ONCE-A-DAY ORAL ADMINISTRATION SUSTAINED-RELEASE FORMULATION COMPRISING ITOPRIDE HYDROCHLORIDE

摘要

An oral administration sustained-release two-layer tablet comprising itopride hydrochloride of the present invention, to satisfy both rapid pharmacological activity expression and sustained pharmacological activity for 24 hours, comprises: a quick-release layer which enables the drug to be dissolved in a rapid manner; and a sustained-release layer which enables the drug to be dissolved in a sustained manner. To exhibit an optimal release, hydroxypropyl methylcellulose having dissolution control properties depending on a certain degree of substitution and viscosity is used as a release regulator. The dissolution rate in gastrointestinal tracts with differing pH and residence time in gastrointestinal tracts are controlled. In addition, in the present invention, provided is a method for manufacturing an oral administration sustained-release two-layer tablet comprising itopride hydrochloride which is designed to increase patients adaptation to medication, prevent side effects caused by excessive release of early phase active ingredients, and maintain a constant dissolution rate.;COPYRIGHT KIPO 2019