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Details for Patent: 7,070,763

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Details for Patent: 7,070,763

Title:Delivery of diphenhydramine through an inhalation route
Abstract: The present invention relates to the delivery of diphenhydramine through an inhalation route. In a composition aspect of the present invention, a composition of a diphenhydramine condensation aerosol is presented. In a method aspect of the present invention, diphenhydramine aerosol is formed by: a) heating a thin layer of diphenhydramine on a solid support to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% degradation product and an aerosol having an MMAD less than 3 microns. In a kit aspect of the present invention, a kit for delivering a condensation aerosol is provided which comprises: a) a thin coating of diphenhydramine; and b) a device for dispensing the diphenhydramine as an aerosol.
Inventor(s): Rabinowitz; Joshua D. (Mountain View, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee: Alexza Pharmaceuticals, Inc. (Palo Alto, CA)
Filing Date:Jan 27, 2004
Application Number:10/766,634
Claims:1. A condensation aerosol for delivery of diphenhydramine wherein the condensation aerosol is formed by heating a thin layer containing diphenhydramine, on a solid support, to produce a vapor of diphenhydramine, and condensing the vapor to form a condensation aerosol, characterized by less than 10% diphenhydramine degradation products by weight, and an MMAD of less than 5 microns.

2. The condensation aerosol according to claim 1, wherein the diphenhydramine is a free base form of diphenhydramine.

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

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

5. A method of producing diphenhydramine in an aerosol form comprising: a. heating a thin layer containing diphenhydramine, on a solid support, to produce a vapor of diphenhydramine, and b. providing an air flow through 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.

6. The method according to claim 5, wherein the diphenhydramine is a free base form of diphenhydramine.

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

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

9. A kit for delivering a diphenhydramine condensation aerosol comprising: a. a thin layer containing diphenhydramine, on a solid support, and b. a device for providing the condensation aerosol, wherein the condensation aerosol is formed by heating the thin layer to produce a vapor of diphenhydramine, and condensing the vapor to form a condensation aerosol characterized by less than 10% diphenhydramine degradation products by weight, and an MMAD of less than 5 microns.

10. The kit according to claim 9, wherein the device comprises: a. a flow through enclosure containing the solid support, b. a power source that can be activated to heat the solid support, and c. at least one portal through which air can be drawn by inhalation, wherein activation of the power source is effective to produce a vapor of the drug, and drawing air through the enclosure is effective to condense the vapor to form the condensation aerosol.

11. The kit according to claim 9, further including instructions for use.

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

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

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

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

16. The condensation aerosol according to claim 15, wherein the condensation aerosol is characterized by less than 2.5% drug degradation products by weight.

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

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

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

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

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

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

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

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

25. The kit according to claim 9, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.

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

27. The kit according to claim 10, wherein the solid support has a surface to mass ratio of greater than 1 cm.sup.2 per gram.

28. The kit according to claim 10, wherein the solid support has a surface to volume ratio of greater than 100 per meter.

29. The kit according to claim 10, wherein the solid support is a metal foil.

30. The kit according to claim 29, wherein the metal foil has a thickness of less than 0.25 mm.
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