Delivery of sedative-hypnotics through an inhalation route
First Claim
1. A condensation aerosol for delivery of a drug selected from the group consisting of zaleplon, zolpidem and zopiclone, 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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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 thin layer of a sedative-hypnotic, on a solid support, to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having 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 layer of a sedative-hypnotic drug and b) a device for dispensing said thin layer a sedative-hypnotic drug as a condensation aerosol.
215 Citations
32 Claims
- 1. A condensation aerosol for delivery of a drug selected from the group consisting of zaleplon, zolpidem and zopiclone, 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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4. A method of producing a drug selected from the group consisting of zaleplon, zolpidem and zopiclone in an aerosol form comprising:
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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, and an MMAD of less than 5 microns. - View Dependent Claims (5, 6, 17, 18, 19, 20, 21, 22, 24, 25, 26)
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27. A condensation aerosol for delivery of zaleplon, wherein the condensation aerosol is formed by heating a thin layer containing zaleplon, on a solid support, to produce a vapor of zaleplon, and condensing the vapor to form a condensation aerosol characterized by less than 5% zaleplon degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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28. A condensation aerosol for delivery of zolpidem, wherein the condensation aerosol is formed by heating a thin layer containing zolpidem, on a solid support, to produce a vapor of zolpidem, and condensing the vapor to form a condensation aerosol characterized by less than 5% zolpidem degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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29. A condensation aerosol for delivery of zopiclone, wherein the condensation aerosol is formed by heating a thin layer containing zopiclone, on a solid support, to produce a vapor of zopiclone, and condensing the vapor to form a condensation aerosol characterized by less than 5% zopiclone degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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30. A method of producing zaleplon in an aerosol form comprising:
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a. heating a thin layer containing zaleplon, on a solid support, to produce a vapor of zaleplon, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% zaleplon degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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31. A method of producing zolpidem in an aerosol form comprising:
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a. heating a thin layer containing zolpidem, on a solid support, to produce a vapor of zolpidem, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% zolpidem degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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32. A method of producing zopiclone in an aerosol form comprising:
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a. heating a thin layer containing zopiclone, on a solid support, to produce a vapor of zopiclone, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% zopiclone degradation products by weight, and an MMAD of about 0.2 to 3 microns.
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Specification