Oral dosage form safeguarded against abuse containing (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol

Abstract

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.

Description

technical field [0001] The present invention relates to an abuse-resistant oral dosage form for once-daily administration of the active ingredient (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl) Phenol controlled release, the dosage form comprises said active ingredient and / or one or more pharmaceutically acceptable salts and / or derivatives thereof (A), at least one synthetic or natural polymer (C) , optional sustained-release matrix material, optional physiologically acceptable auxiliary substances (B) and optionally a wax (D), wherein component (C) or (D) exhibits at least 500 in each case N breaking strength. Background technique [0002] In addition to the excellent pain-relieving action, this active ingredient also exhibits a potential for abuse, ie it may be used by the abuser to produce an action not commensurate with its intended purpose. Thus, for example, such active ingredients are used by abusers to induce narcotic or euphoric states. [0003] These dosage...

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Problems solved by technology

[0009] However, since in the past, in most cases for abuse, it was necessary to comminute dosage forms for the controlled release of active ingredients, the subject of the present invention is complication or prevention of comminuted dosage forms before abuse, which is potentially A dosage form with controlled release (1R, 2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol that can be obtained by abusers through conventional methods, and in such means to provide a dosage form of the active ingredient which, when administered in a purposeful manner, ensures the desired therapeutic effect of once-daily administration, but whereby the active ingredient cannot be converted into a form , the form is suitable for abuse by simply crushing

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