Hot-melt extrusion pharmaceutical 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 produce granules, pellets, immediate-release tablets, controlled-release tablets, and Pellicle. At present, many drugs have been approved for marketing in foreign countries using hot melt extrusion pharmaceutical technology.
Working Principle
Hot melt extrusion pharmaceutical a technology that mixes drugs and polymers and other excipients in a molten state, and extrudes them at a certain pressure, speed, and shape to form products.
After the powder raw materials and auxiliary materials are fully mixed, they are evenly transported to the feed port through the feeding system, and then the API and drug carrier are evenly transported to the temperature-controlled barrel by the twin screw. The barrel is equipped with threaded elements, which perform different unit operations from the feeding position to the die head in sequence. The material moves forward under the conveying action of the threaded elements and melts or softens in the melting section. The melt is evenly mixed under the action of the mixing elements and finally extruded from the die at a certain pressure, speed and shape.