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Details for Patent: 7,087,216

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Details for Patent: 7,087,216

Title:Delivery of sedative-hypnotics through an inhalation route
Abstract: The present invention relates to the delivery of sedative-hypnotics through an inhalation route. Specifically, it relates to aerosols containing sedative-hypnotics that are used in inhalation therapy. In a method aspect of the present invention, a sedative-hypnotic drug is administered to a patient through an inhalation route. The method comprises: a) heating a thin layer of a sedative-hypnotic, on a solid support, to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% sedative-hypnotic drug degradation products. In a kit aspect of the present invention, a kit for delivering a sedative-hypnotic through an inhalation route is provided which comprises: a) a thin layer of a sedative-hypnotic drug and b) a device for dispensing said thin layer a sedative-hypnotic drug as a condensation aerosol.
Inventor(s): Rabinowitz; Joshua D. (Mountain View, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee:
Filing Date:Jan 27, 2004
Application Number:10/766,149
Claims:1. A condensation aerosol for delivery of a drug selected from the group consisting of zaleplon, zolpidem and zopiclone, wherein the condensation aerosol is formed by heating a thin layer containing the drug, on a solid support, to produce a vapor of the drug, and condensing the vapor to form a condensation aerosol characterized by less than 10% drug degradation products by weight, and an MMAD of less than 5 microns.

2. The condensation aerosol according to claim 1, wherein the condensation aerosol is formed at a rate greater than 10.sup.9 particles per second.

3. The condensation aerosol according to claim 2, wherein the condensation aerosol is formed at a rate greater than 10.sup.10 particles per second.

4. A method of producing a drug selected from the group consisting of zaleplon, zolpidem and zopiclone in an aerosol form comprising: a. heating a thin layer containing the drug, on a solid support, to produce a vapor of the drug, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 10% drug degradation products, and an MMAD of less than 5 microns.

5. The method according to claim 4, wherein the condensation aerosol is formed at a rate greater than 10.sup.9 particles per second.

6. The method according to claim 5, wherein the condensation aerosol is formed at a rate greater than 10.sup.10 particles per second.

7. The condensation aerosol according to claim 1, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns.

8. The condensation aerosol according to claim 1, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.

9. The condensation aerosol according to claim 7, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns.

10. The condensation aerosol according to claim 1, wherein the condensation aerosol is characterized by less than 5% drug degradation products by weight.

11. The condensation aerosol according to claim 10, wherein the condensation aerosol is characterized by less than 2.5% drug degradation products by weight.

12. The condensation aerosol according to claim 1, wherein the solid support is a metal foil.

13. The condensation aerosol according to claim 1, wherein the thin layer has a thickness between 1.5 and 4.4 microns.

14. The condensation aerosol according to claim 1, wherein the drug is zaleplon.

15. The condensation aerosol according to claim 1, wherein the drug is zolpidem.

16. The condensation aerosol according to claim 1, wherein the drug is zopiclone.

17. The method according to claim 4, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns.

18. The method according to claim 4, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.

19. The method according to claim 4, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns.

20. The method according to claim 4, wherein the condensation aerosol is characterized by less than 5% drug degradation products by weight.

21. The method according to claim 20, wherein the condensation aerosol is characterized by less than 2.5% drug degradation products by weight.

22. The method according to claim 4, wherein the solid support is a metal foil.

23. The method according to claim 1, wherein the thin layer has a thickness between 1.5 and 4.4 microns.

24. The method according to claim 4, wherein the drug is zaleplon.

25. The method according to claim 4, wherein the drug is zolpidem.

26. The method according to claim 4, wherein the drug is zopiclone.

27. A condensation aerosol for delivery of zaleplon, wherein the condensation aerosol is formed by heating a thin layer containing zaleplon, on a solid support, to produce a vapor of zaleplon, and condensing the vapor to form a condensation aerosol characterized by less than 5% zaleplon degradation products by weight, and an MMAD of about 0.2 to 3 microns.

28. A condensation aerosol for delivery of zolpidem, wherein the condensation aerosol is formed by heating a thin layer containing zolpidem, on a solid support, to produce a vapor of zolpidem, and condensing the vapor to form a condensation aerosol characterized by less than 5% zolpidem degradation products by weight, and an MMAD of about 0.2 to 3 microns.

29. A condensation aerosol for delivery of zopiclone, wherein the condensation aerosol is formed by heating a thin layer containing zopiclone, on a solid support, to produce a vapor of zopiclone, and condensing the vapor to form a condensation aerosol characterized by less than 5% zopiclone degradation products by weight, and an MMAD of about 0.2 to 3 microns.

30. A method of producing zaleplon in an aerosol form comprising: a. heating a thin layer containing zaleplon, on a solid support, to produce a vapor of zaleplon, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% zaleplon degradation products by weight, and an MMAD of about 0.2 to 3 microns.

31. A method of producing zolpidem in an aerosol form comprising: a. heating a thin layer containing zolpidem, on a solid support, to produce a vapor of zolpidem, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% zolpidem degradation products by weight, and an MMAD of about 0.2 to 3 microns.

32. A method of producing zopiclone in an aerosol form comprising: a. heating a thin layer containing zopiclone, on a solid support, to produce a vapor of zopiclone, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% zopiclone degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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