Delivery of stimulants through an inhalation route
View Patent ↗The present invention relates to the delivery of stimulants through an inhalation route. Specifically, it relates to aerosols containing stimulants that are used in inhalation therapy. In a method aspect of the present invention, a stimulant is delivered to a patient through an inhalation route. The method comprises: a) heating a thin coating of a stimulant, on a solid support, to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% stimulant degradation products. In a kit aspect of the present invention, a kit for delivering a stimulant through an inhalation route is provided which comprises: a) a thin coating of a stimulant drug and b) a device for dispensing said thin coating a stimulant as a condensation aerosol.
1. A condensation aerosol for delivery of a drug selected from the group consisting of ephedrine and fenfluramine 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.
2. The condensation aerosol according to claim 1 , wherein the condensation aerosol is formed at a rate greater than 10 9 particles per second.
3. The condensation aerosol according to claim 2 , wherein the condensation aerosol is formed at a rate greater than 10 10 particles per second.
4. A method of producing a drug selected from the group consisting of ephedrine and fenfluramine in an aerosol form comprising:
a. heating a thin layer containing the drug, on a solid support, to produce a vapor of the drug, and
b. providing an air flow through 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.
5. The method according to claim 4 , wherein the condensation aerosol is formed at a rate greater than 10 9 per second.
6. The method according to claim 5 , wherein the condensation aerosol is formed at a rate greater than 10 10 particles per second.
7. The condensation aerosol according to claim 1 , wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns.
8. The condensation aerosol according to claim 1 , wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.
9. The condensation aerosol according to claim 8 , wherein the condensation aerosol is characterized by an MMAD of about 0.2 to about 3 microns.
10. The condensation aerosol according to claim 1 , wherein the condensation aerosol is characterized by less than 5% drug degradation products by weight.
11. The condensation aerosol according to claim 10 , wherein the condensation aerosol is characterized by less than 2.5% drug degradation products by weight.
12. The condensation aerosol according to claim 1 , wherein the solid support is a metal foil.
13. The condensation aerosol according to claim 1 , wherein the drug is ephedrine.
14. The condensation aerosol according to claim 1 , wherein the drug is fenfluramine.
15. The method according to claim 4 , wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns.
16. The method according to claim 4 , wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.
17. The method according to claim 16 , wherein the condensation aerosol is characterized by an MMAD of about 0.2 to about 3 microns.
18. The method according to claim 4 , wherein the condensation aerosol is characterized by less than 5% drug degradation products by weight.
19. The method according to claim 18 , wherein the condensation aerosol is characterized by less than 2.5% drug degradation products by weight.
20. The method according to claim 4 , wherein the solid support is a metal foil.
21. The method according to claim 4 , wherein the drug is ephedrine.
22. The method according to claim 4 , wherein the drug is fenfluramine.
23. A condensation aerosol for delivery of ephedrine, wherein the condensation aerosol is formed by heating a thin layer containing ephedrine, on a solid support, to produce a vapor of ephedrine, and condensing the vapor to form a condensation aerosol characterized by less than 5% ephedrine degradation products by weight, and an MMAD of about 0.2 to about 3 microns.
24. A condensation aerosol for delivery of fenfluramine, wherein the condensation aerosol is formed by heating a thin layer containing fenfluramine, on a solid support, to produce a vapor of fenfluramine, and condensing the vapor to form a condensation aerosol characterized by less than 5% fenfluramine degradation products by weight, and an MMAD of 0.2 to 3 microns.
25. A method of producing ephedrine in an aerosol form comprising:
a. heating a thin layer containing ephedrine, on a solid support, to produce a vapor of ephedrine, and
b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% ephedrine degradation products by weight, and an MMAD of 0.2 to 3 microns.
26. A method of producing fenfluramine in an aerosol form comprising:
a. heating a thin layer containing fenfluramine, on a solid support, to produce a vapor of fenfluramine, and
b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% fenfluramine degradation products by weight, and an MMAD of about 0.2 to about 3 microns.