JP2023504753A - Oral products containing a combination of active ingredients - Google Patents

Abstract

A composition adapted for oral use comprising caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, carrot, citicoline, sunflower lecithin, or combinations thereof. Compositions are provided comprising at least one active ingredient selected from The composition comprises one or more fillers including sugar alcohols, optionally lipids or binders. The composition may be in chewable, tablet or meltable form.

Description

The present disclosure relates to compositions intended for human use. The compositions are configured for oral use and deliver substances such as fragrances and/or active ingredients during use. Such products may contain tobacco or tobacco-derived products or may be tobacco-free alternatives.

Tobacco can be enjoyed in the so-called "smokeless" form. Particularly popular smokeless tobacco products are utilized by placing some form of processed tobacco or tobacco-containing formulation in the user's mouth. Conventional forms for such smokeless tobacco products include moist snuff, snus and chewing tobacco, and smokeless tobacco products are typically formed almost entirely from granulated, granular or chopped tobacco. The smokeless tobacco product is either dispensed by the user or provided to the user in individual portions such as single-use pouches or sachets. Other traditional forms of smokeless products include compressed or agglomerated forms such as plugs, tablets or pellets. Alternative product forms, such as tobacco-containing gums and mixtures of tobacco with other plant materials, are also known. See, for example, Schwartz, US Pat. No. 1,376,586; Pittman et al., US Pat. No. 4,513,756; Sensabaugh, Jr.; U.S. Pat. No. 4,528,993 to Story et al.; U.S. Pat. No. 4,624,269 to Story et al.; U.S. Pat. Sprinkle, III et al., U.S. Pat. No. 5,092,352; White et al., U.S. Pat. No. 5,387,416; Williams, U.S. Pat. No. 6,668,839. US Patent No. 6,834,654 to Williams; US Patent No. 6,953,040 to Atchley et al.; US Patent No. 7,032,601 to Atchley et al.; US Patent Publication No. 2004/0020503 to Williams; US Patent Publication No. 2005/0115580 to Quinter et al.; US Patent Publication No. 2006/0191548 to Strickland et al. Specification; Holton, Jr.; et al., U.S. Patent Publication No. 2007/0062549; Holton, Jr.; US Patent Publication No. 2007/0186941 to Strickland et al.; US Patent Publication No. 2007/0186942 to Strickland et al.; US Patent Publication No. 2008/0029110 to Dube et al.; U.S. Patent Publication No. 2008/0173317 to Robinson et al.; U.S. Patent Publication No. 2008/0209586 to Neilsen et al.; U.S. Patent Publication No. 2009/0065013 to Essen et al.; See U.S. Patent Publication No. 2010/0282267 and WO 2004/095959 to Arnarp et al. for the types, ingredients and processing methods of smokeless tobacco formulations, each of which is incorporated herein by reference. incorporate into

The construction of smokeless tobacco products combining tobacco materials with various binders and fillers has been proposed more recently in exemplary product formats including lozenges, pastels, gels, extruded forms, and the like. there is U.S. Patent Application Publication No. 2008/0196730 to Engstrom et al.; U.S. Patent Application Publication No. 2008/0305216 to Crawford et al.; U.S. Patent Application Publication No. 2009/0293889 to Kumar et al.; U.S. Patent Application Publication No. 2010/0291245; Mua et al. U.S. Patent Application Publication No. 2011/0139164; Cantrell et al. U.S. Patent Application Publication No. 2012/0037175; U.S. Patent Application Publication No. 2012/0138073 to Cantrell et al.; U.S. Patent Application Publication No. 2012/0138074 to Cantrell et al.; Holton, Jr.; US Patent Application Publication No. 2013/0074855; Holton, Jr.; U.S. Patent Application Publication No. 2013/0074856 to Mua et al.; U.S. Patent Application Publication No. 2013/0152953 to Jackson et al.; U.S. Patent Application Publication No. 2013/0274296 to Jackson et al.; US Patent Application Publication No. 2015/0101627 to Marshall et al.; and US Patent Application Publication No. 2015/0230515 to Lampe et al. , each of which is incorporated herein by reference.

U.S. Pat. No. 1,376,586 U.S. Pat. No. 4,513,756 U.S. Pat. No. 4,528,993 U.S. Pat. No. 4,624,269 U.S. Pat. No. 4,991,599 U.S. Pat. No. 4,987,907 U.S. Pat. No. 5,092,352 U.S. Pat. No. 5,387,416 U.S. Pat. No. 6,668,839 U.S. Pat. No. 6,834,654 U.S. Pat. No. 6,953,040 U.S. Pat. No. 7,032,601 U.S. Pat. No. 7,694,686 U.S. Patent Application Publication No. 2004/0020503 U.S. Patent Application Publication No. 2005/0115580 U.S. Patent Application Publication No. 2006/0191548 U.S. Patent Application Publication No. 2007/0062549 U.S. Patent Application Publication No. 2007/0186941 U.S. Patent Application Publication No. 2007/0186942 U.S. Patent Application Publication No. 2008/0029110 U.S. Patent Application Publication No. 2008/0029116 U.S. Patent Application Publication No. 2008/0173317 U.S. Patent Application Publication No. 2008/0209586 U.S. Patent Application Publication No. 2009/0065013 U.S. Patent Application Publication No. 2010/0282267 WO2004/095959 U.S. Patent Application Publication No. 2008/0196730 U.S. Patent Application Publication No. 2008/0305216 U.S. Patent Application Publication No. 2009/0293889 U.S. Patent Application Publication No. 2010/0291245 U.S. Patent Application Publication No. 2011/0139164 U.S. Patent Application Publication No. 2012/0037175 U.S. Patent Application Publication No. 2012/0055494 U.S. Patent Application Publication No. 2012/0138073 U.S. Patent Application Publication No. 2012/0138074 U.S. Patent Application Publication No. 2013/0074855 U.S. Patent Application Publication No. 2013/0074856 U.S. Patent Application Publication No. 2013/0152953 U.S. Patent Application Publication No. 2013/0274296 U.S. Patent Application Publication No. 2015/0068545 U.S. Patent Application Publication No. 2015/0101627 U.S. Patent Application Publication No. 2015/0230515

(brief summary)
The present disclosure generally provides compositions adapted for use in the oral cavity, the compositions comprising at least one active ingredient and one or more fillers. The composition may be in chewable, tablet or meltable form.

In one aspect, the present disclosure is a composition in chewable form configured for use in the oral cavity, the composition comprising caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12 ( or other B vitamins), at least one active ingredient selected from the group consisting of vitamin C, lemon balm extract, carrot, citicoline, sunflower lecithin and combinations thereof; based on the total weight of the composition, at least 50 A composition is provided that is a homogenous mixture comprising one or more sugar alcohols; pectin; and an organic acid, a gelling agent, or both, in a weight percent amount.

In one embodiment, the one or more sugar alcohols is a combination of isomalt and maltitol. In one embodiment, the composition comprises isomalt in an amount of about 10 to about 25 weight percent, based on the total weight of the composition; tall; and pectin in an amount of about 1 to about 3% by weight, based on the total weight of the composition.

In one embodiment, the organic acid is citric acid. In one embodiment, the gelling agent is a calcium salt. In one embodiment, the calcium salt is dicalcium phosphate.

In one embodiment, at least one active ingredient comprises caffeine.

In one embodiment, the at least one active ingredient comprises theanine.

In one embodiment, at least one active ingredient comprises taurine.

In one embodiment, at least one active ingredient comprises GABA.

In one embodiment, at least one active ingredient comprises tryptophan.

In one embodiment, the at least one active ingredient comprises vitamin B6, vitamin B12, or both, eg, about 0.008% to about 0.07% total vitamin B6 and B12 by weight.

In one embodiment, the at least one active ingredient comprises vitamin C.

In one embodiment, the at least one active ingredient comprises carrots.

In one embodiment, the at least one active ingredient comprises lemon balm extract.

In one embodiment, the at least one active ingredient comprises a combination of caffeine, theanine, and optionally carrots. In one embodiment, caffeine is present in an amount of about 1 to about 4 weight percent, based on the total weight of the composition; theanine is about 1 to about 4 weight percent, based on the total weight of the composition. carrots, if present, in an amount of about 0.1 to about 0.6% by weight, based on the total weight of the composition. In one embodiment, the composition further comprises citicoline or sunflower lecithin.

In one embodiment, the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract. In one embodiment, theanine is present in an amount of about 1 to about 3 weight percent, based on the total weight of the composition; GABA is present in an amount of about 1.5 to about 4 weight percent, based on the total weight of the composition. %; lemon balm extract, when present, is in an amount of about 0.25 to about 2% by weight, based on the total weight of the composition.

In one embodiment, the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C. In one embodiment, caffeine is present in an amount of about 1 to about 4 weight percent, based on the total weight of the composition; taurine is about 1 to about 4 weight percent, based on the total weight of the composition. vitamin C is present in an amount of about 1 to about 3% by weight, based on the total weight of the composition. In one embodiment, the composition further comprises trisodium citrate. In one embodiment, the composition further comprises vitamin B6, vitamin B12, or both. In one embodiment, the at least one active ingredient comprises caffeine, taurine and vitamin B6, vitamin B12 or a combination of both.

In one embodiment, the composition further comprises at least one additional ingredient selected from water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof.

In one embodiment, the composition further comprises magnesium, eg, in an amount of from about 0.1% to about 2%, or from about 0.2% to about 1% by weight based on elemental magnesium. In one embodiment, magnesium is in the form of a magnesium salt. In one embodiment, the magnesium salt is magnesium gluconate.

In one embodiment, the composition does not contain nicotine.

In one embodiment, the composition does not contain tobacco.

In another aspect, provided is a composition in tablet form adapted for oral use and comprising caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12 (or other B vitamins), at least one active ingredient selected from the group consisting of vitamin C, lemon balm extract, carrot, citicoline, sunflower lecithin and combinations thereof; a glucose-polysaccharide blend; and a sugar alcohol, in tablet form. is a composition comprising the composition as a homogeneous mixture.

In one embodiment, the glucose-polysaccharide blend is present in an amount of from about 35 to about 55% by weight, based on the total weight of the composition; the sugar alcohol is from about 30 to about It is present in an amount of 45% by weight. In one embodiment, the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof. In one embodiment, the sugar alcohol is isomalt.

In one embodiment, at least one active ingredient comprises caffeine.

In one embodiment, the at least one active ingredient comprises theanine.

In one embodiment, at least one active ingredient comprises taurine.

In one embodiment, at least one active ingredient comprises tryptophan.

In one embodiment, at least one active ingredient comprises GABA.

In one embodiment, the at least one active ingredient comprises vitamin B6, vitamin B12, or both, eg, about 0.008% to about 0.07% total vitamin B6 and B12 by weight.

In one embodiment, the at least one active ingredient comprises vitamin C.

In one embodiment, the at least one active ingredient comprises carrots.

In one embodiment, the at least one active ingredient comprises lemon balm extract.

In one embodiment, the at least one active ingredient comprises a combination of caffeine, theanine, and optionally carrots. In one embodiment, caffeine is present in an amount of about 3 to about 5 weight percent, based on the total weight of the composition; theanine is about 3 to about 5 weight percent, based on the total weight of the composition. carrots, if present, in an amount of about 0.4 to about 0.6% by weight, based on the total weight of the composition. In one embodiment, the composition further comprises citicoline or sunflower lecithin.

In one embodiment, the at least one active ingredient comprises caffeine and vitamin B6, vitamin B12, or a combination of both. In one embodiment, the at least one active ingredient comprises a combination of caffeine and taurine. In one embodiment, the at least one active ingredient comprises caffeine, taurine and vitamin B6, vitamin B12 or a combination of both.

In one embodiment, the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract. In one embodiment, theanine is present in an amount of about 3 to about 5 weight percent, based on the total weight of the composition; GABA is present in an amount of about 4 to about 6 weight percent, based on the total weight of the composition. Lemon balm extract, when present, is present in an amount of about 3 to about 4% by weight, based on the total weight of the composition.

In one embodiment, the at least one active ingredient comprises theanine and tryptophan. In one embodiment, the at least one active ingredient comprises theanine and vitamin B6, vitamin B12, or a combination thereof. In one embodiment, the at least one active ingredient comprises theanine, tryptophan and vitamins B6, B12 or combinations thereof.

In one embodiment, the at least one active ingredient comprises caffeine and taurine. In one embodiment, the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C. In one embodiment, caffeine is present in an amount of about 3 to about 5 weight percent, based on the total weight of the composition; taurine is about 4 to about 6 weight percent, based on the total weight of the composition. vitamin C is present in an amount of about 4 to about 6% by weight, based on the total weight of the composition. In one embodiment, the composition further comprises trisodium citrate.

In one embodiment, the composition further comprises at least one additional ingredient selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof.

In one embodiment, the composition further comprises magnesium, eg, in an amount of from about 0.1% to about 2%, or from about 0.2% to about 1% by weight based on elemental magnesium. In one embodiment, magnesium is in the form of a magnesium salt. In one embodiment, the magnesium salt is magnesium gluconate.

In one embodiment, the composition does not contain nicotine.

In one embodiment, the composition does not contain tobacco.

In another aspect, provided is a composition in meltable form adapted for use in the oral cavity comprising caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12. (or other B vitamins), at least one active ingredient selected from the group consisting of vitamin C, lemon balm extract, carrot, citicoline, sunflower lecithin and combinations thereof; sugar alcohols; A preferred form is a composition comprising the composition as a homogeneous mixture.

In one embodiment, the sugar alcohol is present in an amount of about 35 to about 55% by weight, based on the total weight of the composition; the lipid is about 35 to about 50%, by weight, based on the total weight of the composition. is present in an amount of In one embodiment, the lipid has a melting point of about 29°C or higher. In one embodiment, the lipid has a melting point of about 36°C to about 45°C. In one embodiment, the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, coconut oil, cottonseed oil and combinations thereof, and the oil may be hydrogenated. , may be partially hydrogenated or unhydrogenated.

In one embodiment, the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof. In one embodiment, the sugar alcohol is isomalt.

In one embodiment, at least one active ingredient comprises caffeine.

In one embodiment, the at least one active ingredient comprises theanine.

In one embodiment, at least one active ingredient comprises taurine.

In one embodiment, at least one active ingredient comprises GABA.

