ORAL PRODUCTS WITH ACTIVE INGREDIENT COMBINATIONS

Abstract

Compositions configured for oral use, the compositions including at least one active ingredient selected from caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, or combinations thereof, are provided. The compositions include one or more fillers, including a sugar alcohol, and optionally, a lipid or binder. The compositions may be in chewable, tablet, or meltable forms.

Claims

1. A composition in chewable form, configured for oral use, the composition 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, ginseng, citicoline, sunflower lecithin, and combinations thereof; one or more sugar alcohols in an amount by weight of at least 50%, based on the total weight of the composition; pectin; and an organic acid, a gelation agent, or both, wherein the composition is a homogenous mixture.

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

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

4. The composition of claim 1, wherein the organic acid is citric acid.

5. The composition of claim 1, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally ginseng.

6. The composition of claim 5, wherein: the caffeine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; theanine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; and the ginseng is present in an amount of from about 0.1 to about 0.6% by weight, based on the total weight of the composition.

7. The composition of claim 6, further comprising citicoline or sunflower lecithin.

8. The composition of claim 1, wherein the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.

9. The composition of claim 8, wherein: the theanine is present in an amount of from about 1 to about 3% by weight, based on the total weight of the composition; the GABA is present in an amount of from about 1.5 to about 4% by weight, based on the total weight of the composition; and the lemon balm extract is present in an amount of from about 0.25 to about 2% by weight, based on the total weight of the composition.

10. The composition of claim 1, wherein the at least one active ingredient comprises: theanine; 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 vitamins B6 and vitamin B12.

12. The composition of claim 1, wherein the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.

13. The composition of claim 12, wherein: the caffeine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; the taurine is present in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; and the vitamin C is present in an amount of from about 1 to about 3% by weight, based on the total weight of the composition.

14. The composition of claim 13, further comprising trisodium citrate.

15. The composition of claim 1, further comprising at least one additional component selected from water, sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.

16. The composition of claim 1, wherein the composition is free of nicotine.

17. The composition of claim 1, wherein the composition is free of tobacco.

18. A composition in tablet form configured for oral use, the composition 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, ginseng, citicoline, sunflower lecithin, and combinations thereof; a glucose-polysaccharide blend; and a sugar alcohol; wherein the tablet form comprises the composition as a homogenous mixture.

19. The composition of claim 18, wherein: 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; and the sugar alcohol is present in an amount of from about 30 to about 45% by weight, based on the total weight of the composition.

20. The composition of claim 18, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof.

21. The composition of claim 18, wherein the sugar alcohol is isomalt.

22. The composition of claim 18, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally ginseng.

23. The composition of claim 22, wherein: the caffeine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; theanine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; and the ginseng is present in an amount of from about 0.4 to about 0.6% by weight, based on the total weight of the composition.

24. The composition of claim 23, further comprising citicoline or sunflower lecithin.

25. The composition of claim 18, wherein the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.

26. The composition of claim 25, wherein: the theanine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; the GABA is present in an amount of from 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 from about 3 to about 4% by weight, based on the total weight of the composition.

27. The composition of claim 18, wherein the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.

28. The composition of claim 27, wherein: the caffeine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; the taurine is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition; and the vitamin C is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition.

29. The composition of claim 28, further comprising trisodium citrate.

30. The composition of claim 18, further comprising at least one additional component selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.

31. The composition of claim 18, wherein the composition is free of nicotine.

32. The composition of claim 18, wherein the composition is free of tobacco.

33. A composition in meltable form, configured for oral use, the composition 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, ginseng, citicoline, sunflower lecithin, and combinations thereof; a sugar alcohol; and a lipid; wherein the meltable form comprises the composition as a homogenous mixture.

34. The composition of claim 33, wherein: the sugar alcohol is present in an amount of from about 35 to about 55% by weight, based on the total weight of the composition; and the lipid in an amount of from about 35 to about 50% by weight, based on the total weight of the composition.

35. The composition of claim 33, wherein the lipid has a melting point of about 29° C. or above.

36. The composition of claim 33, wherein the lipid has a melting point from about 36° C. to about 45° C.

37. The composition of claim 33, wherein 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 may be hydrogenated, partially hydrogenated, or non-hydrogenated.

38. The composition of claim 33, wherein the sugar alcohol is isomalt, erythritol, sorbitol, arabitol, ribitol, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, or a combination thereof.

