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Last Updated: September 21, 2021

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Claims for Patent: 9,770,407


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Summary for Patent: 9,770,407
Title:Parenteral carbamazepine formulation
Abstract: The present invention is directed to a carbamazepine-cyclodextrin inclusion complex useful for the parenteral administration of carbamazepine. The carbamazepine-cyclodextrin inclusion complex is prepared by the admixture of a modified cyclodextrin and carbamazepine in a physiologically acceptable fluid. Modified cyclodextrins include 2-hydroxypropyl-beta-cyclodextrin and sulfoalkyl cyclodextrins. More particularly, the sulfoalkyl cyclodextrins are those described and disclosed in U.S. Pat. Nos. 5,134,127 and 5,376,645. A physiologically acceptable fluid includes sterile isotonic water, Ringer's lactate, D5W (5% dextrose in water), physiological saline, and similar fluids suitable for parenteral administration.
Inventor(s): Cloyd; James (Edina, MN), Birnbaum; Angela (Minneapolis, MN), Leppik; Ilo (Minneapolis, MN), Collins; Stephen D. (Lake Forest, IL)
Assignee: LUNDBECK PHARMACEUTICALS LLC (Deerfield, IL)
Application Number:14/051,938
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,770,407
Patent Claims: 1. An injectable pharmaceutical composition comprising i. about 10 mg/mL of carbamazepine, ii. about 25% weight/volume of a sulfoalkyl-cyclodextrin, and iii. a physiologically acceptable fluid, wherein said composition is administered parenterally, and wherein said composition contains carbamazepine in a dose of about 30% to about 100% of a human's oral maintenance dose.

2. The composition of claim 1, wherein the sulfoalkyl-cyclodextrin is sulfobutylether-7-.beta.-cyclodextrin.

3. The composition of claim 1, wherein administration is intravenous, intraarterial, intramuscular, subcutaneous or intraperitoneal.

4. The composition of claim 1, wherein administration is intravenous.

5. The composition of claim 1, wherein said composition contains carbamazepine in a dose of about 65% to about 75% of the human's oral maintenance dose.

6. The composition of claim 1, wherein said composition provides an AUC for carbamazepine from about 70% to about 130% of the AUC for carbamazepine in the oral maintenance dose.

7. The composition of claim 1, wherein said composition provides a minimum plasma concentration of about 70% to about 130% of the minimum carbamazepine plasma concentration of the oral maintenance dose.

8. The composition of claim 1, wherein said composition provides a minimum plasma concentration of about 80% to about 125% of the minimum carbamazepine plasma concentration of the oral maintenance dose.

9. The composition of claim 1, wherein said composition provides trough carbamazepine concentrations within the therapeutic range.

10. The composition of claim 1, wherein said composition provides a carbamazepine half-life of about 8 to about 65 hours.

11. The composition of claim 1, wherein said composition provides a carbamazepine half-life of about 24 hours.

12. The composition of claim 1, wherein said composition has a dosing interval of every 6 hours.

13. An injectable pharmaceutical composition comprising i. about 10 mg/mL of carbamazepine, ii. about 25% weight/volume sulfobutylether-7-.beta.-cyclodextrin, and iii. a physiologically acceptable fluid, wherein said composition is administered intravenously, and wherein said composition contains carbamazepine in a dose of about 30% to about 100% of a human's oral maintenance dose.

14. The composition of claim 13, wherein said composition contains carbamazepine in a dose of about 65% to about 75% of the human's oral maintenance dose.

15. The composition of claim 13, wherein said composition provides an AUC for carbamazepine from about 70% to about 130% of the AUC for carbamazepine in the oral maintenance dose.

16. The composition of claim 13, wherein said composition provides a minimum plasma concentration of about 70% to about 130% of the minimum carbamazepine plasma concentration of the oral maintenance dose.

17. The composition of claim 13, wherein said composition provides a minimum plasma concentration of about 80% to about 125% of the minimum carbamazepine plasma concentration of the oral maintenance dose.

18. The composition of claim 13, wherein said composition provides trough carbamazepine concentrations within the therapeutic range.

19. The composition of claim 13, wherein said composition provides a carbamazepine half-life of about 8 to about 65 hours.

20. The composition of claim 13, wherein said composition provides a carbamazepine half-life of about 24 hours.

21. The composition of claim 13, wherein said composition has a dosing interval of every 6 hours.

22. An injectable pharmaceutical composition comprising i. about 10 mg/mL of carbamazepine, ii. about 25% weight/volume sulfobutylether-7-.beta.-cyclodextrin, and iii. a physiologically acceptable fluid, wherein said composition is administered intravenously, wherein said composition contains carbamazepine in a dose of about 65% to about 75% of a human's oral maintenance dose, and wherein said composition provides a minimum plasma concentration of about 70% to about 130% of the minimum carbamazepine plasma concentration of the oral maintenance dose.

23. The composition of claim 22, wherein said composition provides an AUC for carbamazepine from about 70% to about 130% of the AUC for carbamazepine in the oral maintenance dose.

24. The composition of claim 22, wherein said composition provides an AUC for carbamazepine from about 80% to about 125% of the AUC for carbamazepine in the oral maintenance dose.

25. The composition of claim 22, wherein said composition provides a minimum plasma concentration of about 80% to about 125% of the minimum carbamazepine plasma concentration of the oral maintenance dose.

26. The composition of claim 22, wherein said composition provides trough carbamazepine concentrations within the therapeutic range.

27. The composition of claim 22, wherein said composition provides a carbamazepine half-life of about 8 to about 65 hours.

28. The composition of claim 22, wherein said composition provides a carbamazepine half-life of about 24 hours.

29. The composition of claim 22, wherein said composition has a dosing interval of every 6 hours.

30. An injectable pharmaceutical composition comprising i. about 10 mg/mL of carbamazepine, ii. about 25% weight/volume sulfobutylether-7-.beta.-cyclodextrin, and iii. a physiologically acceptable fluid, wherein said composition is administered intravenously, wherein said composition contains carbamazepine in a dose of about 65% to about 75% of a human's oral maintenance dose, wherein said composition provides a minimum plasma concentration of about 70% to about 130% of the minimum carbamazepine plasma concentration of the oral maintenance dose, wherein said composition provides an AUC for carbamazepine from about 70% to about 130% of the AUC for carbamazepine in the oral maintenance dose, and wherein said composition provides trough carbamazepine concentrations within the therapeutic range.

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