Delivery of erectile dysfunction drugs through an inhalation route
First Claim
1. A composition for delivery of sildenafil consisting of a condensation aerosol a. formed by volatilizing a thin film of sildenafil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of sildenafil and condensing the heated vapor of sildenafil to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% sildenafil degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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Abstract
The present invention relates to the delivery of erectile dysfunction drugs through an inhalation route. Specifically, it relates to aerosols containing erectile dysfunction drugs that are used in inhalation therapy. In a method aspect of the present invention, an erectile dysfunction drug is delivered to a patient through an inhalation route. The method comprises: a) heating a thin film of an erectile dysfunction 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% erectile dysfunction drug degradation products. In a kit aspect of the present invention, a kit for delivering an erectile dysfunction drug through an inhalation route is provided which comprises: a) a thin film of an erectile dysfunction drug composition and b) a device for dispensing said thin film as a condensation aerosol.
101 Citations
18 Claims
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1. A composition for delivery of sildenafil consisting of a condensation aerosol
a. formed by volatilizing a thin film of sildenafil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of sildenafil and condensing the heated vapor of sildenafil to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% sildenafil degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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4. A composition for delivery of tadalafil consisting of a condensation aerosol
a. formed by volatilizing a thin film of tadalafil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of tadalafil and condensing the heated vapor of tadalafil to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% tadalafil degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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7. A composition for delivery of vardenafil consisting of a condensation aerosol
a. formed by volatilizing a thin film of vardenafil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to produce a heated vapor of vardenafil and condensing the heated vapor of vardenafil to form condensation aerosol particles, b. wherein said condensation aerosol particles are characterized by less than 5% vardenafil degradation products, and c. the condensation aerosol has an MMAD of less than 3 microns.
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10. A method of producing sildenafil in an aerosol form comprising:
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a. heating a thin film of sildenafil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the sildenafil to form a heated vapor of the sildenafil, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the sildenafil comprising less than 5% sildenafil degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (11, 12)
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13. A method of producing tadalafil in an aerosol form comprising:
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a. heating a thin film of tadalafil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the tadalafil to form a heated vapor of the tadalafil, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the tadalafil comprising less than 5% tadalafil degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (14, 15)
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16. A method of producing vardenafil in an aerosol form comprising:
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a. heating a thin film of vardenafil on a solid support, having the surface texture of a metal foil, to a temperature sufficient to volatilize the vardenafil to form a heated vapor of the vardenafil, and b. during said heating, passing air through the heated vapor to produce aerosol particles of the vardenafil comprising less than 5% vardenafil degradation products, and an aerosol having an MMAD of less than 3 microns. - View Dependent Claims (17, 18)
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Specification