39. The composition of claim 33, wherein the sugar alcohol is isomalt.

40. The composition of claim 33, wherein the at least one active ingredient comprises a combination of caffeine, theanine, and optionally ginseng.

41. The composition of claim 40, wherein: the caffeine is present in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; theanine is present in an amount of from about 2 to about 4% by weight, based on the total weight of the composition; and the ginseng is present in an amount of from about 0.3 to about 0.5% by weight, based on the total weight of the composition.

42. The composition of claim 41, further comprising citicoline or sunflower lecithin.

43. The composition of claim 40, wherein at least a portion of the caffeine is present in encapsulated form.

44. The composition of claim 33, wherein the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract.

45. The composition of claim 44, wherein: the theanine is present in an amount of from about 2 to about 4% by weight, based on the total weight of the composition; the GABA is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition; and the lemon balm extract is present in an amount of from about 1.5 to about 2.5% by weight, based on the total weight of the composition.

46. The composition of claim 31, wherein the at least one active ingredient comprises a combination of caffeine, taurine, and vitamin C.

47. The composition of claim 46, wherein: the caffeine is present in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; the taurine is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition; and the vitamin C is present in an amount of from about 3.5 to about 4.5% by weight, based on the total weight of the composition.

48. The composition of claim 46, wherein at least a portion of the caffeine is present in encapsulated form.

49. The composition of claim 46, further comprising trisodium citrate.

50. The composition of claim 33, further comprising at least one additional component selected from sweeteners, salts, flavors, buffers, emulsifiers, colorants, processing aids, and combinations thereof.

51. The composition of claim 33, wherein the composition is free of nicotine.

52. The composition of claim 33, wherein the composition is free of tobacco.

53. The composition of claim 1, wherein the at least one active ingredient is a combination of: a) caffeine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; taurine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; vitamin C in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of from about 1 to about 3% by weight, based on the total weight of the composition; b) theanine in an amount of from about 1 to about 5% by weight, based on the total weight of the composition; GABA in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; and lemon balm extract in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; or c) caffeine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; theanine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; ginseng in an amount of from about 0.2 to about 0.6% by weight, based on the total weight of the composition; and optionally, citicoline or sunflower lecithin in an amount of from about 0.3 to about 1.5% by weight, based on the total weight of the composition.

54. The composition of claim 53, further comprising magnesium.

55. The composition of claim 18, wherein the at least one active ingredient is a combination of: a) caffeine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; taurine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; vitamin C in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of from about 1 to about 3% by weight, based on the total weight of the composition; b) theanine in an amount of from about 1 to about 5% by weight, based on the total weight of the composition; GABA in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; and lemon balm extract in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; or c) caffeine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; theanine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; ginseng in an amount of from about 0.2 to about 0.6% by weight, based on the total weight of the composition; and optionally, citicoline or sunflower lecithin in an amount of from about 0.3 to about 1.5% by weight, based on the total weight of the composition.

56. The composition of claim 55, further comprising magnesium.

57. The composition of claim 33, wherein the at least one active ingredient is a combination of: a) caffeine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; taurine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; vitamin C in an amount of from about 2 to about 6% by weight, based on the total weight of the composition; and sodium citrate in an amount of from about 1 to about 3% by weight, based on the total weight of the composition; b) theanine in an amount of from about 1 to about 5% by weight, based on the total weight of the composition; GABA in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; and lemon balm extract in an amount of from about 1 to about 4% by weight, based on the total weight of the composition; or c) caffeine in an amount of from about 1.5 to about 6% by weight, based on the total weight of the composition; theanine in an amount of from about 1.5 to about 5% by weight, based on the total weight of the composition; ginseng in an amount of from about 0.2 to about 0.6% by weight, based on the total weight of the composition; and optionally, citicoline or sunflower lecithin in an amount of from about 0.3 to about 1.5% by weight, based on the total weight of the composition.

58. The composition of claim 57, further comprising magnesium.

Description

EXAMPLES

[0261] Aspects of the present invention are more fully illustrated by the following examples, which are set forth to illustrate certain aspects of the present invention and are not to be construed as limiting thereof.

