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FORMULATION À EFFET RETARD COMPRENANT DU 3-(2-DIMÉTHYLEAMINOMÉTHYLECYCLOHEXYLE)PHENOL
专利权人:
GRUENENTHAL GMBH
发明人:
JUNG, TOBIAS,BARTHOLOMAEUS, JOHANNES
申请号:
EP06805729.8
公开号:
EP1928441B1
申请日:
2006.09.15
申请国别(地区):
EP
年份:
2013
代理人:
摘要:
The invention relates to a dosage form for controlled release of the active ingredient 3-(2-dimethylaminomethylcyclohexyl)phenol, preferably (1R,2R)-3-(2-dimethylamino-methylcyclohexyl)phenol, or one of the pharmaceutically acceptable salts thereof, which (i) in vivo achieves the peak plasma level of the active ingredient after 2 to 10 h, and/or (ii) in vitro, measured in accordance with the European Pharmacopoeia with a paddle stirrer apparatus in buffer at a pH value of 6.8 (preferably 900 ml), a temperature of 37° C. and 75 rpm releases after 0.5 hours 3.0 to 37 wt. %, after 1 hour 5.0 to 56 wt. %, after 2 hours 10 to 77 wt. %, after 3 hours 15 to 88 wt. %, after 6 hours at least 30 wt. %, after 12 hours at least 50 wt. %, after 18 hours at least 70 wt. % and after 24 hours at least 80 wt. % of the active ingredient originally contained in the dosage form.
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