Fast-release extrudates and process for their production, and preparations obtainable therefrom

Abstract

The present invention relates to stable quick-release extrudates that contain low-viscosity hydroxypropylcellulose and at least one active ingredient. This invention also relates to a method for preparing said extrudates without the use of solvents as well as to the use of said extrudates in the production of quick-release preparations.

1 . Stable, fast-release extrudates comprising hydroxypropylcellulose of low viscosity with an average molecular weight of from 30 000 to 100 000 and with a molar degree of substitution of at least 3 in an amount of at least 50% by weight based on the active ingredient/polymer mixture and at least one active pharmaceutical ingredient.  
     
     
         2 . Extrudates as claimed in  claim 1 , characterized in that they comprise hydroxypropylcellulose in an amount of least 66% by weight based on the active ingredient/polymer mixture.  
     
     
         3 . Extrudates as claimed in  claim 1 , characterized in that they comprise hydroxypropylcellulose with an average molecular weight of from 55 000 to 70 000.  
     
     
         4 . The use of extrudates as claimed in any one of  claims 1  to  3  for producing pharmaceutical preparations.  
     
     
         5 . A pharmaceutical preparation as set forth in  claim 4 .  
     
     
         6 . A pharmaceutical preparation as claimed in  claim 5 , characterized in that the preparation is a tablet which comprises the disintegrant crosslinked polyvinylpyrrolidone (PVPP).  
     
     
         7 . A pharmaceutical preparation as claimed in  claim 5 , characterized in that the preparation is a sachet.  
     
     
         8 . A pharmaceutical preparation as claimed in  claim 5 , characterized in that the preparation is a capsule.  
     
     
         9 . A solvent-free process for producing extrudates as claimed in  claim 1 , characterized in that a mixture of at least one active ingredient and hydroxypropylcellulose of low viscosity in an amount of at least 50% by weight based on the active ingredient/polymer mixture is passed through an extruder which has at the place where the product enters a temperature of from 25 to 40° C. and at the exit die has a temperature of ≦225° C., where the exit die(s) has (have) a diameter of from 0.5 to 5 mm, and the extruded strands are comminuted after their emergence.  
     
     
         10 . The process as claimed in  claim 9 , characterized in that the exit die(s) has (have) a diameter of from 1 to 3 mm.