Details for Patent: 7,008,616

Title:	Delivery of stimulants through an inhalation route
Abstract:	The present invention relates to the delivery of stimulants through an inhalation route. Specifically, it relates to aerosols containing stimulants that are used in inhalation therapy. In a method aspect of the present invention, a stimulant is delivered to a patient through an inhalation route. The method comprises: a) heating a coating of a stimulant, on a solid support, to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% stimulant degradation products. In a kit aspect of the present invention, a kit for delivering a stimulant through an inhalation route is provided which comprises: a) a coating of a stimulant drug and b) a device for dispensing said coating a stimulant as a condensation aerosol.
Inventor(s):	Rabinowitz; Joshua D. (Mountain View, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee:	Alexza Pharmaceuticals, Inc. (Palo Alto, CA)
Filing Date:	Apr 01, 2004
Application Number:	10/816,492
Claims:	1. A method of producing appetite suppression, increased energy levels, or a positive inotropic effect in a patient comprising administering a therapeutic amount of a drug condensation aerosol to the patient by inhalation, wherein the drug is selected from the group consisting of ephedrine and fenfluramine, and 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 method according to claim 1, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns. 3. The method according to claim 1, wherein peak plasma drug concentration is reached in less than 0.1 hours. 4. The method according to claim 1, wherein the condensation aerosol is formed at a rate greater than 0.5 mg/second. 5. The method according to claim 1, wherein at least 50% by weight of the condensation aerosol is amorphous in form. 6. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 2 mg and 20 mg of ephedrine delivered in a single inspiration. 7. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 4 mg and 30 mg of fenfluramine delivered in a single inspiration. 8. A method of administering a drug condensation aerosol to a patient comprising administering the drug condensation aerosol to the patient by inhalation, wherein the drug is selected from the group consisting of ephedrine and fenfluramine, and wherein the drug 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. 9. A kit for delivering a drug condensation aerosol comprising: a. a thin layer containing the drug, on a solid support, wherein the drug is selected from the group consisting of ephedrine and fenfluramine, 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 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. 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 10, wherein the heat for heating the solid support is generated by an exothermic chemical reaction. 12. The kit according to claim 11, wherein the exothermic chemical reaction is oxidation of combustible materials. 13. The kit according to claim 10, wherein the heat for heating the solid support is generated by passage of current through an electrical resistance element. 14. The kit according to claim 10, wherein the solid support has a surface area dimensioned to accommodate a therapeutic dose of the drug. 15. The kit according to claim 9, wherein peak plasma drug concentration is reached in less than 0.1 hours. 16. The kit according to claim 9, further including instructions for use. 17. The method according to claim 1, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns. 18. The method according to claim 2, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to about 3 microns. 19. The method according to claim 8, wherein the drug is ephedrine. 20. The method according to claim 8, wherein the drug is fenfluramine. 21. The kit according to claim 9, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns. 22. The kit according to claim 9, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns. 23. The kit according to claim 21, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to about 3 microns. 24. The kit according to claim 9, wherein the drug is ephedrine. 25. The kit according to claim 9, wherein the drug is fenfluramine. 26. 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. 27. The kit according to claim 10, wherein the solid support has a surface to volume ratio of greater than 100 per meter. 28. The kit according to claim 10, wherein the solid support is a metal foil. 29. The kit according to claim 28, wherein the metal foil has a thickness of less than 0.25 mm.