Abstract：OBJECTIVE To put forward considerations for the quality evaluation of solid dispersions prepared by hot melt extrusion (HME) from the perspectives of formulation, production process and quality control, and provide reference for pharmaceutical development. METHODS The solid dispersion preparations which have been marketed in recent years were summarized, and the types and functions of key excipients were discussed. The formulation and production process of HME were introduce, and the basic considerations for the quality control of solid dispersions were put forward. RESULTS The types of excipients commonly used in the formulation of HME solid dispersions included carrier matrixes, plasticizers, surfactants, and glidants. The carrier matrixes used in marketed formulations mainly include PVP/VA, HPMCAS, and HPMC. Hot melt extrusion temperature and screw kneading are the key process parameters that affect the quality of solid dispersions. Quality control should focus on amorphous and dissolution. CONCLUSION It is important to pay attention to the change of quality of solid dispersions under long-term and accelerated storage conditions, especially for amorphous and dissolution.
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MA Jun-wei, AN Na. Consideration for Quality Evaluation of Solid Dispersions Prepared by Hot Melt Extrusion. Chinese Pharmaceutical Journal, 2020, 55(21): 1819-1823.
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