PHARMACEUTICAL COMPOSITION FOR ORAL ADMINISTRATION COMPRISING A TABLET CORE, CONTAINING FLIBANSERIN POLYMORPH A

摘要

Pharmaceutical composition for oral administration useful for the treatment of diseases in which the use of compounds displaying affinity for the 5-HT1A and 5 HT2-receptor comprising a tablet core, containing flibanserin polymorph A having an endothermic maximum at 161°C determined by DSC in amounts of 1 to 50 wt.% based on the total mass of the core in admixture with at least one pharmaceutically acceptable excipient as filler and/or binder components as herein described in amounts of 50 to 99 wt.% based on the total mass of the core, and optionally one or more disintegrants as herein described in amounts of 0.1 to 10 wt.% based on the total mass of the core, one or more flow regulators, lubricants and mould release or antiadhesive agents as herein described in amounts of 0.5 to 5 wt.% based on the total mass of the core and a film coating, enveloping said tablet core characterized in that the film coating comprises titanium dioxide in amounts of 5 to 55% and /or talc in amounts of 5 to 50% and at least one or more film-forming agents selected from among hydroxypropylmethylcellulose, hydroxypropylcollulose, methylcellulose, hydroxymethylcellulose, hydroxyethylcellulose and poly(ethylacrylate) methylmethacrylate and mixtures thereof.