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Claims for Patent: 6,335,032

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Claims for Patent: 6,335,032

Title: Orally administrable solid dosage form
Abstract:An orally administrable solid dosage form containing a compacted ribavirin composition having an advantageously high tap density of at least 0.6 g/mL as well as surprisingly rapid disintegration and dissolution rates and wherein the ribavirin is substantially free of polymorphic forms of ribavirin is disclosed.
Inventor(s): Liebowitz; Stephen M. (Neshanic Station, NJ), Stupak; Elliot I. (West Caldwell, NJ), Chaudry; Imtiaz A. (North Caldwell, NJ), Vadino; Winston A. (Whitehouse Station, NJ), Bowen; Frank E. (Rutherford, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:09/518,871
Patent Claims: 1. A rapidly dissolving ribavirin composition comprising ribavirin wherein the ribavirin is substantially free of another ribavirin polymorphic form and wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

2. An orally administrable solid ribavirin composition comprising ribavirin and a pharmaceutically acceptable disintegrant, wherein the ribavirin is substantially free of another ribavirin polymorphic form.

3. An orally administrable solid ribavirin composition having substantially uniform physical and chemical characteristics, said composition comprising ribavirin and a pharmaceutically acceptable disintegrant and wherein the ribavirin is substantially free of another ribavirin polymorphic form and wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

4. A rapidly dissolving ribavirin composition having a tap density of at least about 0.6 g/mL wherein the ribavirin is substantially free of another ribavirin polymorphic form.

5. The rapidly dissolving ribavirin composition of claim 4 wherein the tap density is in the range of about 0.75 to about 0.85 g/mL.

6. The rapidly dissolving ribavirin composition of claim 4 wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

7. The rapidly dissolving ribavirin composition of claim 4 which further comprises a pharmaceutically acceptable filler.

8. The rapidly dissolving ribavirin composition of claim 4 which further comprises a pharmaceutically acceptable disintegrant.

9. A rapidly dissolving ribavirin composition having a tap density of at least about 0.6 g/mL, wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

10. The rapidly dissolving ribavirin composition of claim 9 wherein the tap density is in the range of about 0.75 to about 0.85 g/mL.

11. The rapidly dissolving ribavirin composition of claim 9 wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

12. The rapidly dissolving ribavirin composition of claim 9 which further comprises a pharmaceutically acceptable filler.

13. The rapidly dissolving ribavirin composition of claim 9 which further comprises a pharmaceutically acceptable disintegrant.

14. The rapidly dissolving ribavirin composition of claim 1, wherein the disintegration time of the composition is less than about 10 minutes.

15. The rapidly dissolving ribavirin composition of claim 1 which further comprises a pharmaceutically acceptable filler.

16. The rapidly dissolving ribavirin composition of claim 1 which further comprises a pharmaceutically acceptable disintegrant.

17. The orally administrable solid ribavirin composition of claim 2, wherein the disintegration time of the composition is less than about 10 minutes.

18. The rapidly dissolving ribavirin composition of claim 2 which further comprises a pharmaceutically acceptable filler.

19. The orally administrable solid ribavirin composition of claim 3, wherein the disintegration time of the composition is less than about 10 minutes.

20. The rapidly dissolving ribavirin composition of claim 3 which further comprises a pharmaceutically acceptable filler.
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