Felbamate With Improved Bulk Density

Abstract

A synthesis and purification of felbamate, an anticonvulsant, are provided. The product of the synthesis and purification is with high untapped and tapped bulk densities, which increase ease of handling and suitability for use in pharmaceutical formulations. The felbamate may be incorporated into pharmaceutical compositions that can be administered orally for treatment of epilepsy.

1 . Felbamate crystals having a tapped bulk density ranging from about 0.35 gm/ml to about 0.6 gm/ml. 
     
     
         2 . The felbamate crystals of  claim 1 , wherein the tapped bulk density ranging from about 0.4 gm/ml to about 0.6 gm/ml. 
     
     
         3 . The felbamate crystals of  claim 2 , wherein the tapped bulk density is about 0.5 gm/ml. 
     
     
         4 . The felbamate crystals of  claim 1 , wherein the felbamate crystals contain less than 0.2% of impurity. 
     
     
         5 . The felbamate crystals of  claim 1 , wherein the felbamate crystals has a particle size distribution of about 90% less than 100 μm. 
     
     
         6 . The felbamate crystals of  claim 5 , wherein the felbamate crystals has a particle size distribution of about 90% less than 70 μm. 
     
     
         7 . The felbamate crystals of  claim 6 , wherein the felbamate crystals has a particle size distribution of about 90% less than 40 μm. 
     
     
         8 . The felbamate crystals of  claim 1 , wherein a therapeutically effective amount of the felbamate is formulated into a pharmaceutical composition. 
     
     
         9 . The felbamate crystals of  claim 8 , wherein the pharmaceutical composition is used for the treatment of epilepsy. 
     
     
         10 . The felbamate crystals of  claim 8 , wherein the pharmaceutical composition is suitable for oral administration. 
     
     
         11 . The felbamate crystals of  claim 10 , wherein the pharmaceutical composition is in the dosage form of oral suspensions, capsules or tablets. 
     
     
         12 . The felbamate crystals of  claim 11 , wherein the oral suspensions contain from 100 mg/5 ml to 1000 mg/5 ml of the felbamate. 
     
     
         13 . The felbamate crystals of  claim 12 , wherein the oral suspensions contain 600 mg/5 ml of the felbamate. 
     
     
         14 . The felbamate crystals of  claim 11 , wherein the tablets contain from 100 mg to 1000 mg of the felbamate. 
     
     
         15 . The felbamate crystals of  claim 14 , wherein the tablets contain from 400 mg to 600 mg of the felbamate.