Selection of the Spray-Drying Process Design Space for an ASD Formulation via Thermodynamic Modelling

3/23/2022 16:05 - 16:35

Amorphous solid dispersions (ASDs) are commonly manufactured using spray-drying processes. The choice of process parameters can decisively influence product quality. Following the quality-by-design approach, identifying the spray-drying process design space is thus an essential task in drug product development. Aiming for a solvent-free and homogeneous ASD, API crystallization and amorphous phase separation must be avoided during drying. This approach provides a predictive tool for determining spray-drying process conditions via considering thermodynamic driving forces for solvent drying and ASD-specific API/ polymer/solvent interactions and glass transitions. The ternary API/polymer/solvent phase behavior is calculated using the Perturbed-Chain Statistical Associating Theory (PC-SAFT) combined with mass and energy balance.

Stefanie Dohrn, Principal Scientist, AbbVie