TAMPER-RESISTANT DOSAGE FORM WITH IMMEDIATE RELEASE AND RESISTANCE AGAINST SOLVENT EXTRACTION

    公开(公告)号:EP3698776A1

    公开(公告)日:2020-08-26

    申请号:EP19157987.9

    申请日:2019-02-19

    申请人: Grünenthal GmbH

    IPC分类号: A61K9/14 A61K9/20 A61K31/00

    摘要: The invention relates to a tamper-resistant pharmaceutical dosage form comprising a multitude of particles which comprise a pharmacologically active compound, preferably selected from opioids; a polyalkylene oxide having a weight average molecular weight within the range of from 200,000 g/mol to 2,000,000 g/mol, and a disintegrant; wherein the pharmacologically active compound is dispersed in a matrix comprising the polyalkylene oxide and the disintegrant; wherein the content of the disintegrant is more than 20 wt.-%, based on the total weight of the particles; wherein the content of the polyalkylene oxide is at least 25 wt.-%, based on the total weight of the particles; and wherein the dosage form provides under in vitro conditions immediate release of the pharmacologically active compound in accordance with Ph. Eur.