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Details for Patent: 7,094,392

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Details for Patent: 7,094,392

Title:Delivery of antihistamines through an inhalation route
Abstract: The present invention relates to the delivery of antihistamines through an inhalation route. Specifically, it relates to aerosols containing antihistamines that are used in inhalation therapy. In a method aspect of the present invention, an antihistamine is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises an antihistamine, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% antihistamine drug degradation products. In a kit aspect of the present invention, a kit for delivering an antihistamine through an inhalation route is provided which comprises: a) a thin coating of an antihistamine drug 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:Dec 30, 2003
Application Number:10/749,536
Claims:1. A method of treating allergy symptoms 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 azatadine, brompheniramine, carbinoxamine, chlorpheniramine, clemastine, cyproheptadine, loratadine, pyrilamine, hydroxyzine and promethazine, 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 between 0.2 mg and 2.5 mg of azatadine delivered in a single inspiration.

7. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.8 mg and 10 mg of brompheniramine delivered in a single inspiration.

8. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.8 mg and 10 mg of carbinoxamine delivered in a single inspiration.

9. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.5 mg and 5 mg of chlorpheniramine delivered in a single inspiration.

10. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.25 mg and 6 mg of clemastine delivered in a single inspiration.

11. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.8 mg and 10 mg of cyproheptadine delivered in a single inspiration.

12. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 2 mg and 25 mg of loratadine delivered in a single inspiration.

13. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 6 mg and 70 mg of pyrilamine delivered in a single inspiration.

14. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 2 mg and 100 mg of hydroxyzine delivered in a single inspiration.

15. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 5 mg and 60 mg of promethazine delivered in a single inspiration.

16. A method of administering a drug condensation aerosol to a patient comprising administering the drug compensation aerosol to the patient by inhalation, wherein the drug is selected from the group consisting of azatadine, brompheniramine, carbinoxamine, chlorpheniramine, clemastine, cyproheptadine, loratadine, pyrilamine, hydroxyzine and promethazine, 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.

17. 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 azatadine, brompheniramine, carbinoxamine, chlorpheniramine, clemastine, cyproheptadine, loratadine, pyrilamine, hydroxyzine and promethazine, 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.

18. The kit according to claim 17, 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.

19. The kit according to claim 18, wherein the heat for heating the solid support is generated by an exothermic chemical reaction.

20. The kit according to claim 19, wherein the exothermic chemical reaction is oxidation of combustible materials.

21. The kit according to claim 18, wherein the heat for heating the solid support is generated by passage of current through an electrical resistance element.

22. The kit according to claim 18, wherein the solid support has a surface area dimensioned to accommodate a therapeutic dose of the drug.

23. The kit according to claim 17, wherein peak plasma drug concentration is reached in less than 0.1 hours.

24. The kit according to claim 17, further including instructions for use.

25. The method according to claim 1, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns.

26. The method according to claim 2, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns.

27. The method according to claim 16, wherein the drug is azatadine.

28. The method according to claim 16, wherein the drug is brompheniramine.

29. The method according to claim 16, wherein the drug is carbinoxamine.

30. The method according to claim 16, wherein the drug is chlorpheniramine.

31. The method according to claim 16, wherein the drug is clemastine.

32. The method according to claim 16, wherein the drug is cyproheptadine.

33. The method according to claim 16, wherein the drug is loratadine.

34. The method according to claim 16, wherein the drug is pyrilamine.

35. The method according to claim 16, wherein the drug is hydroxyzine.

36. The method according to claim 16, wherein the drug is promethazine.

37. The kit according to claim 17, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.

38. The kit according to claim 17, wherein the condensation aerosol is characterized by an MMAD of 0.1 to 5 microns.

39. The kit according to claim 37, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns.

40. The kit according to claim 17, wherein the drug is azatadine.

41. The kit according to claim 17, wherein the drug is brompheniramine.

42. The kit according to claim 17, wherein the drug is carbinoxamine.

43. The kit according to claim 17, wherein the drug is chlorpheniramine.

44. The kit according to claim 17, wherein the drug is clemastine.

45. The kit according to claim 17, wherein the drug is cyproheptadine.

46. The kit according to claim 17, wherein the drug is loratadine.

47. The kit according to claim 17, wherein the drug is pyrilamine.

48. The kit according to claim 17, wherein the drug is hydroxyzine.

49. The kit according to claim 17, wherein the drug is promethazine.

50. The kit according to claim 18, wherein the solid support has a surface to mass ratio of greater than 1 cm.sup.2 per gram.

51. The kit according to claim 18, wherein the solid support has a surface to volume ratio of greater than 100 per meter.

52. The kit according to claim 18, wherein the solid support is a metal foil.

53. The kit according to claim 52, wherein the metal foil has a thickness of less than 0.25 mm.
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