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 form with at least reduced potential for abuse, said dosage form having a breaking hardness of at least 500 N, and said process comprising:
 a) providing a formulation mixture comprising at least one active ingredient with potential for abuse, at least one synthetic or natural polymer (C), and optionally auxiliary substances (B), said active ingredient with potential for abuse being selected from the group consisting of oxymorphone, hydromorphone, morphine, and physiologically acceptable compounds and derivatives thereof,   b) shaping said mixture into formed articles by application of force,   c) optionally singulating the formed articles and optionally in each case grading by size and,   d) 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, optionally providing the formed articles 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 3 , wherein the formulation mixture consists to an extent of at least 50 wt. % of component (C). 
     
     
         5 . A process according to  claim 1 , wherein shaping of the formulation mixture proceeds with is effected by applying a force of at least 0.5 kN and optionally with heating to less than 60° C. 
     
     
         6 . A process according to  claim 1 , which comprises heating the formed articles 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 in b) or d) is performed with the assistance of a press, preferably a tablet press. 
     
     
         8 . A process according to  claim 1 , wherein shaping produces tablets. 
     
     
         9 . A process according to  claim 1 , wherein shaping produces a multiparticulate dosage form with a minimum size of 0.5 mm. 
     
     
         10 . (canceled) 
     
     
         11 . A process according to  claim 1 , wherein the physiologically acceptable compounds and derivatives are salts, solvates, esters, ethers and amides.