Low-dose tablets and preparation process

Abstract

The invention concerns a microgranule tablet comprising a low dose of active principle containing a directly compressible diluent. The invention is characterised in that the directly compressible diluent consists exclusively of neutral microgranules, and the active principle is set on the neutral microgranules and is not coated with an agent designed to modify its release or mask its taste.

1 . A tablet comprising a low dose of active principle formed from microgranules comprising a directly compressible diluent, characterized in that the directly compressible diluent is composed solely of neutral microgranules and in that the active principle is attached as a coating to the neutral microgranules and is not coated with an agent intended to modify its release or to mask its taste. 
     
     
         2 . The tablet as claimed in  claim 1 , wherein the size of the neutral microgranules is between 100 and 2000 μm, preferably between 200 and 600 μm. 
     
     
         3 . The tablet as claimed in  claim 2 , wherein the size of the neutral microgranules is between 200 and 400 μm. 
     
     
         4 . The tablet as claimed in  claim 1 , wherein the hardness of the tablet is between 0 and 20 daN. 
     
     
         5 . The tablet as claimed in  claim 1 , wherein the friability of the tablet is between 0 and 1%. 
     
     
         6 . The tablet as claimed in  claim 1 , wherein the disintegration time of the tablet is less than 15 minutes. 
     
     
         7 . The tablet as claimed in  claim 1 , wherein the tablet is composed of an active principle attached as a coating to neutral microgranules and of compression excipients in an amount of less than 1% by weight with respect to the weight of the tablet. 
     
     
         8 . The tablet as claimed in  claim 7 , wherein the tablet additionally comprises a lubricant in an amount of less than 1% by mass of the tablet. 
     
     
         9 . The tablet as claimed in  claim 8 , wherein the content of lubricant is between 0.125 and 0.75% by mass, preferably of the order of 0.25% by mass. 
     
     
         10 . The tablet as claimed in claimed in  claim 1 , wherein the amount of active principle is less than 40 mg/g of system to be tableted, preferably less than 10 mg/g. 
     
     
         11 . A composition containing
 between 99 and 100% by mass of neutral microgranules to which is attached as a coating of an active principle, and   between 0 and 1% by mass of a lubricant, which composition is intended to be subject to direct compression.   
     
     
         12 . The composition as claimed in  claim 11 , wherein the active principle attached as a coating to the neutral microgranules represents less than 5% by mass of the neutral microgranules. 
     
     
         13 . A process for the preparation of the tablet as claimed in  claim 1 , wherein the tablet is obtained by direct compression of the composition as claimed in either of  claims 11  and  12  by employing a compression force of between 5 and 50 kN, preferably between 10 and 30 kN.