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Claims for Patent: 8,074,644

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Claims for Patent: 8,074,644

Title:Method of forming an aerosol for inhalation delivery
Abstract: The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to a method of forming an aerosol for use in inhalation therapy. In a method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug at a rate greater than 1000.degree. C./s, thereby forming an vapor; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor, wherein the coated composition is in the form of a film less than 10.mu. thick; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor in less than 100 milliseconds, wherein the vapor has a mass greater than 0.1 mg; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy.
Inventor(s): Hale; Ron L. (Sandia Park, NM), Hodges; Craig C. (Walnut Creek, CA), Lloyd; Peter M. (Walnut Creek, CA), Mufson; Daniel (Napa, CA), Rogers; Daniel D. (Oakland, CA), Song; Soonho (Hillsborough, CA), Wensley; Martin J. (Los Gatos, CA), Myers; Daniel J. (Mountain View, CA), McKinney; Jeffrey A. (Lafayette, CA), Quintana; Reynaldo J. (Redwood City, CA), Rabinowitz; Joshua D. (Princeton, NJ)
Assignee: Alexza Pharmaceuticals, Inc. (Mountain View, CA)
Application Number:12/471,070
Patent Claims: 1. A method of forming an aerosol for use in inhalation therapy comprising: (a) heating a substrate coated with a composition comprising a drug, thereby forming a vapor; (b) establishing an airflow over the surface of the coated composition during said heating; and (c) allowing the vapors to cool in the air flow thereby forming an aerosol comprising the drug, wherein a dose of the drug is vaporized in less than 1 second.

2. The method according to claim 1, wherein a dose of the drug is vaporized in less than 500 milliseconds.

3. The method according to claim 2, wherein a dose of the drug is vaporized in less than 100 milliseconds.

4. The method according to claim 3, wherein the formed aerosol is greater than 80 percent by weight of the drug.

5. The method according to claim 3, wherein the formed aerosol contains less than 5 percent by weight of drug decomposition products.

6. The method according to claim 3, wherein the formed aerosol is stable over 1 second.

7. The method according to claim 3, wherein the formed aerosol has an MMAD in the 10 nm to 100 nm range.

8. The method according to claim 3, wherein the formed aerosol has an MMAD in the 1 .mu.m to 3 .mu.m range.

9. The method according to claim 3, wherein the geometric standard deviation of the form aerosol is other than 1.

10. The method according to claim 3, wherein the film is less than 10 .mu.m thick.

11. The method according to claim 10, wherein the film is less than 5 .mu.m thick.

12. The method according to claim 10, wherein the film is between 10 nm and 5 .mu.m thick.

13. The method according to claim 10, wherein the film is less than 3 .mu.m thick.

14. The method according to claim 12, wherein the film is between 10 nm and 3 .mu.m thick.
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