In one embodiment, at least one active ingredient comprises tryptophan.

In one embodiment, the at least one active ingredient comprises vitamin B6, vitamin B12, or both, eg, about 0.008% to about 0.07% total vitamin B6 and B12 by weight.

In one embodiment, the at least one active ingredient comprises vitamin C.

In one embodiment, the at least one active ingredient comprises carrots.

In one embodiment, the at least one active ingredient comprises lemon balm extract.

In one embodiment, the at least one active ingredient comprises a combination of caffeine, theanine, and optionally carrots. In one embodiment, caffeine is present in an amount of about 2 to about 6 weight percent, based on the total weight of the composition; theanine is about 2 to about 4 weight percent, based on the total weight of the composition. carrots, if present, in an amount of about 0.3 to about 0.5% by weight, based on the total weight of the composition.

In one embodiment, the composition further comprises citicoline or sunflower lecithin.

In one embodiment, at least some of the caffeine is present in encapsulated form.

In one embodiment, the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract. In one embodiment, theanine is present in an amount of about 2 to about 4% by weight, based on the total weight of the composition; GABA is present in an amount of about 3.5 to about 4.0%, based on the total weight of the composition. Present in an amount of 5% by weight; lemon balm extract, if present, is in an amount of about 1.5 to about 2.5% by weight, based on the total weight of the composition.

In one embodiment, the at least one active ingredient comprises theanine and tryptophan. In one embodiment, the at least one active ingredient comprises theanine and vitamins B6, B12, or combinations thereof. In one embodiment, the at least one active ingredient comprises theanine, tryptophan and vitamins B6, B12 or combinations thereof.

In one embodiment, the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C. In one embodiment, caffeine is present in an amount of about 2 to about 6 weight percent, based on the total weight of the composition; taurine is present in an amount of about 3.5 to about 4 weight percent, based on the total weight of the composition. Vitamin C is present in an amount of about 3.5 to about 4.5% by weight, based on the total weight of the composition.

In one embodiment, at least some of the caffeine is present in encapsulated form.

In one embodiment, the composition further comprises sodium citrate.

In one embodiment, the composition further comprises at least one additional ingredient selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof.

In one embodiment, the composition further comprises magnesium, eg, in an amount of from about 0.1% to about 2%, or from about 0.2% to about 1% by weight based on elemental magnesium. In one embodiment, magnesium is in the form of a magnesium salt. In one embodiment, the magnesium salt is magnesium gluconate.

In one embodiment, the composition does not contain nicotine.

In one embodiment, the composition does not contain tobacco.

Provided in another aspect is that at least one active ingredient comprises
a) caffeine in an amount of about 1.5 to about 5% by weight, based on the total weight of the composition;
Taurine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition;
vitamin C in an amount of about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of about 1 to about 3%, by weight, based on the total weight of the composition;
is a combination of
b) theanine in an amount of about 1 to about 5% by weight, based on the total weight of the composition;
GABA in an amount of about 1.5% to about 6% by weight, based on the total weight of the composition; and lemon balm extract in an amount of about 1% to about 4%, by weight, based on the total weight of the composition; or a combination of or
c) caffeine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition;
Theanine in an amount of about 1.5 to about 5% by weight, based on the total weight of the composition;
carrots in an amount of about 0.2 to about 0.6 weight percent, based on the total weight of the composition; and optionally about 0.3 to about 1.5 weight, based on the total weight of the composition. % amount of citicoline or sunflower lecithin in a consumable, tablet or meltable form composition disclosed herein.

The disclosure includes, but is not limited to, the following embodiments.

Embodiment 1: A composition in chewable form adapted for use in the oral cavity comprising caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, carrot , citicoline, sunflower lecithin and combinations thereof; one or more sugar alcohols in an amount of at least 50% by weight, based on the total weight of the composition; pectin; A composition comprising an acid, a gelling agent, or both, which is a homogeneous mixture.

Embodiment 2: The composition of embodiment 1, wherein the one or more sugar alcohols is a combination of isomalt and maltitol.

Embodiment 3: isomalt in an amount of about 10 to about 25% by weight, based on the total weight of the composition; maltitol in an amount of about 50 to about 75%, by weight, based on the total weight of the composition; and the composition 3. The composition of embodiment 1 or 2, comprising pectin in an amount of about 1 to about 3% by weight, based on the total weight of the.

Embodiment 4: The composition of any one of embodiments 1-3, wherein the organic acid is citric acid.

Embodiment 5: The composition according to any one of embodiments 1-4, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally carrots.

Embodiment 6: Caffeine is present in an amount of about 1 to about 4% by weight, based on the total weight of the composition; theanine is present in an amount of about 1 to about 4%, by weight of the total composition. the carrot is present in an amount of about 0.1 to about 0.6% by weight, based on the total weight of the composition. .

Embodiment 7: The composition of any one of embodiments 1-6, further comprising citicoline or sunflower lecithin.

Embodiment 8: The composition according to any one of embodiments 1-4, wherein the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract.

Embodiment 9: Theanine is present in an amount of about 1 to about 3 weight percent, based on the total weight of the composition; GABA is about 1.5 to about 4 weight percent, based on the total weight of the composition. and the lemon balm extract, if present, is in an amount of from about 0.25 to about 2% by weight, based on the total weight of the composition. The described composition.

Embodiment 10 to any one of Embodiments 1 to 4, wherein the at least one active ingredient comprises Theanine; Theanine and Tryptophan; or Theanine and one or more of Vitamins B6 and B12; The described composition.

Embodiment 11: The composition according to any one of embodiments 1-4, comprising theanine and one or both of vitamin B6 and vitamin B12.

Embodiment 12: The composition according to any one of Embodiments 1-4, wherein the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C.

Embodiment 13: Caffeine is present in an amount of about 1 to about 4 weight percent, based on the total weight of the composition; Taurine is present in an amount of about 1 to about 4 weight percent, based on the total weight of the composition. Vitamin C is present in an amount of about 1 to about 3% by weight, based on the total weight of the composition.

Embodiment 14: The composition of any one of embodiments 1-13, further comprising trisodium citrate.

Embodiment 15: Any one of embodiments 1-14, further comprising at least one additional ingredient selected from water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof. A composition according to embodiments.

Embodiment 16: The composition according to any one of embodiments 1-15, which is free of nicotine.

Embodiment 17: The composition of any one of Embodiments 1-16, which is free of tobacco.

Embodiment 18: A composition in tablet form configured for oral use comprising caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, carrot , citicoline, sunflower lecithin and combinations thereof; a glucose-polysaccharide blend; and a sugar alcohol, wherein the tablet form comprises the composition as a homogeneous mixture. .

Embodiment 19: The glucose-polysaccharide blend is present in an amount from about 35 to about 55% by weight, based on the total weight of the composition; the sugar alcohol is from about 30 to about 45%, based on the total weight of the composition. 19. The composition of embodiment 18, present in a weight percent amount.

Embodiment 20: The composition of embodiment 18 or 19, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof.

Embodiment 21: The composition according to any one of embodiments 18-20, wherein the sugar alcohol is isomalt.

Embodiment 22: The composition according to any one of embodiments 18-21, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally carrots.

Embodiment 23: Caffeine is present in an amount of about 3 to about 5 weight percent, based on the total weight of the composition; theanine is present in an amount of about 3 to about 5 weight percent, based on the total weight of the composition. the carrot is present in an amount of about 0.4 to about 0.6 weight percent, based on the total weight of the composition. .

Embodiment 24: The composition according to any one of embodiments 18-23, further comprising citicoline or sunflower lecithin.

Embodiment 25: The composition according to any one of embodiments 18-21, wherein the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract.

Embodiment 26: Theanine is present in an amount of about 3 to about 5% by weight, based on the total weight of the composition; GABA is present in an amount of about 4 to about 6%, by weight, based on the total weight of the composition. and the lemon balm extract is present in an amount of about 3 to about 4% by weight, based on the total weight of the composition.

Embodiment 27: The composition according to any one of embodiments 18-21, wherein the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C.

Embodiment 28: Caffeine is present in an amount of about 3 to about 5 weight percent, based on the total weight of the composition; Taurine is present in an amount of about 4 to about 6 weight percent, based on the total weight of the composition. Vitamin C is present in an amount of about 4 to about 6 weight percent, based on the total weight of the composition.

Embodiment 29: A composition according to embodiment 28, further comprising trisodium citrate.

Embodiment 30: to any one of Embodiments 18-21, wherein the at least one active ingredient comprises Theanine; Theanine and Tryptophan; or Theanine and one or more of Vitamins B6 and B12; The described composition.

Embodiment 31: The composition according to any one of embodiments 18-21, comprising theanine and one or both of vitamin B6 and vitamin B12.

Embodiment 32: Any one of Embodiments 18-31, further comprising at least one additional ingredient selected from sweeteners, salts, flavoring agents, buffering agents, emulsifying agents, coloring agents, processing aids and combinations thereof. The composition according to .

Embodiment 33: The composition according to any one of embodiments 18-32, which is free of nicotine.

Embodiment 34: The composition according to any one of embodiments 18-33, which is free of tobacco.

Embodiment 35: A composition in meltable form adapted for use in the oral cavity comprising caffeine, taurine, GABA, tryptophan, theanine, vitamin B6, vitamin B12, vitamin C, lemon balm extract, carrot , citicoline, sunflower lecithin and combinations thereof; a sugar alcohol; and a lipid, wherein the meltable form comprises the composition as a homogeneous mixture.

Embodiment 36: The sugar alcohol is present in an amount of about 35 to about 55% by weight, based on the total weight of the composition; 36. The composition of embodiment 35, present in an amount.

Embodiment 37: The composition of embodiment 35 or 36, wherein the lipid has a melting point of about 29°C or higher.

Embodiment 38: The composition according to any one of Embodiments 35-37, wherein the lipid has a melting point of about 36°C to about 45°C.

Embodiment 39: The lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil and combinations thereof, wherein the oil is optionally hydrogenated; 39. The composition according to any one of embodiments 35-38, which may be partially hydrogenated or unhydrogenated.

Embodiment 40: According to any one of embodiments 35-38, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof composition.

Embodiment 41: The composition according to any one of embodiments 35-40, wherein the sugar alcohol is isomalt.

Embodiment 42: The composition according to any one of embodiments 35-41, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally carrots.

Embodiment 43: Caffeine is present in an amount of about 2 to about 6 weight percent, based on the total weight of the composition; theanine is present in an amount of about 2 to about 4 weight percent, based on the total weight of the composition. 43. The composition of embodiment 42, wherein carrots, if present, are in an amount of about 0.3 to about 0.5 weight percent, based on the total weight of the composition.

Embodiment 44: The composition of embodiment 43, further comprising citicoline or sunflower lecithin.

Embodiment 45: A composition according to embodiment 42, wherein at least a portion of the caffeine is present in encapsulated form.

Embodiment 46: The composition according to any one of embodiments 35-41, wherein the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract.

Embodiment 47: Theanine is present in an amount of about 2 to about 4% by weight, based on the total weight of the composition; GABA is about 3.5 to about 4.5, based on the total weight of the composition. 47. The composition of embodiment 46, wherein the lemon balm extract, if present, is present in an amount of about 1.5 to about 2.5% by weight, based on the total weight of the composition. .

Embodiment 48: The composition according to any one of embodiments 35-41, wherein the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C.

Embodiment 49: Caffeine is present in an amount of about 2 to about 6% by weight, based on the total weight of the composition; taurine is present in an amount of about 3.5 to about 4.0%, based on the total weight of the composition. 49. The composition of embodiment 48, wherein the vitamin C is present in an amount of about 3.5 to about 4.5% by weight, based on the total weight of the composition.

Embodiment 50: A composition according to embodiment 48, wherein at least a portion of the caffeine is present in encapsulated form.

Embodiment 51: The composition of embodiment 48, further comprising trisodium citrate.

Embodiment 52: to any one of embodiments 35 to 41, wherein the at least one active ingredient comprises theanine; theanine and tryptophan; or theanine and one or more of vitamins B6 and B12; optionally tryptophan The described composition.

Embodiment 52: The composition according to any one of embodiments 35-41, comprising theanine and one or both of vitamin B6 and vitamin B12.

Embodiment 53: Any one of embodiments 35-52, further comprising at least one additional ingredient selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof. The composition according to .

Embodiment 54: The composition according to any one of embodiments 35-53, which is free of nicotine.

Embodiment 55: The composition according to any one of embodiments 35-54, which is free of tobacco.

Embodiment 56: At least one active ingredient is
a) caffeine in an amount of about 1.5 to about 5% by weight, based on the total weight of the composition;
Taurine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition;
vitamin C in an amount of about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of about 1 to about 3%, by weight, based on the total weight of the composition;
is a combination of
b) theanine in an amount of about 1 to about 5% by weight, based on the total weight of the composition;
GABA in an amount of about 1.5% to about 6% by weight, based on the total weight of the composition; and lemon balm extract in an amount of about 1% to about 4%, by weight, based on the total weight of the composition; or a combination of or
c) caffeine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition;
Theanine in an amount of about 1.5 to about 5% by weight, based on the total weight of the composition;
carrots in an amount of about 0.2 to about 0.6 weight percent, based on the total weight of the composition; and optionally about 0.3 to about 1.5 weight, based on the total weight of the composition. 36. The composition of any one of embodiments 1, 18, or 35, which is a combination of citicoline or sunflower lecithin in an amount of %.

Embodiment 57: Of embodiments 1-56, further comprising magnesium, for example, magnesium in an amount of from about 0.1 wt% to about 2 wt%, or from about 0.2 to about 1 wt%, based on elemental magnesium. A composition according to any one of the embodiments.

These and other features, aspects and advantages of the present disclosure will become apparent upon reading the following detailed description. The present invention includes any combination of two, three, four, or more of the above embodiments, whether such features or elements are expressly combined with the description of the specific embodiments herein. including any combination of two, three, four or more features or elements described in this disclosure, whether or not. Because this disclosure is intended to be read as a whole, any distinct feature or element of the disclosed invention, in any of its various aspects and embodiments, may be construed otherwise in context. Unless otherwise indicated, it should be assumed that they are meant to be combined.

