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Details for Patent: 7,014,840

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Details for Patent: 7,014,840

Title:Delivery of sumatriptan, frovatriptan or naratriptan through an inhalation route
Abstract: The present invention relates to the delivery of anti-migraine compounds through an inhalation route. Specifically, it relates to aerosols containing sumatriptan, frovatriptan, or naratriptan that are used in inhalation therapy. In a method aspect of the present invention, one of sumatriptan, frovatriptan, or naratriptan is administered to a patient through an inhalation route. The method comprises: a) heating a composition, comprising sumatriptan, frovatriptan, or naratriptan, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol with less than 5% of the drug degradation products. In a kit aspect of the present invention, a kit for delivering sumatriptan, frovatriptan, or naratriptan through an inhalation route is provided which comprises: a) a thin coating of a sumatriptan, frovatriptan, or naratriptan composition; and, b) a device for dispending said thin coating as a condensation aerosol.
Inventor(s): Hale; Ron L. (Woodside, CA), Rabinowitz; Joshua D. (Mountain View, CA), Solas; Dennis W. (San Francisco, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee: Alexza Pharmaceuticals, Inc. (Palo Alto, CA)
Filing Date:Mar 03, 2004
Application Number:10/792,239
Claims:1. A method of treating headache or migraine in a patient comprising administering a therapeutic amount of a sumatriptan condensation aerosol to the patient by inhalation, wherein the therapeutic amount of a sumatriptan condensation aerosol comprises between 5 mg and 40 mg of sumatriptan delivered in a single inspiration, and 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 10% sumatriptan degradation products by weight, and an MMAD of less than 5 microns.

2. A method of treating headache or migraine in a patient comprising administering a therapeutic amount of a frovatriptan condensation aerosol to the patient by inhalation, wherein the therapeutic amount of a frovatriptan condensation aerosol comprises between 0.5 mg and 4 mg of frovatriptan delivered in a single inspiration, and 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 10% frovatriptan degradation products by weight, and an MMAD of less than 5 microns.

3. A method of treating headache or migraine in a patient comprising administering a therapeutic amount of a naratriptan condensation aerosol to the patient by inhalation, wherein the therapeutic amount of a naratriptan condensation aerosol comprises between 0.2 mg and 2 mg of naratriptan delivered in a single inspiration, and 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 10% naratriptan degradation products by weight, and an MMAD of less than 5 microns.

4. A method of administering a dose form of sumatriptan to a patient comprising administering the dose form to the patient by inhalation, wherein the dose form comprises less than 20 mg of sumatriptan, and wherein the dose form further comprises a condensation aerosol 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 10% sumatriptan degradation products by weight, and an MMAD of less than 5 microns.

5. A method of administering a dose form of frovatriptan to a patient comprising administering the dose form to the patient by inhalation, wherein the dose form comprises less than 2 mg of frovatriptan, and wherein the dose form further comprises a condensation aerosol 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 10% frovatriptan degradation products by weight, and an MMAD of less than 5 microns.

6. A method of administering a dose form of naratriptan to a patient comprising administering the dose form to the patient by inhalation, wherein the dose form comprises less than 0.8 mg of naratriptan, and wherein the dose form further comprises a condensation aerosol 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 10% naratriptan degradation products by weight, and an MMAD of less than 5 microns.
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