Pharmaceutical tablet formulation containing gabapentin with improved physical and chemical characteristics and method of making the same

Abstract

A pharmaceutical formulation form with improved physical and chemical characteristics, comprising gabapentin in tablet form for oral administration. The tablet form can be prepared by spray-coating gabapentin with a binder solution and compressing the spray-coated gabapentin into non-friable, stable tablets. This method is particularly useful for tablet formulations that require large doses of active drug.

What is claimed is:  
     
         1 . A pharmaceutical tablet comprising more than about 76% by weight of gabapentin.  
     
     
         2 . A pharmaceutical tablet of  claim 1  comprising more than about 88% by weight of gabapentin.  
     
     
         3 . A pharmaceutical tablet of  claim 1  where the tablet has a friability of less than 0.8%.  
     
     
         4 . A pharmaceutical tablet of  claim 1  where the tablet has a hardness of about 14 kp to about 16 kp.  
     
     
         5 . A pharmaceutical tablet of  claim 1  where the tablet has a lactam level of less than about 0.2%.  
     
     
         6 . A pharmaceutical tablet comprising: 
 (a) more than about 76% by weight of gabapentin;    (b) a friability of less than about 1%;    (c) a hardness of about 10 kp to about 20 kp; and    (d) a lactam level of less than about 0.4% by weight of the tablet.    
     
     
         7 . A pharmaceutical tablet comprising more than about 76% by weight of gabapentin, the tablet being formed from particles of gabapentin spray-coated with a binder solution, mixed with a disintegrant, and a lubricant, and then compressed into the tablet.  
     
     
         8 . A pharmaceutical tablet of  claim 7  comprising more than about 88% by weight of gabapentin.  
     
     
         9 . A pharmaceutical tablet of  claim 7  where the binder solution is hydroxypropyl cellulose or copolyvidone dissolved in alcohol, the disintegrant is crospovidone and the lubricant is calcium stearate.  
     
     
         10 . A pharmaceutical tablet comprising more than about 88% by weight of gabapentin, the tablet being formed from particles of gabapentin spray-coated with hydroxypropyl cellulose dissolved in alcohol, mixed with crospovidone, and calcium stearate, and compressed into the tablet.  
     
     
         11 . A method of producing pharmaceutical tablet comprising: 
 (a) dissolving binder in a solvent to produce a binder solution;    (b) spray-coating the binder solution on gabapentin particles to achieve a spray-coated gabapentin; and    (c) compressing the spray-coated gabapentin into a tablet for oral administration to a patient;    where the tablet contains more than about 76% by weight of gabapentin.    
     
     
         12 . The method of  claim 11  where the tablet contains more than about 88% by weight of gabapentin.  
     
     
         13 . The method of  claim 11  where the tablet has a friability of less than 1%  
     
     
         14 . The method of  claim 11  where the tablet has a hardness of about 10 kp to 20 kp.  
     
     
         15 . The method of  claim 11  where the tablet has a lactam level of less than about 0.4% by weight of the tablet.  
     
     
         16 . The method of  claim 11  where the binder solution comprises hydroxypropyl cellulose or copolyvidone dissolved in alcohol.  
     
     
         17 . The method of  claim 11  further comprising adding a disintegrant and a lubricant to the spray-coated gabapentin.  
     
     
         18 . The method of  claim 17  where the disintegrant is crospovidone and the lubricant is calcium stearate.  
     
     
         19 . A method of producing a pharmaceutical tablet comprising: 
 a) dissolving hydroxypropyl cellulose in alcohol to produce a binder solution;    b) spray-coating the binder solution on gabapentin particles to produce spray-coated gabapentin;    c) mixing the spray-coated gabapentin with crospovidone and calcium stearate to obtain a final blend; and    d) compressing the final blend into a tablet for administration to a patient;    where the tablet contains more than about 88% by weight of gabapentin.    
     
     
         20 . A method of producing a pharmaceutical tablet comprising: 
 (a) dissolving binder in a solvent to produce a binder solution;    (b) spray-coating the binder solution on active drug particles to achieve spray-coated active drug particles;    (c) compressing the spray-coated drug particles into a tablet for oral administration to a patient;    where the tablet contains about 500 mg to about 1200 mg of active drug.