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Details for Patent: 5,504,117

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Details for Patent: 5,504,117

Title: Pharmacologic preparation for the treatment of anal disorders
Abstract:A medical preparation for treating anal disorders comprises an effective amount of a nitric oxide donor, preferably an organic nitrate. The preparation may be in the form of an ointment that is applied to affected tissue at least once daily.
Inventor(s): Gorfine; Stephen R. (New York, NY)
Assignee: Neptune Pharmaceutical Corporation (Kansas City, MO)
Filing Date:May 27, 1994
Application Number:08/250,555
Claims:1. A method of treating an anal fissure present in an anal canal of a patient, comprising topically administering to the anal canal of the patient a preparation comprising an effective amount of a nitric oxide donor.

2. The method of claim 1, wherein the nitric oxide donor is an organic nitrate.

3. The method of claim 2, wherein the organic nitrate is selected from the group consisting of nitroglycerin, ethylene glycol dinitrate, glyceryl 1,2-dinitrate, glyceryl, 1,3-dinitrate, glyceryl 1-mononitrate, butane 1,2,4-triol trinitrate, mannitol hexanitrate, pentaerythrityl tetranitrate, pentaerythrityl trinitrate, isosorbide dinitrate, isosorbide mononitrate, and erythrityl tetranitrate.

4. The method of claim 3, wherein the organic nitrate is nitroglycerin.

5. The method of claim 1, wherein the preparation comprises from about 0.1% to 10% by weight of nitric oxide donor, based upon the total weight of the preparation.

6. The method of claim 1, wherein the preparation comprises an effective amount of a corticosteroid.

7. The method of claim 6, wherein the corticosteroid is hydrocortisone.

8. The method of claim 6, wherein the preparation comprises a corticosteroid in an amount of from about 0.5% to 2.5% by weight, based upon the total amount of the preparation.

9. The method of claim 1, wherein the preparation comprises an effective amount of a topical anesthetic.

10. The method of claim 9, wherein the topical anesthetic is dibucaine.

11. The method of claim 9, wherein the preparation is comprised of topical anesthetic in an amount of from about 0.5% to 2% by weight, based upon the total weight of the preparation.

12. The method of claim 1, wherein the preparation comprises one or more pharmaceutically acceptable carriers or excipients in admixture or otherwise in association with said nitric oxide donor.

13. The method of claim 12, wherein the exicipients comprise one or more excipients selected from the group consisting of white petrolatum, mineral oil, lanolin, distilled water, acetone sodium bisulfite, zinc oxide, and cocoa butter.

14. The method of claim 12, wherein the preparation is an ointment.

15. The method of claim 12, wherein the preparation is a suppository.

16. The method of claim 1, wherein the preparation is applied to the anal canal at least one time daily.

17. The method of claim 16, wherein the preparation is applied to the anal canal from 2 to 8 times daily.

18. A method of treating hemorrhoids present in an anal canal of a patient, comprising topically administering to the anal canal of the patient a preparation comprising an effective amount of a nitric oxide donor.

19. The method of claim 18, wherein said nitric oxide donor is selected from the group consisting of nitroglycerin, ethylene glycol dinitrate, glyceryl, 1,2-dinitrate, glyceryl 1,3-dinitrate, glyceryl 1-mononitrate, butane 1,2,4-triol trinitrate, mannitol hexanitrate, pentaerythrityl tetranitrate, pentaerythrityl trinitrate, isosorbide dinitrate, isosorbide mononitrate, and erythrityl tetranitrate.

20. The method of claim 18, wherein said nitric oxide donor is nitroglycerin in an amount of 0.01% to 5% by weight, based on the total weight of the preparation.

21. A method of treating an anal disorder selected from one or more of the group consisting of anal fissure, anal ulcer, hemorrhoidal disease, and levator spasm and ameliorating pain associated therewith, comprising topically administering to an anal canal of a patient having such a disorder a preparation comprising an effective amount of a preparation comprising an effective amount of a nitric oxide donor.

22. The method of claim 21, wherein said nitric oxide donor is selected from the group consisting of nitroglycerin, ethylene glycol dinitrate, glyceryl 1,2-dinitrate, glyceryl 1,3-dinitrate, glyceryl 1-mononitrate, butane 1,2,4-triol trinitrate, mannitol hexanitrate, pentaerythrityl tetranitrate, pentaerythrityl trinitrate, isosorbide dinitrate, isosorbide mononitrate, and erythrityl tetranitrate.

23. The method of claim 22, wherein said anal disorder is anal fissure or ulcer.

24. The method of claim 22, wherein said anal disorder is hemorrhoidal disease.

25. The method of claim 22, wherein said anal disorder is levator spasm.

26. The method of claim 21, wherein said nitric oxide donor is nitroglycerin in an amount of 0.01% to 5% by weight, based on the total weight of the preparation.
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