DELIVERY OF DRUG AMINES THROUGH AN INHALATION ROUTE
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, h) 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.
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.
2 . The method of claim 1 , wherein said substrate is metallic.
3 . The method of claim 2 , wherein said metallic substrate is aluminum foil or stainless steel.
4 . The method of claim 2 , wherein said heating is on a hot plate.
5 . The method of claim 4 , wherein said heating is to a temperature approximately about 300° C.
6 . The method claim 1 , wherein said heating is resistance heating.
7 . The method of claim 6 , wherein said heating is to a temperature of approximately about 400° C.
8 . The method of claim 1 , wherein the amine drug salt is selected from the group consisting often antibiotic, anticonvulsant, antidepressant, antiemetic, antihistamine, anti parkinsonian drug, antipsychotic, anxiolytic, a drug for erectile dysfunction, a drug for migraine headache, a drug for the treatment of addiction, a muscle relaxant, a non-steroidal anti-inflammatory, an opioid, or other analgesic.
9 . An aerosol comprising an amine drug from an amine drug salt selected by the method of claim 2 , wherein said amine drug salt is vaporized and condensed to form amine drug aerosol particles having a mass median aerodynamic diameter between the range of 1 and 3, and has less than 10% amine drug decomposition products.
10 . The aerosol of claim 9 , wherein said amine drug salt has a molecular weight between 200 to 600.
11 . The aerosol of claim 9 , wherein said amine drug salt is selected from the group consisting of antibiotic, anticonvulsant, antidepressant, antiemetic, antihistamine, antiparkinsonian drug, antipsychotic, anxiolytic, a drug for erectile dysfunction, a drug for migraine headache, a drug for the treatment of addiction, a muscle relaxant, a non-steroidal anti-inflammatory, an opioid, or other analgesic.
12 . A method or 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, running a amine drug vapor, and
c. during said heating, drawing air through said device, condensing said vapor to from aerosol particles containing less than 10% degradation products of the compound.
13 . The method according to claim 12 , wherein said coating of amine drug salt has a thickness between about 0.2 and 20 μm.
14 . The method according to claim 13 , wherein said aerosol particles have a mass median aerodynamic diameter between about 1 and 3 microns.
15 . The method of claim 14 , wherein the amine drug salt is selected from the group consisting of an antibiotic, anticonvulsant, antidepressant, antiemetic, antihistamine, antiparkinsonian drug, antipsychotic, anxiolytic, a drug for erectile dysfunction, a drug liar migraine headache, a drug for the treatment of addiction, a muscle relaxant, a non-steroidal anti-inflammatory, an opioid, or other analgesic.
16 . The method according to claim 15 , wherein said amine drug salt has a molecular weight between 200 to 600.
17 - 23 . (canceled)