Dental composition comprising chelator and base

• US 10,117,823 B2
• Filed: 03/12/2014
• Issued: 11/06/2018
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Primal Therapies, Inc.
• Original Assignee: Primal Therapies, Inc.
• Inventors: Stein, Emily A.
• Primary Examiner(s): Liu, Tracy
• Application Number:
  US14/775,959
• Publication Number:
  US 20160030327A1
• Time in Patent Office: 1,700 Days
• CPC Class Codes: A61K 2800/51 Chelating agents
• CPC Class Codes: A61K 2800/592 Mixtures of compounds complementing their respective functions
• CPC Class Codes: A61K 8/11 Encapsulated compositions
• CPC Class Codes: A61K 8/19 containing inorganic ingredients
• CPC Class Codes: A61K 8/365 Hydroxycarboxylic acids; Ketocarboxylic acids
• CPC Class Codes: A61K 8/41 Amines
• CPC Class Codes: A61K 8/44 Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
• CPC Class Codes: A61K 8/4926 having six membered rings
• CPC Class Codes: A61K 8/55 Phosphorus compounds
• CPC Class Codes: A61K 8/64 Proteins; Peptides; Derivatives or degradation products thereof
• CPC Class Codes: A61K 8/66 Enzymes
• CPC Class Codes: A61K 8/67 Vitamins
• CPC Class Codes: A61K 8/676 Ascorbic acid, i.e. vitamin C
• CPC Class Codes: A61K 8/73 Polysaccharides
• CPC Class Codes: A61K 8/738 Cyclodextrins
• CPC Class Codes: A61K 9/0063 Periodont
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61Q 11/00 Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
• CPC Class Codes: A61Q 17/005 : Antimicrobial preparations
• CPC Class Codes: A61Q 19/00 : Preparations for care of the skin

Abstract

Non-toxic consumable compositions and formulations having chelator and base are disclosed with synergistic effects on microbial metabolism and/or growth and/or pathogenic effectors and their use to promote and maintain health in mammals. The non-toxic consumable compositions have more than one chelator and/or more than one base. Methods for selecting said chelator and base composition and methods for detecting conditions in which selected compositions may be used are also disclosed. The synergistic compositions and methods can be used for maintaining health, promoting health and treating diseases.

Claims

1. A solid dosage form comprising a cyclodextrin and base, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

2. The solid dosage form of claim 1, wherein the amount of the cyclodextrin is between 0.0005% and 30% of the solid dosage form.

3. The solid dosage form of claim 1, wherein the amount of base is between 0.0001% and 15% of the solid dosage form.

4. The solid dosage form of claim 1, further comprising an enhancer.

5. The solid dosage form of claim 4, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the amount is between 0.0001% and 10% of the solid dosage form.

6. The solid dosage form of claim 1, wherein the solid dosage form is for oral care.

7. The solid dosage form of claim 1, wherein the solid dosage form is formulated in a tablet, powder, paste, deodorant, anti-perspirant, capsule, rapid melt tablet, thin strip, or gum.

8. The solid dosage form of claim 1, wherein the solid dosage form is formulated for administration at least once per day.

9. The solid dosage form of claim 1, wherein the solid dosage form is used to promote oral health.

10. The solid dosage form of claim 1, wherein the solid dosage form is for use following consumption of a phosphoric acid or ascorbic acid containing beverage.

11. The solid dosage form of claim 1, wherein the solid dosage form is for use following consumption of food.

13. The solid dosage form of claim 1, wherein the cyclodextrin and base are formulated for contact with a biological surface.

14. The solid dosage form of claim 1, further comprising arginine or a polyarginine.

15. The solid dosage form of claim 1, wherein the solid dosage form has a pH range of approximately 4.2 to 7.2.

35. The solid dosage form of claim 1, wherein the cyclodextrin and base are formulated for contact with an inanimate surface.

36. The solid dosage form of claim 35, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

37. The solid dosage form of claim 13, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

38. The solid dosage form of claim 1, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

39. The solid dosage form of claim 5, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

40. The solid dosage form of claim 1, wherein the solid dosage form has a pH range of approximately 6 to 9.

12. A method of promoting oral health in a mammal comprising:

identifying an individual at increased risk for developing or exhibiting signs of oral disease;

measuring pH, leukocyte esterase, nitrate, microbial marker levels, or plaque-staining dye retention in the mouth of the individual;

comparing said levels to healthy levels to determine if oral pathology is present; and

contacting an effective amount of a solid dosage form comprising a cyclodextrin and base, to an oral surface if evidence of oral pathology is present, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

16. A method of reducing pathogenic microbial activity, the method comprising:

contacting an effective amount of a solid dosage form comprising a cyclodextrin and base with a surface, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

17. The method of claim 16, wherein the surface is a biological surface.

18. The method of claim 17, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

19. The method of claim 16, wherein the surface is an inanimate surface.

20. The method of claim 19, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

21. The method of claim 16, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

22. The method of claim 16, wherein the solid dosage form further comprises an enhancer.

23. The method claim 22, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the amount is between 0.0001% and 10% of the solid composition.

