Details for Patent: 7,070,764

Title:	Delivery of analgesics through an inhalation route
Abstract:	The present invention relates to the delivery of analgesics through an inhalation route. Specifically, it relates to aerosols containing acetaminophen, orphenadrine or tramadol that are used in inhalation therapy. In a method aspect of the present invention, an analgesic is administered to a patient through an inhalation route. The method comprises: a) heating a thin layer of acetaminophen, orphenadrine or tramadol, on a solid support to form a vapor; and, b) passing air through the heated vapor to produce aerosol particles having less than 5% acetaminophen, orphenadrine or tramadol degradation products. In a kit aspect of the present invention, a kit for delivering acetaminophen, orphenadrine or tramadol through an inhalation is provided which comprises: a) a thin coating of an acetaminophen, orphenadrine or tramadol composition and b) a device for dispensing said thin coating as a condensation aerosol.
Inventor(s):	Rabinowitz; Joshua D. (Mountain View, CA), Zaffaroni; Alejandro C. (Atherton, CA)
Assignee:	Alexza Pharmaceuticals, Inc. (Palo Alto, CA)
Filing Date:	Jan 27, 2004
Application Number:	10/766,647
Claims:	1. A condensation aerosol for delivery of a drug selected from the group consisting of acetaminophen, orphenadrine and tramadol, 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.sup.9 particles per second. 3. The condensation aerosol according to claim 2, wherein the condensation aerosol is formed at a rate greater than 10.sup.10 particles per second. 4. A method of producing a drug selected from the group consisting of acetaminophen, orphenadrine and tramadol 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.sup.9 particles per second. 6. The method according to claim 5, wherein the condensation aerosol is formed at a rate greater than 10.sup.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 1, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 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 acetaminophen. 14. The condensation aerosol according to claim 1, wherein the drug is orphenadrine. 15. The condensation aerosol according to claim 1, wherein the drug is tramadol. 16. The method according to claim 4, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns. 17. The method according to claim 4, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns. 18. The method according to claim 4, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns. 19. The method according to claim 4, wherein the condensation aerosol is characterized by less than 5% drug degradation products by weight. 20. The method according to claim 19, wherein the condensation aerosol is characterized by less than 2.5% drug degradation products by weight. 21. The method according to claim 4, wherein the solid support is a metal foil. 22. The method according to claim 4, wherein the drug is acetaminophen. 23. The method according to claim 4, wherein the drug is orphenadrine. 24. The method according to claim 4, wherein the drug is tramadol. 25. A condensation aerosol for delivery of acetaminophen, wherein the condensation aerosol is formed by heating a thin layer containing acetaminophen, on a solid support, to produce a vapor of acetaminophen, and condensing the vapor to form a condensation aerosol characterized by less than 5% acetaminophen degradation products by weight, and an MMAD of about 0.2 to 3 microns. 26. A condensation aerosol for delivery of orphenadrine, wherein the condensation aerosol is formed by heating a thin layer containing orphenadrine, on a solid support, to produce a vapor of orphenadrine, and condensing the vapor to form a condensation aerosol characterized by less than 5% orphenadrine degradation products by weight, and an MMAD of about 0.2 to 3 microns. 27. A condensation aerosol for delivery of tramadol, wherein the condensation aerosol is formed by heating a thin layer containing tramadol, on a solid support, to produce a vapor of tramadol, and condensing the vapor to form a condensation aerosol characterized by less than 5% tramadol degradation products by weight, and an MMAD of about 0.2 to 3 microns. 28. A method of producing acetaminophen in an aerosol form comprising: a. heating a thin layer containing acetaminophen, on a solid support, to produce a vapor of acetaminophen, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% acetaminophen degradation products by weight, and an MMAD of about 0.2 to 3 microns. 29. A method of producing orphenadrine in an aerosol form comprising: a. heating a thin layer containing orphenadrine, on a solid support, to produce a vapor of orphenadrine, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% orphenadrine degradation products by weight, and an MMAD of about 0.2 to 3 microns. 30. A method of producing tramadol in an aerosol form comprising: a. heating a thin layer containing tramadol, on a solid support, to produce a vapor of tramadol, and b. providing an air flow through the vapor to form a condensation aerosol characterized by less than 5% tramadol degradation products by weight, and an MMAD of about 0.2 to 3 microns.