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Details for Patent: 7,045,118

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Details for Patent: 7,045,118

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.
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