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Tamper resistant controlled release pharmaceutical tablets form having convex and concave surfaces
专利权人:
GRUNENTHAL GMBH
发明人:
JANS, EUGEEN, MARIE, JOZEF,KIEKENS, FILIP, RENE, IRENA,VOORSPOELS, JODY, FIRMIN, MARCELINE,FAURE, ANNE,ARKENAU-MARIC, ELISABETH,BARNSCHEID, LUTZ,BARTHOLOMAUS, JOHANNES,FREVEL, MARC,GALIA, ERIC,ZIEGLER
申请号:
NZ58679209
公开号:
NZ586792A
申请日:
2009.01.23
申请国别(地区):
NZ
年份:
2012
代理人:
摘要:
Disclosed is a thermoformed pharmaceutical dosage form (such as in tablet form) with controlled release of a pharmacologically psychotropically active compound (A) (such as tapentadol) contained therein, the pharmaceutical dosage form having a breaking strength B1 of at least 500 N in direction of extension E1 and having a breaking strength B2 of less than 500 N in direction of extension E2; wherein a portion of the surface of the pharmaceutical dosage form is convex, another portion of its surface is concave; the content of the pharmacologically active compound (A) is at least 0.5 wt % based on the total weight of the dosage form; the dosage form contains polymer (C), which is a polyalkylene oxide (and preferably a polyethylene oxide) having a weight average molecular weight of at least 200,000 g/mol; the content of polymer (C) is at least 15 wt. %, based on the total weight of the dosage form; the pharmacologically active compound (A) is embedded in the polymer (C); and the pharmaceutical dosage form is adapted for oral administration once daily or twice daily.
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