products of the present invention, the products can be characterized by a very low acrylamide content. For example, in some embodiments, the smokeless tobacco products are characterized by an acrylamide content of less than about 500 ppb (ng / g), less than about 400 ppb, less than about 300 ppb, less than about 200 ppb, or less than about 100 ppb.

[0191] Accordingly, as used herein, "treated tobacco extract" refers to a tobacco extract (e.g., an ultrafiltered extract) that has been processed in some manner to remove high molecular weight components and thereby improve clarity. A "treated tobacco extract" may or may not have been heat-treated as described herein.

[0192] It should be noted that including tobacco materials in the compositions and products described herein is optional and not required. In some embodiments, the oral care products described herein can generally be characterized as tobacco-free alternatives. For example, in some embodiments, the oral care products of the present disclosure can also be said to be completely or substantially free of tobacco materials (except for purified nicotine as an active ingredient). An oral care product referred to herein as "completely free" or "substantially free" of tobacco materials means an oral care product that can be characterized as having less than about 1.0 wt%, less than about 0.5 wt%, less than about 0.1 wt% of tobacco materials or 0 wt% of tobacco materials.

[0193] Buffer and / or pH adjuster In some embodiments, the products of the present disclosure may further include one or more buffering agents and / or pH adjusters (i.e., acids or bases). In such embodiments, the one or more buffering agents and / or pH adjusters are added to the mixture such that the final oral product has a pH within the desired range. An exemplary pH range for the oral products described herein is generally from about 5 to about 7. In such embodiments, the amount of buffering agent and / or pH adjuster added to the product mixture is simply the amount required to bring the formulation to the desired pH or to keep the formulation at the desired pH. The amount of buffering agent and / or pH adjuster added to any given formulation can be readily calculated by one of ordinary skill in the art based on the desired pH and can, for example, include from about 0.5 wt% to about 1 wt% of the mixture. In some embodiments, the amount of pH adjuster present may vary based on the acidity and basicity of other components that may be present in the composition (e.g., nicotine, salts, buffering agents, etc.). Thus, the buffering agent and / or pH adjuster are provided in an amount sufficient to provide a pH of the composition of from about 5.0 to about 7.0, such as, for example, from about 5.0, about 5.5 or about 6.0 to, about 6.5 or about 7.0. In some embodiments, the organic acid is provided in an amount sufficient to provide a pH of the composition of from about 5.5 to about 6.5, such as, 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.

[0194] It should be noted that the pH level of the oral product may be varied to alter certain characteristics of the product, such as the release profile of the active ingredient contained within the product. For example, in some embodiments, as described above, an amount of a buffering agent (such as citric acid) may be incorporated into the composition to change the overall pH of the product to about 5.0 to 7.0. Preferably, in some embodiments, the pH can be adjusted to a pH of approximately 5.5. Advantageously, by adding citric acid to adjust the pH of the products described herein to a pH around 5.5, it has generally been found that nicotine loss in these products is reduced when compared to products having higher pH values, such as those typically used in traditional smokeless tobacco products (e.g., in the range of about 7 to about 11 or preferably about 8 to about 10). In some embodiments, citric acid can be used as a processing aid in addition to being added to the composition or product to reduce nicotine loss during its production. It should be noted that the use of citric acid in the products disclosed herein is not meant to be limiting, and any buffering agent and / or pH adjuster may be suitable for changing the overall pH of the product. Such buffering agents and / or pH adjusters can be added in a single form or in combination of one or more compounds.

[0195] In addition, various food-grade buffering agents are known and can be used to adjust the pH of the products described herein. Suitable buffering agents include those selected from the group consisting of acetates, glycineates, phosphates, glycerophosphates, citrates such as alkali metal citrates, carbonates, hydrogen carbonates and borates and mixtures thereof. In certain embodiments, the buffering agent is an amino acid, for example, as taught in U.S. Patent Application Publication No. 2008 / 0286341 to Andersson et al. and PCT International Publication No. 2008 / 040371 to Andersson et al., both of which are incorporated herein by reference in their entirety. As described therein, various amino acids and their salts are useful for this purpose, including but not limited to arginine, asparagine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, valine, cysteic acid, N-glycylglycine and ornithine. In certain embodiments, N-glycylglycine or L-lysine is added as a buffering agent. In some embodiments, the amino acid buffering agent is used in combination with another amino acid buffering agent and / or in combination with one or more non-amino acid buffering agents. In certain embodiments, the optional pH adjusting agent is a base (e.g., NaOH). In certain embodiments, L-lysine and NaOH are added to the compositions of the invention.

[0196] Emulsifier In certain embodiments, an emulsifier may be added. In certain embodiments, lecithin is added to the composition to provide a smoother textural property of the composition and can improve fluidity and the mixing of lipids with the remaining components of the composition. Lecithin can be used in an amount of about 0.01 to about 5% dry weight of the composition, such as about 0.1 to about 2.5% or about 0.1 to about 1.0%.

[0197] Further Additives In addition to the ingredients provided in the lozenges and pastille compositions described above, such compositions may further comprise one or more additives. For example, the lozenge and pastille compositions according to the present disclosure may further comprise one or more of a flavoring agent, one or more sweetening agents, one or more additional binders, disintegrating aids, wetting agents, salts, and mixtures thereof.

