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Details for Patent: 7,087,218

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Details for Patent: 7,087,218

Title:Delivery of diazepam through an inhalation route
Abstract: The present invention relates to the delivery of compounds for the treatment of anxiety disorders and symptoms of such disorders through an inhalation route. Specifically, it relates to aerosols containing diazepam that are used in inhalation therapy. In a method aspect of the present invention, diazepam is administered to a patient through an inhalation route. The method comprises: a) heating a thin layer of diazepam on a solid support to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% drug degradation products. In a kit aspect of the present invention, a kit for delivering diazepam through an inhalation route is provided which comprises: a) a thin coating of a diazepam composition; and, b) a device for dispending said thin coating as a condensation aerosol.
Inventor(s): Rabinowitz; Joshua D. (Mountain View, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee: Alexza Pharmaceuticals, Inc. (Palo Alta, CA)
Filing Date:Mar 03, 2004
Application Number:10/792,013
Claims:1. A condensation aerosol for delivery of diazepam wherein the condensation aerosol is formed by heating a thin layer containing diazepam, on a solid support, to produce a vapor of diazepam, and condensing the vapor to form a condensation aerosol characterized by less than 10% diazepam 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. The composition according to claim 1, wherein the condensation aerosol is characterized by less than 2.5% diazepam degradation products by weight.

5. A method of producing diazepam in an aerosol form comprising: a. heating a thin layer containing diazepam, on a solid support, to produce a vapor of diazepam, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 10% diazepam degradation products by weight, and an MMAD of less than 5 microns.

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

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

8. The method according to claim 5, wherein the condensation aerosol is characterized by less than 2.5% diazepam degradation products by weight.

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

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

11. The condensation aerosol according to claim 1, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to about 3 microns.

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

13. The condensation aerosol according to claim 1, wherein the thin layer has a thickness between 1.3 and 5.1 microns.

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

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

16. The method according to claim 5, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.

17. The method according to claim 5, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to about 3 microns.

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

19. The method according to claim 5, wherein the thin layer has a thickness between 1.3 and 5.1 microns.

20. The method according to claim 5, wherein the solid support is a metal foil.

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

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