Example 1

Tablet Comprising Theanine, GABA, and Lemon Balm

[0262] A composition according to an embodiment of the present disclosure in tablet form was prepared from a composition containing a mixture of fillers, a mixture of theanine, GABA (gamma-aminobutyric acid), and lemon balm as the active ingredient, and additional components as disclosed herein (salt, sweeteners, processing aid). The fillers, sweetener, salt, active ingredients, and processing aid were combined and mixed thoroughly. The mixture was compressed and tableted using a Fette 1200i tablet press. The tablets were coated with wax and shellac. The ingredients of the composition and their concentrations in the composition in weight are provided in Table 1. The tablets each weighed 1000 mg.

TABLE-US-00001 TABLE 1 Tablet ingredients Ingredient % w/w isomalt 32-48 Emdex ® 35-55 theanine 3-5 GABA 4-6 lemon balm extract 3-4 sweetener 0.1-0.5 salt 0.2-0.4 sodium stearyl fumarate 0.5-1.5 flavorant .sup. 1-1.5 Carnauba wax 0.05-0.15 shellac 0.2-0.4

Example 2

Tablet Comprising Caffeine, Taurine, and Vitamin C

[0263] A composition according to an embodiment of the present disclosure in tablet form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, taurine, and vitamin C as the active ingredient, and additional components as disclosed herein (salt, sweeteners, buffer, processing aid) using the method of Example 1. The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 2.

[0264] The tablets each weighed 1000 mg.

TABLE-US-00002 TABLE 2 Tablet ingredients Ingredient % w/w isomalt 30-40 Emdex ® 35-55 sweetener 0.1-0.5 caffeine 3-5 taurine 4-6 vitamin C 4-6 trisodium citrate 2-3 salt 0.1-0.5 colorant 1-2 flavorant .sup. 1-1.5 sodium stearyl fumarate 0.5-1.5 Carnauba wax 0.05-0.15 shellac 0.2-0.4

Example 3

Tablet Comprising Caffeine, Theanine, Sunflower Lecithin, and Ginseng

[0265] A composition according to an embodiment of the present disclosure in tablet form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, theanine, sunflower lecithin, and ginseng as the active ingredient, and additional components as disclosed herein (salt, sweeteners, buffer, processing aid) using the method of Example 1. The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 3. The tablets each weighed 1000 mg.

TABLE-US-00003 TABLE 3 Tablet ingredients Ingredient % w/w isomalt 32-48 Emdex ® 35-55 sweetener 0.1-0.5 caffeine 3-5 theanine 3-5 sunflower lecithin 0.5-1.5 ginseng extract 0.4-0.6 trisodium citrate 2-3 salt 0.1-0.5 colorant 1-2 flavorant .sup. 1-1.5 sodium stearyl fumarate 0.5-1.5 Carnauba wax 0.05-0.15 shellac 0.2-0.4

Example 4

Chewable Comprising Caffeine, Taurine, and Vitamin C

[0266] A composition according to an embodiment of the present disclosure in chewable form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, taurine, and vitamin C as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent). The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 4.

[0267] The pectin binder was pre-blended with a portion of the isomalt. Water was added, and the mixture heated to boiling with stirring. Maltitol syrup and any remaining isomalt were added to the boiling mixture, along with the active ingredients (e.g., caffeine, taurine, and vitamin C), followed by trisodium citrate. The mixture was cooked to 78 brix. Heat was removed, and sweetener (e.g., sucralose and acesulfame K, colorant and flavorant were added, along with the citric acid and dicalcium phosphate, and the mixture thoroughly combined, and the composition deposited into starch molds for storage at ambient temperature. The chews each weighed 2600 mg.

TABLE-US-00004 TABLE 4 Chewable ingredients Ingredient % w/w isomalt 12-20 maltitol syrup 48-72 caffeine 1-2 taurine 1.5-2.5 vitamin C 1.5-2.5 water 12-18 dicalcium phosphate 0.4-0.6 citric acid 0.5-1.5 trisodium citrate 0.5-1.5 flavorant 0.6-0.9 pectin 1-2 sweetener 0.05-0.5  colorant 0.05-0.15

Example 5

Chewable Comprising Theanine, GABA, and Lemon Balm

[0268] A composition according to an embodiment of the present disclosure in chewable form was prepared from a composition containing a mixture of fillers, a mixture of theanine, GABA, and lemon balm as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent) using the method of Example 4. The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 5. The chews each weighed 2600 mg.

