PHARMACEUTICAL COMPOSITION AND GALENIC FORM BASED ON DRONEDARONE AND PROCESS FOR PREPARING THE SAME

摘要

The present invention relates, in general, to a pharmaceutical composition for oral administration containing as active principle a benzofuran derivative with antiarrhythmic activity, in particular dronedarone and its pharmaceutically acceptable salts and at least one lipid excipient, said pharmaceutical composition being intended to be used in capsule-type dosage form, in particular with a hard shell. This pharmaceutical composition and said dosage form comprising such a composition are intended to limit the meal effect after oral administration in humans. The lipid excipient makes it possible, on the one hand, to solubilize the active ingredient according to the invention and, on the other hand, to preserve it from the negative effects of pH in the intestinal tract, thus making it possible to escape the meal effect of significantly.