PREPARATION METHOD OF LOW DOSE PHARMACEUTICAL COMPOSITION USING HOT MELT EXTRUSION METHOD

摘要

The present invention relates to a preparation method of a low dose pharmaceutical composition using a hot melt extrusion method, which comprises the steps of: mixing 0.0001-2 parts by weight of pharmaceutically active ingredients with 100 parts by weight of polymers having 70°C or less of melting points; forming extrudates by hot melt extruding the mixed solution at 30-70°C; and formulating the extrudates in pharmaceutical compositions. According to the preparation method of the present invention, polymers are melted by the hot melt extrusion method by using polymers having a relatively lower melting point than the melting point of general active compositions; the active composition prevents decomposition and change of the active compositions through a non-melting method; and formulation of drugs is facilitated so that content uniformity of limaprost, tamsulosin, glimepiride, and the likes which are low dose drugs can be maintained and formulation can be facilitated.