Accurate process modeling for pharmaceutical drug substance development often requires data compiled from small-scale laboratory experiments, particularly leading up to early clinical phase deliveries when the amount of test article – such as advanced intermediate or API – may be limited. Designing these scale-down experiments has been particularly challenging for pharmaceutical agitated contact drying, due to the substantial volume of material needed for equipment such as filter dryers, and the difficulty in being able to monitor the drying process continuously. A novel, material-sparing workflow will be presented that generates real-time data for drying curves and helps elucidate drying kinetics.-These drying curves are then coupled with the Schlünder model (available in process modeling software such as Dynochem®) for elucidating drying kinetics. The influence of agitation, external inert gas sweep, temperature and pressure on the drying kinetics will be illustrated. Ultimately, this workflow can be used to facilitate process transfer from vials to filter dryers and predict the drying behavior on larger (decagram to kilogram) scales.