[0198] As used herein, "flavorant" or "fragrance" is any flavorful or aromatic substance that can modify the sensory characteristics associated with the oral products of the present disclosure. Examples of sensory characteristics that can be modified by a flavorant include taste, mouthfeel, moisture, coldness / heat, and / or aroma / smell. Non-limiting examples of flavorants that can be included in the compositions and / or products include vanilla, coffee, chocolate / cocoa, cream, mint, spearmint, menthol, peppermint, wintergreen, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascarilla, camphor, honey, jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, raspberry, strawberry, trigeminal sensates, terpenes, and any combination thereof. See also Leffingwell et al., Tobacco Flavoring for Smoking Products, R.J. Reynolds Tobacco Company (1972), the contents of which are incorporated herein by reference. A flavorant may include components such as terpenes, terpenoids, aldehydes, ketones, and esters. In some embodiments, the flavorant is a trigeminal sensate. As used herein, "trigeminal sensate" refers to a flavorant that has an effect on the trigeminal nerve and produces sensations including a warming sensation, a cooling sensation, and pain. Non-limiting examples of trigeminal sensate flavorants include capsaicin, citric acid, menthol, Sichuan button, erythritol, and cubebol. The flavorant may also include components that are considered to be humidifying, cooling, or smoothing agents, such as eucalyptus. These flavors may be provided neat (i.e., alone) or in a complex, and may be used as concentrates or flavor packages (e.g., spearmint and menthol, orange and cinnamon, lime and pineapple, etc.). Representative types of components are also described in U.S. Patent No. 5,387,416 to White et al., U.S. Patent Application Publication No. 2005 / 0244521 to Strickland et al., and PCT International Publication No. 05 / 041699 to Quinter et al., the contents of each of which are incorporated herein by reference.In some embodiments, the flavorant may be provided in a spray-dried form or a liquid form.

[0199] The flavorant generally includes at least one volatile flavor component. As used herein, "volatile" refers to a chemical substance that readily forms vapor at ambient temperature (i.e., a chemical substance that has a high vapor pressure relative to non-volatile substances at a given temperature). Typically, the volatile flavor component has a molecular weight of less than about 400 Da and often contains at least one carbon-carbon double bond, carbon-oxygen double bond, or both. In one embodiment, the at least one volatile flavor component includes one or more alcohols, aldehydes, aromatic hydrocarbons, ketones, esters, terpenes, terpenoids, or combinations thereof. Non-limiting examples of aldehydes include vanillin, ethyl vanillin, p-anisaldehyde, hexanal, furfural, isovaleraldehyde, cumin aldehyde, benzaldehyde, and citronellal. Non-limiting examples of ketones include 1-hydroxy-2-propanone and 2-hydroxy-3-methyl-2-cyclopentenone-1-one. Non-limiting examples of esters include allyl hexanoate, ethyl heptanoate, ethyl hexanoate, isoamyl acetate, and 3-methylbutyl acetate. Non-limiting examples of terpenes include sabinene, limonene, gamma-terpinene, beta-farnesene, nerolidol, cedrene, myrcene, geraniol, nerol, citronellol, linalool, and eucalyptol. In one embodiment, the at least one volatile flavor component includes one or more of ethyl vanillin, cinnamaldehyde, sabinene, limonene, gamma-terpinene, beta-farnesene, or citral. In one embodiment, the at least one volatile flavor component includes ethyl vanillin. The flavorant is typically present in an amount of about 0.5 to about 10 weight percent, often about 1 to about 6 weight percent, and most often about 2 to about 5 weight percent, based on the total weight of the composition.

[0200] Sweeteners can be used in natural or artificial forms or as a combination of artificial and natural sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, mannose, galactose, lactose, isomaltulose, stevia, and honey. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, and neotame. In one embodiment, sucrose and sucralose are the main sweetening components. When present, a representative amount of the sweetener, whether artificial sweetener and / or natural sugar, can account for at least about 0.2 percent or at least about 5 percent of the total weight of the composition. Preferably, the amount of sweetener in the composition does not exceed about 40 percent of the total weight of the composition, often does not exceed about 35 percent, and frequently does not exceed about 30 percent. Sucrose can be particularly advantageous as a component in certain embodiments because it is thought to contribute to the chewability or "rebound force" of the final product. In addition, granulated sucrose provides a much less sweetening effect compared to sucralose, while the presence of sucrose can be advantageous as an additional filler component. When these two sweeteners are present together, sucralose is typically present in an amount of at least about 0.25 weight percent, often at least about 0.5 weight percent, most often at least about 1.0 weight percent (e.g., about 0.25 to about 2.0 weight percent), and sucrose is typically present in an amount of at least about 2.0 weight percent, often at least about 3.0 weight percent, most often at least about 4.0 weight percent (e.g., about 1.0 to about 6.0 weight percent). In a further embodiment, sucralose is present in an amount of about 0.01 to about 0.5 weight percent (e.g., about 0.02 to about 0.1 weight percent).

[0201] Salts (e.g., sodium chloride, flower salt) may be used in an amount sufficient to provide the desired sensory properties to the products of the present disclosure. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, and flower salt. When present, representative amounts of salt are at least about 0.5 weight percent or at least about 1.0 weight percent or at least about 1.5 weight percent, but typically will be less than about 5 percent by weight of the total weight of the composition (e.g., about 0.5 to about 4 weight percent).

[0202] Humectants (e.g., glycerin) may be used in an amount sufficient to provide the desired moisture properties to the oral products described herein. Further, in some instances, the humectant may impart to the smokeless tobacco composition the flow characteristics desirable for injection into a mold. When present, representative amounts of humectant are at least about 0.5 weight percent or at least about 1.0 weight percent or at least about 1.5 weight percent, but typically will be less than about 5 percent by weight of the total weight of the composition (e.g., about 0.5 to about 4 weight percent).

[0203] Additional binder(s) (or combinations of binders) may be used in certain embodiments in an amount sufficient to provide the desired physical properties and physical integrity to the mixture, and the binder often also functions as a thickener or gelling agent. Typical binders may be organic or inorganic or combinations thereof. Representative binders include povidone, sodium alginate, starch-based binders, pectin, carrageenan, pullulan, and zein, among others, and combinations thereof. In some embodiments, the binder comprises pectin or carrageenan or combinations thereof. The amount of binder utilized in the composition may vary, but typically will be up to about 30 weight percent, and certain embodiments are characterized by a binder content of at least about 0.1 weight %, e.g., about 1 to about 30 weight % or about 5 to about 10 weight %, based on the total weight of the composition.

