Claims for Patent: 9,440,034

Summary for Patent: 9,440,034

Title:	Drug condensation aerosols and kits
Abstract:	The present invention provides novel condensation aerosols for the treatment of disease and/or intermittent or acute conditions. These condensation aerosols have little or no pyrolysis degradation products and are characterized by having an MMAD of between 1-3 microns. These aerosols are made by rapidly heating a substrate coated with a thin film of drug having a thickness of between 0.05 and 20 .mu.m, while passing a gas over the film, to form particles of a desirable particle size for inhalation. Kits comprising a drug and a device for producing a condensation aerosol are also provided. The device contained in the kit typically, has an element for heating the drug which is coated as a film on the substrate and contains a therapeutically effective dose of a drug when the drug is administered in aerosol form, and an element allowing the vapor to cool to form an aerosol. Also disclosed, are methods for using these aerosols and kits.
Inventor(s):	Hale; Ron L. (Sandia Park, NM), Hodges; Craig C. (Walnut Creek, CA), Lloyd; Peter M. (Walnut Creek, CA), Lu; Amy T. (Los Altos, CA), Myers; Daniel J. (Mountain View, CA), Rabinowitz; Joshua D. (Princeton, NJ), Wensley; Martin J. (Los Gatos, CA), McKinney; Jeffrey A. (Lafayette, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee:	ALEXZA PHARMACEUTICALS, INC. (Mountain View, CA)
Application Number:	14/078,679
Patent Claims:	1. A composition for delivery of loxapine comprising a condensation aerosol a) wherein the condensation aerosol is formed by heating a thin film of loxapine thereof to produce a vapor, wherein said film is a solid and condensing the vapor to form a condensation aerosol comprising loxapine; b) wherein the condensation aerosol comprises particles that are characterized by less than 10% loxapine degradation products by weight; c) wherein the condensation aerosol has an MMAD of less than 5 microns. 2. A kit for delivering a condensation aerosol, the kit comprising: a) a thin film of a loxapine composition comprising loxapine, on a solid support, wherein said film is a solid, and b) a device for providing the condensation aerosol, wherein the condensation aerosol is formed by heating the loxapine composition to produce a vapor, and condensing the vapor to form a condensation aerosol comprising loxapine, wherein the condensation aerosol comprises particles that are characterized by less than 10% loxapine degradation products by weight, wherein the condensation aerosol has an MMAD of less than 5 microns. 3. A loxapine supply article comprising: a substrate having a surface; a layer of loxapine applied to the substrate surface, the layer of loxapine having a select thickness and a select surface area, the select thickness providing less than 10% degradation of loxapine and the select surface area providing a therapeutically effective loxapine dosage upon vaporization of the layer of loxapine, wherein said layer of loxapine is a solid. 4. A method of administering loxapine of a type administered orally or by injection in combination with a solvent or excipient to a patient for inhalation by the patient comprising: a) determining a therapeutically effective dose of loxapine for administration as a condensation aerosol by inhalation by a patient; b) providing a volume of loxapine sufficient to provide the therapeutically effective dose upon vaporization on a substrate without any excipient or solvent, wherein the loxapine is in solid form; c) vaporizing loxapine; d) condensing loxapine to produce a condensation aerosol; and e) delivering the condensation aerosol to a patient for inhalation. 5. A method of making a condensation aerosol from loxapine of the type administered orally or by injection in combination with a solvent or excipient to a patient for inhalation by the patient comprising: a) determining a therapeutically effective dose of loxapine for administration as a condensation aerosol by inhalation by a patient; b) providing a volume of loxapine sufficient to provide the therapeutically effective dose upon vaporization on a substrate without any excipient or solvent, wherein the loxapine is in solid form; c) vaporizing loxapine; and d) condensing loxapine to produce a condensation aerosol.