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Claims for Patent: 6,337,090

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Claims for Patent: 6,337,090

Title: Orally administrable solid ribavirin dosage forms and process for making them
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 and a process for making such solid dosage forms are 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:09/582,060
Patent Claims: 1. An orally administrable solid dosage form comprising a compacted ribavirin composition comprising ribavirin and a pharmaceutically acceptable disintegrant wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

2. An orally administrable solid dosage form comprising a compacted ribavirin composition comprising:

(a) an antivirally effective amount of ribavirin;

(b) an effective amount of at least one filler selected from the group consisting of lactose anhydrous, lactose monohydrate, sucrose, mannitol, microcrystalline cellulose, pregelatinized starches, dibasic calcium phosphate dihydrate, calcium sulfate dihydrate and calcium sulfate trihydrate;

(c) an effective amount of a pharmaceutically acceptable disintegrant selected from the group consisting of croscarmellose sodium, sodium starch glycolate, corn starch, pregelatinized starch, sodium carboxymethyl cellulose, potato starch, microcrystalline cellulose, polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, magnesium aluminium silicate, bentonite, alginic acid and alginates; and

(d) an effective amount of a lubricant selected from the group consisting of magnesium stearate, calcium stearate, zinc stearate, talc, propylene glycol, PEG 4000, PEG 5000, PEG 6000, and stearic acid;

wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

3. The orally administrable solid dosage form as in claim 1 or 2, wherein the composition comprises about 200 mg to about 400 mg of ribavirin.

4. An orally administrable solid dosage form comprising a compacted ribavirin composition comprising:

and wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

5. The orally administrable solid dosage form as in claim 1 or 2 wherein the disintegrant is croscarmellose sodium or polyvinylpyrrolidone or mixtures thereof.

6. The orally administrable solid dosage form as in claims 1, 2 or 4 wherein the ribavirin is substantially free of polymorphic forms of ribavirin.

7. The orally administrable solid dosage form as in claims 1, 2 or 4 wherein the tap density of the composition is at least about 0.6 g/mL.

8. The orally administrable solid dosage form as in claims 1, 2 or 4 wherein the disintegration time of the dosage form is less than about 10 minutes.

9. The orally administrable solid dosage form of claim 4 wherein the tap density of the composition is in the range of about 0.75 g/mL to about 0.85 g/mL.

10. The orally administrable solid dosage form of claims 1, 2 or 4 wherein the dosage form is in the form of a tablet.

11. An orally administrable solid dosage form comprising a compacted ribavirin composition comprising:

wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

12. The orally administrable solid dosage form of claim 11, wherein more than about 90% by weight of the ribavirin dissolves in water in about 15 minutes.

13. The orally administrable solid dosage form of claim 11, wherein the tap density of the composition is in the range of about 0.75 g/mL to about 0.85 g/mL.

14. The orally administrable solid dosage form of claim 11, wherein the tap density of the composition is at least about 0.6 g/mL.

15. The orally administrable solid dosage form of claim 11, wherein the ribavirin is substantially free of polymorphic forms of ribavirin.

16. The orally administrable solid dosage form of claim 11 wherein the disintegration time of the dosage form is less than about 10 minutes.

17. The orally administrable solid dosage form as in any of claims 11, 12, 15 or 16 wherein the dosage form is in the form of a tablet.

18. The orally administrable solid dosage form as in claims 1, 2 or 4, wherein more than about 90% by weight of the ribavirin dissolves in water in about 15 minutes.

19. An orally administrable solid dosage form comprising a compacted composition comprising ribavirin and a pharmaceutically acceptable disintegrant, wherein disintegration time of the dosage form is less than about 10 minutes, and wherein more than about 80% by weight of the ribavirin dissolves in water in about 30 minutes.

20. The orally administrable dosage form as in claim 3, wherein the dosage form is in the form of a tablet.

21. The orally administrable dosage form as in claim 5, wherein the dosage form is in the form of a tablet.

22. The orally administrable dosage form as in claim 6, wherein the dosage form is in the form of a tablet.

23. The orally administrable dosage form as in claim 8, wherein the dosage form is in the form of a tablet.

24. The orally administrable dosage form as in claim 18, wherein the dosage form is in the form of a tablet.

25. The orally administrable dosage form as in claim 19, wherein the dosage form is in the form of a tablet.

26. The orally administrable solid dosage form as in any of claims 1, 2, 4, 11 or 13-23, wherein the dosage form is a capsule.

27. The orally administrable dosage form as in any of claims 1, 4 or 19, which further comprises polyvinylpyrrolidone.

28. The orally administrable solid dosage form as in claim 3, wherein the dosage form is in the form of a capsule.

29. The orally administrable solid dosage form as in claim 5, wherein the dosage form is in the form of a capsule.

30. The orally administrable solid dosage form as in claim 6, wherein the dosage form is in the form of a capsule.

31. The orally administrable solid dosage form as in claim 7, wherein the dosage form is in the form of a capsule.

32. The orally administrable solid dosage form as in claim 8, wherein the dosage form is in the form of a capsule.

33. The orally administrable solid dosage form as in claim 9, wherein the dosage form is in the form of a capsule.

34. The orally administrable solid dosage form as in claim 18, wherein the dosage form is in the form of a capsule.
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