Novel 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.

We claim: 
     
         1 . A method of administering carbamazepine to a mammal in need thereof comprising, parenterally infusing into the mammal a carbamazepine sulfoalkyl-cyclodextrin composition, wherein the composition comprises about 10 mg/mL carbamazepine, about 25% weight/volume sulfobutylether-7-β-cyclodextrin, and a physiologically acceptable fluid. 
     
     
         2 . The method of  claim 1 , wherein the mammal has a seizure disorder. 
     
     
         3 . The method of  claim 2 , wherein the seizure disorder is partial seizures with complex symptoms, generalized tonic-clonic (grand mal) seizures, mixed seizure patterns, epilepsy, status epilipticus, refractory seizure disorders or a combination thereof. 
     
     
         4 . The method of  claim 3 , wherein the seizure disorder is epilepsy. 
     
     
         5 . The method of  claim 3 , wherein the seizure disorder is status epilipticus. 
     
     
         6 . The method of  claim 1 , wherein the composition is administered intravenously, intraarterially, intramuscularly, subcutaneously or intraperitonealy. 
     
     
         7 . The method of  claim 6 , wherein the composition is administered intravenously. 
     
     
         8 . The method of  claim 1 , wherein the mammal is a human. 
     
     
         9 . The method of  claim 1 , wherein the composition is administered as a replacement for oral carbamazepine. 
     
     
         10 . The method of  claim 9 , wherein the carbamazepine sulfoalkyl-cyclodextrin composition is administered in a daily dosage of about 65% to 75% of the mammal's daily oral carbamazepine dosage. 
     
     
         11 . The method of  claim 1 , wherein the mammal has trigeminal neuralgia, glossopharyngeal neuralgia, neurogenic diabetes insipidus, schizoaffective illness, depression, agitation, behavioral disturbances related to dementia, resistant schizophrenia, dyscontrol syndrome associated with limbic system dysfunction, alcohol withdrawal, fibromyalgia, neuropathy, or a combination thereof. 
     
     
         12 . The method of  claim 1 , wherein the mammal has trigeminal neuralgia or fibromyalgia. 
     
     
         13 . The method of  claim 2 , wherein the mammal has trigeminal neuralgia. 
     
     
         14 . A method of administering carbamazepine to a human in need thereof comprising, intravenously infusing into the human a carbamazepine sulfoalkyl-cyclodextrin composition, wherein the composition comprises about 10 mg/mL carbamazepine, about 25% weight/volume sulfobutylether-7-β-cyclodextrin, and a physiologically acceptable fluid. 
     
     
         15 . The method of  claim 14 , wherein the human has a seizure disorder. 
     
     
         16 . The method of  claim 15 , wherein the seizure disorder is partial seizures with complex symptoms, generalized tonic-clonic (grand mal) seizures, mixed seizure patterns, epilepsy, status epilipticus, refractory seizure disorders, or a combination thereof. 
     
     
         17 . The method of  claim 16 , wherein the seizure disorder is epilepsy. 
     
     
         18 . The method of  claim 16 , wherein the seizure disorder is status epilipticus. 
     
     
         19 . The method of  claim 14 , wherein the composition is administered as a replacement for oral carbamazepine. 
     
     
         20 . The method of  claim 19 , wherein the composition is administered in a daily dosage of about 65% to 75% of the human's daily oral carbamazepine dosage. 
     
     
         21 . The method of  claim 14 , wherein the human has trigeminal neuralgia, glossopharyngeal neuralgia, neurogenic diabetes insipidus, schizoaffective illness, depression, agitation, behavioral disturbances related to dementia, resistant schizophrenia, dyscontrol syndrome associated with limbic system dysfunction, alcohol withdrawal, fibromyalgia, neuropathy, or a combination thereof. 
     
     
         22 . The method of  claim 21 , wherein the human has trigeminal neuralgia or fibromyalgia. 
     
     
         23 . The method of  claim 22 , wherein the human has trigeminal neuralgia. 
     
     
         24 . A method of administering carbamazepine to a human in need thereof comprising, intravenously infusing into the human a carbamazepine sulfoalkyl-cyclodextrin composition, wherein the composition comprises about 10 mg/mL carbamazepine, about 25% weight/volume sulfobutylether-7-β-cyclodextrin, and a physiologically acceptable fluid, and wherein the human has epilepsy, status epilipticus, trigeminal neuralgia, fibromyalgia, or a combination thereof. 
     
     
         25 . The method of  claim 24 , wherein the human has epilepsy. 
     
     
         26 . The method of  claim 24 , wherein the composition is administered as a replacement for oral carbamazepine. 
     
     
         27 . The method of  claim 24 , wherein the human has status epilipticus. 
     
     
         28 . The method of  claim 25 , wherein the composition is administered as a replacement for oral carbamazepine. 
     
     
         29 . The method of  claim 24 , wherein the human has trigeminal neuralgia. 
     
     
         30 . The method of  claim 24 , wherein the human has fibromyalgia.