The present disclosure provides compositions adapted for use in the oral cavity, the compositions comprising at least one active ingredient and one or more fillers. The one or more fillers generally comprise a sugar alcohol or a combination of sugar alcohols. The at least one active ingredient may comprise one or more botanicals, stimulants, amino acids, vitamins, antioxidants, nicotinic components, cannabinoids, cannabimimetic, terpenes, pharmaceutical agents or combinations thereof. The composition may be in chewable, tablet or meltable form.

The present disclosure is now described more fully below with reference to exemplary embodiments thereof. These exemplary embodiments are provided 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, this disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments set forth the disclosure. provided to meet applicable legal requirements. As used in this specification and claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. References to "dry weight percent" or "dry weight basis" refer to weight based on dry ingredients (ie, all ingredients except water). References to "wet weight" refer to the weight of the composition including water. Unless otherwise indicated, references to "weight percent" of a composition reflect the total wet weight of the composition (ie, including water).

The compositions described herein comprise at least one active ingredient and one or more fillers. In some embodiments, the composition may further comprise binders, organic acids, water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof. The relative amounts of the various ingredients within the composition can vary and are typically selected to provide the desired sensory and performance attributes for the oral composition. Examples of individual components of the composition are described herein below.

Fillers The compositions described herein contain one or more fillers. Fillers can serve multiple functions, such as enhancing certain organoleptic properties such as texture and mouthfeel, improving product cohesiveness or compressibility, and the like.

The amount of filler can vary, but is typically greater than about 20% and up to about 75% by weight of the composition, based on the total weight of the composition. A typical range of fillers in the composition can be from about 20 to about 75% by weight of the total weight of the composition, for example from about 20, about 25 or from about 30 to about 35, about 40, about 45 or It can be about 50% by weight (eg, about 20 to about 50% by weight or about 25 to about 45% by weight). In certain embodiments, the amount of filler is at least about 20% by weight, based on the total weight of the composition, such as at least about 25%, or at least about 30%, or at least about 35%, or at least about 40%. %.

Generally, fillers are porous particulate materials and are cellulosic. For example, suitable fillers are any non-tobacco plant material or derivative thereof, including cellulosic material derived from such sources. Examples of cellulosic non-tobacco plant materials include grains (e.g., sorghum, oats, barley, rye, buckwheat, etc.), sugar beets (e.g., FIBREX® brand filler available from International Fiber Corporation), bran Includes fibers and mixtures thereof. Non-limiting examples of derivatives of non-tobacco plant materials include starch (eg, from potato, wheat, rice, corn), natural cellulose and modified cellulose materials. Additional examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose, mannitol, xylitol and sorbitol. Combinations of fillers can also be used.

"Starch" as used herein can refer to pure starch, modified starch or starch derivatives from any source. Starch is typically present in granular form in nearly all green plants and various types of plant tissues and organs such as seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains and stems. Starch can vary in composition and granular shape and size. Starches from different sources often have different chemical and physical properties. Specific starches can be selected for inclusion in the composition based on the ability of the starch material to impart specific organoleptic properties to the composition. Starch from various sources can be used. For example, major sources of starch include cereals (eg rice, wheat and sorghum) and root vegetables (eg potatoes and cassava). Other examples of sources of starch are acorns, arrowroot, aracacha, bananas, barley, legumes (e.g. broad beans, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, taro, dogtooth violet, kudzu, malanga. , millet, oats, oka, taro, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, white tuna and yam. Certain starches are modified starches. Modified starches often have one or more structural modifications designed to alter their high thermal properties. Some starches have been developed by genetic modification and are considered "genetically modified" starches. Other starches have been obtained and substantially modified by chemical, enzymatic or physical means. For example, modified starches can undergo chemical reactions such as esterification, etherification, oxidation, acid-catalyzed depolymerization (thinning) or oxidation in the presence of a base, bleaching, transglycosylation and depolymerization (e.g., catalytic dextrinisation), cross-linking, acetylation, hydroxypropylation and/or partial hydrolysis. Enzymatic treatment involves exposing native starch to enzyme isolates or concentrates, microbial enzymes and/or enzymes endogenous to plant material, such as amylases present in corn kernels that modify corn starch. Other starches have been modified by thermal treatments such as pregelatinization, dextrinization and/or cold water expansion treatments. Certain modified starches include phosphorylated starch, phosphate crosslinked starch, phosphate crosslinked starch esterified with sodium trimetaphosphate, phosphate monoesterified phosphate crosslinked starch, acetylated phosphate crosslinked starch, esterified with acetic anhydride. starch acetate esterified with vinyl acetate, starch acetate esterified with vinyl acetate, acetylated adipic acid crosslinked starch, acetylated glycerol crosslinked starch, hydroxypropyl starch, hydroxypropylglycerol crosslinked starch and starch sodium octenylsuccinate.

Additional examples of potential fillers include maltodextrin, dextrose, calcium carbonate, calcium phosphate, lactose and sugar alcohols. Combinations of fillers can also be used. In some embodiments, the filler comprises or is a mixture of polysaccharides derived from glucose and starch. One such suitable mixture of polysaccharides derived from glucose and starch is EMDEX® available from JRS PHARMA LP, USA, 2981 Route 22, Patterson, NY 12563-2359.

In some embodiments, the filler comprises one or more sugar alcohols. Sugar alcohols are polyols derived from mono- or disaccharides in partially or fully hydrogenated form. Sugar alcohols, for example, 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 (eg hydrogenated starch hydrolysate). Isomalt is an equimolar mixture of two disaccharides, each of which is: glucose and mannitol (α-D-glucopyranoside-1,6-mannitol); and glucose and sorbitol (α-D-glucopyranoside-1,6 - sorbitol). In some embodiments, the one or more sugar alcohols comprises isomalt. In some embodiments, the one or more sugar alcohol is isomalt.

In some embodiments, the filler comprises a combination of isomalt and EMDEX®. In some embodiments, the one or more sugar alcohols is a combination of isomalt and EMDEX®.

In some embodiments, one or more sugar alcohols is a combination of two or three sugar alcohols. In some embodiments, the combination of sugar alcohols comprises or is isomalt and maltitol.

The total amount of sugar alcohols can vary, but is typically greater than about 30% and up to about 95% by weight of the composition, based on the total weight of the composition. Typical ranges of sugar alcohols in the composition are, for example, about 35, about 40, about 45, about 50 or about 55 to about 60, about 65, about 70, about 75, about 80, about 85, about 90 or about 95% by weight. In certain embodiments, the amount of sugar alcohol is at least about 50% by weight, such as at least about 55% by weight, or at least about 60%, or at least about 65%, or at least about 70% or at least about 75% or at least about 80% or at least about 85%.

In certain embodiments, the sugar alcohol is from about 35 to about 55% by weight, based on the total weight of the composition, such as from about 35, about 40, or about 45 to about 50, or about 55% by weight. Isomalt.

In certain embodiments, the sugar alcohol is isomalt in an amount of about 10 to about 25 weight percent, such as about 10, about 15, about 20, or about 25 weight percent; and about 50 to about 75 weight percent, such as about A combination of maltitol in amounts of 50, about 55, about 60, about 65% by weight, about 70, about 75% by weight.

In certain embodiments, the filler is isomalt in an amount of about 30 to about 50 weight percent, such as about 30, about 35, about 40, about 45, or about 50 weight percent, based on the total weight of the composition; and a glucose-polysaccharide blend (e.g., EMDEX®) in an amount of about 35 to about 55 wt%, such as about 35, about 40, about 45, or about 50 wt%, based on the total weight of the composition. combination.

Lipids In some embodiments, the composition comprises lipids. Such compositions, in some embodiments, can be described as "meltable" or "melting" compositions, as further described herein below. When present, the lipid of the composition is typically a fat, oil, or wax material derived from animal or plant material (i.e., fat of vegetable origin), typically comprising the majority of the triglycerides in minor amounts. Including with free fatty acids and mono- or diglycerides. In certain embodiments, the lipid is solid or semi-solid at room temperature (i.e., 25° C.) and at least partially liquefies (i.e., "melts") upon exposure to the temperature of the user's oral cavity. is possible. Examples of plant-derived fats include saturated or unsaturated fatty acid chains (including the Most are bound within the triglyceride structure.).

In some embodiments, lipids comprise oils, particularly food grade oils, including fractionated oils. Such oils include, but are not limited to, vegetable oils such as acai oil, almond oil, amaranth oil, apricot kernel oil, apple seed oil, argan oil, avocado oil, babassu oil, beach nut oil, ben oil, honeysuckle oil, black Seed Oil, Blackcurrant Seed Oil, Borage Seed Oil, Borneo Taro Nut Oil, Gourd Oil, Brazil Nut Oil, Buffalo Gord Oil, Butternut Squash Seed Oil, Cape Chestnut Oil, Canola Oil, Carob Cashew Oil, Cocoa Butter, Belgian Fir Oil , coconut oil, corn oil, cofune oil, coriander seed oil, cottonseed oil, date palm seed oil, dika oil, cucumber seed oil, evening primrose oil, flaxseed oil, flaxseed oil, grape seed oil, grapefruit seed oil, hazelnut oil, hemp oil, kapok seed oil, kenaf seed oil, lallemantia oil, lemon oil, linseed oil, macadamia oil, muffle oil, marula oil, meadowfoam seed oil, mongongo Nut Oil, Mustard Oil, Niger Seed Oil, Nutmeg Butter, Okra Seed Oil, Olive Oil, Orange Oil, Palm Oil, Papaya Seed Oil, Peanut Oil, Pecan Oil, Perilla Seed Oil, Persimmon Seed Oil, Pequi Oil, Pili Nut Oil, Pine nut oil, pistachio oil, pomegranate seed oil, poppy seed oil, plakashy oil, prune kernel oil, pumpkin seed oil, quinoa oil, ramtil oil, rape seed oil, rice bran oil, royle oil, Sacha inchi oil, safflower oil, Mexican sable oil, seje oil, sesame oil, shea butter, soybean oil, sunflower oil, taramira oil, tea seed oil, thistle oil, tiger nut oil, tobacco seed oil, tomato seed oil , walnut oil, watermelon seed oil, wheat germ oil and combinations thereof), animal oils (e.g., bovine fat, buffalo fat, sheep fat, goat fat, pig fat, lard, camel fat, tallow, liquid margarine, fish oil, fish liver oil, whale oil, seal oil and combinations thereof) and mineral oils.

In certain embodiments, the plant-based fats of the present disclosure comprise palm oil, palm kernel oil (including fractionated palm oil), soybean oil, cottonseed oil, and mixtures thereof. In one embodiment, the lipid is a blend of palm oil and palm kernel oil. Lipids, for example, may be hydrogenated, partially hydrogenated or non-hydrogenated. Exemplary embodiments of lipids are available from AarhusKarlshamn USA Inc. can be purchased under the tradenames CEBES®, CISAO® or CONFAO® available from Epson.

The melting point of lipids is typically about 29°C or higher, eg, from about 29°C to about 49°C, or from about 36°C to about 45°C, or from about 38°C to about 41°C. In some embodiments, the use of lipids with melting points below about 36° C. is not advantageous due to possible melting during storage or handling of the product. One test for determining the melting point of lipids is the Mettler dropping point method (ASTM D3954-15, Standard Test Method for Dropping Point of Waxes, ASTM International, West Conshohocken, PA, 2015, www.astm.org.). be.

When present, the amount of lipid within the composition can vary. In certain embodiments, the amount of lipid is at least about 10 percent, at least about 20 percent, or at least about 30 percent on a dry weight basis of the composition. In certain embodiments, the amount of lipid is less than about 70 percent, less than about 60 percent, or less than about 50 percent by weight based on the dry weight of the composition. An example weight range for lipids includes about 10 to about 70 dry weight percent, such as about 35 to about 50 dry weight percent. In some embodiments, the amount of lipid is about 35, about 40, about 45, or about 50 weight percent of the total composition.

In some embodiments, the composition comprises lipids. In one embodiment, the lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil and combinations thereof, and the oil may be hydrogenated. , may be partially hydrogenated or unhydrogenated. In one embodiment, the lipid is from AarhusKarlshamn USA Inc. A medium hardness transhydrogenated filling fat such as Confao® 5, available from Co., 131 Marsh Street, Port Newark, NJ 07114.

Active Ingredients The compositions disclosed herein comprise one or more active ingredients. As used herein, "active ingredient" refers to any of the following classes of substances: APIs (Active Pharmaceutical Ingredients), food additives, natural medicines and naturally occurring substances that may have effects on humans. refers to one or more substances belonging to Examples of active ingredients are any ingredients known to affect one or more biological functions in the body, such as pharmacological activity or other direct action in the diagnosis, therapy, mitigation, treatment or prevention of disease. or affect the structure or any function of the human body (e.g., provide an excitatory effect in the central nervous system, have an activating effect, antipyretic or analgesic effect, or have another beneficial effect in the body). Contains ingredients. In some embodiments, the active ingredient can be of the type commonly referred to as a nutraceutical, nutraceutical, "phytochemical" or "functional food." These types of additives are typically from naturally occurring sources (e.g., botanical materials) that sometimes provide one or more beneficial biological effects (e.g., health-promoting, disease-preventing, or other medicinal properties). defined in the art as encompassing substances that are commercially available, but are not classified or regulated as drugs.

Non-limiting examples of active ingredients are botanical ingredients, stimulants, amino acids, nicotine ingredients and/or pharmaceutical ingredients, nutritional ingredients and medicinal ingredients (e.g. vitamins such as A, B3, B6, B12 and C and/or cannabinoids such as , tetrahydrocannabinol (THC) and cannabidiol (CBD)). Each of these classifications is further described herein below. The specific choice of active ingredient will vary depending on the desired flavor, texture and desired attributes of the particular product.

The specific percentages of active ingredient present will vary depending on the desired attributes of the particular product. Typically, the active ingredients or combinations thereof are present in a total concentration of at least about 0.001% by weight of the composition, eg, in a total concentration ranging from 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, based on the total weight of the composition, for example about 0.5% w/w. % w/w to about 10%, about 1% to about 10%, about 1% to about 5% by weight. In some embodiments, the active ingredient or combination of active ingredients is about 0.001%, about 0.01%, about 0.1%, or about 1% by weight, based on the total weight of the composition. , present in a concentration of up to about 20% by weight, such as 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 wt%, about 0.007 wt%, about 0.008 wt%, about 0.009 wt%, 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%, about 0.1 wt%, 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% or about 0.2 wt%. 9% to about 1%, about 2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 16%, about 17%, about 18%, about 19% or about It is present at a concentration of 20% by weight. Further preferred ranges for specific active ingredients are provided herein below.

