R & D of Milling Technology in Pharmaceutical Industry

Abstract

In the pharmaceutical industry, milling process is important to improve the solubility of the bulk drug by grinding them into the small particle size. Small particles as the bulk drug help patients to be easily dissolved in their body, because most of them have very low solubility. However, the grinding characteristics and scale-up methodologies of ordinary milling techniques for pharmaceutical compounds have hardly ever been reported. In this study, five kinds of milling techniques (jet-mill, fluidized jet-mill, pin-mill, cosmomizer and cavitation-mill) for the drug: MK-J1, which we have developed, were evaluated on the basis of the particle size of the milled material and the durability and the scale-ability of these techniques. From this study, the fluidized jet-mill can be found to obtain the finest particle in size and the sharpest distribution and show the most durability. The scale-up number, Fn, derived from the dynamic balance of a centrifugal classifier was defined as the scale-up factor and its application-ability was also evaluated using the larger scale equipment.