Oxacarbazepine film-coated tablets

Abstract

The invention relates to formulations, e.g. film-coated tablets containing oxcarbazepine and to processes for the production of said formulations. The film-coated tablets have a tablet core comprising a therapeutically effective dose of oxacarbazepine being in a finely ground form having a mean particle size of from 4 to 12 μm (median value), and a hydrophilic permeable outer coating.

1 . A formulation comprising oxacarbazepine having a median particle size of approximately 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm and with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%.  
     
     
         2 . A film-coated tablet comprising oxacarbazepine having a median particle size of approximately 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm and with a maximum residue on a 40 μm sieve of up-to 5%, e.g. 2%.  
     
     
         3 . A film-coated tablet which comprises, 
 a) a tablet core comprising a therapeutically effective dose of oxacarbazepine, preferably being in a finely ground form, having a median particle size of approximately from 4 to 12 μm, preferably 4 to 10 μm with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%, and further excipients that are suitable for the production of granules; and    b) a hydrophilic permeable outer coating.    
     
     
         4 . A film-coated tablet according to  claim 3 , which comprises 
 a) a tablet core comprising a therapeutically effective dose of oxacarbazepine, preferably being in a finely ground form, having a median particle size of approximately from 6 to 8 μM with a maximum residue on a 40 μm sieve of 2%, and further excipients that are suitable for the production of dry granules.    
     
     
         5 . A film-coated tablet according to either  claim 3  or  claim 4 , which comprises as component b) a hydrophilic permeable outer coating comprising white pigments, iron oxide pigment and optionally further excipients.  
     
     
         6 . A process for the production of a film-coated tablet containing oxacarbazepine comprising forming the oxacarbazepine, having a median particle size of approximately from 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%, and optionally other excipients into a central core, and coating said core with a hydrophilic permeable outer coating.  
     
     
         7 . A process for producing a film-coated tablet according to  claim 3 , which comprises finely grinding the oxacarbazepine to a median particle size of approximately from 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%, and, with the admixture of excipients that are suitable for granulation processes, forming the active ingredient into granules, compressing the granules to form tablet cores using conventional tabletting processes, and providing the cores with a hydrophilic permeable outer coating.  
     
     
         8 . A process according to  claim 7 , which comprises forming the finely ground oxacarbazepine into wet granules with the admixture of excipients that are suitable for granulation processes, and compressing the wet granules to form tablet cores using conventional tabletting processes.  
     
     
         9 . Oxacarbazepine having a median particle size of approximately 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm.  
     
     
         10 . Oxacarbazepine having a median particle size of approximately 2 to 12 μm, preferably 4 to 12 μm, more preferably 4 to 10 μm and with a maximum residue on a 40 μm sieve of up to 5%, e.g. 2%.