Botanicals In some embodiments, the active ingredients comprise botanical ingredients. As used herein, the term "botanical ingredient" or "botanical" refers to any plant material or fungal-derived material, including plant material in its natural form and plant material derived from natural plant material, such as , extracts or isolates from plant material or plant material that has been treated (e.g. heat treatment, fermentation, bleaching or other treatment processes capable of modifying the physical and/or chemical properties of the material) plant material). For the purposes of this disclosure, "botanical" includes, but is not limited to, "herbal materials," which do not develop a persistent woody texture and whose medicinal or sensory properties are often Refers to a valuable seed-producing plant (eg tea or tisane). Reference to botanical material as "non-tobacco" is intended to exclude tobacco material (ie, does not include any Nicotiana species). In some embodiments, the compositions disclosed herein can be characterized as free of any tobacco material (e.g., any embodiment disclosed herein may contain any tobacco material). also completely or substantially). By "substantially free" is meant that no tobacco material is intentionally added. For example, certain embodiments can be characterized as having less than 0.001 wt% tobacco, or 0.0001 wt% or 0 wt% tobacco.

When present, botanicals are typically at a concentration of about 0.01% w/w to about 10% by weight, based on the total weight of the composition, for example 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 Concentrations of 9% or about 10%, about 11%, about 12%, about 13%, about 14% or about 15% by weight.

Botanical materials useful for this disclosure can include any of the compounds and sources described herein, including, but not limited to, mixtures thereof. Certain botanical materials of this type are sometimes referred to as nutraceuticals, nutraceuticals, "phytochemicals" or "functional foods." Certain botanicals, as plant materials or extracts thereof, find use in traditional herbal medicine and are further described herein. Non-limiting examples of botanicals or botanically-derived materials include Ashwagandha, Bacopa monniera, Baobab, Basil, Centella asiatica, psycho, chamomile, cherry blossom, chlorophyll, cinnamon, citrus, cloves, Cocoa, Cordyceps, Curcumin, Damiana, Dorstenia arifolia, Dorstenia odorata, Essential Oils, Eucalyptus, Fennel, Galphimia glauca, Ginger, Ginkgo biloba), carrots (e.g. Panax ginseng), green tea, Griffonia simplicifolia, guarana, cannabis, hemp, hops, jasmine, Kaempferia parviflora (Thai ginseng), Birch, Lavender, Lemon Balm, Lemongrass, Glycyrrhiza, Lutein, Maca, Matcha, Nardostachys chinensis, Viola odorata oily extract, Peppermint, Quercetin, Resveratrol, Rhizoma gastrodiae (Rhizoma gastrodiae), Rhodiola, Rooibos, Rose essential oil, Rosemary, Sceletium tortuosum, Schisandra, Skullcap, Spearmint extract, Sweet pepper, Terpene, Tizan, Turmeric, Tournella Including Turnera aphrodisiaca, valerian, white mulberry and yerba mate.

In some embodiments, the active ingredient comprises lemon balm. Lemon balm (Melissa officinalis) is a mildly lemon-scented herb that comes from the same family as mints (Lamiaceae). The herb is native to Europe, North Africa and West Asia. Lemon balm tea and essential oils and extracts are used in traditional and alternative medicine. In some embodiments, the active ingredient comprises lemon balm extract. In some embodiments, lemon balm extract is present in an amount of about 1 to about 4 weight percent, based on the total weight of the composition.

In some embodiments, the active ingredient comprises carrots. Ginseng is the root of a plant of the genus Panax, which is characterized by the presence of unique steroidal saponins phytochemicals (ginsenosides) and gintonin. Carrots find use as a dietary supplement in energy drinks or herbal teas and in traditional medicine. Cultivars include Panax ginseng (P. ginseng), Panax ginseng (P. notoginseng) and American ginseng (P. quinquefolius). American ginseng and Asian ginseng vary in the types and amounts of various ginsenosides present. In some embodiments, the carrot is American ginseng or Asian ginseng. In a specific embodiment, the active ingredient comprises ginseng. In some embodiments, carrots are present in an amount of about 0.4 to about 0.6 weight percent, based on the total weight of the composition.

Stimulants In some embodiments, the active ingredient comprises one or more stimulants. As used herein, the term "stimulant" refers to materials that increase activity of the central nervous system and/or the body, e.g., improve concentration, cognition, energy, mood, alertness, and the like. Non-limiting examples of stimulants include caffeine, theacrine, theobromine and theophylline. Theacrine (1,3,7,9-tetramethyluric acid) is a purine alkaloid that is structurally related to caffeine and has stimulant, analgesic and anti-inflammatory effects. The stimulant may be natural, derived from nature or wholly synthetic. For example, certain botanical materials (guarana, tea, coffee, cocoa, etc.) may have stimulant effects, for example due to the presence of caffeine or related alkaloids, and are therefore "natural" stimulants. By "naturally derived" is meant that the stimulant (eg, caffeine, theacrine) is in purified form outside of its natural (eg, botanical) matrix. For example, caffeine can be obtained from botanical sources (eg, tea) by extraction and purification. By "fully synthetic" is meant that the stimulant has been obtained by chemical synthesis. In some embodiments, the active ingredient comprises caffeine. In some embodiments, caffeine is present in encapsulated form. An example of encapsulated caffeine is available from Balchem Corp. , 52 Sunrise Park Road, New Hampton, NY, 10958.

When present, the stimulant or combination of stimulants (e.g. caffeine, theacrine and combinations thereof) is typically from about 0.1% w/w to about 15% w/w based on the total weight of the composition. % concentration, for example about 0.1% w/w, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.6%. 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 11%, about 12%, about 13%, about 14% or about 15% by weight. In some embodiments, the composition comprises caffeine in an amount of about 1.5% to about 6% by weight, based on the total weight of the composition.

Amino Acids In some embodiments, the active ingredient comprises an amino acid. As used herein, the term “amino acid” refers to organic compounds containing amine (—NH ₂ ) and carboxyl (—COOH) or sulfonic acid (SO ₃ H) functional groups with side chains (R groups). Note that the side chains are specific for each amino acid. Amino acids can be proteinogenic or non-proteinogenic. "Proteogenic" means that the amino acid is one of the 12 naturally occurring amino acids found in proteins. 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. By "non-proteinogenic" is meant that any amino acid is not naturally found in a protein or produced directly by intracellular machinery (eg, is the 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 comprises a combination of theanine and tryptophan. In some embodiments, the active ingredient comprises a combination of theanine and one or more B vitamins. In some embodiments, the active ingredient is a combination of caffeine, theanine, and optionally carrot. In some embodiments, the active ingredient comprises taurine. In some embodiments, the active ingredient is a combination of caffeine and taurine.

Without wishing to be bound by any theory of operation, certain amino acids such as theanine, tryptophan, GABA or taurine, especially when combined with other active ingredients such as caffeine or certain botanicals, may improve mood, It is believed that anxiety levels, concentration or cognitive performance can be beneficially affected.

When present, the amino acid or combination of amino acids (eg, theanine, taurine, GABA, tryptophan and combinations thereof) is typically from about 0.01% w/w to about 15% w/w, based on the total weight of the composition. % concentration by weight, e.g. .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 11%, about 12%, about 13%, about 14% or about 15% by weight.

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

Vitamins 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 normal functioning of metabolism in mammals. There are 13 vitamins required for human metabolism, 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 (calciferols), Vitamin E (tocopherols and tocotrienols) and Vitamin K (quinones). In some embodiments, the active ingredient comprises vitamin C. In some embodiments, the active ingredient is a combination of vitamin C, caffeine and taurine. In some embodiments, active ingredients include one or more of vitamins B6 and B12. In some embodiments, active ingredients include theanine and one or more of vitamins B6 and B12. When present, the vitamin or combination of vitamins (eg, vitamin B6, vitamin B12, vitamin E, vitamin C, or combinations thereof) is typically from about 0.0001% to about at a concentration of 6% by weight, e.g. about 0.06%, about 0.07%, about 0.08%, about 0.09%, or about 0.1% w/w to about 0.2%, about 0.3%, about 0.4% , about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1%, about 2%, about 3%, about 4%, about 5% Or at a concentration of about 6% by weight.

In some embodiments, the active ingredient comprises vitamin B6 in an amount of about 0.008% to about 0.06% or about 0.01% to about 0.04% by weight.

In some embodiments, the active ingredient comprises vitamin B12 in an amount of about 0.0001% to about 0.007%, or about 0.0005% to about 0.001% by weight.

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

Antioxidants In some embodiments, the active ingredient comprises one or more antioxidants. As used herein, the term "antioxidant" refers to a substance capable of preventing or inhibiting oxidation by quenching free radical reactions and slowing or preventing some types of cell damage. . Antioxidants can be naturally occurring or synthetic. Naturally occurring antioxidants include those found in foods and botanical materials. Non-limiting examples of antioxidants include certain botanicals, vitamins, polyphenols and phenol derivatives.

Examples of botanicals with antioxidant qualities include, but are not limited to, acai berry, alfalfa, allspice, annatto seed, apricot kernel oil, basil, mint, cornmint, black pepper, blueberry, borage seed oil, chilan, cocoa. , Calamus Root, Peppermint, Catuaba, Cayenne Pepper, Chaga, Chervil, Cinnamon, Dark Chocolate, Potato Skin, Grape Seed, Carrot, 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, feverfew, ginger, goldenseal, hawthorn, hibiscus flower, jiaogulan, birch, lavender, licorice, marjoram, milk thistle, mint, oolong tea , beetroot, orange, oregano, papaya, mint, peppermint, red clover, rooibos (red or green), rosehip, rosemary, sage, clary sage, savory, spearmint, spirulina, slippery elm bark, high tannin bran of sorghum, High tannin cereals of sorghum, sumac bran, comfrey leaves and roots, wolfberry, gotu kola, thyme, turmeric, bearberry, valerian, wild yam root, honeysuckle, yacon root, yellow dock, yerba mate, yerba santa, Includes bacopa monniera, withania somnifera, ericaceae and silybum marianum. Such botanical materials may be provided in fresh or dried form, essential oils or in the form of extracts. Botanical materials (as well as extracts thereof) are often compounds from various classes known to provide antioxidant effects, such as minerals, vitamins, isoflavones, phytosterols, allyl sulfides, dithiolthiones, isothiocyanates, Contains indoles, lignans, flavonoids, polyphenols and carotenoids. Examples of compounds found in botanical extracts or oils include ascorbic acid, peanut endocarp, resveratrol, sulforaphane, beta-carotene, lycopene, lutein, coenzyme Q, carnitine, quercetin, kaempferol, etc. include. For example, Santhosh et al. , Phytomedicine, 12 (2005), 216-220, which is incorporated herein by reference.

Other non-limiting examples of suitable antioxidants are citric acid, vitamin E or derivatives thereof, tocopherol, epicatechol, epigallocatechol, epigallocatechol gallate, erythorbic acid, sodium erythorbate, 4-hexylresorcinol, theaflavin , theaflavin monogallate A or B, theaflavin digallate, phenolic acid, glycoside, quercitrin, isoquercitrin, hyperoside, polyphenol, catechol, resveratrol, oleuropein, butylhydroxyanisole (BHA), butylhydroxytoluene (BHT), Including tertiary butyl hydroquinone (TBHQ) and combinations thereof.

When present, antioxidants are typically at concentrations of from about 0.001% w/w to about 10% by weight, based on the total weight of the composition, e.g. .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%.

Nicotine Component In certain embodiments, the active ingredient comprises a nicotine component. By "nicotine component" is meant any form of nicotine (eg, free base or salt) suitable to effect oral absorption of at least a portion of the nicotine present. Typically, the nicotine component is selected from the group consisting of nicotine free base and nicotine salts. In some embodiments, the nicotine component is nicotine in its free base form, and the nicotine component is readily absorbed in, for example, microcrystalline cellulose material forming a microcrystalline cellulose-nicotine carrier complex. obtain. See, for example, the discussion of nicotine in the free base form in US Patent Publication No. 2004/0191322 to Hansson, which is incorporated herein by reference.

In some embodiments, at least a portion of the nicotine component is available in salt form. Salts of nicotine are described in Cox et al., US Pat. No. 2,033,909 and Perfetti, Beitrage Tabakforschung Int. , 12:43-54 (1983), which are incorporated herein by reference. In addition, nicotine salts are commercially available from Pfaltz and Bauer, Inc.; and K&K Laboratories, Division of ICN Biochemicals, Inc.; available from suppliers such as Typically, the nicotine component is selected from the group consisting of nicotine free base, nicotine salts such as hydrochlorides, dihydrochlorides, monotartrates, bitartrates, sulfates, salicylates and nicotine zinc chloride.

In some embodiments, at least a portion of the nicotine can be in the form of a resin complex of nicotine, wherein the nicotine is bound to an ion exchange resin such as nicotine Polacrilex, wherein the nicotine is, for example, Amberlite IRP64 , Purolite C115HMR or Dishion P551, nicotine bound to polymethacrylic acid. See, for example, Lichtneckert et al., US Pat. No. 3,901,248, which is incorporated herein by reference. Another example is nicotine-polyacrylcarbomer conjugates such as Carbopol 974P. In some embodiments, nicotine may be present in the form of a nicotine polyacrylic complex.

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

In some embodiments, the products or compositions of this disclosure can be characterized as free of any nicotine ingredients (e.g., any of the embodiments disclosed herein are completely free of any nicotine ingredients). or not substantially included). By "substantially free" is meant that nicotine, for example, is not intentionally added in excess of trace amounts that may be naturally present in the botanical material. For example, certain embodiments can be characterized as having less than 0.001 wt.% nicotine, or 0.0001 wt.% or 0 wt.% nicotine, calculated as the free base.

In some embodiments, the active ingredient comprises a nicotine component (e.g., any product or composition of this disclosure will include any active ingredient or combination of active ingredients disclosed herein). In addition, it may further contain a nicotine component.).

