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Claims for Patent: 6,790,837

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Claims for Patent: 6,790,837

Title: Ribavirin syrup formulations
Abstract:A liquid formulation comprising ribavirin having a longer shelf life and improved taste is disclosed.
Inventor(s): Heimbecher; Susan K. (Morris Plains, NJ), Sequeira; Joel A. (Edison, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:10/285,119
Patent Claims: 1. A liquid formulation comprising ribavirin, a buffering system, wherein the pH of the liquid formulation is in the range of about 4.8 to about 5.3, at least one pharmaceutically acceptable sweetening agent, and at least one pharmaceutically acceptable viscosity increasing agent.

2. The liquid formulation according to claim 1, wherein the buffering system comprises sodium citrate dihydrate and citric acid anhydrous.

3. The liquid formulation according to claim 2, wherein the sodium citrate dihydrate is present in a concentration of about 5 grams/liter and the citric acid anhydrous is present in a concentration of about 2 grams/liter.

4. The liquid formulation according to claim 1, wherein the ribavirin is present in a concentration of about 20 to about 65 grams/liter.

5. The liquid formulation according to claim 4, wherein the ribavirin is present in a concentration of about 40 grams/liter.

6. The liquid formulation according to claim 1, wherein there is at least two pharmaceutically acceptable sweetening agents.

7. The liquid formulation according to claim 6, wherein the at least two pharmaceutically acceptable sweetening agents that are present are granulated sucrose and sorbitol solution.

8. The liquid formulation according to claim 7, wherein the granulated sucrose is present in a concentration of about 300 grams/liter and the sorbitol solution is present in a concentration of about 100 grams/liter to about 150 grams/liter.

9. The liquid formulation according to claim 7, further comprising at least one additional pharmaceutically acceptable sweetening agent.

10. The liquid formulation according to claim 1, wherein the at least one pharmaceutically acceptable viscosity increasing agent is propylene glycol USP.

11. The liquid formulation according to claim 10, wherein the propylene glycol USP is present in a concentration of about 100 grams/liter.

12. The liquid formulation according to claim 1, further comprising an antimicrobial agent.

13. The liquid formulation according to claim 1, wherein the liquid formulation is storage stable for at least 18 months.

14. A pharmaceutically acceptable syrup formulation comprising ribavirin, a buffering system, wherein the pH of the pharmaceutically acceptable syrup formulation is in the range of about 4.8 to about 5.3, at least one pharmaceutically acceptable sweetening agent, and at least one pharmaceutically acceptable viscosity increasing agent.

15. The pharmaceutically acceptable syrup formulation according to claim 14, wherein the buffering system comprises sodium citrate dihydrate and citric acid anhydrous.

16. The pharmaceutically acceptable syrup formulation according to claim 15, wherein the sodium citrate dihydrate is present in a concentration of about 5 grams/liter and the citric acid anhydrous is present in a concentration of about 2 grams/liter.

17. The pharmaceutically acceptable syrup formulation according to claim 14, wherein the ribavirin is present in a concentration of about 20 to about 65 grams/liter.

18. The pharmaceutically acceptable syrup formulation according to claim 17, wherein the ribavirin is present in a concentration of about 40 grams/liter.

19. The pharmaceutically acceptable syrup formulation according to claim 14, wherein there is at least two pharmaceutically acceptable sweetening agents.

20. The pharmaceutically acceptable syrup formulation according to claim 19, wherein the at least two pharmaceutically acceptable sweetening agents that are present are granulated sucrose and sorbitol solution.

21. The pharmaceutically acceptable syrup formulation according to claim 20, wherein the granulated sucrose is present in a concentration of about 300 grams/liter and the sorbitol solution is present in a concentration of about 100 grams/liter to about 150 grams/liter.

22. The pharmaceutically acceptable syrup formulation according to claim 19, further comprising at least one additional pharmaceutically acceptable sweetening agent.

23. The pharmaceutically acceptable syrup formulation according to claim 14, wherein the at least one pharmaceutically acceptable viscosity increasing agent is propylene glycol USP.

24. The pharmaceutically acceptable syrup formulation according to claim 23, wherein the propylene glycol USP is present in a concentration of about 100 grams/liter.

25. The pharmaceutically acceptable syrup formulation according to claim 14, further comprising an antimicrobial agent.

26. The pharmaceutically acceptable syrup formulation according to claim 14, wherein the pharmaceutically acceptable syrup formulation is storage stable for at least 18 months.

27. A pharmaceutically acceptable syrup formulation comprising ribavirin, a buffering system, said buffering system comprising sodium citrate dihydrate and citric acid anhydrous, wherein the pH of the pharmaceutically acceptable syrup formulation is in the range of about 4.8 to about 5.3, at least one pharmaceutically acceptable sweetening agent, and at least one pharmaceutically acceptable viscosity increasing agent.

28. The pharmaceutically acceptable syrup formulation according to claim 27, wherein the sodium citrate dihydrate is present in a concentration of about 5 grams/liter and the citric acid anhydrous is present in a concentration of about 2 grams/liter.

29. The pharmaceutically acceptable syrup formulation according to claim 27, wherein the ribavirin is present in a concentration of about 20 to about 65 grams/liter.

30. The pharmaceutically acceptable syrup formulation according to claim 29, wherein the ribavirin is present in a concentration of about 40 grams/liter.

31. The pharmaceutically acceptable syrup formulation according to claim 27, wherein there is at least two pharmaceutically acceptable sweetening agents.

32. The pharmaceutically acceptable syrup formulation according to claim 31, wherein the at least two pharmaceutically acceptable sweetening agents that are present are granulated sucrose and sorbitol solution.

33. The pharmaceutically acceptable syrup formulation according to claim 32, wherein the granulated sucrose is present in a concentration of about 300 grams/liter and the sorbitol solution is present in a concentration of about 100 grams/liter to about 150 grams/liter.

34. The pharmaceutically acceptable syrup formulation according to claim 31, further comprising at least one additional pharmaceutically acceptable sweetening agent.

35. The pharmaceutically acceptable syrup formulation according to claim 27, wherein the at least one pharmaceutically acceptable viscosity increasing agent is propylene glycol USP.

36. The pharmaceutically acceptable syrup formulation according to claim 35, wherein the propylene glycol USP is present in a concentration of about 100 grams/liter.

37. The pharmaceutically acceptable syrup formulation according to claim 27, further comprising an antimicrobial agent.

38. The pharmaceutically acceptable syrup formulation according to claim 27, wherein the pharmaceutically acceptable syrup formulation is storage stable for at least 18 months.
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