In-line UV-VIS spectroscopy in small scale extrusion as process analytical technology during early stage development of amorphous solid dispersions

The poor solubility of a large number of active pharmaceutical ingredients (API) is a major challenge in pharmaceutical research. Therefore, the extrusion of amorphous solid dispersions (ASDs) is one promising approach to enhance the dissolution rate by molecularly dissolve the API in an amorphous carrier polymer. During ASD development, crucial parameters as the dissolution and the decomposition need to be monitored. Within this study, a small scale twin screw extruder was coupled with special ColVisTec UV-Vis probes that are characterized by their small dimensions. This setup enables a systematic formulation development and optimization based on in-line monitoring of crucial parameters using small amounts of material.