Tamper resistant dosage form comprising inorganic salt

Disclosed is a pharmaceutical dosage form prepared by hot-melt extrusion exhibiting a breaking strength of at least 500 N and containing: 1) a pharmacologically active ingredient (A) which is an opioid, and preferably selected from tapentadol, oxymorphone, hydromorphone, oxycodone, morphine and the...

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Sprache:eng
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Zusammenfassung:Disclosed is a pharmaceutical dosage form prepared by hot-melt extrusion exhibiting a breaking strength of at least 500 N and containing: 1) a pharmacologically active ingredient (A) which is an opioid, and preferably selected from tapentadol, oxymorphone, hydromorphone, oxycodone, morphine and the physiologically acceptable salts thereof; 2) an inorganic salt (B), wherein the content of the inorganic salt (B) is from 12 to 60 wt.-% and the inorganic salt (B) contains at least one component selected from the group consisting of alkali carbonates, earth alkali carbonates, alkali hydrogen carbonates, earth alkali hydrogen carbonates, alkali phosphates, earth alkali phosphates, alkali hydrogen phosphates, earth alkali hydrogen phosphates, alkali dihydrogen phosphates, earth alkali dihydrogen phosphates and pentaalkali tri(poly)phosphates, based on the total weight of the dosage form; 3) a polyalkylene oxide (C) having a weight average molecular weight within the range of from 1 to 15 million g/mol, wherein the content of the polyalkylene oxide (C) is at least 30 wt.-%, based on the total weight of the dosage form; wherein the pharmacologically active ingredient (A) is embedded in a controlled release matrix comprising the inorganic salt (B) and the polyalkylene oxide (C), and wherein, under in vitro conditions, the release profile of the pharmacologically active ingredient (A) from said matrix comprises at least a time interval during which the release follows a zero order kinetics.