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.

1 . A method for treatment of a disease in a patient in need thereof selected from the group consisting of seizures, mania, mixed episodes, bipolar depression, major depressive disorder, and trigeminal neuralgia, the method comprising the administration of a therapeutically effective amount of a composition comprising carbamazepine and sulfobutylether-7-β-cyclodextrin, wherein the composition comprises less than about 60 ppm 10-Br-carbamazepine relative to carbamazepine. 
     
     
         2 . The method of  claim 1 , wherein the patient has seizures selected from the group consisting of
 a. partial seizures with complex symptomatology,   b. generalized tonic-clonic seizures, and   c. mixed seizures pattern comprising
 i. partial seizures with complex symptomatology and generalized tonic-clonic seizures, or 
 ii. partial or generalized seizures. 
   
     
     
         3 . The method of  claim 1 , wherein the composition comprises about 10 mg/mL carbamazepine and about 25% weight/volume sulfobutylether-7-β-cyclodextrin, and wherein the composition is administered intravenously. 
     
     
         4 . The method of  claim 3 , wherein the composition is administered as a replacement for oral carbamazepine in a daily dosage of about 65% to about 75% of a human's daily oral dosage. 
     
     
         5 . The method of  claim 4 , wherein the administration occurs over a period from about 5 to about 60 minutes. 
     
     
         6 . The method of  claim 2 , wherein the patient has partial seizures with complex symptomatology. 
     
     
         7 . The method of  claim 2 , wherein the patient has generalized tonic-clonic seizures. 
     
     
         8 . The method of  claim 2 , wherein the patient has mixed seizures patterns. 
     
     
         9 . The method of  claim 1 , wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 
     
     
         10 . The method of  claim 9 , wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine. 
     
     
         11 . The method of  claim 2 , wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 
     
     
         12 . The method of  claim 11 , wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine. 
     
     
         13 . The method of  claim 3 , wherein the composition comprises less than about 30 ppm 10-Br-carbamazepine relative to carbamazepine. 
     
     
         14 . The method of  claim 13 , wherein the composition comprises less than about 10 ppm 10-Br-carbamazepine relative to carbamazepine.