Extended release tablet formulations of flibanserin and method for manufacturing the same
First Claim
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1. A pharmaceutical extended release system for an active substance with pH-dependent water solubility, comprising:
- a) flibanserin or a pharmaceutically acceptable derivative thereof as the active substance;
b) one or more pharmaceutically acceptable pH-dependent polymers;
c) between 15-30% by weight of one or more pharmaceutically acceptable pH-independent polymers;
d) one or more pharmaceutically acceptable acids; and
e) optionally one or more additives.
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Abstract
The invention is directed to a Pharmaceutical extended release system, particularly for oral administration, of a pH-dependent water-soluble active substance, comprising or essentially consisting of
- a) flibanserin or a pharmaceutically acceptable derivative thereof as active substance;
- b) one or more pharmaceutically acceptable pH-dependent polymers;
- c) one or more pharmaceutically acceptable pH-independent polymers;
- d) one or more pharmaceutically acceptable acids; and
- e) optionally one or more additives.
The present invention provides a release profile of flibanserin which is independent on the pH in the gastrointestinal tract when administered orally resulting in a significantly improved bioavailability.
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Citations
22 Claims
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1. A pharmaceutical extended release system for an active substance with pH-dependent water solubility, comprising:
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a) flibanserin or a pharmaceutically acceptable derivative thereof as the active substance; b) one or more pharmaceutically acceptable pH-dependent polymers; c) between 15-30% by weight of one or more pharmaceutically acceptable pH-independent polymers; d) one or more pharmaceutically acceptable acids; and e) optionally one or more additives. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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Specification