TAMPER-RESISTANT FIXED DOSE COMBINATION PROVIDING FAST RELEASE OF TWO DRUGS FROM DIFFERENT PARTICLES

摘要

A tamper-resistant pharmaceutical dosage form comprising two pharmacologically active ingredients, wherein the dosage form provides under in vitro conditions fast release, preferably immediate release according to Ph. Eur., of both pharmacologically active ingredients. The dosage form is useful for pharmaceutical combination therapy that is achieved by administering dosage forms containing more than one pharmacologically active ingredient as fixed-dose combinations.

主权项

1. A tamper-resistant pharmaceutical dosage form comprising a pharmacologically active ingredient a having a psychotropic effect and a pharmacologically active ingredient b;
wherein at least a portion of the pharmacologically active ingredient a is contained in one or more particles A which comprise a polymer matrix in which the pharmacologically active ingredient a is embedded; and at least a portion of the pharmacologically active ingredient b is contained in one or more particles B that differ from the one or more particles A; and wherein the dosage form releases under in vitro conditions after 30 min at least 50 wt.-% of the pharmacologically active ingredient a originally contained in the dosage form; and/or at least 50 wt.-% of the pharmacologically active ingredient b originally contained in the dosage form.