Rivaroxaban Orally Disintegrating Film Composition, and Preparation Method and Use Thereof

Abstract

The present invention provides a rivaroxaban orally disintegrating film composition, a preparation method thereof and a use thereof. The rivaroxaban orally disintegrating film composition comprises an active drug and a film-forming material; the active drug is one or more of 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide represented by Formula I, pharmaceutically acceptable salts, hydrates and solvates thereof. The rivaroxaban orally disintegrating film composition provided by the present invention has the advantages of good taste, stable properties, high dissolution rate, immediate dissolution in the oral cavity without drinking water, no gritty feeling after dissolution in the oral cavity, and fast oral absorption rate. Meanwhile, the present invention has simple process, no sedimentation during the preparation of film liquid, content uniformity meeting requirements, high drug loading, improved clinical patient compliance, is particularly suitable for patients with dysphagia, and has good marketization prospect.