Advancements and Challenges in Hot Melt Extrusion (HME) for Pharmaceutical Applications

Review Article

Abstract

Hot melt extrusion (HME) is a continuous pharmaceutical process utilizing controlled conditions to melt materials and extrude them through an aperture. Thermoplastic binders and polymers, pumped at or above their glass transition temperature (Tg) or melting temperature (Tm), facilitate molecular level mixing of active compounds and binders. HME technology has demonstrated reliability in creating solid dispersions, enhancing bioavailability, and masking the taste of bitter Active Pharmaceutical Ingredients (API). Primarily employed in rubber, plastics, and the food industry, HME is increasingly utilized in pharmaceuticals to manufacture tablets and suppositories. Through agitation, pressure, and heat applied via extrusion channels, HME combines materials. Despite authorization from the FDA, HME products have drawbacks, necessitating further steps to enhance drug solubility and dispersion. This article discusses HME screw design, 3D printing, materials, manufacturing processes, qualitative risk management strategies, scaling up processes, and current pharmaceutical applications