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MODIFIED RELEASE FORMULATION AND METHODS OF USE
专利权人:
VALEANT PHARMACEUTICALS INTERNATIONAL
发明人:
NADJSOMBATI, BILJANA
申请号:
EP11735033
公开号:
EP2525660A4
申请日:
2011.01.18
申请国别(地区):
EP
年份:
2013
代理人:
摘要:
A modified release pharmaceutical formulation includes about 30-70% N-(2-amino-4- (fluorobenzylamino)-phenyl) carbamic acid ethyl ester (retigabine), or a pharmaceutically acceptable salt, solvate or hydrate thereof, about 5-30% of a drug delivery matrix including hydroxypropylmethylcellulose (HPMC), and an enteric polymer. The pharmaceutical formulation produces a sustained plasma concentration of retigabine following administration to a subject for 4- 20 hours longer than the time required for in vitro release of 80% of retigabine. The plasma concentration vs. time profile of this formulation is substantially flat over an extended period lasting for about 4 hours to about 36 hours. A method of treating a disorder characterized by nervous system hyperexcitability includes administering to a subject an effective amount of these pharmaceutical formulations.
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