[0204] In some embodiments, the lozenge and / or pastille products described herein may include one or more colorants. The colorants may be used in an amount sufficient to provide the desired physical properties to the composition or product. Examples of colorants include various dyes and pigments, such as caramel color and titanium dioxide. The amount of colorant utilized in the composition or product may vary, but if present, typically ranges from about 0.1 weight percent, about 0.5 weight percent, or about 1 weight percent to about 3 weight percent, based on the total weight of the composition, up to about 3 weight percent.

[0205] Various other substances can also be added to the compositions of the present invention. For example, excipients such as fillers or carriers for active ingredients (e.g., polycarbophil calcium, microcrystalline cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, corn starch, silicon dioxide, calcium carbonate, lactose and starches including potato starch, corn starch, etc.), thickening agents, film-forming agents and binders (e.g., hydroxypropyl cellulose, hydroxypropyl methyl cellulose, acacia, sodium alginate, xanthan gum and gelatin), anti-adhesion agents (e.g., talc), lubricants (e.g., colloidal silica), wetting agents (e.g., glycerin), preservatives and antioxidants (e.g., sodium benzoate and ascorbyl palmitate), surfactants (e.g., polysorbate 80), dyes or pigments (e.g., titanium dioxide or D&C Yellow No. 10) and lubricants or processing aids (e.g., calcium stearate or magnesium stearate) are added to the compositions in certain embodiments. Further examples of additional types of additives that can be used in the present compositions and products include thickening or gelling agents (e.g., fish gelatin), emulsifying agents, oral care additives (e.g., thyme oil, eucalyptus oil and zinc), preservatives (e.g., potassium sorbate, etc.), disintegration aids, zinc or magnesium salts selected to be relatively water-soluble in the case of compositions having high water solubility (e.g., magnesium gluconate or zinc gluconate) or relatively water-insoluble in the case of compositions having reduced water solubility (e.g., magnesium oxide or zinc oxide) or combinations thereof. See, for example, U.S. Patent No. 9,237,769 to Mua et al., U.S. Patent No. 7,861,728 to Holton, Jr. et al., U.S. Patent Application Publication No. 2010 / 0291245 to Gao et al. and U.S. Patent Application Publication No. 2007 / 0062549 to Holton, Jr. et al., each of which is incorporated herein by reference, for representative components, combinations of components, relative amounts of these components and ways and methods for using these components.Typical inclusion ranges for such additional additives can vary depending on the nature and function of the additive and the intended effect in the final mixture, but an example range is up to about 10 wt%, for example about 0.1 to about 5 wt%, based on the total weight of the mixture.

[0206] In some embodiments, the composition includes a magnesium salt. Non-limiting examples of suitable magnesium salts are magnesium gluconate. In some embodiments, the composition includes magnesium in an amount by weight of about 0.1% to about 2% or about 0.2 to about 1%, based on elemental magnesium.

[0207] The aforementioned types of additives can be used together (e.g., as an additive formulation) or separately (e.g., individual additive components can be added at different stages involved in the preparation of the final oral product). The relative amounts of the various components within the oral product can vary and are typically selected to provide the desired functional and performance characteristics to the oral product. Moreover, the aforementioned types of additives may be encapsulated at the time they are provided to the final product or composition. Example encapsulated additives are described, for example, in WO 2010 / 132444 A2 to Atchley, which is hereby incorporated by reference herein.

[0208] The ways in which the various components of the lozenge and pastille compositions mentioned above can be combined can be various. The various components of these compositions can be brought into contact, combined, or mixed together, for example, in a conical type blender, mixing drum, or ribbon blender, such as a Hobart mixer. As described above, the overall mixture of the various components and the active ingredient can be relatively uniform in nature. See also, for example, the types of methodologies described in U.S. Pat. No. 4,148,325 to Solomon, 6,510,855 to Korte, and 6,834,654 to Williams, each of which is hereby incorporated by reference herein.

[0209] Method for manufacturing a pastille product Representative pastille compositions and products may incorporate, based on the total weight of the product, at least one active ingredient of about 10 weight percent or less, a sweetening agent of about 0.01 to about 2 percent, a wetting agent of about 0.1 to about 5 percent, at least one sugar alcohol filler of about 25 to about 45 percent, at least one gum of about 35 to about 55 percent, at least one flavoring agent of about 0.1 to about 5 percent, and a salt of about 0.1 to about 5 percent. The percentage and selection of specific ingredients can vary depending on the desired flavor, texture, and other characteristics.

[0210] The ways and methods used to formulate and manufacture the pastille products described above in this specification may vary. For example, the composition forming the pastille product is prepared such that the mixture can be used in a starch-based process for forming the pastille product. Example pastille production processes are described in U.S. Patent No. 4,725,440 to Ridgway et al. and 6,077,524 to Bolder et al., which are incorporated herein by reference in their entirety. In some embodiments, the composition for forming the pastille product may be prepared such that the mixture can be used in a starchless process for forming the pastille product (e.g., a casting process that does not include starch-based components).

[0211] In one embodiment, the process includes heating the gum and optionally hydrolyzing its gum components with water and then incorporating at least one active ingredient into the heated gum component and stirring. Generally, the gum can be heated to a temperature in the range of about 60°C to about 80°C for a period of seconds to minutes. In some embodiments, the gum may be heated to a temperature of about 71°C so that at least one active ingredient dissolves therein before stirring in the at least one active ingredient. In some examples, an aqueous mixture is formed in a separate container by mixing one or more additives (such as salts, sweeteners, wetting agents, emulsifiers, flavoring agents, and others) with water for forming the aqueous mixture. The aqueous mixture can then be admixed with the heated gum (including at least one active ingredient added thereto) to form a mixture in the form of a slurry.

