Method and compositions for treating impotence

• US 6,056,966 A
• Filed: 05/18/1998
• Issued: 05/02/2000
• Est. Priority Date: 05/18/1998
• Status: Expired due to Fees

• Current Assignee: Baker Norton Pharmaceuticals Inc.
• Original Assignee: Baker Norton Pharmaceuticals Inc.
• Inventors: Bauer, John A., Testman, Robert, Fung, Ho-Leung, Selim, Sami
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): WARE, TODD
• Application Number:
  US09/081,108
• Time in Patent Office: 715 Days
• Field of Search: 514/659, 514/663, 514/645, 514/968, 514/969, 514/401, 424/481, 424/45, 424/449, 424/443, 424/434, 424/422
• US Class Current: 424/401
• CPC Class Codes: A61K 31/04 Nitro compounds
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61P 15/00 Drugs for genital or sexual disorders for disorders of sex hormones A61P5/24; Contraceptives
• CPC Class Codes: A61P 15/10 for impotence

Abstract

Pharmaceutical compositions in topical or parenteral form containing specific organic mono- or dinitrates, some of them novel compounds, are effective in treating male impotence and erectile dysfunction through topical or intracavernosal administration to the penis. Methods of treatment utilizing the mono- or dinitrate-containing compositions are also disclosed.

Claims

1. A pharmaceutical composition for the treatment of male impotence or erectile dysfunction comprising an organic mono- or dinitrate in a pharmaceutically acceptable topical or parenteral carrier, said mono- or dinitrate being selected from the group consisting of 1,5-pentane dinitrate, 1,4-butane dinitrate, 1,6-hexane dinitrate, 1,7-heptane dinitrate, isoamyl nitrate, isobutyl nitrate, neopentyl nitrate, cyclopentyl nitrate, 2-pentane nitrate, 1-pentene-5-nitrate, and 2-methyl-2-butene-4-nitrate, wherein said organo mono- or dinitrate is present in an amount effective to treat impotence or erectile disfunction.

2. A composition according to claim 1 wherein said carrier is a topical carrier.

3. A composition according to claim 2 wherein said topical carrier is selected from the group consisting of ointments, gels, creams, lotions, liquids, sprays, patches and tapes.

4. A composition according to claim 2 wherein said topical carrier is an ointment.

5. A composition according to claim 2 which comprises sufficient organic mono- or dinitrate to provide about 0.1 mg-40 mg of nitrate per dose applied to the penis.

6. A composition according to claim 5 which comprises about 15 mg of mono-or dinitrate per dose.

7. A composition according to claim 5 wherein said dose comprises about 50-800 mg of topical composition.

8. A composition according to claim 1 wherein said carrier is a parenteral carrier.

9. A composition according to claim 8 wherein said carrier includes a non-aqueous solvent or diluent.

10. A composition according to claim 9 wherein said solvent or diluent is ethanol, benzyl alcohol or propylene glycol.

11. A composition according to claim 8 which contains sufficient mono- or dinitrate to provide about 0.01-1.0 mg of dinitrate per dose injected into the penis.

12. A composition according to claim 11 wherein said dose comprises about 0.1-0.5 ml of parenteral composition.

13. A composition according to claim 1 comprising 1,5-pentane dinitrate.

14. A method of treating male impotence or erectile dysfunction in humans by local administration to the penis of a pharmaceutical composition comprising an organic mono- or dinitrate in a pharmaceutically acceptable topical or parenteral carrier, said mono- or dinitrate being selected from the group consisting of 1,5-pentane dinitrate, 1,4-butane dinitrate, 1,6-hexane dinitrate, 1,7-heptane dinitrate, isoamyl nitrate, isobutyl nitrate, neopentyl nitrate, cyclopentyl nitrate, 2-pentane nitrate, 1-pentene-5-nitrate, and 2-methyl-2-butene-4-nitrate, wherein said organo mono- or dinitrate is present in an amount effective to treat impotence or erectile disfunction.

15. A method according to claim 14 wherein said composition is administered by topical application or intracavernosal injection.

16. A method according to claim 15 wherein said composition is applied topically to the penis.

17. A method according to claim 16 wherein said carrier is a topical carrier.

18. A method according to claim 17 wherein said topical carrier is selected from the group consisting of ointments, gels, creams, lotions, liquids, sprays, patches and tapes.

19. A method according to claim 16 wherein said topical carrier is an ointment.

20. A method according to claim 16 wherein said composition contains sufficient organic mono- or dinitrate to provide about 0.1-40 mg of dinitrate per dose applied to the penis.

21. A method according to claim 20 wherein said composition comprises about 15 mg of mono- or dinitrate per dose.

22. A method according to claim 20 wherein said dose comprises about 50-800 mg of topical composition.

23. A method according to claim 14 wherein said composition is injected intracavernosally.

24. A method according to claim 23 wherein said carrier is a parenteral carrier.

25. A method according to claim 24 wherein said carrier is a non-aqueous solvent or diluent.

26. A method according to claim 25 wherein said solvent or diluent is ethanol or propylene glycol.

27. A method according to claim 23 wherein said composition comprises sufficient organic mono- or dinitrate to provide about 0.01-1.0 mg of nitrate per injectable dose.

28. A method according to claim 27 wherein said composition comprises about 0.1-0.5 ml of parenteral composition.

29. A method according to claim 14 wherein said composition comprises 1,5-pentane dinitrate.