Hot-melt extrusion is a proven manufacturing process that complies with FDA Process Analytical Technology (PAT) goals for designing, analyzing and controlling manufacturing process programs. This technology can be used to produce granules, pellets, immediate-release tablets, controlled-release tablets, and Pellicle. At present, many drugs have been approved for marketing in foreign countries using HME technology.

Statistics show that 40% of the drugs sold globally are poorly soluble drugs, and the proportion of poorly soluble drugs among the drugs under research is as high as 90%. Solubility has become a key factor affecting the development and application of such drugs. With the upgrading of the industry and the advancement of production technology, the “serial production” method may be gradually replaced by the “continuous production”. Have her cake, and eat it, too — a technology that can not only improve the solubility of poorly soluble drugs but also realize continuous production mode – hot melt extrusion technology, has emerged.