HOT-MELT EXTRUSION TECHNOLOGY IN PHARMACEUTICAL MANUFACTURING: AN IMRAD-BASED REVIEW

Abstract

Hot-melt extrusion (HME) has emerged as an important pharmaceutical manufacturing technology due to its solvent-free, continuous, and scalable processing capabilities. The technology is widely utilized for improving the solubility and bioavailability of poorly water-soluble drugs, producing controlled-release formulations, taste-masked dosage forms, and advanced drug delivery systems. This review summarizes the principles, equipment, materials, pharmaceutical applications, and recent advancements in HME. Particular emphasis is placed on twin-screw extrusion, polymer selection, process analytical technology (PAT), and integration with three-dimensional (3D) printing. Current challenges associated with scale-up, thermal degradation, and process optimization are also discussed. The review highlights the growing significance of HME in modern pharmaceutical manufacturing and its future potential in personalized medicine and continuous manufacturing