10-01-2019 дата публикации
Номер: US20190008849A1
The invention relates to a dosage form that is thermoformed without discoloration and is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse. The invention also relates to a corresponding method for producing said dosage form. 1. An abuse-proofed dosage form thermoformed by extrusion without discoloration comprising one or more active ingredients with abuse potential (A) , optionally physiologically acceptable auxiliary substances (B) , at least one synthetic or natural polymer (C) and optionally at least one wax (D) ,wherein the dosage form exhibits a breaking strength of at least 500 N.2. The dosage form according to claim 1 , which is in the form of a tablet.3. The dosage form according to claim 1 , which contains as polymer (C) at least one polymer selected from the group consisting of polyalkylene oxide claim 1 , polyethylene claim 1 , polypropylene claim 1 , polyvinyl chloride claim 1 , polycarbonate claim 1 , polystyrene claim 1 , polyacrylate claim 1 , copolymers thereof and mixtures thereof.4. The dosage form according to claim 3 , wherein the polyalkylene oxide is selected from the group consisting of polymethylene oxide claim 3 , polyethylene oxide claim 3 , polypropylene oxide claim 3 , copolymers thereof and mixtures thereof.5. The dosage form according to claim 1 , wherein the polymer (C) comprises polyethylene oxide having a molecular weight of at least 0.5 million.6. The dosage form according to claim 5 , wherein the molecular weight of the polyethylene oxide (C) is at least 1 million.7. The dosage form according to claim 6 , wherein the molecular weight of the polyethylene oxide is in the range of from about 1 to about 15 million.8. The dosage form according to claim 1 , which contains the wax (D) claim 1 , and the wax (D) is at least one natural claim 1 , semi-synthetic or synthetic wax with a softening ...
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