Delivery of compounds for the treatment of migraine through an inhalation route
View Patent ↗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.
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 9 particles per second.
3. The condensation aerosol according to claim 2 , wherein the condensation aerosol is formed at a rate greater than 10 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 9 particles per second.
7. The method according to claim 6 , wherein the condensation aerosol is formed at a rate of greater than 10 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.