Claims for Patent: 8,119,148

Summary 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.