Forma de dosificacion farmaceutica oral resistente a rompimiento de al menos 300n comprendiendo agonista opioide, antagonista opioide y un oxido de polialquileno de pm 200.000 g/mol

A pharmaceutical dosage form for oral administration having a breaking strength of at least 300 N and comprising an opioid agonist, an opioid antagonist, and a polyalkylene oxide having an average molecular weight of at least 200,000 g/mol, wherein in accordance with Ph. Eur. the in vitro release pr...

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Hauptverfasser: BARNSCHEID, LUTZ, GEISSLER. ANJA
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Zusammenfassung:A pharmaceutical dosage form for oral administration having a breaking strength of at least 300 N and comprising an opioid agonist, an opioid antagonist, and a polyalkylene oxide having an average molecular weight of at least 200,000 g/mol, wherein in accordance with Ph. Eur. the in vitro release profile of the opioid agonist essentially corresponds to the in vitro release profile of the opioid antagonist, and wherein the opioid agonist and the opioid antagonist are intimately mixed with one another and homogeneously dispersed in the polyalkylene oxide. The pharmaceutical dosage form is useful, for example, to treat pain in a patient in need of such treatment.