Oxidation-stabilized tamper-resistant dosage form
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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Abstract
A thermoformed pharmaceutical dosage form having a breaking strength of at least 300 N, said dosage form comprising
- a pharmacologically active ingredient (A),
- a free physiologically acceptable acid (B) in an amount of from 0.001 wt.-% to 5.0 wt.-%, based on the total weight of the pharmaceutical dosage form, and
- a polyalkylene oxide (C) having a weight average molecular weight Mw of at least 200,000 g/mol.
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Citations
10 Claims
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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:
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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; anda 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 Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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Specification