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Pharmaceutical extended release system comprising flibanserin and ph dependent polymers, a process for preparing it and a capsule comprising it
Pharmaceutical extended release system comprising flibanserin and ph dependent polymers, a process for preparing it and a capsule comprising it
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机译:包含氟班色林和ph依赖性聚合物的药物延长释放系统,其制备方法和包含其的胶囊
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摘要
The present invention provides pharmaceutical release systems comprising an therapeutically effective amount of flibanserin and at least one pharmaceutically acceptable excipient, characterized in that said pharmaceutical release systems exhibit a pharmacokinetic profile that is characterized by an average maximum flibanserin plasma concentration Cmax lower than 300 ng/mL, preferably lower than 200 ng/mL after administration of a single dose to healthy volunteers in fasted state or directly after a meal.
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机译:本发明提供了包含治疗有效量的氟班色林和至少一种药学上可接受的赋形剂的药物释放系统,其特征在于,所述药物释放系统表现出药代动力学特征,其特征在于平均最大氟班色林血浆浓度Cmax低于300ng / mL。在空腹状态下或餐后直接向健康志愿者单剂量给药后,最好低于200 ng / mL。
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