Cannabinoids In some embodiments, the active ingredient comprises one or more cannabinoids. As used herein, the term “cannabinoid,” also known as the endocannabinoid system, refers to a class of diverse chemical compounds that act on cannabinoid receptors in cells that modify the release of neurotransmitters in the brain. Refers to a compound. Ligands for these receptor proteins include endocannabinoids naturally produced in the body by animals; phytocannabinoids found in cannabis; and synthetic cannabinoids produced artificially. Cannabinoids found in cannabis include, but are not limited to, cannabigerol (CBG), cannabichromene (CBC), cannabidiol (CBD), tetrahydrocannabinol (THC), cannabinol (CBN), cannabinodiol (CBDL), cannabidivarin (CBL), cannabivarin (CBV), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), cannabichromevarin (CBCV), cannabigerovarin (CBGV), cannabigerol monomethyl ether (CBGM), Includes cannabinellolic acid, cannabidiolic acid (CBDA), cannabinol propyl variant (CBNV), cannabtriol (CBO), tetrahydrocannabinolic acid (THCA) and tetrahydrocannabinolic acid (THCV A). In certain embodiments, the cannabinoids are tetrahydrocannabinol (THC), the major psychoactive compound in cannabis, and cannabidiol (CBD), another major component of the plant, but lacking psychoactivity. is selected from All of the above compounds can be used in the form of isolates from plant material or can be derived synthetically.

Alternatively, the active ingredient may be a cannabimimetic, which is a class of compounds derived from plants other than cannabis that have similar biological effects in the endocannabinoid system as cannabinoids. Examples include yangonin, alpha-amyrin or beta-amyrin (also classified as a terpene), cyanidin, curcumin (turmeric), catechins, quercetin, salvinorin A, N-acylethanolamines and N-alkylamide lipids. .

When present, the cannabinoid (e.g., CBD) or cannabimimetic is typically at a concentration of at least about 0.1% by weight of the composition, e.g., about 0.1%, based on the total weight of the composition. % to about 30%, 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%, Concentrations of about 9%, about 10%, about 15%, about 20% or about 30% by weight.

Terpenes Active ingredients suitable for use in the present disclosure can also be classified as terpenes, many of which are associated with biological effects such as sedative effects. Terpenes have the general formula _{( C5H8} ) _n and are understood to include monoterpenes, sesquiterpenes and diterpenes. Terpenes can be acyclic, monocyclic or bicyclic in structure. Some terpenes produce an entourage effect when used in combination with cannabinoids or cannabinimetics. Examples are beta-caryophyllene, linalool, limonene, beta-citronellol, linalyl acetate, pinene (alpha or beta), geraniol, carvone, eucalyptol, menthone, iso-menthone, which can be used alone or in combination, Including piperitone, myrcene, beta-bourvonene and germacrene.

Pharmaceutical Ingredients In some embodiments, the active ingredient comprises an active pharmaceutical ingredient (API). An API can be any known pharmaceutical agent suitable for therapeutic, prophylactic or diagnostic use. These include, for example, synthetic organic compounds, proteins and peptides, polysaccharides and other sugars, lipids, phospholipids, inorganic compounds (e.g. magnesium, selenium, zinc, nitrates), which have therapeutic, prophylactic or diagnostic activity. ), neurotransmitters or their precursors (eg, serotonin, 5-hydroxytryptophan, oxytriptan, acetylcholine, dopamine, melatonin) as well as nucleic acid sequences. Non-limiting examples of APIs are analgesics and antipyretics (eg, acetylsalicylic acid, acetaminophen, 3-(4-isobutylphenyl)propanoic acid), phosphatidylserine, myoinositol, docosahexaenoic acid (DHA, omega-3), arachidone Acids (AA, omega-6), S-adenosylmethionine (SAM), beta-hydroxy-beta-methylbutyrate (HMB), citicoline (cytidine-5'-diphosphate-choline) and cotinine. In some embodiments, the active ingredient comprises citicoline. In some embodiments, the active ingredient is a combination of citicoline, caffeine, theanine and carrot. In some embodiments, the active ingredient comprises sunflower lecithin. In some embodiments, the active ingredient is a combination of sunflower lecithin, caffeine, theanine and carrot.

The amount of API can vary. For example, when present, the API is typically at a concentration of about 0.001% w/w to about 10% by weight, based on the total weight of the composition, eg, about 0.01, about 0.01% w/w. 02, about 0.03, about 0.04, about 0.05, about 0.06, about 0.07, about 0.08, about 0.09, about 0.1% w/w, about 0.2 , about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9 or about 1 to about 2, about 3, about 4, about 5 , about 6, about 7, about 8, about 9 or about 10% by weight.

In some embodiments, the composition is substantially free of any API. By "substantially free of any API" is meant that the composition is a therapeutic agent herein, such as any Food and Drug Administration (FDA) approved therapeutic agent intended to treat any medical condition. It does not contain, and specifically excludes, the presence of any API defined in the document.

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, carrot, citicoline, sunflower lecithin, and combinations thereof. be done. For example, active ingredients may include a combination of caffeine, theanine, and optionally carrots. In another embodiment, the active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), and optionally lemon balm extract. In further embodiments, the active ingredient comprises theanine, theanine and tryptophan, theanine and one or more of B vitamins B6 and B12, or tryptophan, theanine and one or more of B vitamins B6 and B12. In still further embodiments, the active ingredients comprise a combination of caffeine, taurine and vitamin C, optionally further comprising one or more B vitamins (eg, vitamin B6 or B12). Magnesium salts (eg, magnesium gluconate) can be added to any of the above combinations, especially combinations that also include theanine.

The moisture content (eg, water content) of the water composition may vary depending on the desired properties of the product prior to consumer use. Typically, the composition is less than about 60% water, generally from about 1 to about 60% water, such as from about 5 to about 55% water, by weight prior to insertion into the user's oral cavity. from about 10 to about 50%, from about 20 to about 45%, or from about 25 to about 40% by weight water, and at least about 5%, at least about 10%, at least about 15%, and at least about 20% by weight; % water content.

Salts In some embodiments, the compositions typically include salts (eg, alkali metal salts) utilized in amounts sufficient to provide desired sensory attributes to the composition. Non-limiting examples of suitable salts include sodium chloride, potassium chloride, ammonium chloride, powdered common salt, sodium acetate, sodium citrate, calcium citrate, and the like. In some embodiments, the salt is sodium chloride, ammonium chloride, or combinations thereof. In some embodiments, the salt is trisodium citrate, calcium citrate, or a combination thereof.

When present, a typical amount of salt is about 0.1 wt% or more, about 0.5 wt% or more, about 1.0 wt% or more, or about 1.5 wt% or more, but typically , constitutes no more than about 10%, or no more than about 7.5%, or no more than about 5% (eg, about 0.1 to about 5% by weight) of the total weight of the composition.

Sweeteners One or more sweeteners may be added to improve the sensory properties of compositions according to the present disclosure. The sweetener can be any sweetener or combination of sweeteners, in natural or artificial form or as a combination of natural and artificial sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, isomaltulose, mannose, galactose, lactose, stevia, honey and the like. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, and the like. In some embodiments, sweeteners include one or more sugar alcohols. Sugar alcohols are polyols derived from mono- or disaccharides in partially or fully hydrogenated form. Sugar alcohols, for example, 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 (eg hydrogenated starch hydrolysate). In some embodiments, the sweetener is sucralose, acesulfame K, or a combination thereof.

When present, the sweetener or combination of sweeteners constitutes from about 0.01 to about 20% or more by weight of the composition, for example from about 0.01 to about 0.1%, based on the total weight of the composition. , about 0.1 to about 1 weight percent, about 1 to about 5 weight percent, about 5 to about 10 weight percent, or about 10 to about 20 weight percent. In some embodiments, the combination of sweeteners is present at a concentration of about 0.01 to about 0.1% by weight of the composition, such as about 0.01, about 0.02, about 0.1% of the composition. 0.03, about 0.04, about 0.05, about 0.06, about 0.07, about 0.08, about 0.09 or about 0.1 weight percent. In some embodiments, the combination of sweeteners is present at a concentration of about 0.1 to about 0.5% by weight of the composition, such as about 0.1, about 0.2, about 0.5% of the composition. .3, about 0.4 or about 0.5% by weight. In some embodiments, the combination of sweeteners is present at a concentration of about 1 to about 3% by weight of the composition.

Flavoring Agents In some embodiments, the composition comprises a flavoring agent. As used herein, a "flavorant", "flavour" or "flavourant" is any flavored or aromatic substance capable of modifying the sensory attributes associated with an oral product. is. Examples of sensory attributes that can be modified by flavoring agents include taste, texture, moistness, coolness/warmth and/or aroma/aroma. Flavoring agents may be natural or synthetic, and the flavor characteristics imparted thereby may be described, without limitation, as refreshing, sweet, herbal, confectionery, floral, fruity, or spicy. Specific types of flavors include, but are not limited to, vanilla, coffee, chocolate/cocoa, cream, mint, spearmint, menthol, peppermint, honeysuckle, eucalyptus, lavender, cardamom, nutmeg, cinnamon, clove, cascara, sandalwood, honey, Jasmine, ginger, anise, sage, licorice, lemon, orange, apple, peach, lime, cherry, strawberry, trigeminal sensate, terpenes and any combination thereof. Also, Leffingwell et al., Tobacco Flavoring for Smoking Products, R.I. J. See Reynolds Tobacco Company (1972), which is incorporated herein by reference. Flavoring agents can also include ingredients that are considered humectants, cooling agents or leveling agents, such as eucalyptus. These flavors can be provided neat (i.e., alone) or in combination, and can be utilized as concentrates or flavor packages (e.g., spearmint and menthol, orange and cinnamon, lime, pineapple, etc.). Representative classes of ingredients are also disclosed in US Patent No. 5,387,416 to White et al.; US Patent Application Publication No. 2005/0244521 to Strickland et al.; , each of which is incorporated herein by reference. In some examples, flavoring agents may be provided in spray-dried or liquid form.

The amount of flavoring agent utilized in the composition can vary, but is typically up to about 10% by weight, with certain embodiments including at least about 0.5%, based on the total weight of the composition. characterized by a flavoring agent content of 1% by weight, such as from about 0.5% to about 10%, from about 1% to about 5%, or from about 2% to about 4%.

Taste Modifiers To improve the organoleptic properties of the compositions disclosed herein, the compositions may be added, for example, to mask, modify, mask or improve the flavors described herein. The composition may contain one or more taste modifiers (“taste modifiers”) that are capable of functioning. Non-limiting examples of such taste modifiers include analgesic or anesthetic herbs, spices and those that produce perceived cooling (e.g. menthol, eucalyptus, mint), warming (e.g. cinnamon) or pain (e.g. capsaicin) sensations. Contains irritant fragrance. Certain taste modifiers fall into more than one overlapping class.

In some embodiments, the taste modifier modifies one or more of bitter, sweet, salty, or sour tastes. In some embodiments, the taste modifier targets pain receptors. In some embodiments, the composition comprises an active ingredient that has a bitter taste and a taste modifier that masks or blocks the perception of bitter taste. In some embodiments, taste modifiers are substances that target pain receptors (e.g., vanilloid receptors) in the user's mouth, e.g., mask the bitter taste of another ingredient (e.g., an active ingredient). be. Suitable taste modifiers include, but are not limited to, capsaicin, gamma-aminobutyric acid (GABA), adenosine monophosphate (AMP), lactisol, or combinations thereof.

Typical amounts of taste modifiers, when present, are about 0.01% or more, about 0.1% or more, or about 1.0% or more by weight, but typically less than about 10% by weight (e.g., about 0.01%, about 0.05%, about 0.1%, or about 0.5% to about 1%, about 5% by weight or about 10% by weight).

Binders Binders (or combinations of binders) can be utilized in certain embodiments in amounts sufficient to provide the desired physical attributes and physical integrity to the composition, wherein the binders They also often function as thickeners or gelling agents. Typical binders can be organic or inorganic or combinations thereof. Representative binders include cellulose derivatives (eg, cellulose ethers), povidone, sodium alginate, starch-based binders, pectin, gums, carrageenan, pullulan, zein, and the like, and combinations thereof. In some embodiments, the binder comprises pectin or carrageenan or a combination thereof.

The amount of binder utilized in the composition can vary based on the binder and desired composition properties, but is typically up to about 30% by weight, and certain embodiments include: It is characterized by a binder content of at least about 0.1 weight percent, for example from about 0.5 to about 30 weight percent, or from about 1 to about 10 weight percent, based on the total weight of the composition.

In certain embodiments, the binder comprises a gum, such as natural gum. As used herein, natural gum refers to a naturally occurring polysaccharide material that has binding properties and is also useful as a thickening or gelling agent. Representative natural gums derived from plants that are typically water soluble to some extent include xanthan gum, guar gum, gum arabic, gum gum, gum tragacanth, gum karaya, locust bean gum, gellan gum and combinations thereof. When present, the natural gum binder material is typically present in an amount up to about 5% by weight, based on the total weight of the composition, for example, about 0.1, about 0.2, about 0.3, about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9 or about 1% by weight to about 2, about 3, about 4 or about 5 Present in weight percent amounts.

In some embodiments, the binder comprises pectin. Pectins are natural polymers related to carbohydrates and are acidic heteropolysaccharides (polysaccharides containing a large number of monosaccharide units). Unlike carbohydrates, the C-6 position of pectin contains a carboxylic acid (or corresponding methyl ester or carboxamide) group instead of a hydroxymethyl group. The major subunit is known as galacturonic acid, which can be copolymerized with L-rhamnose. Other sugars have been characterized as side chain substituents. Pectin acts as a thickening and gelling agent. Isolated from sources such as apple pomace, citrus peel, sugar beet waste from sugar manufacturing, discarded sunflower heads from seed harvest, mango waste and other commercially available pectin. pectin can be used. In combination with certain sugars, under acidic conditions (e.g., pH of about 2.5 to about 5) or in the presence of a gelling agent (calcium or other divalent alkaline earth elements), pectin is can provide a gel or gum consistency to the compositions disclosed in . In some embodiments, the binder comprises low methoxy pectin. Suitable low-methoxy pectins include, for example, "GENU® Pectin Type LM-104 AS" available from CP Kelco, Atlanta, GA, USA. In some embodiments, the binder comprises low methoxy pectin in combination with a gelling agent. In some embodiments, the gelling agent comprises calcium ions, such as, but not limited to calcium diphosphate. In some embodiments, the binder comprises high methoxy pectin in combination with an organic acid as described herein below. In some embodiments, the binder comprises high methoxy pectin combined with citric acid.

