Hot-Melt Extrusion

Amorphous solid dispersions have enabled the successful formulation and advancement of many low aqueous solubility compounds by providing enhanced oral bioavailability from the modified drug form. While there are several platform technologies and manufacturing techniques to produce amorphous solid dispersions, hot-melt extrusion (HME) is a leading approach based on mature process understanding, small process footprint, continuous operation and readily scalable. These attributes allow for more of a plug-and-play unit operation, resulting in relatively lower manufacturing costs and making it a more appealing commercial process train.