Tamper-resistant oral pharmaceutical dosage form comprising a pharmacologically active ingredient, an opioid antagonist and/or aversive agent, polyalkylene oxide and anionic polymer

摘要

Provided is a pharmaceutical dosage form for oral administration having a breaking strength of at least 300 N and comprising (i) a pharmacologically active ingredient; (ii) an opioid antagonist and/or an aversive agent; (iii) a polyalkylene oxide having an average molecular weight of at least 200,000 g/mol; and (iv) comprising an anionic polymer; and/or having a storage stability at 40°C of at least 3 months. In a preferred embodiment the dosage form includes an anionic polymer, and the aversive agent is selected from (a) substances which irritate the nasal passages and/or pharynx, (b) viscosity-increasing agents and/or gelling agents; (c) emetics; (d) dyes; (e) bitter substances; and (f) surfactants.