ACTIVE INGREDIENT (I) CONTAINING COMPOSITION AND METHOD FOR PREPARING SAME

摘要

The present invention relates to a composition comprising 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxazolidin-5-yl}-methyl]-2-thiophene carboxyamide as an active ingredient, manufactured by a melt extrusion method. The composition according to the present invention has a wide variety of advantages such as securing dissolution rate and bioavailability of the active ingredient, improving absorption deviation depending on whether a patient has a meal or not, and securing stability during the manufacturing process. The present invention further provides a method which can manufacture the said composition.

主权项

1. A rivaroxaban-containing composition manufactured by a melt extrusion method using rivaroxaban and at least one pharmaceutically acceptable polymer,
wherein the rivaroxaban is in the amorphous or thermodynamically metastable crystal form, and the pharmaceutically acceptable polymer is vinylpyrrolidone-vinylacetate copolymer, polyethylene glycol-polyvinylcaprolactam-polyvinylacetate copolymer, or a mixture thereof.