Formulations of flibanserin and method for manufacturing the...

A - Human Necessities – 61 – K

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A61K 9/20 (2006.01) A61K 9/48 (2006.01) A61K 31/496 (2006.01)

Patent

CA 2660476

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.

La présente invention concerne des systèmes de libération pharmaceutique comprenant une quantité thérapeutiquement efficace de flibansérine et au moins un excipient pharmaceutiquement acceptable, lesdits systèmes de libération pharmaceutiques étant caractérisés par le fait qu'ils présentent un profil pharmacocinétique caractérisé par une concentration plasmatique moyenne maximale en flibansérine (Cmax) inférieure à 300 ng/ml, de préférence inférieure à 200 ng/ml, après l'administration d'une seule dose à des volontaires sains à jeun ou juste après un repas.

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