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Details for Patent: 8,404,217

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Details for Patent: 8,404,217

Title:Formulation for pulmonary administration of antifungal agents, and associated methods of manufacture and use
Abstract: Formulations are provided for pulmonary administration of an antifungal agent to a patient. Methods of using the formulations in the treatment of antifungal infections are also provided, including treatment of pulmonary aspergillosis with amphotericin B-containing formulations. Methods of manufacturing the formulations to achieve optimum properties are provided as well.
Inventor(s): Tarara; Thomas E. (Burlingame, CA), Weers; Jeffry G. (Belmont, CA), Eldon; Michael A. (Redwood City, CA), Narashimhan; Rangachari (Thornhill, CA), Clark; Andrew (Woodside, CA)
Assignee: Novartis AG (Basel, CH)
Filing Date:Jul 22, 2005
Application Number:11/187,757
Claims:1. A pharmaceutical formulation for pulmonary administration, comprising a plurality of particulates having a mass median diameter less than 20 .mu.m, wherein each particulate comprises: (a) a lipid matrix; and (b) at least one particle of an active agent in the lipid matrix, said active agent having an aqueous solubility of less than 1.0 mg/ml, wherein at least 90% of the active agent particles in the formulation have a geometric diameter less than 3 .mu.m.

2. The pharmaceutical formulation of claim 1 wherein the plurality of particulates has a mass median diameter less than 10 .mu.m.

3. The pharmaceutical formulation of claim 2, wherein the plurality of particulates has a mass median diameter less than 5 .mu.m.

4. The pharmaceutical formulation of claim 1, wherein at least at least 95% of the active agent particles have a geometric diameter less than 3 .mu.m.

5. The pharmaceutical formulation of claim 4, wherein at least 50% of the active agent particles have a geometric diameter between 0.5 .mu.m and 3 .mu.m.

6. The pharmaceutical formulation of claim 5, wherein at least 50% of the active agent particles have a geometric diameter between 1 .mu.m and 3 .mu.m.

7. The pharmaceutical formulation of claim 1, wherein the lipid matrix comprises a phospholipid.

8. The pharmaceutical formulation of claim 7, wherein the phospholipid has a gel to liquid phase transition temperature greater than about 40.degree. C.

9. The pharmaceutical formulation of claim 8, wherein the phospholipid has a gel to liquid phase transition temperature greater than about 60.degree. C.

10. The pharmaceutical formulation of claim 9, wherein the phospholipid has a gel to liquid phase transition temperature greater than about 80.degree. C.

11. The pharmaceutical formulation of claim 7, wherein the phospholipid is a phosphoglyceride.

12. The pharmaceutical formulation of claim 7, wherein the phospholipid is a saturated phospholipid.

13. The pharmaceutical formulation of claim 7, wherein the particulates further include a polyvalent cation effective to increase the gel-to-liquid transition temperature of the phospholipid.

14. The pharmaceutical formulation of claim 1, wherein the particulates further include a polyvalent cation.

15. The pharmaceutical formulation of claim 14, wherein the polyvalent cation is a divalent cation.

16. The pharmaceutical formulation of claim 15, wherein the divalent cation is Ca.sup.2+, Mg.sup.2+, or Zn.sup.2+.

17. The pharmaceutical formulation of claim 1, wherein the active agent is an antifungal agent.

18. The pharmaceutical formulation of claim 17, wherein the antifungal agent is a polyene.

19. The pharmaceutical formulation of claim 18, wherein the antifungal agent is selected from ambruticin, amphotericin B, hamycin, natamycin, nystatin, and pimaricin.

20. The pharmaceutical formulation of claim 19, wherein the antifungal agent is amphotericin B.

21. The pharmaceutical formulation of claim 1, further including particles of the active agent that are not incorporated in the particulates.
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