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Oxidation-stabilized tamper-resistant dosage form

  • US 10,493,033 B2
  • Filed: 02/21/2018
  • Issued: 12/03/2019
  • Est. Priority Date: 07/22/2009
  • Status: Active Grant
First Claim
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1. A tamper-resistant pharmaceutical dosage form in form of a tablet having a breaking strength of at least 300 N thermoformed by hot-melt extrusion of a mixture comprising the following components:

  • a pharmacologically active ingredient (A), wherein the pharmacologically active ingredient (A) is selected from the group consisting of oxycodone and physiologically acceptable salts thereof;

    citric acid in an amount of from 0.5 wt.-% to 5.0 wt.-%, based on the total weight of the pharmaceutical dosage form;

    α

    -tocopherol in an amount of from 0.001 wt.-% to 5.0 wt.-%, based on the total weight of the pharmaceutical dosage form;

    wherein the weight ratio of citric acid to α

    -tocopherol being in a range of from 4.2;

    1 to 1;

    3; and

    a polyalkylene oxide (C) having a weight average molecular weight Mw of at least 500,000 to 15,000,000 g/mol, the polyalkylene oxide (C) being present in the pharmaceutical dosage form in an amount of 56.8-77.8 wt.-% based on the total weight of the pharmaceutical dosage form and wherein the polyalkylene oxide (C) is polyethylene oxide.

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