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Details for Patent: 6,479,049

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Details for Patent: 6,479,049

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 Therapeutic Systems, Inc. (San Carlos, CA)
Filing Date:Feb 17, 2000
Application Number:09/506,426
Claims:1. A spray-dried powder composition for pulmonary delivery, comprising: (i) a therapeutically effective amount of an interferon, and (ii) a pharmaceutically acceptable carrier, wherein said composition is substantially free from penetration enhancers.

2. The composition of claim 1, wherein said carrier comprises human serum albumin.

3. The composition of claim 1, wherein said carrier is selected from the group consisting of carbohydrates, amino acids, and polypeptides.

4. The composition of claim 3, wherein said carrier is a carbohydrate selected from the group consisting of monosaccharides, disaccharides, cyclodextrins, and polysaccharides.

5. The composition of claim 3, wherein said carrier is a carbohydrate selected from the group consisting of lactose, trehalose, raffinose, maltodextrins, and mannitol.

6. The composition of claim 3, wherein said carrier is an amino acid.

7. The composition of claim 6, wherein said amino acid is selected from the group consisting of alanine, glycine, tryptophan, tyrosine, leucine, and phenylalanine.

8. The composition of claim 3, wherein said carrier is a polypeptide.

9. The composition of claim 3, wherein said carrier comprises a carbohydrate and an amino acid.

10. The composition of claim 3, wherein said carrier comprises a carbohydrate and a polypeptide.

11. The composition of claim 3, wherein said carrier comprises an amino acid and a polypeptide.

12. The composition of claim 11, further comprising a carbohydrate.

13. The composition of claim 1, wherein said interferon is interferon-beta.

14. The composition of claim 1, wherein said interferon is naturally-occurring.

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

16. The composition of claim 15, wherein about 80% of the mass of the dry powder composition has a particle size of less than 5 .mu.m.

17. A unit dosage form for pulmonary delivery of an interferon, comprising a unit dosage receptacle containing the dry powder composition of claim 1.
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