×

Oxidation-stabilized tamper-resistant dosage form

  • US 9,925,146 B2
  • Filed: 09/01/2015
  • Issued: 03/27/2018
  • Est. Priority Date: 07/22/2009
  • Status: Active Grant
First Claim
Patent Images

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) selected from the group consisting of oxymorphone 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.

View all claims
  • 1 Assignment
Timeline View
Assignment View
    ×
    ×