Drug condensation aerosols and kits
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Accused Products
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 μm, 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.
209 Citations
267 Claims
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1-82. -82. (canceled)
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83. A drug supply article comprising:
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a substrate having a surface;
a layer of a drug applied to the substrate surface, the layer of the drug having a select thickness and a select surface area, the select thickness providing less than 10% degradation of the drug and the select surface area providing a therapeutically effective drug dosage upon vaporization of the layer of the drug. - View Dependent Claims (84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114)
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115. A drug supply article comprising:
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a substrate having a surface;
a layer of a drug applied to the substrate surface, the layer of the drug having a select thickness and a select surface area, the select thickness providing vaporization of the drug in less than 2 seconds at a temperature of at least 200°
C. and the select surface area providing a therapeutically effective drug dosage upon vaporization of the layer of the drug. - View Dependent Claims (116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134)
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135. A drug supply article comprising:
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a substrate having a surface;
a layer of a drug applied to the substrate surface, the layer of the drug having a select thickness and a select surface area, the select thickness providing vaporization of at least about 50% of a total volume of drug and the select surface area providing a therapeutically effective drug dosage upon vaporization of the layer of the drug.
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136. A method of making a drug supply article comprising:
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a) determining a therapeutically effective volume of the drug for delivery as a condensation aerosol;
b) applying a layer of the drug to a substrate in a select thickness providing less than 10% degradation of the drug upon vaporization of the drug and a select surface area providing the therapeutically effective volume upon vaporization of the drug. - View Dependent Claims (137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151)
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152. A method of making a drug supply article comprising:
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determining a therapeutically effective volume of a drug for delivery as a condensation aerosol; and
applying the drug to a substrate in a select thickness providing vaporization of the drug in less than 2 seconds at a temperature of at least 200°
C. and a select surface area providing the therapeutically effective volume upon vaporization.
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153. A method of making a drug supply article comprising:
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determining a therapeutically effective volume of the drug for delivery as a condensation aerosol; and
applying the drug to the substrate in a select thickness providing vaporization of at least about 50% of a total volume of drug and the select surface area providing a therapeutically effective volume of the drug upon vaporization of the layer of the drug.
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154. A method of applying a drug coating to a substrate comprising:
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a) determining a therapeutically effective volume of the drug for delivery as a condensation aerosol;
b) applying a layer of the drug to the substrate in a select thickness providing less than 10% degradation of the drug upon vaporization of the drug and a select surface area providing the therapeutically effective volume upon vaporization of the drug. - View Dependent Claims (155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169)
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170. A method of applying a drug coating to a substrate comprising:
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determining a therapeutically effective volume of the drug for delivery as a condensation aerosol; and
applying the drug to the substrate in a select thickness providing vaporization of the drug in less than 2 seconds at a temperature of at least 200°
C. and a select surface area providing the therapeutically effective volume upon vaporization.
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171. A method of applying a drug coating to a substrate comprising:
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determining a therapeutically effective volume of the drug for delivery as a condensation aerosol; and
applying the drug to the substrate in a select thickness providing vaporization of at least about 50% of a total volume of drug and the select surface area providing a therapeutically effective volume of the drug upon vaporization of the layer of the drug.
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172. A device for making a condensation aerosol from a drug comprising:
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a first chamber configured to receive a substrate bearing a drug layer;
a heater within the chamber in operative association with the drug layer to vaporize the drug layer;
carrier gas flow means for flowing a carrier gas through the first chamber at a first velocity sufficient to transport the vaporized drug away from the heater before greater than 10% degradation of the drug; and
a second chamber in fluid communication with the first chamber, the second chamber being configured to produce aerosol particles of a therapeutically effective size. - View Dependent Claims (173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185, 186, 187)
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188. A method of administering a drug of a type administered orally or by injection in combination with a solvent or excipient to a patient for inhalation by the patient comprising:
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a) determining a therapeutically effective dose of the drug for administration as a condensation aerosol by inhalation by a patient;
b) providing a volume of the drug sufficient to provide the therapeutically effective dose upon vaporization on a substrate without any excipient or solvent;
c) vaporizing the drug;
d) condensing the drug to produce a condensation aerosol; and
e) delivering the condensation aerosol to a patient for inhalation. - View Dependent Claims (189, 190, 191, 192, 193, 194, 195)
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196. A method of making a condensation aerosol from a drug of the type administered orally or by injection in combination with a solvent or excipient to a patient for inhalation by the patient comprising:
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a) determining a therapeutically effective dose of the drug for administration as a condensation aerosol by inhalation by a patient;
b) providing a volume of the drug sufficient to provide the therapeutically effective dose upon vaporization on a substrate without any excipient or solvent;
c) vaporizing the drug; and
d) condensing the drug to produce a condensation aerosol. - View Dependent Claims (197, 198, 199, 200, 201, 202, 203)
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- 204. An aerosol for delivery of a drug by inhalation comprising condensation particles having an MMAD between 0.2-5 microns and a stable concentration of the condensation particles.
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210. An aerosol for delivery of a heat stable drug by inhalation, wherein the heat stable drug is a solid at room temperature, the aerosol comprising a condensation aerosol that is at least 90% free of other compounds and has condensation particles of an MMAD between 0.2-5 microns.
- 214. An aerosol for delivery of a drug by inhalation comprising condensation particles having an MMAD between 0.2-5 microns and a particle density greater than 106 particles/mL.
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220. A device for delivery of a condensation aerosol for inhalation comprising:
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an aerosolizer comprising a drug on a substrate and a heater for vaporizing the drug;
a site of inhalation; and
a passageway linking the aerosolizer with the site of inhalation, the passageway being configured to cause condensation of the vaporized drug into a condensation aerosol. - View Dependent Claims (221, 222, 223, 224, 225, 226, 227, 228, 229, 230, 231, 232)
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233. A method of making an aerosol for delivery to a patient comprising:
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vaporizing a drug;
entraining the vaporized drug in a carrier gas flowing at a first velocity; and
condensing the vaporized drug in the carrier gas with the carrier gas flowing at a second velocity less than the first velocity. - View Dependent Claims (234, 235, 236, 237, 239, 240)
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238. The method of clam 237 wherein the second velocity provides a stable concentration of particles.
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241. A device for delivery of a condensation aerosol of a drug by inhalation comprising:
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a housing;
vaporizing means within the housing for vaporizing a solid composition of a drug within the housing;
an air inlet and mouthpiece associated with the housing and airflow means for providing an airflow across the vaporizing means from the inlet to the mouthpiece upon inhalation by a patent at the mouthpiece; and
condensing means for condensing a drug vapor between vaporizing means and the mouthpiece. - View Dependent Claims (242, 243, 244, 245, 246, 247, 248, 249, 250, 251, 252, 253, 254, 255, 256)
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257. A drug vaporizer comprising:
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a substrate;
a layer containing a drug coated on the substrate having a thickness of 0.5-5 microns; and
a heating element operatively associated with the substrate. - View Dependent Claims (258, 259, 260, 261, 262, 263, 264, 265, 266, 267)
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Specification