Oral dosage form safeguarded against abuse containing (1r,...

A - Human Necessities – 61 – K

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Details

A61K 9/22 (2006.01) A61K 31/135 (2006.01)

Patent

CA 2572352

The invention relates to an oral dosage form, which is safeguarded against abuse and which has a controlled release of (1R, 2R)-3-(3-dimethylamino-1- ethyl-2-methyl-propyl)-phenol for a once daily administering. The invention is characterized in that the oral dosage form comprises the active ingredient and/or one or more pharmaceutically acceptable compounds (A) thereof, at least one synthetic and/or natural polymer (C), retarding adjuvants, optionally comprises additional physiologically compatible adjuvants (B), and optionally comprises a wax (D). The oral dosage form has a breaking resistance of at least 500 N, preferably at least 750 N. The dosage form contains at least one of the following abuse-preventing constituents (a)-(f); (a) at least one substance that irritates the nasal and/or pharyngeal cavity; (b) at least one viscosity-increasing agent; (c) at least one antagonist for the active ingredient having an abuse potential; (d) at least one emetic; (e) at least one colorant serving as an aversive agent, and; (f) at least one bitter substance.

L'invention concerne une forme posologique anti-abus pour administration par voie orale, à libération contrôlée de (1R, 2R)-3-(3-diméthylamino-1-éthyl-2-méthyl-propyl)-phénol à administrer une fois par jour, qui se caractérise en ce qu'elle contient un principe actif et/ou au moins un composé (A) pharmaceutiquement acceptable de celui-ci, au moins un polymère (C) synthétique et/ou naturel, des adjuvants de retardement, éventuellement d'autres adjuvants (B) physiologiquement compatibles, et éventuellement une cire (D). Cette forme posologique présente une résistance à la rupture d'au moins 500 N, de préférence d'au moins 750 N. Elle contient au moins un des composants anti-abus suivants: (a) au moins une substance irritant le nez et/ou la gorge; (b) au moins un agent augmentant la viscosité; (c) au moins un antagoniste du principe actif présentant un certain potentiel d'abus; (d) au moins un émétique; (e) au moins un colorant en tant qu'agent répulsif; et (f) au moins une substance amère.

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