[0212] In some embodiments, at least one sugar alcohol component may be added separately to the mixture, or in other embodiments, at least one sugar alcohol may be combined with the gum and the active ingredient before being added to the mixture. In some examples, at least one sugar alcohol may still be heated in a separate container and added separately to the mixture. For example, in some embodiments, at least one sugar alcohol (which may optionally include isomalt / maltitol / erythritol) may be heated to a temperature in the range of about 160°C to about 190°C before being added to the mixture. In some embodiments, at least one sugar alcohol may be heated to a temperature of at least about 160°C, at least about 170°C, at least about 180°C, or at least about 190°C. In some examples, the heated sugar alcohol may be cooled to a temperature in the range of about 120°C to about 160°C before being added to the mixture. In some embodiments, for example, the heated sugar alcohol may be cooled to a temperature of about 160°C or less, about 150°C or less, about 140°C or less, or about 130°C or less before being added to the mixture.

[0213] In some examples, the heated (and optionally cooled) sugar alcohol is combined with a mixture (e.g., a heated gum, at least one active ingredient, and an aqueous mixture) to provide a paste composition that may be in the form of a slurry and may be agitated using a high shear mixer or a Hobart mixing bowl with a whipping attachment. The paste composition may then be heated to an elevated temperature for a period of time, e.g., for a period of about 1 to about 3 minutes, to about 40°C to about 80°C, typically to about 71°C, to dissolve any dry components within the paste composition. The heating step can be characterized by heating at a temperature of at least about 50°C, at least about 60°C, or at least about 70°C. The paste composition typically has a moisture content of at least about 40 weight percent water, based on the total weight of the composition.

[0214] According to some embodiments, a paste composition in the form of a slurry may optionally be subjected to a degassing step or process to reduce or eliminate air bubbles present in the slurry mixture before being placed in a mold or subjected to other processing steps. Air bubbles trapped within the slurry can affect the final weight of the paste, thereby compromising the weight uniformity between final product units. As such, any degassing method and system may be used to remove such air bubbles from the slurry material. For example, the slurry may be placed under reduced pressure (i.e., below atmospheric pressure) to vent air bubbles outside of the slurry mixture. In some examples, a vacuum degassing process may be used, in which the slurry mixture is placed in a vacuum degassing apparatus for degassing the slurry mixture using reduced pressure. In some examples, the slurry mixture may be under vacuum for about 1 to about 10 minutes, typically about 3 to about 5 minutes. The degassing step may be suitably observed and adjusted to controllably remove gaseous components from the slurry mixture.

[0215] The viscosity of the heated and degassed slurry mixture can be measured, for example, using a Brookfield viscometer HA series, SC4 water jacket, 27 / 13R sample chamber, and No. 27 spindle. The paste composition can have a viscosity of about 5.7 Pascal-seconds (Pa·s) to about 6.2 Pa·s when heated to a temperature of about 38°C, about 4.9 Pa·s to about 5.4 Pa·s when heated to a temperature of about 43°C, and about 4.2 Pa·s to about 4.7 Pa·s when heated to a temperature of about 50°C. In some examples, excess water may be added to the paste composition to provide the desired viscosity of the paste composition.

[0216] Once the desired viscosity is achieved, the heated paste composition can then be poured into a mold, such as a starch mold. The processes described further herein are directed to forming paste products using starch molds, but it should be noted that other types of molds, such as starch-free molds, pectin molds, plastic tray molds, metal tray molds, neoprene tray molds, etc., may be used in the process.

[0217] In examples involving the use of a starch mold, the starch mold may be pre-dried to remove the contained moisture from the starch mold itself. That is, before accommodating the slurry or viscous paste composition, the starch mold may be subjected to a high temperature to expel the moisture in the starch mold. For example, in some examples, the starch mold may initially have a moisture content of about 10 to 15 weight percent. Such a moisture level may potentially have an effect on the uniformity of the resulting product. In this regard, a certain moisture level in the starch mold may potentially have a wrinkling effect or a pruning effect on the product, and the final product may have a shriveled or otherwise wrinkled appearance. As described above, the starch mold may be dried at a high temperature to reduce the moisture content of the starch mold to about 4 to about 10 weight percent, preferably about 6 to about 8 weight percent, based on the total weight of the starch mold. By incorporating such steps, the product may, in some examples, have a uniform and non-uniform appearance. Moreover, the starch mold may be heated to a high temperature before accommodating the paste composition so that the starch mold itself is at a high temperature when accommodating the paste composition.

[0218] The paste composition remains at a high temperature, for example, in the range of about 40°C to about 80°C (e.g., at least about 40°C or at least about 50°C), typically about 60°C, in the starch mold. The paste composition may be held at the high temperature for a predetermined duration, for example, about 15 to 48 hours, typically about 24 hours, so that the paste composition cures and solidifies into the paste form, during which the water content of the paste composition reaches the desired final water level. As described above, in some embodiments, the desired final water level of the paste product may be in the range of about 5 to about 25 weight percent or about 8 to about 20 weight percent or about 10 to about 15 weight percent based on the total weight of the product unit. In this regard, curing generally refers to the solidification process in which water loss occurs, the viscosity of the composition increases, and chemical and physical changes begin to occur (e.g., crystallization, crosslinking, gelation, film formation, etc.). After cooling, the paste composition is removed from the starch mold. In some examples, the paste composition may be cooled in refrigeration or cooled below ambient temperature. A blower / vibrating device can be used to remove the starch residue from the paste composition after it is removed from the mold.

[0219] The paste composition is then post-cured at a time and temperature suitable for the composition to equilibrate to the desired moisture, shape, and form. The time and temperature can vary, without departing from the present invention, based in part on the final characteristics desired for the product. In one embodiment, the post-curing is carried out at ambient temperature for at least about 20 hours after removal from the mold. The resulting paste product can be provided in individual pieces weighing from about 0.5 grams to about 5 grams, although aspects of the present disclosure are not limited to such weights.

[0220] The curing time and temperature of the paste composition can be varied as desired. In this regard, such changes may affect the final visual appearance of the paste product. For example, an extended curing time and / or a low curing temperature may affect the final outer configuration or shape of the paste product. That is, the rate of drying and / or curing of the product can affect the final properties of the product. In some examples, for instance, by lowering the curing temperature and extending the curing time, the paste product can have a relatively smooth outer surface. In contrast, curing at a higher temperature for a shorter period may result in a rough or wrinkled appearance of the product.

