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Details for Patent: 7,449,175

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Details for Patent: 7,449,175

Title:Delivery of erectile dysfunction drugs through an inhalation route
Abstract: The present invention relates to the delivery of erectile dysfunction drugs through an inhalation route. Specifically, it relates to aerosols containing erectile dysfunction drugs that are used in inhalation therapy. In a method aspect of the present invention, an erectile dysfunction drug is delivered to a patient through an inhalation route. The method comprises: a) heating a thin film of an erectile dysfunction drug, on a solid support, to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% erectile dysfunction drug degradation products. In a kit aspect of the present invention, a kit for delivering an erectile dysfunction drug through an inhalation route is provided which comprises: a) a thin film of an erectile dysfunction drug composition and b) a device for dispensing said thin film as a condensation aerosol.
Inventor(s): Rabinowitz; Joshua D (Princeton, NJ), Zaffaroni; Alejandro C (Atherton, CA)
Assignee: Alexza Pharmaceuticals, Inc. (Mountain View, CA)
Filing Date:Jul 05, 2006
Application Number:11/481,279
Claims:1. A condensation aerosol for delivery of sildenafil formed by heating a composition containing sildenafil coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of sildenafil and less than 5 percent by weight of sildenafil degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

2. The condensation aerosol according to claim 1, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

3. The condensation aerosol according to claim 1 or claim 2, wherein the geometric standard deviation around the MMAD is less than 3.0.

4. A condensation aerosol for delivery of tadalafil formed by heating a composition containing tadalafil coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of tadalafil and less than 5 percent by weight of tadalafil degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

5. The condensation aerosol according to claim 4, wherein the condensation aerosol has an MMAD 0.2 to 3 microns.

6. The condensation aerosol according to claim 4 or claim 5, wherein the geometric standard deviation around the MMAD is less than 3.0.

7. A condensation aerosol for delivery of vardenafil formed by heating a composition containing vardenafil coated on a solid support to form a vapor and condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise at least 10 percent by weight of vardenafil and less than 5 percent by weight of vardenafil degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

8. The condensation aerosol according to claim 7, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

9. The condensation aerosol according to claim 7 or claim 8, wherein the geometric standard deviation around the MMAD is less than 3.0.

10. A method of forming a sildenafil containing aerosol comprising: (a) heating a composition containing sildenafil coated on a solid support to form a vapor; and (b) condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise less than 5 percent by weight of sildenafil degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

11. The method according to claim 10, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

12. The method according to claim 11, wherein the coated composition comprises at least 10 percent by weight of sildenafil.

13. A method of forming a tadalafil containing aerosol comprising: (a) heating a composition containing tadalafil coated on a solid support to form a vapor; and (b) condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise less than 5 percent by weight of tadalafil degradation product, and the condensation aerosol has an MMAD of less than 5 microns.

14. The method according to claim 13, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

15. The method according to claim 14, wherein the coated composition comprises at least 10 percent by weight of tadalafil.

16. A method of forming a vardenafil containing aerosol comprising: (a) heating a composition containing vardenafil coated on a solid support to form a vapor; and (b) condensing the vapor to form a condensation aerosol comprising particles, wherein the particles comprise less than 5 percent by weight of vardenafil degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

17. The method according to claim 16, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

18. The method according to claim 17, wherein the coated composition comprises at least 10 percent by weight of vardenafil.

19. A method of forming a drug containing aerosol comprising: (a) heating a composition containing the drug and a pharmaceutically acceptable excipient coated on a solid support to form a vapor; and (b) condensing the vapor to form a condensation aerosol comprising particles, wherein the drug is selected from the group consisting of sildenafil, tadalafil, and vardenafil, and wherein the particles comprise at least 10 percent by weight of the drug and less than 5 percent by weight of the drug degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

20. The method according to claim 19, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

21. The method according to claim 20, wherein the coated composition comprises at least 10 percent by weight of the drug.

22. A method of forming a drug containing aerosol comprising: (a) heating a composition containing a salt form of the drug coated on a solid support to form a vapor; and (b) condensing the vapor to form a condensation aerosol comprising particles, wherein the drug is selected from the group consisting of sildenafil, tadalafil, and vardenafil, and wherein the particles comprise at least 10 percent by weight of the drug and less than 5 percent by weight of the drug degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

23. The method according to claim 22, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

24. The method according to claim 23, wherein the coated composition comprises at least 10 percent by weight of the salt form of the drug.

25. The condensation aerosol according to claim 2, wherein the condensing comprises allowing the vapor to cool.

26. The condensation aerosol according to claim 5, wherein the condensing comprises allowing the vapor to cool.

27. The condensation aerosol according to claim 8, wherein the condensing comprises allowing the vapor to cool.

28. The method according to claim 11, wherein the condensing comprises allowing the vapor to cool.

29. The method according to claim 14, wherein the condensing comprises allowing the vapor to cool.

30. The method according to claim 17, wherein the condensing comprises allowing the vapor to cool.

31. The method according to claim 20, wherein the condensing comprises allowing the vapor to cool.

32. The method according to claim 23, wherein the condensing comprises allowing the vapor to cool.

33. A method of forming a drug containing aerosol comprising: (a) heating a composition containing the drug coated on a solid support to form a vapor, and (b) condensing the vapor to form a condensation aerosol comprising particles, wherein the drug is selected from the group consisting of sildenafil, tadalafil, and vardenafil, wherein the condensation aerosol is formed at a rate greater than 0.5 mg/second, and wherein the particles comprise at least 10 percent by weight of the drug and less than 5 percent by weight of the drug degradation products, and the condensation aerosol has an MMAD of less than 5 microns.

34. The method according to claim 33, wherein the condensation aerosol has an MMAD of 0.2 to 3 microns.

35. The method according to claim 34, wherein the condensation aerosol is formed at a rate greater than 0.75 mg/second.

36. The method according to claim 35, wherein the condensation aerosol is formed at a rate greater than 1 mg/second.

37. The method according to claim 36, wherein the condensation aerosol is formed at a rate greater than 2 mg/second.

38. The method according to claim 34, wherein the condensing comprises allowing the vapor to cool.
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