Claims for Patent: 9,629,797

Summary for Patent: 9,629,797

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:	13/547,866
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,629,797
Patent Claims:	1. A method of administering a carbamazepine sulfoalkyl-cylcodextrin composition to a human in need thereof comprising, a) providing a carbamazepine sulfoalkyl-cyclodextrin composition, and b) parenteraly infusing said composition to said human, wherein the composition is administered as a replacement for oral carbamazepine in a dose of about 30% to about 100% of the human's oral maintenance dose. 2. The method of claim 1, wherein the sulfoalkyl-cyclodextrin is present at about 25% weight/volume. 3. The method of claim 1, wherein the carbamazepine sulfoalkyl-cyclodextrin composition is administered in a daily dosage of about 65% to 75% of the human's daily oral dosage. 4. The method of claim 1, wherein the sulfoalkyl-cyclodextrin is sulfobutylether-7.beta.-cyclodextrin. 5. The method of claim 1, wherein the composition comprises about 10 mg/mL carbamazepine. 6. The method of claim 1, wherein the human has a seizure disorder. 7. The method of claim 6, wherein the seizure disorder is selected from partial seizures with complex symptoms, generalized tonic-clonic seizures, mixed seizure patterns, epilepsy, status epilipticus and refractory seizure disorders. 8. The method of claim 7, wherein the seizure disorder is epilepsy. 9. The method of claim 7, wherein the seizure disorder is status epilipticus. 10. The method of claim 1, wherein the composition is administered intravenously, intraarterially, intramuscularly, subcutaneously or intraperitonealy. 11. The method of claim 10, wherein the composition is administered intravenously. 12. The method of claim 1, wherein trough carbamazepine concentrations remain within the therapeutic range. 13. The method of claim 1, wherein the area under plasma concentration-time curve (AUC) for carbamazepine is about 70% to about 130% of the AUC for the oral maintenance dose. 14. The method of claim 1, wherein the area under plasma concentration-time curve (AUC) for carbamazepine is about 80% to about 125% of the AUC for the oral maintenance dose. 15. The method of claim 1, wherein the minimum carbamazepine plasma concentration is about 70% to about 130% of the minimum plasma concentration for the oral maintenance dose. 16. The method of claim 1, wherein the minimum carbamazepine plasma concentration is about 80% to about 125% of the minimum plasma concentration for the oral maintenance dose. 17. A method of administering a carbamazepine sulfoalkyl-cyclodextrin composition to a human having a seizure disorder comprising, a) providing a carbamazepine sulfoalkyl-cyclodextrin composition, and b) intravenously administering said composition to said human, wherein the composition is administered as a replacement for oral carbamazepine in a dose of about 30% to about 100% of the human's oral maintenance dose. 18. The method of claim 17, wherein the sulfoalkyl-cyclodextrin is sulfobutylether-7.beta.-cyclodextrin. 19. The method of claim 17, wherein the composition comprises about 10 mg/mL carbamazepine and about 25% w/v sulfoalkyl-cyclodextrin. 20. The method of claim 17, wherein the seizure disorder is epilepsy. 21. The method of claim 17, wherein the seizure disorder is status epilipticus. 22. The method of claim 17, wherein the seizure disorder is partial seizures with complex symptoms. 23. The method of claim 17, wherein the seizure disorder is generalized tonic-clonic seizures. 24. The method of claim 17, wherein the seizure disorder is mixed seizure patterns. 25. A method of administering a carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition to a human having epilepsy or status epilipticus comprising, a) providing a carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition, wherein the composition comprises about 10 mg/mL carbamazepine and about 25% w/v sulfobutylether-7-.beta.-cyclodextrin; and b) intravenously administering the composition to said human, wherein the composition is administered as a replacement for oral carbamazepine in a daily dosage of about 65% to 75% of the human's daily oral dosage, and wherein administration occurs over a period from about 5 to about 60 minutes. 26. The method of claim 25, wherein administration occurs over a period of about 30 minutes. 27. The method of claim 25, wherein administration occurs over a period of about 15 minutes. 28. The method of claim 25, wherein administration occurs over a period of about 5 minutes. 29. The method of claim 25, further comprising a dosing interval of about every 4-12 hours. 30. The method of claim 25, wherein the carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition is administered in a daily dosage of about 70% of the human's daily oral dosage. 