Claims for Patent: 7,537,009

Summary for Patent: 7,537,009

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. (Woodside, CA), Hodges; Craig C. (Walnut Creek, CA), Lloyd; Peter M. (Walnut Creek, CA), Mufson; Daniel (Napa, CA), Rogers; Daniel D. (Oakland, CA), Song; Soonho (Stanford, CA), Wensley; Martin J. (San Francisco, CA), Myers; Daniel J. (Mountain View, CA), McKinney; Jeffrey A. (Foster City, CA), Quintana; Reynaldo J. (Redwood City, CA), Rabinowitz; Joshua D. (Mountain View, CA)
Assignee:	Alexza Pharmaceuticals, Inc. (Mountain View, CA)
Application Number:	10/146,088
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 for a period of time, thereby forming a vapor, wherein the period is less than 500 milliseconds and wherein the increase in temperature of the substrate over the period is greater than 1000.degree. C./s; and (b) allowing the vapor to cool, thereby forming an aerosol comprising the drug. 2. The method according to claim 1, wherein the increase in temperature of the substrate over the period is greater than 2000.degree. C./s. 3. The method according to claim 1, wherein greater than 0.1 mg of the composition is vaporized in less than 100 milliseconds from the start of heating. 4. The method according to claim 1, wherein the increase in temperature of the substrate over the period is greater than 5,000.degree. C./s. 5. The method according to claim 4, wherein greater than 0.25 mg of the composition is vaporized in less than 100 milliseconds from the start of heating. 6. The method according to claim 5, wherein the increase in temperature of the substrate over the period is greater than 7,500.degree. C./s. 7. A method of forming an aerosol for use in inhalation therapy comprising: (a) heating a substrate coated with a composition comprising a drug to form a vapor in a period of time 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 comprising the drug. 8. The method according to claim 7, wherein the vapor has a mass greater than 0.25 mg. 9. The method according to claim 7, wherein the vapor is formed in less than 75 milliseconds. 10. The method according to claim 8, wherein the vapor has a mass greater than 0.5 mg. 11. The method according to claim 9, wherein the period of time is less than 50 milliseconds. 12. The method according to claim 3, wherein the formed aerosol is greater than 80 percent by weight of the drug. 13. The method according to claim 3, wherein the formed aerosol contains less than 5 percent by weight of drug decomposition products. 14. The method according to claim 3, wherein the formed aerosol is stable over 1 second. 15. The method according to claim 3, wherein the formed aerosol has an MMAD in the 10 nm to 100 nm range. 16. The method according to claim 3, wherein the formed aerosol has an MMAD in the 1 .mu.m to 3 .mu.m range. 17. The method according to claim 3, wherein the geometric standard deviation of the form aerosol is other than 1. 18. The method according to claim 7, wherein the formed aerosol is greater than 80 percent by weight of the drug. 19. The method according to claim 7, wherein the formed aerosol contains less than 5 percent by weight of drug decomposition products. 20. The method according to claim 7, wherein the formed aerosol is stable over 1 second. 21. The method according to claim 7, wherein the formed aerosol has an MMAD in the 10 nm to 100 nm range. 22. The method according to claim 7, wherein the formed aerosol has an MMAD in the 1 .mu.m to 3 .mu.m range. 23. The method according to claim 7, wherein the geometric standard deviation of the form aerosol is other than 1. 24. The method according to claim 3, wherein the film is less than 10 .mu.m thick. 25. The method according to claim 24, wherein the film is less than 5 .mu.m thick. 26. The method according to claim 24, wherein the film is between 10 nm and 5 .mu.m thick. 27. The method according to claim 25, wherein the film is less than 3 .mu.m thick. 28. The method according to claim 26, wherein the film is between 10 nm and 3 .mu.m thick. 29. The method according to claim 7, wherein the film is less than 10 .mu.m thick. 30. The method according to claim 29, wherein the film is less than 5 .mu.m thick. 31. The method according to claim 29, wherein the film is between 10 nm and 5 .mu.m thick. 32. The method according to claim 30, wherein the film is less than 3 .mu.m thick. 33. The method according to claim 31, wherein the film is between 10 nm and 3 .mu.m thick.