Delivery of physiologically active compounds through an inhalation route
First Claim
1. A method of treating anxiety, vertigo, alcohol withdrawal, nicotine withdrawal, sedation, hot flashes, peptic ulcers or for testosterone replacement therapy, hormone replacement therapy, or prevention of pregnancy 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 chlordiazepoxide, betahistine, clonidine, testosterone, a conjugated estrogen, an estrogen ester, estradiol, an estradiol ester, ethinyl estradiol, an ethinyl estradiol ester and hyoscyamine, 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 physiologically active compounds through an inhalation route. Specifically, it relates to aerosols containing physiologically active compounds that are used in inhalation therapy. In a method aspect of the present invention, a physiologically active compound is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises a physiologically active compound, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% physiologically active compound degradation products. In a kit aspect of the present invention, a kit for delivering a physiologically active compound through an inhalation route is provided which comprises: a) a thin coating of a physiologically active compound composition and b) a device for dispensing said thin coating as a condensation aerosol.
220 Citations
44 Claims
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1. A method of treating anxiety, vertigo, alcohol withdrawal, nicotine withdrawal, sedation, hot flashes, peptic ulcers or for testosterone replacement therapy, hormone replacement therapy, or prevention of pregnancy 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 chlordiazepoxide, betahistine, clonidine, testosterone, a conjugated estrogen, an estrogen ester, estradiol, an estradiol ester, ethinyl estradiol, an ethinyl estradiol ester and hyoscyamine, 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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13. 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 chlordiazepoxide, betahistine, clonidine, testosterone, a conjugated estrogen, an estrogen ester, estradiol, an estradiol ester, ethinyl estradiol, an ethinyl estradiol ester and hyoscyamine, 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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14. 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 chlordiazepoxide, betahistine, clonidine, testosterone, a conjugated estrogen, an estrogen ester, estradiol, an estradiol ester, ethinyl estradiol, an ethinyl estradiol ester and hyoscyamine, 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 (15, 16, 17, 18, 19, 20, 21, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44)
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Specification