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Details for Patent: 5,693,676

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Details for Patent: 5,693,676

Title: Nitric oxide donor composition and method for treatment of anal disorders
Abstract:A pharmaceutical composition contains a nitric oxide donor and advantageously an optional corticosteroid and/or topical anesthetic. The composition is useful in a method for treating anal disorders such as anal fissure, anal ulcer, hemorrhoidal disease, levator spasm, and so forth, by topical application to or proximate the affected area.
Inventor(s): Gorfine; Stephen R. (New York, NY)
Assignee: Neptune Pharmaceutical Corporation (Kansas City, MO)
Filing Date:Jun 20, 1996
Application Number:08/666,264
Claims:1. A method for treating an anal disease comprising contacting an appropriate anal area with a composition comprising an effective amount of nitroglycerin.

2. The method as set forth in claim 1, wherein the nitroglycerin is present in the composition in an amount of from about 0.01 to about 5% by weight.

3. A method for treating an anal disease comprising contacting an appropriate anal area with an effective mount of nitric oxide delivered by release from a composition comprising an organic nitric oxide donor, wherein at least one agent selected from the group consisting of a corticosteroid and a topical anesthetic is employed in conjunction with the nitric oxide donor.

4. The method as set forth in claim 3, wherein the organic nitric oxide donor is present in the composition in an amount from about 0.01 to about 5 percent by weight.

5. The method of claim 3, wherein at least one agent selected from the group consisting of a corticosteroid and a topical anesthetic is employed in conjunction with the nitric oxide donor.

6. The method of claim 5, wherein the corticosteroid is hydrocortisone, and the topical anesthetic is dibucaine.

7. A method for treating an anal disease and controlling pain associated therewith comprising contacting an appropriate anal area with an effective amount of nitric oxide.

8. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising an organic nitric oxide donor.

9. The method as set forth in claim 8, wherein the organic nitric oxide donor is present in the composition in an amount of from about 0.01 to about 10% by weight.

10. The method as set forth in claim 9, wherein the organic nitric oxide donor is an organic nitrate represented by the following general formula:

wherein:

R, R' and R" are, independently at each occurrence, organic or hydro moiety or covalent bond, and

x is an integer from 1 to about 12.

11. The method as set forth in claim 10, wherein

R is a 2 to about 12 carbon hydrocarbon or oxygen-substituted hydrocarbon;

R' is of 2 to 6 carbons and from 0 to 2 oxygen(s), a hydro moiety or a covalent bond;

R" is a hydro moiety; and

x is from 2 to 6.

12. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of one or more of ethylene glycol dinitrate, isopropyl nitrate, glyceryl-1-mononitrate, glyceryl-1,2-dinitrate, glyceryl-1,3-dinitrate, nitroglycerin, butane-1,2,4-triol-trinitrate, erythrityl tetranitrate, pentaerythrityl tetranitrate, isosorbide mononitrate, and isosorbide dinitrate.

13. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of nitroglycerin.

14. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 5% by weight nitroglycerin.

15. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of isosorbide dinitrate.

16. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 7.5% isosorbide dinitrate.

17. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of erythrityl tetranitrate.

18. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight erythrityl tetranitrate.

19. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of pentaerythrityl tetranitrate.

20. The method as set forth in claim 7, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight pentaerythrityl tetranitrate.

21. A method for treating an anal fissure or anal ulcer comprising contacting an appropriate anal area with an effective amount of nitric oxide.

22. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising an organic nitric oxide donor.

23. The method as set forth in claim 22, wherein the organic nitric oxide donor is present in the composition in an amount of from about 0.01 to about 10% by weight.

24. The method as set forth in claim 23, wherein the organic nitric oxide donor is an organic nitrate represented by the following general formula:

wherein:

R, R' and R" are, independently at each occurrence, organic or hydro moiety or covalent bond, and

x is an integer from 1 to about 12.

25. The method as set forth in claim 24, wherein

R is a 2 to about 12 carbon hydrocarbon or oxygen-substituted hydrocarbon;

R' is of 2 to 6 carbons and from 0 to 2 oxygen(s), a hydro moiety or a covalent bond;

R" is a hydro moiety; and

x is from 2 to 6.

26. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising an effective mount of one or more of ethylene glycol dinitrate, isopropyl nitrate, glyceryl-1-mononitrate, glyceryl-1,2-dinitrate, glyceryl-1,3-dinitrate, nitroglycerin, butane-1,2,4-triol-trinitrate, erythrityl tetranitrate, pentaerythrityl tetranitrate, isosorbide mononitrate, and isosorbide dinitrate.

27. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of nitroglycerin.

28. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 5% by weight nitroglycerin.

29. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of isosorbide dinitrate.

30. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 7.5% isosorbide dinitrate.

31. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of erythrityl tetranitrate.

32. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight erythrityl tetranitrate.

33. The method as Set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of pentaerythrityl tetranitrate.

34. The method as set forth in claim 21, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight pentaerythrityl tetranitrate.

35. A method for treating hemorrhoid disease comprising contacting an appropriate anal area with an effective amount of nitric oxide.

36. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising an organic nitric oxide donor.

37. The method as set forth in claim 36, wherein the organic nitric oxide donor is present in the composition in an amount of from about 0.01 to about 10% by weight.

38. The method as set forth in claim 37, wherein the organic nitric oxide donor is an organic nitrate represented by the following general formula:

wherein:

R, R' and R" are, independently at each occurrence, organic or hydro moiety or covalent bond, and

x is an integer from 1 to about 12.

39. The method as set forth in claim 38, wherein

R is a 2 to about 12 carbon hydrocarbon or oxygen-substituted hydrocarbon;

R' is of 2 to 6 carbons and from 0 to 2 oxygen(s), a hydro moiety or a covalent bond;

R" is a hydro moiety; and

x is from 2 to 6.

40. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of one or more of ethylene glycol dinitrate, isopropyl nitrate, glyceryl-1-mononitrate, glyceryl-1,2-dinitrate, glyceryl-1,3-dinitrate, nitroglycerin, butane-1,2,4-triol-trinitrate, erythrityl tetranitrate, pentaerythrityl tetranitrate, isosorbide mononitrate, and isosorbide dinitrate.

41. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising an effective mount of nitroglycerin.

42. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 5% by weight nitroglycerin.

43. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of isosorbide dinitrate.

44. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 7.5% isosorbide dinitrate.

45. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of erythrityl tetranitrate.

46. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight erythrityl tetranitrate.

47. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising an effective mount of pentaerythrityl tetranitrate.

48. The method as set forth in claim 35, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight pentaerythrityl tetranitrate.

49. A method for treating levator spasm comprising contacting an appropriate anal area with an effective amount of nitric oxide.

50. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising an organic nitric oxide donor.

51. The method as set forth in claim 50, wherein the organic nitric oxide donor is present in the composition in an amount of from about 0.01 to about 10% by weight.

52. The method as set forth in claim 51, wherein the organic nitric oxide donor is an organic nitrate represented by the following general formula:

wherein:

R, R' and R" are, independently at each occurrence, organic or hydro moiety or covalent bond, and

x is an integer from 1 to about 12.

53. The method as set forth in claim 52, wherein

R is a 2 to about 12 carbon hydrocarbon or oxygen-substituted hydrocarbon;

R' is of 2 to 6 carbons and from 0 to 2 oxygen(s), a hydro moiety or a covalent bond;

R" is a hydro moiety; and

x is from 2 to 6.

54. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of one or more of ethylene glycol dinitrate, isopropyl nitrate, glyceryl-1-mononitrate, glyceryl-1,2-dinitrate, glyceryl-1,3-dinitrate, nitroglycerin, butane-1,2,4-triol-trinitrate, erythrityl tetranitrate, pentaerythrityl tetranitrate, isosorbide mononitrate, and isosorbide dinitrate.

55. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of nitroglycerin.

56. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 5% by weight nitroglycerin.

57. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of isosorbide dinitrate.

58. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 7.5% isosorbide dinitrate.

59. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of erythrityl tetranitrate.

60. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight erythrityl tetranitrate.

61. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising an effective amount of pentaerythrityl tetranitrate.

62. The method as set forth in claim 49, wherein the nitric oxide is delivered by release from a composition comprising from about 0.01 to about 4% by weight pentaerythrityl tetranitrate.
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