Preparations, Methods And Kits Useful For The Treatment of Cough

• US 20090130199A1
• Filed: 11/20/2008
• Published: 05/21/2009
• Est. Priority Date: 11/21/2007
• Status: Active Grant

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Williams, Kristin Rhedrick, Sargent, Jeffrey Alan, Kemp, Helen Rochelle, Jump, Mary Lynn, Kovacs, Stephen Andras
• Granted Patent: US 9,149,429 B2
• Time in Patent Office: Days
• US Class Current: 424/455
• CPC Class Codes: A61K 31/16 Amides, e.g. hydroxamic acids
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 11/14 Antitussive agents

Abstract

The invention relates to a respiratory preparation providing cough relief in a human comprising: a film forming agent; a thickening agent; and the respiratory preparation provides on demand relief. Additionally, the invention relates to a method of providing cough relief in a human comprising: the steps of administering to a human a respiratory preparation comprising: a film forming agent; a thickening agent; and wherein said respiratory preparation provides on demand cough relief as needed.

Claims

1. A respiratory preparation providing cough relief in a human comprising:

a) a film forming agent;

b) a thickening agent; and

wherein said respiratory preparation provides on demand relief.

2. The respiratory preparation of claim 1, comprising from about 0.01% to about 60% of said film forming agent, by weight of the respiratory preparation.

3. The respiratory preparation of claim 1, comprising from about 0.1% to about 40% of said film forming agent, by weight of the respiratory preparation.

4. The respiratory preparation of claim 1, wherein said film forming agent is selected from the group comprising polyethylene oxide, muco-adhesive compounds, muco-adhesive polymers, hydrating agents, fatty acid, surfactant, polyethylene glycol, pectin, carrageenan, whey protein, soy protein, micro-particulated whey protein, milk fat, vegetable fat, edible oil, fat, cocoa butter, tapioca starch, and combinations thereof.

5. The respiratory preparation of claim 4, wherein said film forming agent comprising polyethylene oxide, muco-adhesive polymers, muco-adhesive compounds, hydrating agents, and combinations thereof.

6. The respiratory preparation of claim 1, comprising from about 0.01% to about 15%, thickening agent, by weight of the preparation.

7. The respiratory preparation of claim 1, wherein said thickening agent is selected from the group comprising pregelatinized starch, pregelatinized high amylose content starch, pregelatinized hydrolyzed starches, chemically modified starches such as pregelatinized substituted starches locust bean gum, guar gum, gellan gum, xanthan gum, gum ghatti, modified gum ghatti, tragacanth gum, carrageenan, anionic polymers derived from cellulose such as carboxymethylcellulose (CMC), sodium carboxymethylcellulose, polaxamer, and mixtures thereof

8. The respiratory preparation of claim 1, further comprising from about 0.01% to about 30% of a benefit agent, by weight of the respiratory preparation.

9. The respiratory preparation of claim 8, comprising from about 0.02% to about 25% of said benefit agent, by weight of the respiratory preparation.

10. The respiratory preparation of claim 8, wherein said benefit agent is selected from the group comprising cooling agent, warming agent, flavoring agent, salivating agent, and combinations thereof.

11. The respiratory preparation of claim 1, having a viscosity from about 100 centipoise (cP) to about 600 cP.

12. The respiratory preparation of claim 1, having a density from about 0.5 grams/milliliter (g/ml) to about 5 g/ml.

13. The respiratory preparation of claim 1, having a surface tension from about 30 milliNewton/meter (mN/m) to about 90 mN/m.

14. The respiratory preparation of claim 1, further comprising at least one additional component selected from the group consisting of a tea extract, Vitamin A, Vitamin C, Vitamin B, Vitamin D, carotenoid, rosemary, rosemary extract, caffeic acid, coffee extract, tumeric extract, curcumin, blueberry extract, grapeseed extract, rosemaric acid, antioxidant, amino acid, enzyme, prebiotic, probiotic, andrographis extract, 1-tryptophan, Allium sativum, herbal remedies, vitamins, supplements, antioxidants, natural ingredients, minerals, energy boosting ingredients, sleep aids, immune system boosting agents, colorant, preservative, fragrance, flavorant, fruit extract, a salivating stimulator, and combinations thereof.

15. The respiratory preparation of claim 1, further comprising at least one optional ingredients selected from the group consisting of excipient, emulsifiers, topical analgesics, film formers, fragrance compounds, humectants, opacifying agents, plasticizers, propellants, reducing agents, solvents, foam boosters, stabilizers, hydrotropes, solubilizing agents, suspending agents (non-surfactant), a solvent, viscosity increasing agents (aqueous and non-aqueous), sequestrants, buffers, keratolytics, and the like, and combinations thereof.

16. The respiratory preparation of claim 1, wherein said respiratory preparation further comprising a sweetener.

17. The respiratory preparation of claim 16, wherein said sweetener comprises an artificial sweetener.

18. The respiratory preparation of claim 1, wherein said respiratory preparation is an oral composition.

19. The respiratory preparation of claim 18, wherein said oral composition is selected from the group consisting of liquid compositions, nasal compositions, beverage, supplemental water, pills, soft gels, tablets, capsules, gel compositions, foam compositions, and combinations thereof.

20. The respiratory preparation of claim 1, wherein said respiratory preparation is delivered to a site of treatment with a delivery device.

21. The respiratory preparation of claim 20, wherein said delivery device is selected from the group consisting of pump, spray, liquid dropper, cup, bottle, liquid filled gel, liquid filled gummy, center filled gum, chews, films, center filled lozenge, gum filled lozenge, liquid filled compressed tablet, liquid filled gelatin capsule, liquid filled capsule, squeezable sachets, power shots, and combinations thereof.