[0221] According to another aspect of the present disclosure, instead of using a mold for preparing the paste product, an extrusion process may be used in which the final paste product is extruded. In some examples, the paste composition in slurry form is formed into a sheet and dried to a moisture content of, for example, about 15 weight percent to about 25 weight percent water to form a sticky or otherwise pasty material in a physically handleable form. This material can then be cut or otherwise trimmed into smaller pieces, for example, using a mixer. The cut material can then be extruded through an extrusion device into any desired shape / size, including shapes that may be difficult or impossible to achieve using a mold. In some examples, the extruded product may then be dried to achieve the desired moisture content. A similar type of process is described in U.S. Pat. No. 3,806,617 to Smylie et al., which is incorporated herein by reference in its entirety. Additionally, the paste composition may be subjected to a co-extrusion process with another composition.

[0222] For example, shapes such as rods and cubes can be formed by first extruding a material through a die having a desired cross-section (e.g., circular or square), and then optionally cutting the extruded material to a desired length. Techniques and equipment for extruding tobacco materials are described in U.S. Patent Nos. 3,098,492 to Wursburg, 4,874,000 to Tamol et al., 4,880,018 to Graves et al., 4,989,620 to Keritsis et al., 5,072,744 to Luke et al., 5,829,453 to White et al., and 6,182,670 to White et al., each of which is incorporated herein by reference. Examples of suitable extrusion equipment for use include food or gum extruders or industrial paste extruders, such as the Model TP 200 / 300 available from Emiliomiti, LLC of Italy. In some examples, a single machine, such as a kneading system available from Buss AG, may be capable of achieving multiple steps of the processes described herein.

[0223] Pastille products can be provided in any suitable predetermined shape or form, most preferably in a form having a common shape such as a pill, pellet, tablet, coin, bead, egg shape, obloid or cube. The mouthfeel of the smokeless tobacco product preferably has some chewable and soluble characteristics with a gentle elasticity or "resilience" during chewing, thereby gradually creating greater malleability during use. According to one aspect, the pastille product can preferably last in the user's mouth for about 10 to 15 minutes until it completely dissolves. Preferably, the product leaves no residue in the user's mouth to any substantial degree and does not give the user's mouth an oily, waxy or slimy feeling.

[0224] According to some embodiments, the pastille composition may be coated with a coating substance after being removed from the starch mold and before drying. For example, a finishing or anti - sticking coating substance, such as CAPOL 410 (available from Centerchem, Inc.), may be applied to the pastille composition to provide free - flowing properties. The outer coating can also help improve the storage stability of the pastille products of the present disclosure and the packaging process by reducing friability and dusting. Devices for providing an outer coating layer to the products of the present disclosure include pan coater and spray coater, and in particular, coating devices available as CompuLab 24, CompuLab 36, Accela - Cota 48 and Accela - Cota 60 from Thomas Engineering.

[0225] Exemplary outer coatings include film - forming polymers, such as cellulosic polymers, optional plasticizers and optional flavoring agents, coloring agents, salts, sweeteners or other additives of the types described herein. Coating compositions are typically aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as pan coating. Exemplary film - forming polymers include cellulosic polymers such as methylcellulose, hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose and carboxymethylcellulose. Exemplary plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate.

[0226] In one embodiment, the coating composition comprises up to about 75 weight percent of a film-forming polymer solution (e.g., about 40 to about 70 weight percent based on the total weight of the coating formulation), up to about 5 weight percent of a plasticizer (e.g., about 0.5 to about 2 weight percent), up to about 5 weight percent of a sweetening agent (e.g., about 0.5 to about 2 weight percent), up to about 10 weight percent of one or more colorants (e.g., about 1 to about 5 weight percent), up to about 5 weight percent of one or more flavoring agents (e.g., about 0.5 to about 3 weight percent), up to about 2 weight percent of a salt such as NaCl (e.g., about 0.1 to about 1 weight percent), and the balance water. Exemplary coating compositions and methods of application are described in U.S. Application No. 12 / 876,785 to Hunt et al., filed September 7, 2010, the contents of which are incorporated herein by reference.

[0227] The foregoing description has focused on a uniform composition throughout each product unit, but it is also possible to form a product that includes multiple different formulations having different properties within the same product unit. For example, two different compositions can be injected into a single mold to produce a layered product. Still further, two different compositions can be coextruded to form a product having different features across a cross-section. Using such processes, it is possible to provide a product that includes two different compositions characterized by different dissolution rates, where a first portion of the product dissolves at a first rate (e.g., a faster rate) and a second portion dissolves at a second, slower rate.

[0228] The products of the present disclosure can be packaged and stored in any suitable packaging. For example, U.S. Patent No. 7,014,039 to Henson, U.S. Patent No. 7,537,110 to Kutsch, U.S. Patent No. 7,584,843 to Kutsch, U.S. Patent No. D592,956 to Thiellier, U.S. Patent No. D594,154 to Patel, U.S. Patent Application Publication No. 2008 / 0173317 to Robinson, U.S. Patent Application Publication No. 2009 / 0014343 to Clark, U.S. Patent Application Publication No. 2009 / 0014450 to Bjorkholm, U.S. Patent Application Publication No. 2009 / 0250360 to Bellamah, U.S. Patent Application Publication No. 2009 / 0266837 to Gelardi, U.S. Patent Application Publication No. 2009 / 0223989 to Gelardi, U.S. Patent Application Publication No. 2009 / 0230003 to Thiellier, U.S. Patent Application Publication No. 2010 / 0084424 to Gelardi, U.S. Patent Application Publication No. 2010 / 0133140 to Bailey, and U.S. Patent Application No. 29 / 342,212 to Bailey filed on August 20, 2009, U.S. Patent Application No. 12 / 425,180 to Bailey filed on April 16, 2009, U.S. Patent Application No. 12 / 685,819 to Bailey filed on January 12, 2010, and U.S. Patent Application No. 12 / 814,015 to Gelardi filed on June 11, 2010, the contents of which are incorporated herein by reference, may be referred to for various types of containers for smokeless type products.

