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Last Updated: March 26, 2026

Claims for Patent: 11,529,357

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Summary for Patent: 11,529,357

Title:	Injectable carbamazepine composition essentially free of 10-bromo-carbamazepine
Abstract:	An injectable pharmaceutical composition comprising carbamazepine and sulfobutylether-7-β-cyclodextrin, wherein said composition is essentially free of 10-Br-carbamazepine, is disclosed. Methods for the manufacture of said composition and methods for treatment of disease using said composition are also disclosed.
Inventor(s):	Hans Petersen, Jesper Tungelund LARSEN
Assignee:	H Lundbeck AS
Application Number:	US16/778,302
Patent Claims:	1. An injectable pharmaceutical composition comprising carbamazepine and a sulfobutylether-7-β-cyclodextrin, wherein said composition comprises less than about 60 ppm 10-Br-carbamazepine relative to carbamazepine. 2. The composition according to claim 1, wherein the composition comprises about 10 mg/mL carbamazepine and about 250 mg/mL sulfobutylether-7-β-cyclodextrin, wherein the sulfobutylether-7-β-cyclodextrin is sulfobutylether-7-β-cyclodextrin sodium. 3. The composition according to claim 2, wherein the composition further comprises about 0.78 mg/mL sodium phosphate monobasic dihydrate and water, the composition having about 6.2. 4. The composition according to claim 1 comprising a) about 10 mg/mL of carbamazepine, b) about 25% weight/volume of sulfobutylether-7-β-cyclodextrin, and further comprising c) a physiologically acceptable fluid, wherein said composition is administered intravenously, and contains carbamazepine in a dose of about 30% to about 100% of a human's oral maintenance dose. 5. The composition according to claim 4, wherein said composition contains carbamazepine in a dose of about 65% to about 75% of the human's oral maintenance dose. 6. The composition according to claim 1, wherein said carbamazepine is manufactured in a process that achieves less than about 60 ppm 10-Br-carbamazepine relative to carbamazepine, wherein the process comprises a chemical reaction selected from the group consisting of wherein R is H, carbamoyl, a protecting group, or a group that may be transformed to carbamoyl. 7. The composition according to claim 6, wherein said process comprises the chemical reaction wherein R is H, carbamoyl, a protecting group, or a group that may be transformed to carbamoyl. 8. The composition according to claim 6, wherein the composition comprises about 10 mg/mL, carbamazepine and about 250 mg/mL, sulfobutylether-7-β-cyclodextrin, wherein the sulfobutylether-7-β-cyclodextrin is sulfobutylether-7-β-cyclodextrin sodium. 9. The composition according to claim 8, wherein the composition further comprises about 0.78 mg/mL, sodium phosphate monobasic dihydrate and water, the composition having pH about 6.2. 10. The composition according to claim 1, wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 11. The composition according to claim 10, wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine. 12. The composition according to claim 2, wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 13. The composition according to claim 12, wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine. 14. The composition according to claim 4, wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 15. The composition according to claim 14, wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine. 16. The composition according to claim 5, wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 17. The composition according to claim 16, wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine. 18. The composition according to claim 8, wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 19. The composition according to claim 18, wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine.

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