Recent Progress in High-Throughput Formulation of Nanocrystals at Laboratory Scale

Drug nanocrystals (NCs) have radically changed the panorama of hydrophobic drug delivery by enhancing bioavailability and enabling long-acting FDA-approved injectable products like Invega Sustenna®, Trinza®, Hafyera®, and Cabenuva®. However, early-stage NCs formulation often requires substantial APIs amounts and extended processing times, major barriers when working with high-cost compounds or limited API availability. This presentation addresses these limitations by showcasing four innovative lab-scale strategies developed by our group for rapid, cost-effective NCs production using common lab equipment: 1) a milligram-scale mill producing NCs as small as 150 nm with 7.5 mg drug; 2) an ultra-fast method producing NCs in 1-minute, reducing time up to 1,440-fold; 3) a temperature-controlled device for precise NC production; 4) a parallel milling system producing 24 batches simultaneously with minimal API. The talk will show how these resource-efficient approaches can accelerate formulation development, reduce material consumption and processing time, and facilitate faster, scalable, more cost-effective development processes.