Hot melt extrusion (HME) is a powerful technology to enhance the solubility and bioavailability of poorly water-soluble drugs
by producing amorphous solid dispersions. Although the number of articles and patents about HME increased dramatically in the past
twenty years, there are very few commercial products by far. The three main obstacles limiting the commercial application of HME are
summarized as thermal degradation of heat-sensitive drugs at high process temperature, recrystallization of amorphous drugs during storage
and dissolving process, and difficulty to obtain products with reproducible physicochemical properties. Many efforts have been taken
in recent years to understand the basic mechanism underlying these obstacles and then to overcome them. This article reviewed and
summarized the limitations, recent advances, and future prospects of HME.
Keywords: Hot melt extrusion, amorphous solid dispersion, thermal degradation, recrystallization.
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