A review of hot melt extrusion technology: Advantages, applications, key factors and future prospects

After decades of development, hot melt extrusion (HME) technology has matured as a well-established pharmaceutical methodology. Through the process of extruding both drug and carrier materials in a molten state under specific conditions of pressure, velocity, and screw design, this technology facilitates the dispersion of the drug within the carrier in various states such as molecular, amorphous, or sub-stable, thereby significantly improving the solubility and bioavailability of challenging drugs. Currently, over 20 drugs have obtained FDA approval for production and formulation via hot-melt extrusion, underscoring the demonstrated effectiveness and dependability of this technique. This review aims to offer an in-depth examination of the principles, benefits, and applications of hot-melt extrusion in pharmaceutical science, with a particular focus on the key determinants that impact the success of hot-melt extrusion. Additionally, it aims to explore the future applications and potential developmental opportunities of this technology, with an emphasis on its utility for continuous manufacturing (CM) and personalized drug delivery.