[0229] Method for manufacturing a lozenge product Typical lozenge compositions and products may incorporate at least one active ingredient of about 10 weight percent or less, based on the total weight of the product, about 0.01 to about 2 percent artificial sweetener, about 1 to about 5 percent humectant, about 1 to about 5 percent natural sweetener, at least about 80 percent sugar substitute, about 0.1 to about 10 percent sugar alcohol syrup, up to about 5 percent by weight of one or more flavoring agents, and up to about 3 percent by weight of salt. The percentage and selection of specific ingredients will vary depending on the desired flavor, texture, and other characteristics.

[0230] The ways and methods used to formulate and manufacture the lozenge products described above in this specification may vary. For example, the composition can be prepared by any method customarily used for the preparation of hard-boiled candies. Example methods for the preparation of hard candies can be found, for example, on pages 21 - 44 of LFRA Ingredients Handbook, Sweeteners, Janet M. Dalzell (ed.), Leatherhead Food RA (December 1996), which is incorporated herein by reference.

[0231] Typically, a first mixture of ingredients is prepared. The composition of the first mixture of ingredients can vary, but typically includes a sugar substitute and may contain various additional substances (such as sugar alcohol syrup, NaCl, preservatives, further sweeteners, water and / or flavorings). In certain embodiments, the first mixture includes a sugar substitute, salt, and vanilla. In other embodiments, the first mixture includes a sugar substitute and a sugar alcohol syrup. Typically, the first mixture of ingredients does not contain the active ingredient, although in some embodiments, the active ingredient may be incorporated into the first mixture of ingredients.

[0232] The first mixture of ingredients is heated until the mixture melts and is then heated to the hard crack stage or beyond. In candy making, the hard crack stage is defined as the temperature at which a thread of the heated mixture (obtained by pulling a sample of the cooled syrup between the thumb and forefinger) becomes brittle or the temperature at which the syrup cracks when an attempt is made to shape it. According to this method, the temperature at which the hard crack stage is achieved can vary depending on the specific composition of the product mixture, but generally is about 145°C to about 170°C. Typically, the mixture is not heated above about 171°C, which is the temperature at which caramelization begins to occur. In the process of the present disclosure, the mixture is typically heated above the temperature of the hard crack stage and then cooled. The heating can be carried out at atmospheric pressure or under vacuum. Typically, the method of the present invention is carried out at atmospheric pressure.

[0233] In an exemplary embodiment, the first mixture of ingredients contains a high percentage of isomalt and the mixture is heated to about 143°C. When all the ingredients are dissolved, the temperature is raised beyond the hard crack stage (e.g., to about 166°C). The mixture is heated to this temperature and then removed from the heat and the mixture is cooled.

[0234] In certain embodiments, the active ingredients described above and optionally additional ingredients (e.g., additional sweeteners, fillers, flavorants and water) are combined separately into a second mixture. The second mixture is typically added to the first mixture of ingredients after the first mixture of ingredients has been removed from the heat. The addition of the second mixture may, in some embodiments, be made only after the heated first mixture of ingredients has cooled to a predetermined temperature (e.g., in certain embodiments, about 132°C). In certain embodiments, one or more flavorants are added to the second mixture immediately prior to adding the heated first mixture of ingredients to the mixture. Certain flavorants are volatile and thus are preferably added after the mixture has cooled somewhat.

[0235] The combined mixture is then formed into the desired shape. In certain embodiments, the mixture is poured directly into a mold and formed (e.g., rolled or pressed) or extruded into the desired shape. If desired, the mixture can be extruded or injection molded. In certain embodiments, the mixture is formed or extruded into a mold of the desired shape in a closed system, although the closed system may require low temperatures and may limit the evaporation of certain mixture components. For example, such a system may limit the evaporation of volatile components, including but not limited to flavorants. Other methods of producing lozenges are also intended to be encompassed herein.

[0236] Typical conditions related to the manufacture of food-grade lozenge products, such as those described herein, include heating and temperature control (i.e., the degree of heating to which various components are exposed during manufacture and the temperature of the manufacturing environment), moisture content (e.g., the degree of moisture present within individual components and within the final composition), humidity within the manufacturing environment, atmosphere control (e.g., nitrogen atmosphere), air flow to which various components are exposed during the manufacturing process, and other similar types of factors. In addition, various process steps involved in product manufacture can relate to the selection of certain solvents and processing aids, the use of heating and radiation, refrigeration and low-temperature conditions, and the mixing rate of components, among others. Manufacturing conditions can also be controlled based on the selection of the form of various components (e.g., solid, liquid, or gas), the particle size or crystal properties of components in solid form, or the concentration of components in liquid form. Components can be processed into the desired composition, for example, by techniques such as extrusion, compression, and spraying.

[0237] In certain embodiments, the lozenge product can be transparent or translucent. As used herein, "translucent" or "translucency" refers to a material transmitting a certain level of light by diffusion through the material. In certain embodiments, the lozenge products of the present disclosure can have a high degree of clarity such that the material can be classified as "transparent" or exhibiting "transparency", where transparency is defined as the material allowing light to pass freely without significant diffusion. The clarity of the lozenge product is such that there is a level of translucency, which is the opposite of opacity (where opacity refers to a material through which light cannot pass). Transparency / translucency can be determined by any means conventionally used in the art, but is typically measured by spectrophotometric light transmission over a range of wavelengths (e.g., about 400 - 700 nm). Alternatively, optical methods such as turbidimetry (or nephelometry) and colorimetry can be used to quantify the haze (light scattering) and color (light absorption) of the lozenge products provided herein, respectively. Translucency can also be confirmed by visual inspection by simply holding the material (e.g., extract) or product up to a light source and determining whether the light diffuses through the product.

Example

[0238] Experiment The following examples are provided to illustrate further aspects related to the present disclosure and should not be construed as limiting its scope. Unless otherwise stated, all parts and percentages are by dry weight.

