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Amorphous solid dispersions: Stability mechanism, design strategy and key production technique of hot melt extrusion
Jiawei Han1, Mengyuan Tang2, Yang Yang2
1School of Pharmacy & School of Biological and Food Engineering, Changzhou University, Changzhou 213164, PR China; Changzhou Pharmaceutical Factory Co., LTD, Changzhou 213018, PR China; College of Chemistry, Chemical Engineering and Materials Science, Soochow University, Suzhou 215123, PR China.
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.
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