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Details for Patent: 7,473,433

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Details for Patent: 7,473,433

Title:Pulmonary delivery of polyene antifungal agents
Abstract: The present invention provides spray-dried polyene compositions for oral inhalation to the lung. The polyene antifungal compositions demonstrate superior aerosol properties, do not exhibit appreciable degradation of the polyene upon spray-drying, and are useful in the treatment and prophylaxis of both pulmonary and systemic fungal infections.
Inventor(s): Weikert; Michael (Belmont, CA), Gordon; Marc S. (Sunnyvale, CA), Kumar; Sandeep (Sunnyvale, CA), Yang; Bing (Redwood City, CA), Sarwar; Razaq (Fremont, CA)
Assignee: Nektar Therapeutics (San Carlos, CA)
Filing Date:Dec 21, 2001
Application Number:10/032,239
Claims:1. A dry powder for delivery by inhalation to the lungs, the dry powder produced by a method comprising: i) dissolving a polyene antifungal compound in an acidified solvent to form an acidic polyene-containing solution, and ii) spray drying said polyene-containing solution to form an inhaleable dry powder containing no more than about 10% polyene degradation products and characterized by an emitted dose greater than 60%.

2. A dry powder produced by a method comprising: i) suspending a polyene antifungal compound in an aqueous solvent to form a suspension, ii) wet milling the suspension from (i) to form a wet-milled suspension, and iii) spray drying the wet milled suspension to produce an inhaleable dry powder containing no more than about 10% polyene degradation products and characterized by an emitted dose greater than about 60%.

3. A spray-dried powder composition suitable for oral inhalation to the lung comprising a therapeutically effective amount of a polyene antifungal compound, wherein the composition comprises no more than about 10% polyene degradation products and is characterized by an emitted dose greater than about 60%.

4. The powder composition of claim 3, containing no more than about 5% polyene degradation products.

5. The powder composition of claim 3, wherein the powder comprises particles having an MMAD of less than about 5 microns.

6. The powder composition of claim 5, wherein the powder comprises particles having an MMAD of less than about 3.5 microns.

7. The powder composition of claim 3, which is non-proteinaceous.

8. The powder composition of claim 3, wherein said polyene is nystatin or amphotericin B.

9. The powder composition of claim 3, wherein said polyene is non-encapsulated.

10. The powder composition of claim 9, wherein said polyene is non-liposome and non-polymer encapsulated.

11. The powder composition of claim 3 substantially comprising neat polyene.

12. The powder composition of claim 3, further comprising a pharmaceutically acceptable excipient.

13. The powder composition of claim 12, wherein said excipient is selected from the group consisting of buffers, leucine, and trileucine.

14. The powder composition of claim 12, comprising at least about 30% by weight polyene.

15. The powder composition of claim 14, comprising at least about 50% by weight polyene.

16. The powder composition of claim 3, having a water content greater than about 4% by weight.

17. The powder composition of claim 16, having a water content ranging from about greater than 4% by weight to about 10% by weight.

18. A spray-dried powder composition suitable for oral inhalation to the lung comprising a therapeutically effective amount of a polyene antifungal compound and a leucyl-containing excipient comprising from 1 to 3 amino acid residues.

19. An aerosolized, spray-dried powder composition suitable for oral inhalation to the lung comprising a therapeutically effective amount of a polyene antifungal compound, wherein the composition comprises no more than about 10% polyene degradation products and is characterized by an emitted dose greater than about 60%.

20. A method for treating or preventing fungal infection in a subject in need thereof, said method comprising administering to said subject by oral inhalation a therapeutically effective amount of a spray dried powder composition of claim 3 in aerosolized form.
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