TAMPER RESISTANT DOSAGE FORM COMPRISING AN ANIONIC POLYSACCHARIDE
The invention relates to a pharmaceutical dosage form having a breaking strength of at least 300 N, said dosage form comprising -an opioid (A) selected from the group consisting of Oxymorphone, Oxycodone, Tapentadol, Hydromorphone, Hydrocodone, Morphine, and the physiologically acceptable salts ther...
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Zusammenfassung: | The invention relates to a pharmaceutical dosage form having a breaking strength of at least 300 N, said dosage form comprising -an opioid (A) selected from the group consisting of Oxymorphone, Oxycodone, Tapentadol, Hydromorphone, Hydrocodone, Morphine, and the physiologically acceptable salts thereof; wherein the weight content of the opioid (A) is within the range of from 5.0 to 35 wt.-%, based on the total weight of the pharmaceutical dosage form; -an anionic polysaccharide (B) selected from the group consisting of croscarmellose, carmellose, crosslinked carboxymethyl starch, carboxymethyl starch, and the physiologically acceptable salts thereof; wherein the weight content of the anionic polysaccharide (B) is within the range of from 5.0 to 35 wt.-%, based on the total weight of the pharmaceutical dosage form; and -a polyalkylene oxide (C) having a weight average molecular weight of at least 200,000 g/mol; wherein the weight content of the polyalkylene oxide (C) is within the range of from 20 to 80 wt.-%, based on the total weight of the pharmaceutical dosage form; wherein the opioid (A) is present in a controlled-release matrix comprising the anionic polysaccharide (B) and the polyalkylene oxide (C). |
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