Exploring Hot Melt Extrusion from Process to Product with Methodologies and Drug-Delivery Applications: A Review.

For the pharmaceutical industry, hot-melt extrusion (HME) has become a cutting-edge production process. Compared to conventional procedures, HME is a solvent-free approach that offers numerous applications, cost-effectiveness, and continuous manufacturing. Studying the formulation and process characteristics should be prioritized in order to satisfy requirements. Many distinct dosage forms for different purposes can be formulated by altering the equipment design and a few processing parameters. For the intended outcome, the HME process must run smoothly and continuously. In this regard, pre-formulation study plays a main role in selecting the carrier, drug, and other required excipients. This review provides a comprehensive understanding of various equipment parts, HME materials and processes, formulation development, and HME in the delivery of drugs. It also highlights the applications and patents of HME.