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Details for Patent: 9,211,382

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Details for Patent: 9,211,382

Title:Drug condensation aerosols and kits
Abstract: The present invention provides novel condensation aerosols for the treatment of disease and/or intermittent or acute conditions. These condensation aerosols have little or no pyrolysis degradation products and are characterized by having an MMAD of between 1-3 microns. These aerosols are made by rapidly heating a substrate coated with a thin film of drug having a thickness of between 0.05 and 20 .mu.m, while passing a gas over the film, to form particles of a desirable particle size for inhalation. Kits comprising a drug and a device for producing a condensation aerosol are also provided, wherein the device, has an element for heating the drug which is coated as a film on the substrate and contains a therapeutically effective dose of a drug when the drug is administered in aerosol form, and an element allowing the vapor to cool to form an aerosol. Methods for use are also disclosed.
Inventor(s): Hale; Ron L. (Woodside, CA), Hodges; Craig C. (Walnut Creek, CA), Lloyd; Peter M. (Walnut Creek, CA), Lu; Amy T. (Los Altos, CA), Myers; Daniel J. (Mountain View, CA), Rabinowitz; Joshua D. (Princeton, NJ), Wensley; Martin J. (Los Gatos, CA), McKinney; Jeffrey A. (Lafayette, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee: Alexza Pharmaceuticals, Inc. (Mountain View, CA)
Filing Date:Aug 07, 2012
Application Number:13/569,006
Claims:1. A drug supply article comprising: a heat-conductive substrate having an impermeable surface; a drug composition comprising the drug coated on at least a portion of the surface in the form of a film, wherein said film is a solid having a thickness; and a heat source operable to supply heat to the substrate at a rate that achieves a temperature sufficient to vaporize all or a portion of the coated drug composition within a period of 2 seconds; wherein the vaporized drug composition comprises a therapeutically effective amount of the drug; wherein the film has a thickness between 0.05 and 20 microns; wherein the drug is selected from the group consisting of alprazolam, fentanyl, loxapine, prochlorperazine and zaleplon.

2. The drug supply article of claim 1, wherein the drug is in a free base form.

3. The drug supply article of claim 1, wherein the drug is in a salt form.

4. The drug supply article of claim 1, wherein the drug composition comprises only pure drug.

5. The drug supply article of claim 1, wherein the drug composition comprises a pharmaceutically acceptable excipient.

6. The drug supply article of claim 1, wherein the drug is alprazolam.

7. The drug supply article of claim 6, wherein the film thickness is between 1 and 10 microns.

8. The drug supply article of claim 1, wherein the drug is loxapine.

9. The drug supply article of claim 8, wherein the film thickness is between 1 and 20 microns.

10. The drug supply article of claim 1, wherein the drug is prochlorperazine.

11. The drug supply article of claim 10, wherein the film thickness is between 1 and 20 microns.

12. The drug supply article of claim 1, wherein the drug is zaleplon.

13. The drug supply article of claim 12, wherein the film thickness is between 1 and 15 microns.

14. The drug supply article of claim 1, wherein the drug is fentanyl.

15. The drug supply article of claim 14, wherein the film thickness is between 1 and 10 microns.

16. The drug supply article of claim 7, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 0.5 to 3.5 microns.

17. The aerosol drug supply article of claim 16, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 0.5 to 2.0 microns.

18. The drug composition of claim 6, wherein the drug composition particles following vaporization are characterized by less than 2.5% drug degradation products.

19. The drug composition of claim 18, wherein the drug composition particles following vaporization are characterized by less than 1.5% drug degradation products.

20. The drug supply article of claim 9, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 1.0 to 3.5 microns.

21. The drug supply article of claim 20, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 1.5 to 2.5 microns.

22. The drug composition of claim 8, wherein the drug composition particles following vaporization are characterized by less than 2.5% drug degradation products.

23. The drug composition of claim 22, wherein the drug composition particles following vaporization are characterized by less than 1.0% drug degradation products.

24. The drug supply article of claim 11, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 1.0 to 3.5 microns.

25. The drug supply article of claim 24, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 1.5 to 2.5 microns.

26. The drug composition of claim 10, wherein the drug composition particles following vaporization are characterized by less than 5% drug degradation products.

27. The drug composition of claim 26, wherein the drug composition particles following vaporization are characterized by less than 2.5% drug degradation products.

28. The drug supply article of claim 12, wherein the film thickness is between 0.1 and 15 microns.

29. The drug supply article of claim 12, wherein the film thickness is between 1 and 10 microns.

30. The drug supply article of claim 12, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 0.5 to 3.5 microns.

31. The drug supply article of claim 30, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 0.5 to 2.0 microns.

32. The drug composition of claim 12, wherein the drug composition particles following vaporization are characterized by less than 2.5% drug degradation products.

33. The drug supply article of claim 14, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 0.5 to 3.5 microns.

34. The drug supply article of claim 33, wherein the mass median aerodynamic diameter of the drug composition particles following vaporization is in the range of 1.0 to 2.5 microns.

35. The drug composition of claim 14, wherein the drug composition particles following vaporization are characterized by less than 2.5% drug degradation products.

36. The drug composition of claim 35, wherein the drug composition particles following vaporization are characterized by less than 1.0% drug degradation products.
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