When present, pectin binders are typically present in an amount up to about 3% by weight based on the total weight of the composition, for example about 0.1, about 0.2, about 0.3 , about 0.4, about 0.5, about 0.6, about 0.7, about 0.8, about 0.9 or about 1 to about 1.1, about 1.2, about 1.3, about 1.4, about 1.5, about 1.6, about 1.7, about 1.8, about 1.9, about 2, about 2.1, about 2.2, about 2.3, about 2. 4, about 2.5, about 2.6, about 2.7, about 2.8, about 2.9, or about 3% by weight.

Organic Acids In some embodiments, the composition comprises an organic acid. As used herein, the term "organic acid" refers to organic (ie, carbon-based) compounds characterized by acidic properties. Typically, organic acids are relatively weak acids such as carboxylic acids (--CO ₂ H) or sulfonic acids (--SO ₂ OH) (ie, they do not completely dissociate in the presence of water). As used herein, references to organic acids mean those organic acids that are intentionally added. In this regard, the organic acid differs from being essentially only present as a component of another mixture component (e.g., minor organic acids that may be inherently present in a mixture component such as tobacco material), It can be intentionally added as a specific mixture component. In some embodiments, one or more organic acids are added neat (ie, in their free acid, native solid or liquid form) or as a solution, eg, to water. In some embodiments, one or more organic acids are added in salt form, as described herein below.

Suitable organic acids typically have a range of lipophilicity (ie, polarities that give the right balance of water and organic solubility). Lipophilicity is conventionally assessed using logP, the partition coefficient of the molecule between the aqueous and lipophilic phases, usually water and octanol, respectively. Typically, the lipophilicity of organic acids can be from about -2 to about 6.5. In some embodiments, the organic acid may be more soluble in water than octanol (ie, have a negative logP value, such as from about -2 to about -1). In some embodiments, the organic acid can be approximately equally soluble in water and octanol (ie, have a logP value of about 0). In some embodiments, the organic acid may be more soluble in octanol than in water (ie, have a positive logP value, such as from about 1 to about 6.5). In some embodiments, the organic acid has a logP value of about 1.5 to about 5.0, such as about 1.5, about 2.0, about 2.5 or about 3.0 to about It has a logP value of 3.5, about 4.0, about 4.5 or about 5.0.

In some embodiments, the organic acid is a carboxylic acid or a sulfonic acid. A carboxylic acid or sulfonic acid functional group can be attached to any alkyl, cycloalkyl, heterocycloalkyl, aryl or heteroaryl group, eg, having from 1 to 12 carbon atoms (C ₁ -C ₂₀ ). . In some embodiments, the organic acid is an alkyl, cycloalkyl, heterocycloalkyl, aryl or heteroaryl carboxylic or sulfonic acid.

As used herein, "alkyl" refers to any straight or branched chain hydrocarbon. The alkyl groups can be saturated (ie, have all sp ³ carbon atoms) or unsaturated (ie, have at least one site of unsaturation). As used herein, the term “unsaturated” refers to the presence of carbon-carbon, sp ² double bonds at one or more locations within the alkyl group. Unsaturated alkyl groups can be mono- or polyunsaturated. Representative straight chain alkyl groups include, but are not limited to, methyl, ethyl, n-propyl, n-butyl, n-pentyl and n-hexyl. Branched chain alkyl groups include, but are not limited to, isopropyl, sec-butyl, isobutyl, tert-butyl, isopentyl and 2-methylbutyl. Representative unsaturated alkyl groups include, but are not limited to, ethylene or vinyl, allyl, 1-butenyl, 2-butenyl, isobutylenyl, 1-pentenyl, 2-pentenyl, 3-methyl-1-butenyl, 2-methyl-2 -butenyl, 2,3-dimethyl-2-butenyl, and the like. An alkyl group can be unsubstituted or substituted.

"Cycloalkyl," as used herein, refers to a carbocyclic group, which can be monocyclic or bicyclic. Cycloalkyl groups include rings having from 3 to 7 carbon atoms as monocyclic rings or from 7 to 12 carbon atoms as bicyclic rings. Examples of monocyclic cycloalkyl groups include cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl and cyclooctyl. Cycloalkyl groups can be unsubstituted or substituted and can contain one or more sites of unsaturation (eg, cyclopentenyl or cyclohexenyl).

The term "aryl," as used herein, refers to carbocyclic aromatic groups. Examples of aryl groups include, but are not limited to, phenyl and naphthyl. An aryl group may be unsubstituted or substituted.

"Heteroaryl" and "Heterocycloalkyl" as used herein refer to aromatic or non-aromatic ring systems, respectively, in which one or more ring atoms are heteroatoms such as nitrogen, oxygen and sulfur. A heteroaryl or heterocycloalkyl group contains up to 20 carbon atoms and 1-3 heteroatoms selected from N, O and S. Heteroaryl or heterocycloalkyl is a monocyclic ring having 3-7 ring members (eg, 2-6 carbon atoms and 1-3 heteroatoms selected from N, O and S) or 7- bicyclic having 10 ring members (eg 4 to 9 carbon atoms and 1 to 3 heteroatoms selected from N, O and S), eg bicyclo[4,5], [5, 5], [5,6] or [6,6] systems. Examples of heteroaryl groups include, but are not limited to, pyridyl, thiazolyl, tetrahydrothiophenyl, pyrimidinyl, furanyl, thienyl, pyrrolyl, pyrazolyl, imidazolyl, tetrazolyl, benzofuranyl, thianaphthalenyl, indolyl, indolenyl, quinolinyl, isoquinolinyl, benzimidazolyl, Isoxazolyl, pyrazinyl, pyridazinyl, indolidinyl, isoindolyl, 3H-indolyl, 1H-indazolyl, purinyl, 4H-quinolidinyl, phthalazinyl, naphthyridinyl, quinoxalinyl, quinazolinyl, cinnolinyl, pteridinyl, 4aH-carbazolyl, carbazolyl, phenanthridinyl, acridinyl, pyrimidinyl , phenanthrolinyl, phenazinyl, phenothiazinyl, furazanyl, phenoxazinyl, isochromanyl, chromanyl, imidazolidinyl, imidazolinyl, pyrazolidinyl, pyrazolinyl, benzotriazolyl, benzoisoxazolyl and isatinyl. Examples of heterocycloalkyl include, by way of example and without limitation, dihydropyridyl, tetrahydropyridyl (piperidyl), tetrahydrothiophenyl, piperidinyl, 4-piperidonyl, pyrrolidinyl, 2-pyrrolidonyl, tetrahydrofuranyl, tetrahydropyranyl, Includes bis-tetrahydropyranyl, tetrahydroquinolinyl, tetrahydroisoquinolinyl, decahydroquinolinyl, octahydroisoquinolinyl, piperazinyl, quinuclidinyl and morpholinyl. Heteroaryl and heterocycloalkyl groups can be unsubstituted or substituted.

"Substituted," as used herein and applied to any of the above alkyl, aryl, cycloalkyl, heteroaryl, heterocyclyl, each one or more halogen atoms independently It means that it is replaced with a substituent. Typical substituents include, but are not limited to, -Cl, Br, F, alkyl, -OH, -OCH ₃ , NH ₂ , -NHCH ₃ , -N(CH ₃ ) ₂ , -CN, -NC(=O )CH ₃ , —C(=O)—, —C(=O)NH ₂ and —C(=O)N(CH ₃ ) ₂ . Whenever a group is described as being "optionally substituted," that group can be substituted with one or more of the above substituents, independently selected for each situation. In some embodiments, substituents can be one or more methyl groups or one or more hydroxyl groups.

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

In some embodiments, alkylcarboxylic or sulfonic acids are substituted with one or more hydroxyl groups. Non-limiting examples include glycolic acid, 4-hydroxybutyric acid and lactic acid.

In some embodiments, the organic acid may contain two or more carboxylic acid groups or two or more sulfonic acid groups (eg, two, three or more carboxylic acid groups). Non-limiting examples include oxalic acid, fumaric acid, maleic acid and glutaric acid. In organic acids containing multiple carboxylic acids (eg, 2-4 carboxylic acid groups), one or more of the carboxylic acid groups can be esterified. Non-limiting examples include monoethyl succinate, monomethyl fumarate, monomethyl or dimethyl citrate, and the like.

In some embodiments, the organic acid may contain two or more carboxylic acid groups and one or more hydroxyl groups. Non-limiting examples of such acids include tartaric acid, citric acid, and the like. In some embodiments, the organic acid is citric acid, sodium citrate, calcium citrate, or combinations thereof.

In some embodiments, the organic acid is an arylcarboxylic acid or arylsulfonic acid. Non-limiting examples of arylcarboxylic and arylsulfonic acids include benzoic acid, toluic acid, salicylic acid, benzenesulfonic acid and p-toluenesulfonic acid.

Additional non-limiting examples of suitable organic acids are 2,2-dichloroacetic acid, 2-hydroxyethanesulfonic acid, 2-oxoglutaric acid, 4-acetamidobenzoic acid, 4-aminosalicylic acid, acetic acid, adipic acid, ascorbic acid ( L), aspartic acid (L), camphoric acid (+), camphor-10-sulfonic acid (+), capric acid, caproic acid, caprylic acid, cinnamic acid, cyclamic acid, decanoic acid, dodecyl sulfate, ethane-1 , 2-disulfonic acid, ethanesulfonic acid, formic acid, fumaric acid, galactaric acid, gentisic acid, glucoheptonic acid, gluconic acid, glucuronic acid, glutamic acid, glycerophosphoric acid, glycolic acid, hippuric acid, isobutyric acid, lactobionic acid, lauric acid, Malonic acid, mandelic acid, methanesulfonic acid, naphthalene-1,5-disulfonic acid, naphthalene-2-sulfonic acid, oleic acid, palmitic acid, pamoic acid, pyroglutamic acid, sebacic acid, stearic acid and undecylenic acid.

In some embodiments, the one or more organic acids is a single organic acid. In some embodiments, the one or more organic acids is a combination of several acids, such as two, three or more organic acids.

The amount of organic acid present in the composition can vary. Generally, the mixture contains from about 0.1 to about 10 weight percent organic acid present as one or more organic acids, based on the total weight of the composition. In some embodiments, the composition contains about 0.1 wt%, about 0.2 wt%, about 0.3 wt%, about 0.4 wt%, about 0 wt%, based on the total weight of the composition. .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 %, about 5%, about 6%, about 7%, about 8%, about 9%, or about 10% by weight organic acid. In some embodiments, the composition comprises from about 0.1 to about 0.5 weight percent organic acid, based on the total weight of the composition, such as about 0.1, about 0.15, about 0.2, about 0.25, about 0.3, about 0.35, about 0.4, about 0.45, or about 0.5% by weight. In some embodiments, the composition comprises from about 0.25 to about 0.35 weight percent organic acid, based on the total weight of the composition, such as about 0.25, about 0.26, about 0.27, about 0.28, about 0.29 or about 0.3 to about 0.31, about 0.32, about 0.33, about 0.34 or about 0.35 weight percent. When a salt of an organic acid is added (eg, sodium citrate), weight percents are calculated based on the weight of the free acid, without any counterions that may be present.

The organic acid (eg, citric acid) can be added neat (ie, as a solid) or in solution, eg, to water. In some embodiments, the organic acid is added as a 50% aqueous solution.

Buffering Agents In certain embodiments, the compositions of the present disclosure may include pH adjusting agents or buffering agents. Examples of pH adjusting and buffering agents that can be used include, but are not limited to, metal hydroxides (such as alkali metal hydroxides such as sodium hydroxide and potassium hydroxide) and other alkali metal buffers; Examples include metal carbonates (eg, potassium carbonate or sodium carbonate) or metal bicarbonates, such as sodium bicarbonate. Non-limiting examples of suitable buffering agents include alkali metal acetates, glycinates, phosphates, glycerophosphates, citrates, carbonates, hydrocarbonates, borates or combinations thereof. In some embodiments, the buffering agent is sodium bicarbonate.

When present, buffering agents are typically present in an amount of less than about 5% by weight, based on the weight of the composition, for example, from about 0.1% to about It is present in an amount of 5% by weight, such as from about 0.1% to about 1% or from about 0.1% to about 0.5%.

Colorants Colorants can be utilized in amounts sufficient to provide the desired physical attributes to the composition. Examples of colorants include various dyes and pigments such as caramel color and titanium dioxide. Natural coloring agents such as curcumin, beet juice extract, spirulina; and various synthetic pigments can also be used. The amount of colorant utilized in the composition can vary, but when present typically up to about 3% by weight, based on the total weight of the composition, for example about 0.1 % by weight, from about 0.5% by weight, or from about 1% to about 3% by weight.

Wetting Agents In certain embodiments, one or more wetting agents can be utilized in the composition. Examples of humectants include, but are not limited to, glycerin, propylene glycol, and the like. When included, wetting agents are typically provided in amounts sufficient to provide the desired wetting attributes to the composition. Additionally, in some instances, wetting agents can impart desirable flow properties to the composition for deposition into a mold. When present, humectants typically comprise no more than about 5% (eg, from about 0.1 to about 5%) by weight of the composition, eg, about 0.5%, based on the total weight of the composition. 1% to about 1% or from about 1% to about 5% by weight.

Oral Care Additives In some embodiments, the composition comprises oral care ingredients (or mixtures of such ingredients). Oral care ingredients inhibit tooth decay or loss, inhibit periodontal disease, reduce oral pain, whiten teeth or inhibit tooth staining, induce stimulation of saliva, reduce breath Provides the ability to block odors, freshen breath, etc. For example, effective amounts of ingredients such as thyme oil, eucalyptus oil and zinc (such as the ingredients of the formulation marketed as ZYTEX® by Discus Dental) can be incorporated into the composition. Other examples of ingredients that can be incorporated into the present compositions in desired effective amounts are described in Takahashi et al., Oral Microbiology and Immunology, 19(1), pp. 61-64 (2004); , 527; and U.S. Patent Application Publication No. 2006/0210488 to Jakubowski and U.S. Patent Application Publication No. 2006/02228308 to Cummins et al. It can contain things that are Other exemplary ingredients of tobacco-containing formulations include those contained in formulations marketed as MALTISORB® by Roquette and DENTIZYME® by NatraRx. When present, a typical amount of oral care additive is at least about 1%, often at least about 3%, and frequently at least about 5% of the total dry weight of the composition. The amount of oral care additive within the composition typically does not exceed about 30%, often does not exceed about 25%, and frequently does not exceed about 20% of the total dry weight of the composition.

