Tamper-resistant dosage form containing ethylene-vinyl acetate polymer

Abstract

The invention relates to a tamper-resistant, oral pharmaceutical dosage form comprising a pharmacologically active ingredient having psychotropic action and an ethylene-vinyl acetate (EVA) polymer which provides resistance against solvent extraction, resistance against grinding, and resistance against dose-dumping in aqueous ethanol.

1 . An oral pharmaceutical dosage form comprising a homogeneous mixture of: (A) a pharmacologically active ingredient and (B) a prolonged release matrix comprising 55 to 80 wt.-% relative to a total weight of the dosage form of an ethylene-vinyl acetate (EVA) polymer. 
     
     
         2 . The pharmaceutical dosage form according to  claim 1 , wherein the EVA polymer comprises repetition units derived from ethylene and vinyl acetate and/or vinyl alcohol. 
     
     
         3 . The pharmaceutical dosage form according to  claim 1 , wherein the EVA polymer contains at least 50 wt.-% of ethylene repetition units, relative to the total weight of the EVA polymer. 
     
     
         4 . The pharmaceutical dosage form according to  claim 3 , wherein the EVA polymer contains from 50 to 95 wt.-% of ethylene repetition units, relative to the total weight of the EVA polymer. 
     
     
         5 . The pharmaceutical dosage form according to  claim 1 , wherein the EVA polymer has a melt flow rate at 190° C. and 2.16 kg within the range of from 1 to 160 g/10 min measured according to ASTM D1238. 
     
     
         6 . The pharmaceutical dosage form according to  claim 1 , which is monolithic and has a breaking strength of at least 300 N. 
     
     
         7 . The pharmaceutical dosage form according to  claim 1 , which is multiparticulate, wherein at least a fraction of individual particles have a breaking strength of at least 300 N. 
     
     
         8 . The pharmaceutical dosage form according to  claim 1 , which is monolithic and has an extension in any direction of at least 2.0 mm. 
     
     
         9 . The pharmaceutical dosage form according to  claim 1 , which is multiparticulate, wherein individual drug-containing particles have an extension in any direction of at least 2.0 mm. 
     
     
         10 . The pharmaceutical dosage form according to  claim 1 , which is hot-melt extruded.