31. The method of claim 25, wherein trough carbamazepine concentrations remain within the therapeutic range. 32. The method of claim 25, wherein the area under plasma concentration-time curve (AUC) for carbamazepine is about 70% to about 130% of the AUC for the oral maintenance dose. 33. The method of claim 25, wherein the area under plasma concentration-time curve (AUC) for carbamazepine is about 80% to about 125% of the AUC for the oral maintenance dose. 34. The method of claim 25, wherein the minimum carbamazepine plasma concentration is about 70% to about 130% of the minimum plasma concentration for the oral maintenance dose. 35. The method of claim 25, wherein the minimum carbamazepine plasma concentration is about 80% to about 125% of the minimum plasma concentration for the oral maintenance dose. 36. A method of administering a carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition to a human having a seizure disorder comprising, a) providing a carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition, wherein the composition comprises about 10 mg/mL carbamazepine and about 25% w/v sulfobutylether-7-.beta.-cyclodextrin; and b) intravenously administering the composition to said human, wherein the composition is administered as a replacement for oral carbamazepine in a dosage of about 65% to 75% of the human's oral dosage, wherein the area under plasma concentration-time curve (AUC) for carbamazepine is about 70% to about 130% of the AUC for the oral maintenance dose, the minimum carbamazepine plasma concentration is about 70% to about 130% of the minimum plasma concentration for the oral maintenance dose, and wherein trough carbamazepine concentrations remain within the therapeutic range. 37. The method of claim 36, wherein the seizure disorder is selected from partial seizures with complex symptoms, generalized tonic-clonic seizures, mixed seizure patterns, epilepsy, status epilipticus and refractory seizure disorders. 38. The method of claim 37, wherein the seizure disorder is epilepsy. 39. The method of claim 37, wherein the seizure disorder is status epilipticus. 40. The method of claim 37, wherein the seizure disorder is partial seizures with complex symptoms. 41. The method of claim 37, wherein the seizure disorder is generalized tonic-clonic seizures. 42. The method of claim 37, wherein the seizure disorder is mixed seizure patterns. 43. The method of claim 37, wherein the seizure disorder is refractory seizure disorders. 44. A method of administering a carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition to a human having partial seizures with complex symptoms, generalized tonic-clonic seizures, or mixed seizure patterns comprising, a) providing a carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition, wherein the composition comprises about 10 mg/mL carbamazepine and about 25% w/v sulfobutylether-7-.beta.-cyclodextrin; and b) intravenously administering the composition to said human, wherein the composition is administered as a replacement for oral carbamazepine in a daily dosage of about 65% to 75% of the human's daily oral dosage, and wherein administration occurs over a period from about 5 to about 60 minutes. 45. The method of claim 44, wherein the human has partial seizures with complex symptoms. 46. The method of claim 44, wherein the human has generalized tonic-clonic seizures. 47. The method of claim 44, wherein the human has mixed seizure patterns. 48. The method of claim 44, wherein administration occurs over a period of about 30 minutes. 49. The method of claim 44, wherein administration occurs over a period of about 15 minutes. 50. The method of claim 44, wherein administration occurs over a period of about 5 minutes. 51. The method of claim 44, further comprising a dosing interval of about every 4-12 hours. 52. The method of claim 44, wherein the carbamazepine sulfobutylether-7-.beta.-cyclodextrin composition is administered in a daily dosage of about 70% of the human's daily oral dosage. 53. The method of claim 44, wherein trough carbamazepine concentrations remain within the therapeutic range. 54. The method of claim 44, wherein the area under plasma concentration-time curve (AUC) for carbamazepine is about 70% to about 130% of the AUC for the oral maintenance dose. 55. The method of claim 44, wherein the area under plasma concentration-time curve (AUC) for carbamazepine is about 80% to about 125% of the AUC for the oral maintenance dose. 56. The method of claim 44, wherein the minimum carbamazepine plasma concentration is about 70% to about 130% of the minimum plasma concentration for the oral maintenance dose. 57. The method of claim 44, wherein the minimum carbamazepine plasma concentration is about 80% to about 125% of the minimum plasma concentration for the oral maintenance dose.