Amorphous solid dispersions: Stability mechanism, design strategy and key production technique of hot melt extrusion

Abstract

Solid dispersion (SD) system has been used as an effective formulation strategy to increase in vitro and in vivo performances of poorly water-soluble drugs, such as solubility/dissolution, stability and bioavailability. This review provides a comprehensive SD classification and identifies the most popular amorphous solid dispersions (ASDs). Meanwhile, this review further puts forward the systematic design strategy of satisfactory ASDs in terms of drug properties, carrier selection, preparation methods and stabilization mechanisms. In addition, hot melt extrusion (HME) as the continuous manufacturing technique is described including the principle and structure of HME instrument, key process parameters and production application, in order to guide the scale-up of ASDs and develop more ASD products to the market in pharmaceutical industry.

Keywords: Classification; Design strategy; Hot melt extrusion; Solid dispersion; Stability.