Processing Aids If necessary for downstream processing of the composition such as granulation, blending or molding, a flow aid can also be added to the composition to improve the flowability of the composition. In some embodiments, the composition (eg, in the form of melts and chews) can be surface treated with a dripping agent such as oil, silicone, and the like. Exemplary flow aids include microcrystalline cellulose, silica, polyethylene glycol, stearic acid, calcium stearate, magnesium stearate, zinc stearate, sodium stearyl fumarate, carnauba wax, and combinations thereof. In some embodiments, the flow aid is sodium stearyl fumarate.

When present, a representative amount of flow aid can constitute at least about 0.5 percent or at least about 1 percent of the total dry weight of the composition. Preferably, the amount of flow aid in the composition does not exceed about 5 percent, and frequently does not exceed about 3 percent, of the total dry weight of the composition.

Emulsifiers In certain embodiments, emulsifiers can be added. In some embodiments, the emulsifier is lecithin. For example, lecithin (e.g., soy lecithin or sunflower lecithin) is added to the composition to provide a smoother texture characteristic to the composition, e.g., to improve the fluidity and mixing of lipids, including the remaining ingredients of the composition. can do. Emulsifiers (eg, lecithin) can be used in amounts of about 0.01 to about 5% by dry weight of the composition, for example, about 0.1 to about 2.5%, based on the total weight of the composition. % or amounts from about 0.1 to about 1.0%.

Other Additives Other additives can be included in the disclosed compositions. For example, the composition can be processed, blended, formulated, combined and/or mixed with other materials or ingredients. Additives can be artificial or obtained or derived from herbs or biological sources. Examples of further types of additives are thickeners or gelling agents (e.g. fish gelatin), emulsifiers, preservatives (e.g. potassium sorbate, etc.), disintegration aids, compositions with higher water solubility. Zinc or magnesium salts selected to be relatively water soluble (e.g., magnesium gluconate or zinc gluconate) or zinc or magnesium salts selected to be relatively poorly water soluble in compositions with low water solubility Including salts (eg, magnesium oxide or zinc oxide) or combinations thereof. See, for example, Mua et al., US Pat. No. 9,237,769; Holton, Jr.; U.S. Patent No. 7,861,728 to Gao et al., U.S. Patent Application Publication No. 2010/0291245 to Gao et al. and Holton, Jr. et al. See representative ingredients thereof, combinations of ingredients, relative amounts of those ingredients, and techniques and methods for utilizing those ingredients, as set forth in U.S. Patent Application Publication No. 2007/0062549, et al. Each of these documents is hereby incorporated by reference. Typical comprehensive ranges for such additional additives can vary depending on the nature and function of the additive and the intended effect of the final composition; Up to about 10% (eg, about 0.1 to about 5%) by weight.

In some embodiments, the composition includes a magnesium salt. A non-limiting example of a suitable magnesium salt is magnesium gluconate. In some embodiments, the composition comprises magnesium in an amount of about 0.1 wt% to about 2 wt%, or about 0.2 to about 1 wt% based on elemental magnesium.

The aforementioned excipients are utilized together (e.g., an excipient formulation) or separately (e.g., individual excipient components can be added at different stages involved in preparing the final composition). be able to. Additionally, additives of the types described above can be encapsulated as provided in the final product or composition. Exemplary encapsulated additives are described, for example, in Atchley's WO2010/132444, previously incorporated herein by reference.

Configured for Oral Use Provided herein are compositions configured for oral use. The term "configured for use in the oral cavity", as used herein, means that the composition is such that, during use, saliva in the user's mouth absorbs components of the composition (e.g., flavorants and/or or active ingredient) is provided in a form that delivers it to the user's oral cavity. In certain embodiments, the composition is adapted to deliver ingredients to the user through the mucous membranes of the user's oral cavity, the user's digestive system, or both, and in some examples is an active ingredient (such as, but not limited to, stimulants, vitamins, amino acids, botanicals, or combinations thereof) that can be absorbed through the oral mucosa or through the gastrointestinal tract when the product is used.

Compositions configured for oral use as described herein can be in a variety of forms including gels, pastels, gums, chews, melts, tablets, lozenges, powders and pouches. can take. Gels can be soft or hard. Certain compositions designed for use in the oral cavity are in the form of pastels. As used herein, the term "pastel" refers to a dissolvable oral composition made by solidifying a liquid or gel composition such that the final composition is a somewhat hardened solid gel. point to things The stiffness of gels varies greatly. Certain compositions of this disclosure are in solid form. Certain compositions, for example, exhibit one or more of the following characteristics: crispy, grainy, chewy, syrupy, pasty, fluffy, smooth and/or creamy. can be done. In certain embodiments, the desired textural properties are adhesion, cohesiveness, density, dryness, breakability, graininess, tackiness, hardness, heaviness, moisture absorption, moisture release, mouth coating, roughness, slippage. can be selected from the group consisting of properties, smoothness, viscosity, wettability and combinations thereof.

The compositions disclosed herein include pills, tablets, spheres, strips, films, sheets, coins, cubes, beads, ovals, obloids, cylinders, beans. It can be formed into a variety of shapes, including tablets, sticks or rods. The cross-sectional shape of the composition can vary, and exemplary cross-sectional shapes include circular, square, oval, rectangular, and the like. Such shapes can be formed in a variety of ways using equipment such as moving belts, nips, extruders, granulating devices, compression molding devices, and the like.

Compositions of the present disclosure are dissolvable. As used herein, the terms "dissolve," "dissolving," and "dissolvable" refer to the gentle consumption of the composition by interacting with moisture in the oral cavity and flowing into solution. refers to a composition having a water-soluble component that provides a According to one aspect, the dissolvable composition is allowed to remain in the user's oral cavity for a predetermined period of time until completely dissolved. Dissolution rates can vary over a wide range from about 1 minute or less to about 60 minutes. For example, immediate release compositions are typically desired in about 2 minutes or less, often about 1 minute or less (eg, about 50 seconds or less, about 40 seconds or less, about 30 seconds or less, or about 20 seconds or less). (eg, active ingredients, fragrances, etc.). Dissolution can occur by any means such as melting, mechanical disruption (eg, chewing), enzymatic or other chemical degradation, or disruption of interactions between components of the composition. In other embodiments, the product does not dissolve during residence of the product in the user's mouth.

In some embodiments, the composition can be a chewable agent, meaning that the composition has a mild elasticity or "bounce" when chewed, meaning it has a desired degree of softness. A composition in chewable form is in the form of an undissolved gum that can dissolve completely or only certain ingredients (e.g. active ingredients, flavors, sweeteners) dissolve, leaving an undissolved matrix. obtain. Chewable embodiments generally include binders such as natural gums or pectin. In some embodiments, the composition in chewable form comprises pectin and organic acid along with one or more sugar alcohols in an amount of at least 50% by weight, based on the total weight of the composition. Generally, pectin is present in an amount of about 1 to about 3 weight percent, based on the total weight of the composition.

In some embodiments, the composition can be a meltable agent as discussed, for example, in US Patent Application Publication No. 2012/0037175 to Cantrell et al., which is incorporated herein by reference in its entirety. As used herein, "melt," "melting," and "meltable agent" refer to the ability of a composition to change from a solid state to a liquid state. That is, melting typically occurs when the application of heat causes a substance (eg, a composition disclosed herein) to change from a solid to a liquid. Application of heat to the compositions disclosed herein results from the internal temperature of the user's oral cavity. Thus, the term "meltable" refers to a composition capable of liquefying in the oral cavity of the user as the composition undergoes a phase change from solid to liquid and interacts with wetting of the composition. It is intended to distinguish between compositions that merely dissolve in the oral cavity as water-soluble ingredients and compositions that merely disintegrate in the oral cavity through loss of tackiness. Generally, the meltable composition comprises lipids as described herein above. In some embodiments, the composition in meltable form contains lipids in an amount of about 35 to about 50% by weight, based on the total weight of the composition, and about 35 to about It contains sugar alcohols in an amount of 55% by weight. In some embodiments, the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof. In some embodiments, the sugar alcohol is isomalt.

In certain embodiments, the composition is in the form of compressed or molded pellets. Example pellet weights range from about 250 mg to about 1500 mg, such as from about 250 mg to about 700 mg or from about 700 mg to about 1500 mg. The pellets can have any of a variety of shapes, including traditional pill or tablet shapes. Compositions in tablet form generally include a glucose-polysaccharide blend as well as a sugar alcohol. In some embodiments, the glucose-polysaccharide blend is present in an amount of about 35% to about 50% by weight, based on the total weight of the composition; the sugar alcohol is about 30%, based on the total weight of the composition. present in an amount of to about 45% by weight. In some embodiments, the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or combinations thereof. In some embodiments, the sugar alcohol is isomalt.

Composition Preparation The manner in which the various components of the composition (eg, fillers, active ingredients, etc.) are combined can vary. As such, the overall composition, including, for example, powdered composition components, can be relatively homogenous (eg, homogeneous) in nature. The above ingredients, which may be in liquid or dry solid form, are mixed in a pretreatment step prior to mixing with any remaining ingredients of the composition or simply mixed together with all other liquid or dry ingredients. can be made Compositions of the present disclosure are prepared by dry blending dry ingredients such as, for example, fillers, sweeteners, salts, and the like. In certain embodiments, water can be added to the dry blend at this stage. Additionally, it is optional to add, for example, active ingredients and/or flavoring agents by spraying the dry blend followed by mixing.

The various components of the composition can be contacted, combined or mixed together using any mixing technique or equipment known in the art. Any mixing method that brings the composition components into intimate contact can be used, for example, a mixing device featuring an impeller or other structure that permits agitation. Examples of mixing equipment include casting drums, conditioning cylinders or drums, liquid atomizers, conical blenders, ribbon blenders, Littleford Day, Inc. and mixers available as FKM 130, FKM 600, FKM 1200, FKM 2000 and FKM 3000 manufactured by the Company, Plough Share type mixer cylinders, Hobart mixers and the like. Also, for example, Solomon et al., US Pat. No. 4,148,325; Korte et al., US Pat. No. 6,510,855; and Williams, US Pat. No. 6,834,654. Each of these documents is incorporated herein by reference, although reference is made to the types of methods described. In some embodiments, the ingredients forming the composition are prepared such that the mixture can be used in a starch molding process to form the composition. Techniques and methods for formulating the compositions will be apparent to those skilled in the art. See also, for example, Solomon et al., U.S. Pat. No. 4,148,325; Korte et al., U.S. Pat. No. 6,510,855; and Williams, U.S. Pat. No. 4,725,440 to Bolder et al. and U.S. Pat. No. 6,077,52 to Bolder et al. Incorporated herein by reference.

In some embodiments, the composition is in the form of compressed pellets or tablets. In one embodiment, the process of making pellets or tablets includes first mixing a bulk filler (eg, EMDEX®) and an active ingredient. The remaining composition ingredients (eg, sugar alcohol and any other desired ingredients such as binders, colorants, sweeteners, flavors, etc.) are then added. Optionally, the colorant can be added to one of the composition components in a separate step prior to mixing with the remaining components of the composition. Mixing of the composition can be performed using any mixing device. The final composition is then compressed into pellets or tablets using conventional tableting techniques and optionally coated. Compressed composition pellets can be produced by compression molding the composition containing any relevant formulation ingredients in the form of pellets, optionally coating each pellet with an overcoat material. Exemplary compression molding devices, such as compression molding presses, are available as Colton 2216 and Colton 2247 from Vector Corporation and 1200i, 2200i, 3200, 2090, 3090 and 4090 from Fette Compacting. Devices for applying outer coating layers to compression molded pelletized compositions are available as CompuLab 24, CompuLab 36, Accela-Cota 48 and Accela-Cota 60 from Thomas Engineering. When present, the coating typically comprises a film-forming polymer, such as a cellulosic polymer, an optional plasticizer and an optional flavorant, colorant, salt, sweetener, or as described herein. Including other additives of the kind. The coating composition is generally aqueous in nature and can be applied using any pellet or tablet coating technique known in the art, such as pan coating. Examples of film-forming polymers include cellulosic polymers such as methylcellulose, hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose and carboxymethylcellulose. Examples of plasticizers include aqueous solutions or emulsions of glyceryl monostearate and triethyl citrate. Additional potential coatings include food grade shellac, waxes such as carnuaba wax and combinations thereof.

In some embodiments, the composition is in chewable form. For the preparation of chewable forms of the composition, the pectin binder is generally pre-blended with a portion of the isomalt. Water is added and the mixture is heated to boiling with stirring. Maltitol syrup and any remaining isomalt are added to the boiling mixture along with the active ingredients (eg caffeine, taurine and vitamin C) followed by trisodium citrate. The mixture is cooked to 78 Brix. Heat is removed and sweeteners (eg sucralose and acesulfame K) and flavors are added along with colorants and citric acid solution (or dicalcium phosphate) and the mixture is combined thoroughly. The composition is deposited into starch molds for storage at ambient temperature.

In some embodiments, the composition is in meltable form. For the preparation of meltable compositions, the lipids are typically heated to slightly above their melting temperature to liquefy the lipids. Optionally, active ingredients, flavors and/or lecithin can be added to the liquefied lipids at this stage. Thus, all or a portion of the liquefied lipid can be blended with the dry blend and mixed until the composition reaches a desired level of homogeneity or achieves desired textural properties. The mixture is ground (eg, on a dry roll mill) to a particle size of less than about 20 microns. The ground isomalt-palm oil is combined with any remaining lipids and the dry ingredients and flavorings are mixed therein. The base is generally allowed to warm to a liquid consistency. The composition can be separated into separate portions, for example, by pouring the composition into a sheet-like structure, cooling, and then cutting the structure into individual portions, or by depositing the composition in a mold and allowing it to cool. .

