Delivery of nonsteroidal antiinflammatory drugs through an inhalation route
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/12
A61K-009/14
A61M-015/00
출원번호
US-0735199
(2003-12-12)
발명자
/ 주소
Rabinowitz,Joshua D.
Zaffaroni,Alejandro C.
출원인 / 주소
Alexza Pharmaceuticals, Inc.
대리인 / 주소
Swanson &
인용정보
피인용 횟수 :
52인용 특허 :
77
초록▼
The present invention relates to the delivery of nonsteroidal antiinflammatory drugs (NSAIDs) through an inhalation route. Specifically, it relates to aerosols containing NSAIDs that are used in inhalation therapy. In a method aspect of the present invention, an NSAID is delivered to a patient thro
The present invention relates to the delivery of nonsteroidal antiinflammatory drugs (NSAIDs) through an inhalation route. Specifically, it relates to aerosols containing NSAIDs that are used in inhalation therapy. In a method aspect of the present invention, an NSAID is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises an NSAID, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% NSAID degradation products. In a kit aspect of the present invention, a kit for delivering an NSAID through an inhalation route is provided which comprises: a) a thin coating of an NSAID composition and b) a device for dispensing said thin coating as a condensation aerosol.
대표청구항▼
The invention claimed is: 1. A method of treating inflammation in a patient comprising administering a therapeutic amount of a drug condensation aerosol to the patient by inhalation, wherein the drug is selected from the group consisting of indomethacin, ketoprofen, celcoxib, rofecoxib, meclofenami
The invention claimed is: 1. A method of treating inflammation in a patient comprising administering a therapeutic amount of a drug condensation aerosol to the patient by inhalation, wherein the drug is selected from the group consisting of indomethacin, ketoprofen, celcoxib, rofecoxib, meclofenamic acid, fenoprofen, diflunisal, tolfenamic acid, naproxen, ibuprofen, flurbiprofen and nabumetone, and 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 method according to claim 1, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns. 3. The method according to claim 1, wherein peak plasma drug concentration is reached in less than 0.1 hours. 4. The method according to claim 1, wherein the condensation aerosol is formed at a rate greater than 0.5 mg/second. 5. The method according to claim 1, wherein at least 50% by weight of the condensation aerosol is amorphous in form. 6. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises greater than 5 mg of the drug delivered in a single inspiration. 7. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises greater than 7.5 mg of the drug delivered in a single inspiration. 8. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises greater than 10 mg of the drug delivered in a single inspiration. 9. A method of administering a drug condensation aerosol to a patient comprising administering the drug condensation aerosol to the patient by inhalation, wherein the drug is selected from the group consisting of indomethacin, ketoprofen, celcoxib, rofecoxib, meclofenamic acid, fenoprofen, diflunisal, tolfenamic acid, naproxen, ibuprofen, flurbiprofen and nabumetone, and wherein the drug 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. 10. A kit for delivering a drug condensation aerosol comprising: a. a thin layer containing the drug, on a solid support, wherein the drug is selected from the group consisting of indomethacin, ketoprofen, celcoxib, rofecoxib, meclofenamic acid, fenoprofen, diflunisal, tolfenamic acid, naproxen, ibuprofen, flurbiprofen and nabumetone, and b. a device for providing the condensation aerosol, wherein the condensation aerosol is formed by heating the thin layer 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. 11. The kit according to claim 10, wherein the device comprises: a. a flow through enclosure containing the solid support, b. a power source that can be activated to heat the solid support, and c. at least one portal through which air can be drawn by inhalation, wherein activation of the power source is effective to produce a vapor of the drug, and drawing air through the enclosure is effective to condense the vapor to form the condensation aerosol. 12. The kit according to claim 11, wherein the heat for heating the solid support is generated by an exothermic chemical reaction. 13. The kit according to claim 12, wherein the exothermic chemical reaction is oxidation of combustible materials. 14. The kit according to claim 11, wherein the heat for heating the solid support is generated by passage of current through an electrical resistance element. 15. The kit according to claim 11, wherein the solid support has a surface area dimensioned to accommodate a therapeutic dose of the drug. 16. The kit according to claim 10, wherein peak plasma drug concentration is reached in less than 0.1 hours. 17. The kit according to claim 10, further including instructions for use. 18. The method according to claim 1, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns. 19. The method according to claim 1, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns. 20. The method according to claim 9, wherein the drug is indomethacin. 21. The method according to claim 9, wherein the drug is ketoprofen. 22. The method according to claim 9, wherein the drug is celcoxib. 23. The method according to claim 9, wherein the drug is rofecoxib. 24. The method according to claim 9, wherein the drug is meclofenamic acid. 25. The method according to claim 9, wherein the drug is fenoprofen. 26. The method according to claim 9, wherein the drug is diflunisal. 27. The method according to claim 9, wherein the drug is tolfenamic acid. 28. The method according to claim 9, wherein the drug is naproxen. 29. The method according to claim 9, wherein the drug is ibuprofen. 30. The method according to claim 9, wherein the drug is flurbiprofen. 31. The method according to claim 9, wherein the drug is nabumetone. 32. The kit according to claim 10, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns. 33. The kit according to claim 10 wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns. 34. The kit according to claim 32, wherein the condensation aerosol is characterized by an MMAiD of about 0.2 to 3 microns. 35. The kit according to claim 10, wherein the drug is indomethacin. 36. The kit according to claim 10, wherein the drug is ketoprofen. 37. The kit according to claim 10, wherein the drug is celcoxib. 38. The kit according to claim 10, wherein the drug is rofecoxib. 39. The kit according to claim 10, wherein the drug is meclofenamic acid. 40. The kit according to claim 10, wherein the drug is fenoprofen. 41. The kit according to claim 10, wherein the drug is diflunisal. 42. The kit according to claim 10, wherein the drug is tolfenamic acid. 43. The kit according to claim 10, wherein the drug is naproxen. 44. The kit according to claim 10, wherein the drug is ibuprofen. 45. The kit according to claim 10, wherein the drug is flurbiprofen. 46. The kit according to claim 10, wherein the drug is nabumetone. 47. The kit according to claim 11, wherein the solid support has a surface to mass ratio of greater than 1 cm2 per gram. 48. The kit according to claim 11, wherein the solid support has a surface to volume ratio of greater than 100 per meter. 49. The kit according to claim 11, wherein the solid support is a metal foil. 50. The kit according to claim 49, wherein the metal foil has a thickness of less than 0.25 mm.
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