Process for the production of an abuse-proofed dosage form

Abstract

The present invention relates to a process for the production of abuse-proofed, thermoformed dosage forms containing, apart from one or more active ingredients with potential for abuse and optionally physiologically acceptable auxiliary substances, at least one synthetic or natural polymer with a breaking strength of at least 500 N.

1 . A process for the production of a solid pharmaceutical dosage forms with at least reduced potential for abuse, comprising:
 a) shaping a formulation mixture into formed articles by application of force, the formulation mixture comprising at least one active ingredient with potential for abuse, at least one synthetic or natural polymer (C), which exhibits a breaking strength of at least 500 N, and optionally auxiliary substances (B);   b) optionally singulating and optionally in each case grading the formed articles by size and,   c) after or during heating at least to the softening point of the polymer (C), exposing the formed articles to force until they have a breaking hardness of at least 500 N, and optionally providing them with a cover and optionally mixing all the formed articles back together again.   
     
     
         2 . A process according to  claim 1 , which is performed continuously or discontinuously. 
     
     
         3 . A process according to  claim 1 , wherein the formulation mixture consists to an extent of at least 30 wt. % of component (C). 
     
     
         4 . A process according to  claim 1 , wherein the formulation mixture consists to an extent of at least 50 wt. % of component (C). 
     
     
         5 . A process according to  claim 1 , wherein a) shaping of the formulation mixture proceeds with application of a force of at least 0.5 kN and optionally with heating to less than 60° C. 
     
     
         6 . A process according to  claim 1 , wherein, according to c), the formed articles are heated to at least 60° C. before or during application of force of at least 0.1 kN. 
     
     
         7 . A process according to  claim 1 , wherein the application of force according to a) or c) is performed with the assistance of a press, shaping rollers or with shaping belts equipped with rollers. 
     
     
         8 . A process according to  claim 1 , wherein shaping according to a) gives rise to tablets. 
     
     
         9 . A process according to  claim 1 , wherein shaping according to a) gives rise to a multiparticulate dosage form with a minimum size of 0.5 mm. 
     
     
         10 . A process according to  claim 1 , wherein opioid active ingredients are used as active ingredients.