A significant number of new active pharmaceutical ingredients (APIs) are poorly water soluble and cannot be formulated and processed with traditional aqueous methods. Hot melt extrusion (HME) has become an effective solubilization tool in improving the dissolution rate of poorly water soluble drugs to enhance their bioavailability after oral administration1. These crystalline hydrophobic drugs can be dispersed in hydrophilic polymers using HME to manufacture amorphous solid dispersions.

Hot melt extrusion has been widely used as a processing method for many purposes, including formation of a solid molecular dispersion to increase the bioavailability of poorly soluble drugs. Analytical tools and techniques can greatly reduce time and improve success rates in development of hot melt extrusion formulations. In the formulation development stage, analytical characterization of molecular dispersion simplifies the process to compare and contrast different hot melt formulations. In the scale-up phase, analytical characterization techniques ensure similar solubility enhancement occurs on larger extrusion equipment as with the lab-scale equipment used for formulation development.