Process for the production of an abuse-proofed dosage form

Abstract

The present invention relates to a process for the production of an abuse-proofed dosage form 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 (C) with a breaking strength of at least 500 N, wherein the formulation mixture is combined with a solvent for the polymer (C) at least in quantities such that the formulation mixture is at least uniformly moistened, the at least moistened composition is optionally divided into sub-portions, dried and shaped to yield the dosage form.

What is claimed is: 
     
         1 . A process for the production of a solid dosage form with at least reduced potential for abuse, said dosage form exhibiting a breaking strength of at least 500 N, said process comprising:
 a) producing a formulation mixture comprising at least one active ingredient with potential for abuse (A) and at least one synthetic or natural polymer (C);   b) moistening the mixture with at least a sufficient quantity of a solvent for the polymer (C) to uniformly moisten the mixture;   c) optionally dividing the mixture from step b) into sub-portions;   d) drying the sub-portion(s) from step c) or the mixture from step b); and   e) shaping the dried sub-portion or mixture from step d) to yield the dosage form.   
     
     
         2 . The process according to  claim 1 , where the dried sub-portions in each case correspond to the mass of a unit of the dosage form. 
     
     
         3 . The process according to  claim 1 , which further comprises dispersing the formulation mixture in a liquid dispersant in which the polymer component (C) is not soluble before addition of the solvent. 
     
     
         4 . The process according to  claim 3 , which further comprises dividing the formulation mixture into sub-portions in each case corresponding to the mass of a unit of the dosage form either before or after the formulation mixture is dispersed. 
     
     
         5 . The process according to  claim 3 , where the solvent and the dispersant are miscible with one another. 
     
     
         6 . The process according to  claim 1 , which further comprises incorporating the solvent into the formulation mixture as a foam. 
     
     
         7 . The process according to  claim 6 , which further comprises stabilizing the foam with the assistance of foam stabilizers. 
     
     
         8 . The process according to  claim 6 , which further comprises drying the sub-portion(s) or the mixture in granular form. 
     
     
         9 . The process according to  claim 8 , which further comprises drying the mixture in granular form, and then dividing the dried, granulated mixture into sub-portions, which in each case correspond to the mass of a unit of the dosage form, and shaping to yield the dosage form. 
     
     
         10 . The process according to  claim 1 , which further comprises adding solvent to the formulation mixture in an amount such that a shapeable paste is obtained. 
     
     
         11 . The process according to  claim 10 , which further comprises drying the paste and, before or after it is dried, the paste is divided into sub-portions and shaping or converting into the dosage form the dried portions, optionally after further dividing each case into a portion corresponding to the mass of a unit of the dosage form. 
     
     
         12 . The process according to  claim 11 , where the sub-portions have the form of strands. 
     
     
         13 . The process according to  claim 12 , which further comprises producing the strands with the assistance of a screen or strand former. 
     
     
         14 . The process according to  claim 12 , which further comprises singulating and shaping dried strands to yield the dosage form. 
     
     
         15 . The process according to  claim 14 , where shaping proceeds with the assistance of a tablet press. 
     
     
         16 . The process according to  claim 12 , which further comprises shaping dried strands with the assistance of shaping rollers or shaping belts equipped with rollers to yield the dosage form. 
     
     
         17 . The process according to  claim 11 , which further comprises converting the paste into a planar structure, from which the dosage form is stamped. 
     
     
         18 . The process according to  claim 10 , where the process is performed with the assistance of an extruder. 
     
     
         19 . The process according to  claim 1 , which further comprises adding a quantity of solvent sufficient to dissolve at least the polymer component (C) to the formulation mixture. 
     
     
         20 . The process according to  claim 19 , which further comprises converting the solution into a planar structure. 
     
     
         21 . The process according to  claim 20 , which further comprises producing the planar structure with the assistance of an extruder with a flat die or by casting the solution onto a level planar support. 
     
     
         22 . The process according to  claim 19 , which further comprises shaping the dosage form by stamping from the dried planar structure or by calendaring. 
     
     
         23 . The process according to  claim 19 , where the mixture is divided into portions such that, after drying, the portions correspond in each case to the mass of a unit of the dosage form. 
     
     
         24 . The process according to  claim 23 , which further comprises placing the portions in molds corresponding to the shape of a unit of the dosage form. 
     
     
         25 . The process according to  claim 19 , which further comprises dividing the mixture into any desired portions, and, after drying, optionally recombining the portions, and shaping to yield the dosage form.