COMPOSITION FOR SELF-EMULSIFYING PREPARATION COMPRISING DUTASTERIDE AND MANUFACTURING PROCESS THEREOF

摘要

PURPOSE: A solidification composition using a self-emulsified drug delivery system is provided to minimize drug particle and to improve drug solubility, stability, and hardness. CONSTITUTION: A solidified formulation of dutasteride comprises a first coating solution containing dutasteride, adsorbing agent, pharmaceutically acceptable excipient, and mixture of soluble polymers and insoluble polymers; a second coating solution containing water-insoluble polymer. The formulation further contains oil, surfactant, and stabilizing agent. A method for manufacturing the formulation comprises: a step of dissolving dutasteride, surfactant, oil, and stabilizing agent in an organic solvent and adding the adsorbing agent and excipient to prepare solidified formulation; a step of coating with the first coating solution to the formulation; and a step of coating with the second coating solution.