Manufacturing strategies to develop amorphous solid dispersions: An overview.

Since the past several decades, poor water solubility of existing and new drugs in the pipeline have remained a challenging issue for the pharmaceutical industry. Literature describes several approaches to improve the overall solubility, dissolution rate, and bioavailability of drugs with poor water solubility. Moreover, the development of amorphous solid dispersion (SD) using suitable polymers and methods have gained considerable importance in the recent past. In the present review, we attempt to discuss the important and industrially scalable thermal strategies for the development of amorphous SD. These include both solvent (spray drying and fluid bed processing) and fusion (hot melt extrusion and KinetiSol®) based techniques. The current review also provides insights into the thermodynamic properties of drugs, their polymer miscibility and solubility, and their molecular dynamics to develop stable and more efficient amorphous SD.