Delivery of drug amines through an inhalation route
First Claim
1. A method of selecting an amine drug salt suitable for use in forming a condensation aerosol, comprising a. dissolving or suspending an amine drug salt in a solvent, b. coating the suspended or dissolved amine drug salt on a substrate, c. heating the coated substrate to form a compound vapor, d. cooling the vapor to form aerosol particles, e. collecting the aerosol particles, f. analyzing the collected particles to determine the purity of the aerosol particles;
- and g. selecting the amine drug based on a decomposition index less than 0. 15.
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Abstract
The present invention relates to the delivery of drug amines through an inhalation route. Specifically, it relates to aerosols containing drug amines that are used in inhalation therapy. In one aspect of the present invention, a method of delivering an amine drug in an aerosol form is provided. The method comprises: a) heating a coating, which includes an amine drug salt on a substrate contained in a device to a temperature sufficient to volatilize the amine drug from the coating, b) by said heating, forming an amine drug vapor, and c) during said heating, drawing air through said device, condensing said vapor to form aerosol particles containing less than 10% degradation products of the compound.
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Citations
23 Claims
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1. A method of selecting an amine drug salt suitable for use in forming a condensation aerosol, comprising
a. dissolving or suspending an amine drug salt in a solvent, b. coating the suspended or dissolved amine drug salt on a substrate, c. heating the coated substrate to form a compound vapor, d. cooling the vapor to form aerosol particles, e. collecting the aerosol particles, f. analyzing the collected particles to determine the purity of the aerosol particles; - and
g. selecting the amine drug based on a decomposition index less than 0. 15. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of delivering an amine drug in an aerosol form, comprising
a. heating a coating, which includes an amine drug salt on a substrate contained in a device to a temperature sufficient to volatilize the amine drug from the coating, b. by said heating, forming a amine drug vapor, and c. during said heating, drawing air through said device, condensing said vapor to form aerosol particles containing less than 10% degradation products of the compound.
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17. A thermal vapor comprising gas and amine drug aerosol particles,
a. wherein said gas comprises an acid halide vapor, organic acid vapor, or organic acid decomposition product vapor, and b. wherein said amine drug aerosol particles i. comprise at least 10 micrograms of an amine drug and less than 10% amine drug decomposition products relative to said total mass of amine drug in the particles, and ii. have a mass median aerodynamic diameter in the range 1 to 5 micrometers.
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22. A method of forming an effective human therapeutic inhalation dose of drug amine aerosol particles having less than 10% degradation products and a drug amine particle mass median aerodynamic diameter between about 1 and 5 micrometers, comprising
a) providing a drug delivery article comprising a body defining an interior flow-through chamber having upstream and down stream chamber ends and a drug supply unit contained within such chamber, wherein said drug supply unit comprises a heat-conductive substrate coated with a composition comprising at least a therapeutic amount of amine drug salt having a decomposition index less than 0.10; -
b) heating said heat-conductive substrate to a temperature of greater than 200°
C. over a period of less than 5 seconds, thereby producing a vapor of a therapeutic dose of said amine drug salt; and
c) flowing a gas through said chamber thereby cooling said vapor to form drug amine aerosol particles. - View Dependent Claims (23)
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Specification