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Details for Patent: 6,123,936

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Details for Patent: 6,123,936

Title: Methods and compositions for the dry powder formulation of interferons
Abstract:According to the present invention, methods and compositions are provided for spray-dried, interferon-based dry powder compositions, particularly interferon-beta. The compositions are useful for treating conditions in humans that are responsive to treatment with interferons. In particular, the methods of the present invention rely on spray drying to produce stable, high-potency dry powder formulations of interferons, including but not limited to IFN-beta. Surprisingly, it has been found that IFN can be prepared in high potency, dry powder formulations by spray drying. Such dry powder formulations find particular utility in the pulmonary delivery of IFN.
Inventor(s): Platz; Robert M. (Half Moon Bay, CA), Kimura; Shigenobu (Hyogo, JP), Satoh; Yu-ichiro (Sapporo, JP), Foster; Linda C. (Mountain View, CA)
Assignee: Inhale Therapeutics Systems, Inc. (San Carlos, CA)
Filing Date:Nov 22, 1999
Application Number:09/444,116
Claims:1. A dispersible dry powder for pulmonary delivery, comprising a therapeutically effective amount of an interferon in combination with a hydrophobic amino acid.

2. A spray-dried powder of claim 1.

3. The dry powder of claim 1, wherein said amino acid is selected from the group consisting of tryptophan, tyrosine, leucine, and phenylalanine.

4. The dry powder of claim 1, further comprising a pharmaceutically acceptable carrier.

5. The dry powder of claim 1, wherein about 95% of the mass of the dry powder has a particle size of less than 10 .mu.m.

6. The dry powder of claim 1, wherein about 80% of the mass of the dry powder has a particle size of less than 5 .mu.m.

7. The dry powder of claim 1, wherein the interferon is naturally-occurring.

8. The dry powder of claim 1, wherein the interferon is interferon-beta.

9. The dry powder of claim 1, having a moisture content of less than about 5%.

10. A unit dosage form for pulmonary delivery of interferon comprising a unit dosage receptacle containing the dry powder of any one of claims 1-6.

11. The dry powder of claim 3, wherein said amino acid is leucine.

12. The dry powder of claim 4, wherein said carrier comprises a carbohydrate bulking agent.

13. The dry powder of claim 12, wherein said carbohydrate is selected from the group consisting of lactose, trehalose, raffinose, maltodextrins, and mannitol.

14. A method for treating a disease state responsive to treatment by an interferon, comprising pulmonarily administering to a subject in need thereof a physiologically effective amount of a disperisible dry powder comprising a therapeutically effective amount of an interferon in combination with a hydrophobic amino acid.

15. The method of claim 14, wherein said powder is spray-dried.

16. The method of claim 14, wherein said hydrophobic amino acid is selected from the group consisting of tryptophan, tyrosine, leucine, and phenylalanine.

17. The method of claim 14, wherein said powder further comprises a pharmaceutically acceptable carrier.

18. The method of claim 16, wherein said hydrophobic amino acid is leucine.

19. A method for aerosolizing an interferon-containing dry powder, said method comprising:

dispersing an amount of the dry powder of any one of claims 1-6 in a gas stream to form an aerosol, and

capturing the aerosol in a chamber for subsequent inhalation by a patient.

20. A method for preparing an interferon-based dry powder suitable for pulmonary delivery, said method comprising:

spray-drying an aqueous mixture of an interferon and a hydrophobic amino acid under conditions effective to provide a respirable powder.

21. The method of claim 20, wherein the spray-dried powder is substantially amorphous.

22. The method of claim 20, wherein the interferon in the spray-dried powder maintains at least about 75% of its initial activity.
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