Method for the preparation of modified release multi-unit oral dosage form of doxylamine succinate and pyridoxine hydrochloride

摘要

The present invention relates to a method for preparing a modified release multi-unit oral dosage form comprising a plurality of modified release pellets of doxylamine or a salt thereof and a modified release pellet of pyridoxine or a salt thereof; The method comprises: doxylamine pellets having an inner active coating layer and an intermediate enteric coating layer; and coating the pellets of pyridoxine having an inner active coating layer, wherein the coating step includes simultaneous spraying of a mixture comprising an enteric and modified release coating agent and adding a pore former in powder form. .