Are traditional small-scale screening methods reliable to predict pharmaceutical spray drying?

摘要: Driven by the new trend to build quality into products and reducing empiricism, small-scale screening techniques have been frequently used evaluate, thermodynamic of drug solubility in polymer, drug-polymer kinetic amorphous miscibility. In this paper, these methods overviewed shed light on their liabilities predicting spray-dried solid dispersions' (ASDs) properties. By scrutinizing relevant open literature, several inconsistencies recognized, deemed be due inability conventional miniaturized means simulate spray drying process operations/constraints formulating active pharmaceutical ingredients (APIs). Given complex interplay thermodynamics mixing, heat mass transfer, fluid dynamics process, scaling rules introduced remedy arisen issues tools. Accordingly, is analyzed considering fundamental physical transformations involved, i.e. atomization drying. Each transformation explored from a perspective with an emphasis key response factors, ways retain them for each across scales. Prospective bifurcated developments may improve odds successful formulations/process conditions later during development stages.