Solid Dispersions – A Versatile Formulation Strategy for Poorly Soluble Drugs
Summary: The influx of poorly soluble compounds into the drug development pipeline is likely to continue unabated. Solid dispersions provide a formulation technique that is well-suited to help tackle solubility challenges. But are they a universal approach for all drug substances? This expert review presents strategies for selecting a suitable formulation technique for poorly soluble drugs and describes in detail the characteristics of amorphous solid dispersions (ASD), and methods of manufacturing including spray-drying and hot melt extrusion. Recent advances in screening and modelling techniques for predicting solubility are also discussed. In addition, details of commercial products using ASDs and an upward trend in the approval of solid dispersion-based formulations are highlighted.