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Application of the combination of ball-milling and hot-melt extrusion in the development of an amorphous solid dispersion of a poorly water-soluble drug with high melting point

机译：球磨和热熔挤出的组合在开发高熔点水溶性差的药物的无定形固体分散体中的应用

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The aim of the study was to develop an amorphous solid dispersion of a poorly water-soluble drug with high melting point by ball milling and hot melt extrusion as a co-processing method. Solid dispersion systems were prepared by ball milling-hot melt extrusion and then compared with those prepared with hot melt extrusion. The effects of three process parameters in the co-processing method, namely, barrel temperature, screw speed, and cooling rate, were systematically studied. The physical state of prepared solid dispersion was characterized by differential scanning calorimetry, X-ray diffraction, Fourier transform infrared spectroscopy, scanning electron microscopy, phase solubility, and dissolution study. The Resveratrol–Eudragit? EPO system exhibited good miscibility and significant dissolution enhancement. Resveratrol in the amorphous solid dispersion existed in an amorphous state and had molecular interactions with Eudragit? EPO. Stability studies showed no apparent difference in the physical state of the solid dispersion after 6 months. In conclusion, combining ball milling with hot melt extrusion is a promising method for preparing the amorphous solid dispersion of a poorly water-soluble drug with high melting point.
机译：该研究的目的是通过球磨和热熔挤出作为共处理方法，开发一种熔点高，水溶性差的药物的无定形固体分散体。通过球磨-热熔挤出制备固体分散体系，然后与热熔挤出制备的体系进行比较。系统地研究了三种工艺参数在协同处理方法中的影响，即机筒温度，螺杆速度和冷却速率。制备的固体分散体的物理状态通过差示扫描量热法，X射线衍射，傅立叶变换红外光谱，扫描电子显微镜，相溶解度和溶解度研究来表征。白藜芦醇-Eudragit？ EPO系统显示出良好的可混溶性和明显的溶出度增强。非晶态固体分散体中的白藜芦醇以非晶态存在，并且与Eudragit？有分子相互作用。 EPO。稳定性研究表明6个月后，固体分散体的物理状态没有明显差异。总之，将球磨与热熔挤出相结合是制备具有高熔点的水溶性差的药物的无定形固体分散体的有前途的方法。

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