Many modifications and other embodiments of the invention will come to mind to one skilled in the art to which the invention pertains having the benefit of the teachings presented in the foregoing description. It is therefore understood that the invention is not limited to the particular embodiments disclosed, but that modifications and other embodiments are included within the scope of the appended claims. Should. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

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

Example 1. Tablets Comprising Theanine, GABA and Lemon Balm A composition in tablet form according to an embodiment of the present disclosure comprises a mixture of fillers, a mixture of theanine, GABA (gamma-aminobutyric acid) and lemon balm as active ingredients and a mixture disclosed herein. from compositions containing additional ingredients (salts, sweeteners, processing aids). Fillers, sweeteners, salts, active ingredients and processing aids were combined and mixed thoroughly. The mixture was compressed into tablets using a Fette 1200i tablet press. Tablets were coated with wax and shellac. The components of the composition and their concentrations in the composition in weight percent are shown in Table 1. The tablet weight was 1000 mg each.

Example 2. Tablets Comprising Caffeine, Taurine and Vitamin C A composition in the form of tablets according to embodiments of the present disclosure was prepared using the method of Example 1 using a mixture of fillers, caffeine, taurine and vitamin C as active ingredients. as well as compositions containing additional ingredients (salts, sweeteners, buffers, processing aids) disclosed herein. The components of the composition and their concentrations in the composition in weight percent are shown in Table 2. The tablet weight was 1000 mg each.

Example 3. Tablets Comprising Caffeine, Theanine, Sunflower Lecithin and Carrot A composition in tablet form according to an embodiment of the present disclosure was prepared using the method of Example 1 by adding a mixture of fillers, caffeine as active ingredients, theanine, Prepared from a composition containing a sunflower lecithin and carrot mixture and additional ingredients disclosed herein (salts, sweeteners, buffers, processing aids). The components of the composition and their concentrations in the composition in weight percent are shown in Table 3. The tablet weight was 1000 mg each.

Example 4. Chewable Agents Containing Caffeine, Taurine and Vitamin C A composition in chewable form according to embodiments of the present disclosure comprises a mixture of fillers, a mixture of caffeine, taurine and vitamin C as active ingredients and a mixture of caffeine, taurine and vitamin C as described herein. Prepared from compositions containing additional disclosed ingredients (salts, sweeteners, flavors, water, binders, citric acid, gelling agents). The components of the composition and their concentrations in the composition in weight percent are shown in Table 4.

A pectin binder was pre-blended with a portion of the isomalt. Water was added and the mixture was heated to boiling with stirring. The maltitol syrup and any remaining isomalt was added to the boiling mixture along with the active ingredients (eg caffeine, taurine and vitamin C) followed by trisodium citrate. The mixture was heated to 78 Brix. Remove from heat, add sweeteners (e.g., sucralose and acesulfame K), colors and flavors along with citric acid and dicalcium phosphate, mix thoroughly, and store the composition for storage at ambient temperature. was deposited in the starch mold. The chew weight was 2600 mg each.

Example 5. Chewable Agents Comprising Theanine, GABA, and Lemon Balm A composition in chewable form according to embodiments of the present disclosure was prepared using the method of Example 4 by adding a mixture of fillers, theanine, GABA, and lemon balm as active ingredients. Mixtures were prepared from compositions containing additional ingredients disclosed herein (salts, sweeteners, flavoring agents, water, binders, citric acid, gelling agents). The components of the composition and their concentrations in the composition in weight percent are shown in Table 5. The chew weight was 2600 mg each.

Example 6. Chewable Agents Comprising Caffeine, Theanine and Carrots A composition in chewable form according to embodiments of the present disclosure is prepared using the method of Example 4 by adding a mixture of fillers, caffeine, theanine and ginseng as active ingredients. It was prepared from a composition containing a mixture of carrots and additional ingredients disclosed herein (salts, sweeteners, flavoring agents, water, binders, citric acid, gelling agents). The components of the composition and their concentrations of the composition in weight percent are shown in Table 6. The chew weight was 2600 mg each.

Example 7. Meltable Agents Comprising Theanine, GABA and Lemon Balm Compositions in meltable form according to embodiments of the present disclosure comprise fillers, lipids, a mixture of theanine, GABA and lemon balm as active ingredients and disclosed herein. Prepared from compositions containing additional ingredients (salts, sweeteners, flavors). The components of the composition and their concentrations of the composition in weight percent are shown in Table 7.

Part of the palm oil was melted and mixed with the isomalt in a mixer. The mixture was transferred to a dry roll mill and ground to a particle size of less than 20 microns. In a mixer, the ground isomalt-palm oil was combined with the remaining portion of palm oil. The base was warmed to a liquid consistency. The sunflower oil, dry ingredients and fragrance were mixed. The isomalt-palm oil-component mixture was transferred to a heated depositing funnel. An appropriate weight of sample was deposited into the mold. If necessary, the mold was placed on a vibrator to ensure filling. The product was allowed to cool, solidify and then removed from the mold. The melt weight was 1300 mg each.

Example 8. Meltable Agents Comprising Theanine, Caffeine and Carrots A composition in meltable form according to embodiments of the present disclosure was prepared using the method of Example 7 by adding fillers, lipids, theanine as active ingredients, caffeine and carrots. It was prepared from a composition containing a mixture of carrots and additional ingredients (salts, sweeteners, flavoring agents, buffering agents) disclosed herein. The components of the composition and their concentrations in the composition in weight percent are shown in Table 8. The melt weight was 1300 mg each.

Example 9. A meltable agent comprising taurine, caffeine and vitamin C A composition according to embodiments of the present disclosure in a meltable form was prepared using the method of Example 7 by adding fillers, lipids, taurine as active ingredients and caffeine. and vitamin C and additional ingredients disclosed herein (salts, sweeteners, flavoring agents, buffering agents, emulsifying agents). The components of the composition and their concentrations of the composition in weight percent are shown in Table 9. The melt weight was 1300 mg each.

Claims (54)

A composition in chewable form adapted for use in the oral cavity, comprising:
at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, carrot, citicoline, sunflower lecithin and combinations thereof;
one or more sugar alcohols in an amount of at least 50% by weight, based on the total weight of the composition;
pectin; and an organic acid, a gelling agent, or both, wherein said composition is a homogeneous mixture. 2. A composition according to claim 1, wherein the one or more sugar alcohols is a combination of isomalt and maltitol. isomalt in an amount of about 10 to about 25% by weight, based on the total weight of the composition;
maltitol in an amount of about 50 to about 75% by weight, based on the total weight of the composition; and pectin in an amount of about 1 to about 3%, by weight, based on the total weight of the composition. 2. The composition according to 2. A composition according to any preceding claim, wherein the organic acid is citric acid. A composition according to any preceding claim, wherein the at least one active ingredient comprises a combination of caffeine, theanine and optionally carrots. caffeine is present in an amount of about 1 to about 4% by weight, based on the total weight of the composition;
theanine is present in an amount of about 1 to about 4% by weight, based on the total weight of the composition;
carrots are present in an amount of about 0.1 to about 0.6% by weight, based on the total weight of the composition;
6. A composition according to claim 5. 7. The composition of claim 6, further comprising citicoline or sunflower lecithin. A composition according to any preceding claim, wherein the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), optionally lemon balm extract. theanine is present in an amount of about 1 to about 3% by weight, based on the total weight of the composition;
GABA is present in an amount of about 1.5 to about 4% by weight, based on the total weight of the composition;
lemon balm extract is present in an amount of about 0.25 to about 2% by weight, based on the total weight of the composition;
A composition according to claim 8 . A composition according to any one of claims 1 to 4, wherein at least one active ingredient is
Theanine;
A composition comprising theanine and tryptophan; or theanine and vitamin B6, vitamin B12 or both. 11. The composition of claim 10, comprising theanine and one or both of vitamin B6 and vitamin B12. A composition according to any preceding claim, wherein at least one active ingredient comprises a combination of caffeine, taurine and vitamin C. caffeine is present in an amount of about 1 to about 4% by weight, based on the total weight of the composition;
taurine is present in an amount of about 1 to about 4% by weight, based on the total weight of the composition;
Vitamin C is present in an amount of about 1 to about 3% by weight, based on the total weight of the composition;
13. The composition of claim 12. 14. The composition of claim 13, further comprising trisodium citrate. 15. The method of any one of claims 1-14, further comprising at least one additional ingredient selected from water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof. Composition. A composition according to any one of claims 1 to 15, which does not contain nicotine. A composition according to any one of claims 1 to 16, which does not contain tobacco. A composition in the form of a tablet adapted for oral use, comprising:
at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, carrot, citicoline, sunflower lecithin and combinations thereof;
A composition comprising a glucose-polysaccharide blend; and a sugar alcohol, wherein said tablet form comprises the composition as a homogeneous mixture. the glucose-polysaccharide blend is present in an amount of about 35 to about 55% by weight, based on the total weight of the composition;
the sugar alcohol is present in an amount of about 30 to about 45% by weight, based on the total weight of the composition;
19. The composition of claim 18. 20. A composition according to claim 18 or 19, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol or a combination thereof. A composition according to any one of claims 18-20, wherein the sugar alcohol is isomalt. A composition according to any one of claims 18-21, wherein the at least one active ingredient comprises a combination of caffeine, theanine and optionally carrots. caffeine is present in an amount of about 3 to about 5% by weight, based on the total weight of the composition;
theanine is present in an amount of about 3 to about 5% by weight, based on the total weight of the composition;
carrots are present in an amount of about 0.4 to about 0.6% by weight, based on the total weight of the composition;
23. The composition of claim 22. 24. The composition of claim 23, further comprising citicoline or sunflower lecithin. A composition according to any one of claims 18 to 21, wherein the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), optionally lemon balm extract. theanine is present in an amount of about 3 to about 5% by weight, based on the total weight of the composition;
GABA is present in an amount of about 4 to about 6% by weight, based on the total weight of the composition;
lemon balm extract is present in an amount of about 3 to about 4% by weight, based on the total weight of the composition;
26. The composition of claim 25. A composition according to any one of claims 18-21, wherein the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C. caffeine is present in an amount of about 3 to about 5% by weight, based on the total weight of the composition;
taurine is present in an amount of about 4 to about 6 weight percent, based on the total weight of the composition;
Vitamin C is present in an amount of about 4 to about 6% by weight, based on the total weight of the composition;
28. The composition of claim 27. 29. The composition of claim 28, further comprising trisodium citrate. A composition according to any one of claims 18 to 29, further comprising at least one additional ingredient selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof. . The composition according to any one of claims 18-30, which does not contain nicotine. A composition according to any one of claims 18 to 31, which does not contain tobacco. A composition in meltable form adapted for use in the oral cavity, comprising:
at least one active ingredient selected from the group consisting of caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, carrot, citicoline, sunflower lecithin and combinations thereof;
A composition comprising a sugar alcohol; and a lipid, wherein said meltable form comprises the composition as a homogeneous mixture. the sugar alcohol is present in an amount of about 35 to about 55% by weight, based on the total weight of the composition;
the lipid is present in an amount of about 35 to about 55% by weight, based on the total weight of the composition;
34. The composition of claim 33. 35. The composition of claim 33 or 34, wherein the lipid has a melting point of about 29[deg.]C or higher. The composition of any one of claims 33-35, wherein the lipid has a melting point of about 36°C to about 45°C. The lipid is an oil selected from the group consisting of palm oil, palm kernel oil, soybean oil, sunflower oil, cottonseed oil, coconut oil and combinations thereof, wherein the oil is optionally hydrogenated and partially hydrogenated. A composition according to any one of claims 33 to 36, which may be hydrogenated or non-hydrogenated. A composition according to any one of claims 33 to 37, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol or a combination thereof. A composition according to any one of claims 33 to 38, wherein the sugar alcohol is isomalt. A composition according to any one of claims 33 to 39, wherein the at least one active ingredient comprises a combination of caffeine, theanine and optionally carrots. caffeine is present in an amount of about 2 to about 6% by weight, based on the total weight of the composition;
theanine is present in an amount of about 2 to about 4% by weight, based on the total weight of the composition;
carrots are present in an amount of about 0.3 to about 0.5% by weight, based on the total weight of the composition;
41. The composition of claim 40. 42. The composition of claim 41, further comprising citicoline or sunflower lecithin. 41. The composition of Claim 40, wherein at least a portion of the caffeine is present in encapsulated form. A composition according to any one of claims 33 to 39, wherein the at least one active ingredient comprises a combination of theanine, gamma-aminobutyric acid (GABA), optionally lemon balm extract. theanine is present in an amount of about 2 to about 4% by weight, based on the total weight of the composition;
GABA is present in an amount of about 3.5 to about 4.5% by weight, based on the total weight of the composition;
lemon balm extract is present in an amount of about 1.5 to about 2.5% by weight, based on the total weight of the composition;
45. The composition of claim 44. 38. A composition according to any one of claims 31-37, wherein the at least one active ingredient comprises a combination of caffeine, taurine and vitamin C. caffeine is present in an amount of about 2 to about 6% by weight, based on the total weight of the composition;
taurine is present in an amount of about 3.5 to about 4.5% by weight, based on the total weight of the composition;
Vitamin C is present in an amount of about 3.5 to about 4.5% by weight, based on the total weight of the composition;
47. The composition of claim 46. 47. The composition of Claim 46, wherein at least a portion of the caffeine is present in encapsulated form. 47. The composition of claim 46, further comprising trisodium citrate. A composition according to any one of claims 33 to 49, further comprising at least one additional ingredient selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids and combinations thereof. . A composition according to any one of claims 33 to 50, which does not contain nicotine. 52. The composition of any one of claims 33-51, which does not contain tobacco. at least one active ingredient
a) caffeine in an amount of about 1.5 to about 5% by weight, based on the total weight of the composition;
Taurine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition;
vitamin C in an amount of about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of about 1 to about 3%, by weight, based on the total weight of the composition;
is a combination of
b) theanine in an amount of about 1 to about 5% by weight, based on the total weight of the composition;
GABA in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition; and lemon balm extract in an amount of about 1 to about 4% by weight, based on the total weight of the composition;
or c) caffeine in an amount of about 1.5 to about 6% by weight, based on the total weight of the composition;
Theanine in an amount of about 1.5 to about 5% by weight, based on the total weight of the composition;
carrots in an amount of about 0.2 to about 0.6 weight percent, based on the total weight of the composition; and optionally about 0.3 to about 1.5 weight, based on the total weight of the composition. 34. The composition of any one of claims 1, 18 or 33, which is a combination of citicoline or sunflower lecithin in an amount of %. 54. The composition of any one of claims 1-53, further comprising magnesium.