Delivery of sedative-hypnotics through an inhalation route
First Claim
1. A method of treating insomnia in a patient comprising administering a therapeutic amount of a drug condensation aerosol to the patient by inhalation,wherein the drug is selected from the group consisting of zaleplon, zolpidem and zopiclone, andwherein 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.
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Abstract
The present invention relates to the delivery of sedative-hypnotics through an inhalation route. Specifically, it relates to aerosols containing sedative-hypnotics that are used in inhalation therapy. In a method aspect of the present invention, a sedative-hypnotic drug is administered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises a sedative-hypnotic, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% sedative-hypnotic drug degradation products. In a kit aspect of the present invention, a kit for delivering a sedative-hypnotic through an inhalation route is provided which comprises: a) a thin coating of a sedative-hypnotic drug composition and b) a device for dispensing said thin coating as a condensation aerosol.
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Citations
34 Claims
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1. A method of treating insomnia in a patient comprising administering a therapeutic amount of a drug condensation aerosol to the patient by inhalation,
wherein the drug is selected from the group consisting of zaleplon, zolpidem and zopiclone, and 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.
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6. A method of administering a drug condensation aerosol to a patient comprising administering the drug condensation aerosol to the patient by inhalation,
wherein the drug is selected from the group consisting of zaleplon, zolpidem and zopiclone, and wherein the drug 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.
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7. A kit for delivering a drug condensation aerosol comprising:
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a. a thin layer containing the drug, on a solid support, wherein the drug is selected from the group consisting of zaleplon, zolpidem and zopiclone, and b. a device for providing the condensation aerosol, wherein the condensation aerosol is formed by heating the thin layer 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. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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Specification