Details for Patent: 7,045,118
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Title: | Delivery of compounds for the treatment of migraine through an inhalation route |
Abstract: | The present invention relates to the delivery of a migraine headache drug through an inhalation route. Specifically, it relates to aerosols containing a migraine headache drug that are used in inhalation therapy. In a method aspect of the present invention, a migraine headache drug is administered to a patient through an inhalation route. The method comprises: a) heating a thin layer of a migraine headache drug, on a solid support to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% drug degradation products. In a kit aspect of the present invention, a kit for delivering a migraine headache drug through an inhalation route is provided which comprises: a) a thin coating of an a migraine drug composition and b) a device for dispensing said thin coating 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: | Jan 27, 2004 |
Application Number: | 10/766,574 |
Claims: | 1. A condensation aerosol for delivery of a drug selected from the group consisting of rizatriptan, zolmitriptan, sumatriptan, frovatriptan and naratriptan, 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 condensation aerosol according to claim 1, wherein the condensation aerosol is formed at a rate greater than 10.sup.9 particles per second. 3. The condensation aerosol according to claim 2, wherein the condensation aerosol is formed at a rate greater than 10.sup.10 particles per second. 4. The condensation aerosol according to claim 1, wherein said condensation aerosol is characterized by less than 2.5% drug degradation products by weight. 5. A method of producing a drug selected from the group consisting of rizatriptan, zolmitriptan, sumatriptan, frovatriptan and naratriptan in an aerosol form comprising: a. heating a thin layer containing the drug, on a solid support, to produce a vapor of the drug, 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 condensation aerosol is formed at a rate greater than 10.sup.9 particles per second. 7. The method according to claim 6, wherein the condensation aerosol is formed at a rate of greater than 10.sup.10 particles per second. 8. The condensation aerosol according to claim 1, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns. 9. The condensation aerosol according to claim 1, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns. 10. The condensation aerosol according to claim 9, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns. 11. The condensation aerosol according to claim 1, wherein the condensation aerosol is characterized by less than 5% drug degradation products by weight. 12. The condensation aerosol according to claim 1, wherein the thin layer has a thickness between 0.7 and 5.0 microns. 13. The condensation aerosol according to claim 1, wherein the solid support is a metal foil. 14. The method according to claim 6, wherein the condensation aerosol is characterized by an MMAD of 0.2 to 5 microns. 15. The method according to claim 5, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns. 16. The method according to claim 5, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to about 3 microns. 17. The method according to claim 5, wherein the condensation aerosol is characterized by less than 5% drug degradation products by weight. 18. The method according to claim 17, wherein the condensation aerosol is characterized by less than 2.5% drug degradation products by weight. 19. The method according to claim 5, wherein the thin layer has a thickness between 0.7 and 5.0 microns. 20. The method according to claim 16, wherein the solid support is a metal foil. 21. A condensation aerosol for delivery of rizatriptan, wherein the condensation aerosol is formed by heating a thin layer containing rizatriptan, on a solid support, to produce a vapor of rizatriptan, and condensing the vapor to form a condensation aerosol characterized by less than 5% rizatriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 22. A condensation aerosol for delivery of zolmitriptan, wherein the condensation aerosol is formed by heating a thin layer containing zolmitriptan, on a solid support, to produce a vapor of zolmitriptan, and condensing the vapor to form a condensation aerosol characterized by less than 5% zolmitriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 23. A condensation aerosol for delivery of sumatriptan, wherein the condensation aerosol is formed by heating a thin layer containing sumatriptan, on a solid support, to produce a vapor of sumatriptan, and condensing the vapor, to form a condensation aerosol characterized by less than 5% sumatriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 24. A condensation aerosol for delivery of frovatriptan, wherein the condensation aerosol is formed by heating a thin layer containing frovatriptan, on a solid support, to produce a vapor of frovatriptan, and condensing the vapor to form a condensation aerosol characterized by less than 5% frovatriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 25. A condensation aerosol for delivery of naratriptan, wherein the condensation aerosol is formed by heating a thin layer containing naratriptan, on a solid support, to produce a vapor of naratriptan, and condensing the vapor to form a condensation aerosol characterized by less than 5% naratriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 26. A method of producing rizatriptan in an aerosol form comprising: a. heating a thin layer containing rizatriptan, on a solid support, to produce a vapor of rizatriptan, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% rizatriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 27. A method of producing zolmitriptan in an aerosol form comprising: a. heating a thin layer containing zolmitriptan, on a solid support, to produce a vapor of zolmitriptan and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% zolmitriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 28. A method of producing sumatriptan in an aerosol form comprising: a. heating a thin layer containing sumatriptan, on a solid support, to produce a vapor of sumatriptan, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% sumatriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 29. A method of producing frovatriptan in an aerosol form comprising: a. heating a thin layer containing frovatriptan, on a solid support, to produce a vapor of frovatriptan, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% frovatriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. 30. A method of producing naratriptan in an aerosol form comprising: a. heating a thin layer containing naratriptan, on a solid support, to produce a vapor of naratriptan, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% naratriptan degradation products by weight, and an MMAD of about 0.2 to 3 microns. |