[0239] [Example 1] An oral product configured for oral use in the form of a pastille (referred to herein as "Pastille A") is provided in the following manner.

[0240] An aqueous mixture is prepared. The aqueous mixture is formed by mixing water, salts, sweeteners, wetting agents, and flavoring agents. Next, the gum is heated to a temperature of about 71 °C and then at least one active ingredient is stirred and added to the heated gum component. Then, the heated gum (containing at least one active ingredient therein) is added to the aqueous composition to form a mixture. Next, at least one sugar alcohol is heated to a temperature of about 175 °C and then cooled to a temperature of about 150 °C. Then, the cooled sugar alcohol is added to the mixture and stirred in a Hobart mixing bowl to form a pastille composition.

[0241] The pastille composition is heated to about 71 °C and then poured into a starch mold. The pastille composition is kept in the starch mold at about 60 °C for about 24 hours. The pastille composition is cooled and then removed from the starch mold. Then, the oral composition is cured at ambient room temperature for about 24 hours to provide a pastille product configured for oral use. Table 1 below represents the relative percentages of each individual component in the final oral product prepared as described herein.

[0242]

Table 1

[0243] [Example 2] An oral product configured for oral use in the form of a pastille (referred to herein as "Pastille B") is provided in the following manner.

[0244] An aqueous mixture is prepared. The aqueous mixture is formed by admixing water, salts, a sweetening agent (sucralose), a humectant (glycerin), and a flavoring agent. Next, the gum (gum arabic solution) is heated to a temperature of about 71°C and then at least one active ingredient (e.g., including caffeine, taurine, and ascorbic acid) is stirred and added to the heated gum component. Next, the heated gum (containing at least one active ingredient therein) is added to the aqueous composition to form a mixture. Then, at least one sugar alcohol (e.g., including isomalt, maltitol, and erythritol) is heated to a temperature of about 175°C and then cooled to a temperature of about 150°C. Next, the cooled sugar alcohol is added to the mixture and stirred in a Hobart mixing bowl to form a pastille composition, which is cooled.

[0245] The pastille composition is heated to about 71°C and then poured into a starch mold. The pastille composition is retained in the starch mold at about 60°C for about 24 hours. The pastille composition is cooled and then removed from the starch mold. Next, the oral composition is cured at ambient room temperature for about 24 hours to provide a pastille product configured for oral use. Table 2 below represents the relative percentages of each individual component in the final oral product prepared as described herein.

[0246]

Table 2

[0247] [Example 3] An oral product configured for oral use in the form of a pastille (referred to herein as "Pastille C") is provided in the following manner.

[0248] An aqueous mixture is prepared. The aqueous mixture is formed by admixing water, salt, a sweetening agent (sucralose), a wetting agent (glycerin), and a flavoring agent. Next, the gum (gum arabic solution) is heated to a temperature of about 71 °C and then at least one active ingredient (e.g., including theanine, GABA, and lemon balm) is stirred and added to the heated gum component. Then, the heated gum (containing at least one active ingredient therein) is added to the aqueous composition to form a mixture. Next, at least one sugar alcohol (e.g., including isomalt, maltitol, and erythritol) is heated to a temperature of about 175 °C and then cooled to a temperature of about 150 °C. Then, the cooled sugar alcohol is added to the mixture and stirred in a Hobart mixing bowl to form a pastille composition, which is cooled.

[0249] The pastille composition is heated to about 71 °C and then poured into a starch mold. The pastille composition is retained in the starch mold at about 60 °C for about 24 hours. The pastille composition is cooled and then removed from the starch mold. Then, the oral composition is cured at ambient room temperature for about 24 hours to provide a pastille product configured for oral use. Table 3 below represents the relative percentages of each individual component in the final oral product prepared as described herein.

[0250] [Table 3]

[0251] [Example 4] An oral product configured for oral use in the form of a pastille (referred to herein as "Pastille D") is provided in the following manner.

[0252] An aqueous mixture is prepared. The aqueous mixture is formed by mixing water, salt, a sweetening agent (sucralose), a wetting agent (glycerin), and a flavoring agent. Next, the gum (gum arabic solution) is heated to a temperature of about 71°C, and then at least one active ingredient (for example, including caffeine, theanine, and ginseng) is stirred and added to the heated gum component. Then, the heated gum (containing at least one active ingredient therein) is added to the aqueous composition to form a mixture. Next, at least one sugar alcohol (for example, including isomalt, maltitol, and erythritol) is heated to a temperature of about 175°C and then cooled to a temperature of about 150°C. Then, the cooled sugar alcohol is added to the mixture and stirred in a Hobart mixing bowl to form a pastille composition, which is cooled.

[0253] The pastille composition is heated to about 71°C and then poured into a starch mold. The pastille composition is kept in the starch mold at about 60°C for about 24 hours. The pastille composition is cooled and then removed from the starch mold. Then, the oral composition is cured at ambient room temperature for about 24 hours to provide a pastille product configured for oral use. Table 4 below represents the relative percentages of each individual component in the final oral product prepared as described herein.

[0254]

Table 4

[0255] Many modifications and other embodiments of the present invention will come to the mind of those skilled in the art to which this invention pertains and who have the benefit of the teachings presented in the foregoing description. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are used herein, they are used in a general and descriptive sense only and not for purposes of limitation.