24. The method of claim 22, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

25. A method of promoting oral health in an individual comprising administering an effective amount of a solid dosage form comprising a cyclodextrin and base to the individual, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and is present at about 50 ng to about 1,000 mg per dose, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and is present at about 50 ng to about 1,000 mg per dose.

26. The method of claim 25, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

27. The method of claim 25, wherein the individual has one or more of halitosis, tooth plaque, tooth decay, periodontitis, gingivitis and cavity.

28. The method of claim 25, wherein the solid dosage form further comprises an enhancer.

29. The method of claim 28, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the amount of the enhancer is between 0.0001% and 10% of the solid dosage form.

30. The method of claim 28, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

31. The method of claim 25, wherein the solid dosage form has a pH range of approximately 4.2 to 7.2.

32. The method of claim 25, wherein the solid dosage form has a pH range of approximately 6 to 9.

33. The method of claim 25, wherein the solid dosage form is administered following consumption of a phosphoric acid or ascorbic acid containing beverage.

34. The method of claim 25, wherein the solid dosage form is administered following consumption of food.

41. A liquid composition comprising a cyclodextrin and base, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.

42. The liquid composition of claim 41, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

43. The liquid composition of claim 41, wherein the concentration of the cyclodextrin is between 0.0005% and 30% of the liquid composition.

44. The liquid composition of claim 41, wherein the concentration of base is between 0.0001% and 15% of the liquid composition.

45. The liquid composition of claim 41, further comprising an enhancer.

46. The liquid composition of claim 45, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the concentration is between 0.0001% and 10% of the liquid composition.

47. The liquid composition of claim 45, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

48. The liquid composition of claim 41, wherein the liquid composition is for oral care.

49. The liquid composition of claim 41, wherein the liquid composition is formulated as a spray, deodorant, anti-perspirant, cream, gel, concentrate, wipe, or wash.

50. The liquid composition of claim 49, wherein the wash is a mouthwash.

51. The liquid composition of claim 41, wherein the liquid composition has a pH range of approximately 4.2 to 7.2.

52. The liquid composition of claim 41, wherein the liquid composition has a pH range of approximately 6 to 9.

53. The liquid composition of claim 41, wherein the cyclodextrin and base are formulated for contact with a biological surface.

54. The liquid composition of claim 53, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

55. The liquid composition of claim 41, wherein the cyclodextrin and base are formulated for contact with an inanimate surface.

56. The liquid composition of claim 55, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

57. A method of reducing pathogenic microbial activity, the method comprising contacting an effective amount of a liquid composition comprising a cyclodextrin and base with a surface, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.

58. The method of claim 57, wherein the surface is a biological surface.

59. The method of claim 58, wherein the biological surface is selected from the group consisting of food, dermal surfaces, tooth surfaces, and mucosal surfaces.

60. The method of claim 57, wherein the surface is an inanimate surface.

61. The method of claim 60, wherein the inanimate surface is selected from the group consisting of floors, counters, utensils, tools, and handles.

62. The method of claim 57, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

63. The method of claim 57, wherein the liquid composition further comprises an enhancer.

64. The method of claim 63, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the concentration is between 0.0001% and 10% of the liquid composition.

65. The method of claim 63, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

66. A method of promoting oral health in an individual comprising administering an effective amount of a liquid composition comprising a cyclodextrin and base to the individual, wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, and wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.

67. The method of claim 66, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

68. The method of claim 66, wherein the individual has one or more of halitosis, tooth plaque, tooth decay, periodontitis, gingivitis and cavity.

69. The method of claim 66, wherein the liquid composition further comprises an enhancer.

70. The method of claim 69, wherein the enhancer is proline, phenylalanine, boric acid, ascorbic acid, sugar alcohols, or extracts from citrus, berries, teas, peppermint, mint or cinnamon and the concentration is between 0.0001% and 10% of the liquid composition.

71. The method of claim 69, wherein the base further comprises sodium bicarbonate, arginine, or a combination thereof.

72. The method of claim 66, wherein the liquid composition has a pH range of approximately 4.2 to 7.2.

73. The method of claim 66, wherein the liquid composition has a pH range of approximately 6 to 9.

74. The method of claim 66, wherein the liquid composition is administered following consumption of a phosphoric acid or ascorbic acid containing beverage.

75. The method of claim 66, wherein the liquid composition is administered following consumption of food.

76. A method of promoting oral health in a mammal comprising:

identifying an individual at increased risk for developing or exhibiting signs of oral disease;

measuring pH, leukocyte esterase, nitrate, microbial marker levels, or plaque-staining dye retention in the mouth of the individual;

comparing said levels to healthy levels to determine if oral pathology is present; and

contacting an effective amount of a liquid composition comprising a cyclodextrin and base to an oral surface if evidence of oral pathology is present, and wherein the cyclodextrin and base are active ingredients that reduce pathogenic microbial activity, wherein the base comprises pyridoxal-5-phosphate and has a concentration of about 750 pM to about 250 mM, and wherein the cyclodextrin is alpha, beta, or gamma cyclodextrin and has a concentration of about 0.1 nM to about 500 mM.