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Details for Patent: 7,070,766

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Details for Patent: 7,070,766

Title:Delivery of physiologically active compounds through an inhalation route
Abstract: The present invention relates to the delivery of physiologically active compounds through an inhalation route. Specifically, it relates to aerosols containing physiologically active compounds that are used in inhalation therapy. In a method aspect of the present invention, a physiologically active compound is delivered to a patient through an inhalation route. The method comprises: a) heating a composition, wherein the composition comprises a physiologically active compound, to form a vapor; and, b) allowing the vapor to cool, thereby forming a condensation aerosol comprising particles with less than 5% physiologically active compound degradation products. In a kit aspect of the present invention, a kit for delivering a physiologically active compound through an inhalation route is provided which comprises: a) a thin coating of a physiologically active compound 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 30, 2004
Application Number:10/769,046
Claims:1. A method of treating anxiety, vertigo, alcohol withdrawal, nicotine withdrawal, sedation, hot flashes, peptic ulcers or for testosterone replacement therapy, hormone replacement therapy, or prevention of pregnancy 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 chlordiazepoxide, betahistine, clonidine, testosterone, a conjugated estrogen, an estrogen ester, estradiol, an estradiol ester, ethinyl estradiol, an ethinyl estradiol ester and hyoscyamine, 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 1 mg and 40 mg of chlordiazepoxide delivered in a single inspiration.

7. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.5 mg and 50 mg of betahistine delivered in a single inspiration.

8. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.02 mg and 2 mg of clonidine delivered in a single inspiration.

9. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.1 mg and 20 mg of testosterone delivered in a single inspiration.

10. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.05 mg and 5 mg of a conjugated estrogen or an estrogen ester delivered in a single inspiration.

11. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.001 mg and 0.2 mg of estradiol, an estradiol ester, ethinyl estradiol or an ethinyl estradiol ester delivered in a single inspiration.

12. The method according to claim 1, wherein the therapeutic amount of a drug condensation aerosol comprises between 0.01 mg and 1 mg of hyoscyamine delivered in a single inspiration.

13. 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 chlordiazepoxide, betahistine, clonidine, testosterone, a conjugated estrogen, an estrogen ester, estradiol, an estradiol ester, ethinyl estradiol, an ethinyl estradiol ester and hyoscyamine, 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.

14. 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 chlordiazepoxide, betahistine, clonidine, testosterone, a conjugated estrogen, an estrogen ester, estradiol, an estradiol ester, ethinyl estradiol, an ethinyl estradiol ester and hyoscyamine, 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.

15. The kit according to claim 14, 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.

16. The kit according to claim 15, wherein the heat for heating the solid support is generated by an exothermic chemical reaction.

17. The kit according to claim 16, wherein the exothermic chemical reaction is oxidation of combustible materials.

18. The kit according to claim 15, wherein the heat for heating the solid support is generated by passage of current through an electrical resistance element.

19. The kit according to claim 15, wherein the solid support has a surface area dimensioned to accommodate a therapeutic dose of the drug.

20. The kit according to claim 14, wherein peak plasma drug concentration is reached in less than 0.1 hours.

21. The kit according to claim 14, further including instructions for use.

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

23. The method according to claim 1, wherein the condensation aerosol is characterized by an MMAD of about 0.2 to 3 microns.

24. The method according to claim 13, wherein the drug is chlordiazepoxide.

25. The method according to claim 13, wherein the drug is betahistine.

26. The method according to claim 13, wherein the drug is clonidine.

27. The method according to claim 13, wherein the drug is testosterone.

28. The method according to claim 13, wherein the drug is a conjugated estrogen or an estrogen ester.

29. The method according to claim 13, wherein the drug is estradiol, an estradiol ester, ethinyl estradiol or an ethinyl estradiol ester.

30. The method according to claim 13, wherein the drug is hyoscyamine.

31. The kit according to claim 14, wherein the condensation aerosol is characterized by an MMAD of less than 3 microns.

32. The kit according to claim 14 wherein the condensation aerosol is characterized by an MMAD of 0.2 to 5 microns.

33. The kit according to claim 14, wherein the condensation aerosol is characterized by an MMAD of 0.2 to 3 microns.

34. The kit according to claim 14, wherein the drug is chlordiazepoxide.

35. The kit according to claim 14, wherein the drug is betahistine.

36. The kit according to claim 14, wherein the drug is clonidine.

37. The kit according to claim 14, wherein the drug is testosterone.

38. The kit according to claim 14, wherein the drug is a conjugated estrogen or an estrogen ester.

39. The kit according to claim 14, wherein the drug is estradiol, an estradiol ester, ethinyl estradiol or an ethinyl estradiol ester.

40. The kit according to claim 14, wherein the drug is hyoscyamine.

41. The kit according to claim 15, wherein the solid support has a surface to mass ratio of greater than 1 cm.sup.2 per gram.

42. The kit according to claim 15, wherein the solid support has a surface to volume ratio of greater than 100 per meter.

43. The kit according to claim 15, wherein the solid support is a metal foil.

44. The kit according to claim 43, wherein the metal foil has a thickness of less than 0.25 mm.
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