Claims

**Claim 1** An oral product comprising at least one active ingredient in an amount of about 10 weight percent or less, at least one sugar alcohol in an amount of about 25 wt% to about 45 wt%, and a gum in an amount of about 35 wt% to about 55 wt%, based on the total weight of the product, wherein the oral product is in the form of a pastille, and the at least one active ingredient comprises vitamin B6 and one or more of caffeine, taurine, and theanine. **Claim 2** The oral product according to claim 1, wherein the at least one active ingredient is further selected from the group consisting of nicotine components, botanicals, dietary supplements, stimulants, amino acids, vitamins, cannabinoids, cannabinimimetics, terpenes, and combinations thereof. **Claim 3** The oral product according to claim 1, wherein the at least one active ingredient is further selected from the group consisting of GABA, tryptophan, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof. **Claim 4** The oral product according to claim 3, wherein the at least one active ingredient further comprises ascorbic acid. **Claim 5** The oral product according to claim 4, wherein caffeine is present in an amount of about 2 wt% to about 4 wt%, taurine is present in an amount of about 2 wt% to about 4 wt%, and ascorbic acid is present in an amount of about 1 wt% to about 3 wt%, based on the total weight of the product. **Claim 6** The oral product according to claim 3, wherein the at least one active ingredient further comprises gamma-aminobutyric acid and optionally lemon balm. **Claim 7** The oral product according to claim 6, wherein theanine is present in an amount of about 2 wt% to about 4 wt%, gamma-aminobutyric acid is present in an amount of about 2 wt% to about 4 wt%, and lemon balm is present in an amount of about 1 wt% to about 3 wt%, based on the total weight of the product. **Claim 8** The oral product according to claim 3, wherein the at least one active ingredient further comprises ginseng. **Claim 9** The oral product according to claim 8, wherein caffeine is present in an amount of about 2% to about 4%, theanine is present in an amount of about 2 wt% to about 4 wt%, and ginseng is present in an amount of about 0.1 wt% to about 1 wt%, based on the total weight of the product. **Claim 10** The oral product according to claim 3, wherein the at least one active ingredient further comprises tryptophan or vitamin B12. **Claim 11** The oral product according to claim 10, comprising vitamin B12. **Claim 12** The oral product according to any one of claims 1 to 11, wherein at least one active ingredient is present in an amount in the range of about 6% to about 8% by weight based on the total weight of the product.

13. The oral product according to any one of claims 1 to 11, which does not contain tobacco materials.

14. The oral product according to any one of claims 1 to 11, which does not contain nicotine or nicotine-derived components.

15. The oral product according to any one of claims 1 to 11, which further contains tobacco materials.

16. The oral product according to any one of claims 1 to 11, wherein at least one sugar alcohol is selected from the group consisting of erythritol, arabinitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof.

17. The oral product according to claim 16, wherein at least one sugar alcohol is selected from the group consisting of isomalt, maltitol, erythritol, and combinations thereof.

18. The oral product according to claim 17, wherein at least one sugar alcohol contains about 20% to about 35% by weight of isomalt, about 1% to about 10% by weight of maltitol, and about 0.1% to about 2% by weight of erythritol based on the total weight of the product.

19. The oral product according to any one of claims 1 to 11, wherein the gum is selected from the group consisting of gum arabic, xanthan gum, guar gum, ghatti gum, tragacanth gum, karaya gum, locust bean gum, gellan gum, and combinations thereof.

20. The oral product according to claim 19, wherein the gum is gum arabic.

21. The oral product according to any one of claims 1 to 11, which further contains additives selected from the group consisting of flavoring agents, sweetening agents, additional binders, emulsifiers, disintegrating aids, wetting agents, salts, and mixtures thereof.

22. The oral product according to any one of claims 1 to 11, which further contains a sufficient amount of buffer and / or pH adjuster to adjust the pH of the oral product to be within the range of about 5.0 to about 7.

0.

23. The oral product according to any one of claims 1 to 11, wherein the oral product has an outer coating coated thereon.

24. The oral product according to any one of claims 1 to 11, wherein the water content of the oral product is in the range of about 5% by weight to about 20% by weight based on the total weight of the oral product.

25. The oral product according to claim 24, wherein the water content of the oral product is in the range of about 5% by weight to about 10% by weight based on the total weight of the oral product.

26. A sugar alcohol in an amount in the range of 25% by weight to 45% by weight based on the total weight of the composition, a gum in an amount in the range of about 35% by weight to about 55% by weight, a vitamin B6 in an amount of about 10% by weight or less, and at least one active ingredient containing one or more of caffeine, taurine, and theanine, a humectant in an amount in the range of about 0.1% by weight to about 5% by weight, a salt in an amount in the range of about 0.1% by weight to about 5% by weight, a flavoring agent in an amount in the range of about 0.1% by weight to about 5% by weight, a water content in the range of about 5% by weight to about 10% by weight and at least about 0.01% by weight of a sweetening agent An oral product containing.

27. A method for preparing an oral product, comprising: mixing a gum with a vitamin B6 and at least one active ingredient containing one or more of caffeine, taurine, and theanine to obtain a combined mixture of these; adding water, at least one additive, and at least one flavoring agent to the combined mixture to obtain an aqueous mixture; separately adding at least one sugar alcohol to the aqueous mixture to obtain an oral composition; heating the oral composition; injecting the oral composition into a mold; and hardening the oral composition to obtain an oral product in the form of a pastille A method including.

28. The method according to claim 27, wherein the gum is heated to a temperature in the range of about 40°C to about 80°C before being mixed with at least one active ingredient.

29. The method according to claim 27, wherein at least one sugar alcohol is heated to a temperature in the range of about 160°C to about 190°C before being added to the aqueous mixture, and then optionally cooled to a temperature in the range of about 120°C to about 150°C.

30. The method according to claim 27, wherein heating the oral composition includes heating to a temperature in the range of about 60°C to about 80°C.

31. The method according to claim 27, wherein at least one active ingredient is further selected from the group consisting of nicotine components, botanicals, dietary supplements, stimulants, amino acids, vitamins, cannabinoids, cannabinimimetics, terpenes, and combinations thereof.

32. The method according to claim 27, wherein at least one sugar alcohol is selected from the group consisting of erythritol, arabinitol, ribitol, isomalt, maltitol, xylitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof.

33. The method according to claim 27, wherein at least one additive is selected from the group consisting of flavoring agents, sweetening agents, additional binders, emulsifiers, disintegration aids, wetting agents, salts, and mixtures thereof.

34. The oral product according to any one of claims 1 to 26, further comprising magnesium.

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