COMPOSITION FOR SELF-EMULSIFYING OF INSOLUBLE DUTASTERIDE AND THE TABLET CONTAINING THEREOF

摘要

PURPOSE: A method for manufacturing a tablet containing a solidified self-emusifying drug delivery system is provided to improve elution rate of dutasteride. CONSTITUTION: A solidified self-emusifying emulsion composition of dutasteride contains 1 weight part of dutasteride; 20-30 weight parts of water soluble polymer of hydroxypropylmethylcellulose(HPMC), polyvinylpyrrolidone(PVP K17), hydroxylpropylcellulose(HPC) or hydroxyethylcellulose(HEC); 10-20 weight parts of surfactant of sucrose palmitic acid esters, polyoxyethylene stearates, sodium dodecyl sulfate, or poroxamer; and 40-60 weight parts of oil of soybean oil, caprylic/carprylic acid triglyceride or propylene glycol monocarprylate. A solidified formulation of dutasteride is obtained by adding diluting agent and disintegrant to the self-emulsifying emulsion composition of dutasteride.