MOSAPRIDE SUSTAINED-RELEASE FORMULATION FOR PROVIDING PHARMACEUTICAL CLINICAL EFFECTS WITH ONCE-A-DAY DOSING

摘要

A formulation for oral administration containing mosapride or a salt thereof of the present invention is a bilayer formulation composed of an immediate-release layer to rapidly release a drug and a sustained-release layer to slowly release a drug to simultaneously achieve rapid exhibition of a pharmacological activity, and sustenance the pharmacological activity for 24 hours. The formulation is characterized by controlling retention time in a gastrointestinal tract and/or the dissolution rate in sites of the gastrointestinal tract having different pH by mixing and using hydroxypropylmethyl cellulose (HPMC) having high viscosity, and hydroxypropylmethyl cellulose (HPMC) having low viscosity such that the ratio of hydroxypropylmethyl cellulose (HPMC) having high viscosity is higher for a release control mechanism in a sustained-release layer. Furthermore, the present invention has an advantage of increasing the dosing compliance for the patients, since the total weight of the formulation of the present invention is small, i.e., 200 mg or less, preferably 150-160 mg.