PROCESS FOR PREPARING MICRONIZED DICLOFENAC DIETHYLA-MINE AND A TOPICAL FORMULATION THEREOF

摘要

A process for preparing micron sized diclofenac dimethylamine, comprises the steps of mi-cronization of diclofenac dimethylamine by high energy milling technology using kinetic impact; employing pressurized process gas imparting high velocity to particles of diclofenac dimethylamine; reducing particle size of said diclofenac dimethylamine in a powder form to micron size; separating said particles by the exhaust process gas stream; and collecting the micron sized particles ranging between 1-500 microns and a topical formulation comprising diclofenac dimethylamine (micronized form) ranging between 0.5 5% by weight in com-bination with one or more pharmaceutically accepted vehicles, carriers, inactives and excipi-ents. Figure 1.