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Claims for Patent: 8,119,148

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Claims for Patent: 8,119,148

Title:Suspension comprising oxcarbazepine
Abstract: This invention provides a pharmaceutical composition in the form of a suspension comprising oxcarbazepine.
Inventor(s): Sigg; Juergen (Loerrach, DE), Billington; Michael (Riehen, CH)
Assignee: Novartis Pharmaceuticals Corporation (East Hanover, NJ)
Application Number:10/168,248
Patent Claims: 1. A pharmaceutical composition in the form of a suspension comprising oxcarbazepine in an amount of 5 to 7 g/100 mL, an antioxidant, a mixture of carboxymethylcellulose and microcrystalline cellulose in a range of 1.25 to 1.95 g/100 mL, and 0 g/100 mL of hydroxyethylcellulose.

2. The composition according to claim 1 wherein the ratio of carboxymethylcellulose to microcrystalline cellulose in the mixture is 1:5 to 1:12.

3. The composition according to claim 1 wherein the carboxymethylcellulose in the mixture is a sodium salt.

4. The composition according to claim 1 wherein the antioxidant is ascorbic acid.

5. The composition according to claim 1 wherein the antioxidant is present in a range of 0.75 to 2 g/100 mL.

6. The composition according to claim 4 wherein the antioxidant is present in a range of 0.75 to 2 g/100 mL.

7. The composition according to claim 1 having a pH in the range of 2 to 4.

8. A container having a fill volume of from about 50 ml to about 300 ml comprising an oxcarbazepine suspension according to claim 1 and a dosing syringe adapted to fit said container.

9. A method for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or without secondary generalization, which method comprises administering to a subject in need thereof a composition according to claim 1.

10. The composition according to claim 1 comprising oxcarbazepine in an amount of 6 g/100 mL.

11. The composition according to claim 1 wherein the mixture of carboxymethylcellulose and microcrystalline cellulose is present in an amount of 1.35 to 1.65 g/100 mL.

12. The composition according to claim 11 wherein the mixture of carboxymethylcellulose and microcrystalline cellulose is present in an amount of 1.5 g/100 mL.

13. The composition according to claim 1 wherein the ratio of carboxymethylcellulose to microcrystalline cellulose in the mixture is 1:8 to 1:10.

14. The composition according to claim 1 having a pH in the range of 2.7 to 3.7.

15. A pharmaceutical composition in the form of a suspension comprising oxcarbazepine in an amount of 5 to 7 g/100 mL, ascorbic acid, a mixture of carboxymethylcellulose and microcrystalline cellulose in a range of 1.25 to 1.95 g/100 mL, and 0 g/100 mL of hydroxyethylcellulose, and having a pH in the range of 2 to 4.

16. The composition according to claim 15 wherein the ratio of carboxymethylcellulose to microcrystalline cellulose in the mixture is 1:5 to 1:12.

17. The composition according to claim 15 wherein the carboxymethylcellulose in the mixture is a sodium salt.

18. A container having a fill volume of from about 50 ml to about 300 ml comprising an oxcarbazepine suspension according to claim 15 and a dosing syringe adapted to fit said container.

19. A method for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or without secondary generalization, which method comprises administering to a subject in need thereof a composition according to claim 15.

20. The composition according to claim 15 comprising oxcarbazepine in an amount of 6 g/100 mL.

21. The composition according to claim 15 wherein the mixture of carboxymethylcellulose and microcrystalline cellulose is present in an amount of 1.35 to 1.65 g/100 mL.

22. The composition according to claim 21 wherein the mixture of carboxymethylcellulose and microcrystalline cellulose is present in an amount of 1.5 g/100 mL.

23. The composition according to claim 15 wherein the ratio of carboxymethylcellulose to microcrystalline cellulose in the mixture is 1:8 to 1:10.

24. The composition according to claim 15 having a pH in the range of 2.7 to 3.7.

25. The composition according to claim 24 wherein the ascorbic acid is present in a range of 0.75 to 2 g/100 mL.

26. A pharmaceutical composition in the form of a suspension consisting essentially of: oxcarbazepine in an amount of 1 to 20 g/100 mL; water; optionally at least one water-miscible organic co-solvent in an amount of 0.5 to 10 g/100 mL; ascorbic acid; a mixture of carboxymethylcellulose and microcrystalline cellulose in a range of 1.25 to 1.95 g/100 mL; optionally at least one preservative; optionally at least one wetting agent; optionally at least one sweetener; optionally at least one flavoring agent; wherein the composition has a pH in the range of 2 to 4.

27. The composition according to claim 26 wherein the ascorbic acid is present in a range of 0.75 to 2 g/100 mL and which has a pH in the range of 2.7 to 3.7.

28. The composition according to claim 27 wherein the oxcarbazepine is in an amount of 5 to 7 g/100 mL.

29. The composition according to claim 26 wherein there is said at least one water-miscible organic co-solvent in an amount of 0.5 to 10 g/100 mL.

30. The composition according to claim 26 wherein the ratio of carboxymethylcellulose to microcrystalline cellulose in the mixture is 1:5 to 1:12.

31. The composition according to claim 26 wherein the carboxymethylcellulose in the mixture is a sodium salt.

32. The composition according to claim 26 wherein the antioxidant is present in a range of 0.75 to 2 g/100 mL.

33. A container having a fill volume of from about 50 ml to about 300 ml comprising an oxcarbazepine suspension according to claim 26 and a dosing syringe adapted to fit said container.

34. A method for the treatment of primary generalized tonic-clonic seizures and partial seizures, with or without secondary generalization, which method comprises administering to a subject in need thereof a composition according to claim 26.

35. The composition according to claim 26 comprising oxcarbazepine in an amount of 6 g/100 mL.

36. The composition according to claim 26 wherein the mixture of carboxymethylcellulose and microcrystalline cellulose is present in an amount of 1.35 to 1.65 g/100 mL.

37. The composition according to claim 11 wherein the mixture of carboxymethylcellulose and microcrystalline cellulose is present in an amount of 1.5 g/100 mL.

38. The composition according to claim 26 wherein the ratio of carboxymethylcellulose to microcrystalline cellulose in the mixture is 1:8 to 1:10.

39. The composition according to claim 26 having a pH in the range of 2.7 to 3.7.
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