Professor Graz University of Technology Graz, Austria
Hot melt extrusion (HME) process and product design for polymeric amorphous solid dispersions (ASDs) will be presented and discussed within this presentation. Especially, application of preformulation approach focused for the formulation and process (parameter) selection for HME will be illustrated including in silico screen design for polymer selection, supersaturation screening, physical phase characterization and in vitro dissolution and short term stability. Also, application of molecular dynamics simulation to support ASD formulation development and polymer selection will be presented. Namely, the stability descriptors such as mixing energy and molecular mobility evolving from MD simulation can provide insight into the relative contribution of one factor over other in the (in)stability. In case of HME modeling, the use of integrated 3D smoothed particle hydrodynamics (SPH) modeling with 1D model for HME process design will be discussed along with relevant case studies.