TABLE-US-00005 TABLE 5 Chewable ingredients Ingredient % w/w isomalt 12-20 maltitol syrup 48-72 theanine 1.2-1.8 GABA 1.5-2.5 lemon balm extract 0.5-1.5 water 12-20 citric acid 0.5-1.5 dicalcium phosphate 0.4-0.6 pectin 2-3 sweetener 0.05-0.5  flavor 0.5-0.7

Example 6

Chewable Comprising Caffeine, Theanine, and Ginseng

[0269] A composition according to an embodiment of the present disclosure in chewable form was prepared from a composition containing a mixture of fillers, a mixture of caffeine, theanine, and ginseng as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, water, binder, citric acid, gelation agent) using the method of Example 4. The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 6. The chews each weighed 2600 mg.

TABLE-US-00006 TABLE 6 Chewable ingredients Ingredient % w/w isomalt 12-20 maltitol syrup 48-72 caffeine 1.2-1.8 theanine 1.2-1.8 Ginseng extract 0.1-0.3 water 12-18 citric acid 0.4-0.6 pectin 1.2-1.8 sunflower lecithin 0.3-0.5 sweetener 0.05-0.5  colorant 0.05-0.15 flavor 0.5-1.5 Trisodium citrate 0.8-1.2 Dicalcium phosphate 0.2-0.4

Example 7

Meltable Comprising Theanine, GABA, and Lemon Balm

[0270] A composition according to an embodiment of the present disclosure in meltable form was prepared from a composition containing a filler, a lipid, a mixture of theanine, GABA, and lemon balm as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent). The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 7.

[0271] A portion of the palm oil was melted and mixed with the isomalt in a mixer. The mixture was transferred to a dry roll mill and milled until the particle size was less than 20 microns. In a mixer, the milled isomalt-palm oil was combined with the remaining portion of palm oil. The base was warmed to a fluid consistency. Sunflower oil, the dry ingredients, and flavor were mixed in. The isomalt-palm oil-ingredient mixture was transferred to a heated depositing funnel. The appropriate weight of the samples was deposited into a shape mold. If needed, the mold was placed on a vibrator to ensure even filling. The product was allowed to cool and solidify, then removed from the mold. The melts each weighed 1300 mg.

TABLE-US-00007 TABLE 7 Meltable ingredients Ingredient % w/w isomalt 35-55 Lipid (e.g., palm oil) 32-48 theanine 2.5-3.5 GABA 3.5-4.5 lemon balm extract 1.5-2.5 salt 0.5-1.5 sunflower lecithin 0.25-0.5  Sunflower oil .sup. 2-3.5 sweetener 0.05-0.5  flavor 0.5-1.5

Example 8

Meltable Comprising Theanine, Caffeine, and Ginseng

[0272] A composition according to an embodiment of the present disclosure in meltable form was prepared from a composition containing a filler, a lipid, a mixture of theanine, caffeine, and ginseng as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, buffer) using the method of Example 7. The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 8. The melts each weighed 1300 mg.

TABLE-US-00008 TABLE 8 Meltable ingredients Ingredient % w/w isomalt 35-55 lipid (e.g., palm oil) 35-50 caffeine 3-4 theanine 2.5-3.5 Ginseng extract 0.3-0.5 sunflower lecithin 0.5-1.sup.  Sunflower oil 2-4 colorant 0.4-0.6 trisodium citrate .sup. 1-2.5 salt 0.5-1.5 flavor 0.5-1.5 sweetener 0.05-0.5 

Example 9

Meltable Comprising Taurine, Caffeine, and Vitamin C.

[0273] A composition according to an embodiment of the present disclosure in meltable form was prepared from a composition containing a filler, a lipid, a mixture of taurine, caffeine, and vitamin C as the active ingredient, and additional components as disclosed herein (salt, sweeteners, flavoring agent, buffer, emulsifier) using the method of Example 7. The ingredients of the composition and their concentrations in the composition in weight % are provided in Table 9. The melts each weighed 1300 mg.

TABLE-US-00009 TABLE 9 Meltable ingredients Ingredient % w/w isomalt 35-55 lipid (e.g., palm oil) 35-50 taurine 3.5-4.5 caffeine 2.5-3.5 trisodium citrate .sup. 1-2.5 vitamin C 3.5-4.5 salt 0.5-1.5 sweetener 0.05-0.5  sunflower lecithin 0.3-0.5 flavor 0.5-1.5 Sunflower oil 2.5-3.5 colorant 0.4-0.6