Extended release tablet formulations of flibanserin and method for manufacturing the same
First Claim
1. A pharmaceutical release system comprising a therapeutically effective amount of flibanserin, or pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient, wherein the composition exhibits a pharmacokinetic profile that is characterized by an average maximum flibanserin plasma concentration Cmax of less than 300 ng/mL after administration of a single dose to healthy volunteers in fasted state or directly after a meal.
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Abstract
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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Citations
12 Claims
- 1. A pharmaceutical release system comprising a therapeutically effective amount of flibanserin, or pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient, wherein the composition exhibits a pharmacokinetic profile that is characterized by an average maximum flibanserin plasma concentration Cmax of less than 300 ng/mL after administration of a single dose to healthy volunteers in fasted state or directly after a meal.
Specification