22. The respiratory preparation of claim 18, wherein said oral composition is administered at least once daily.

23. A method of providing cough relief and sore throat relief in a human comprising:

the steps of administering to a human a respiratory preparation comprising

a) a film forming agent;

b) a thickening agent; and

wherein said respiratory preparation provides on demand cough relief.

24. The method of claim 23, wherein said respiratory preparation is an oral composition.

25. The method of claim 24, wherein said oral composition is selected from the group consisting of liquid compositions, nasal compositions, beverage, supplemental water, pills, soft gels, tablets, capsules, gel compositions, foam compositions, and combinations thereof.

26. The method of claim 23, wherein said respiratory preparation is delivered to a site of treatment with a delivery device.

27. The method of claim 26, wherein said delivery device is selected from the group consisting of pump, spray, liquid dropper, cup, bottle, liquid filled gel, liquid filled gummy, center filled gum, chews, films, center filled lozenge, gum filled lozenge, liquid filled compressed tablet, liquid filled gelatin capsule, liquid filled capsule, squeezable sachets, power shots, and combinations thereof.

28. The method of claim 23, wherein said oral composition is administered at least once daily.

29. A kit comprising:

a delivery device and a respiratory preparation contained in said delivery device;

wherein said respiratory preparation comprising

a) a film forming agent;

b) a thickening agent; and

wherein said respiratory preparation provides on demand cough relief.

30. The kit of claim 29, further comprising a set of instructions.

31. A device comprising;

a respiratory preparation contained in said device;

wherein said respiratory composition comprises;

a) a film forming agent;

b) a thickening agent; and

wherein said device is a delivery device.

32. The device of claim 31, wherein said delivery device delivers said respiratory preparation to the site of treatment.

33. The device of claim 31, wherein said delivery device is selected from the group consisting of pump, spray, liquid dropper, cup, bottle, liquid filled gel, liquid filled gummy, center filled gum, chews, films, center filled lozenge, gum filled lozenge, liquid filled compressed tablet, liquid filled gelatin capsule, liquid filled capsule, squeezable sachets, power shots, and combinations thereof.

34. The device of claim 31, wherein said respiratory preparation is an oral composition.

35. The method of claim 34, wherein said oral composition is selected from the group consisting of liquid compositions, beverage, supplemental water, pills, soft gels, tablets, capsules, gel compositions, foam compositions, nasal compositions, and combinations thereof.

36. The device of claim 31, wherein said respiratory preparation provides on demand relief cough relief as needed.

37. A respiratory preparation providing cough relief in a human comprising:

a. a film forming agent;

b. a thickening agent; and

wherein said respiratory preparation having a viscosity from about 100 centipoise (cP) to about 600 cP.

38. The respiratory preparation of claim 37, having a viscosity from about 150 centipoise (cP) to about 400 cP.

39. The respiratory preparation of claim 37, having a viscosity from about 180 centipoise (cP) to about 300 cP.

40. The respiratory preparation of claim 37, comprising from about 0.1% to about 40% of said film forming agent, by weight of the respiratory preparation.

41. The respiratory preparation of claim 37, comprising from about 01% to about 15%, thickening agent, by weight of the preparation.

42. The respiratory preparation of claim 37, further comprising from about 0.01% to about 30% of a benefit agent, by weight of the respiratory preparation.

55. A method of providing cough relief and sore throat relief in a human comprising:

the steps of administration to a human a respiratory preparation from claim 37;

wherein said respiratory preparation provides on demand cough relief.

43. A respiratory preparation providing cough relief in a human comprising:

a. a film forming agent;

b. a thickening agent; and

wherein said respiratory preparation having a density from about 0.5 grams/milliliter (g/ml) to about 5 g/ml.

44. The respiratory preparation of claim 43, having a density from about 0.8 grams/milliliter (g/ml) to about 4 g/ml.

45. The respiratory preparation of claim 43, having a density from about 1.0 grams/milliliter (g/ml) to about 3 g/ml.

46. The respiratory preparation of claim 43, comprising from about 0.1% to about 40% of said film forming agent, by weight of the respiratory preparation.

47. The respiratory preparation of claim 43, comprising from about 01% to about 15%, thickening agent, by weight of the preparation.

48. The respiratory preparation of claim 43, further comprising from about 0.01% to about 30% of a benefit agent, by weight of the respiratory preparation.

56. A method of providing cough relief and sore throat relief in a human comprising:

the steps of administration to a human a respiratory preparation from claim 43;

wherein said respiratory preparation provides on demand cough relief.

49. A respiratory preparation providing cough relief in a human comprising:

a. a film forming agent;

b. a thickening agent; and

wherein said respiratory preparation having a surface tension from about 30 milliNewton/meter (mN/m) to about 90 mN/m.

50. The respiratory preparation of claim 49, having a surface tension from about 35 milliNewton/meter (mN/m) to about 80 mN/m.

51. The respiratory preparation of claim 49, having a surface tension from about 40 milliNewton/meter (mN/m) to about 75 mN/m.

52. The respiratory preparation of claim 49, comprising from about 1% to about 40% of said film forming agent, by weight of the respiratory preparation.

53. The respiratory preparation of claim 49, comprising from about 01% to about 15%, thickening agent, by weight of the preparation.

54. The respiratory preparation of claim 49, further comprising from about 0.01% to about 30% of a benefit agent, by weight of the respiratory preparation.

57. A method of providing cough relief and sore throat relief in a human comprising:

the steps of administration to a human a respiratory preparation from claim 49;

wherein said respiratory preparation provides on demand cough relief.