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Hot-melt extrusion promotes dissolution,extends“spring-parachute”process and inhibits crystallization in supersaturating microparticle systems

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Particuology 2023年第7期78卷 35-48页

作者： Yanfei Zhang Huifeng Zhang Huan Yu Yinghui Ma Chengyi Hao Xiaoying Lin Yong Zhang Zhengqiang Li Xianrong Qi Jia Zeng Nianqiu Shi School of Pharmacy jilin Medical University Jilin132013jilin ProvinceChina Collge of Life Science Jilin UniversityChangchun130012jilin ProvinceChina Department of Pharmaceutics School of Pharmaceutical SciencePeking UniversityBeijing100191China College of Pharmaceutical Sciences Yanbian UniversityYanji133002jilin ProvinceChina

Despite the potential advantages of amorphism-induced supersaturation,the merit of new amorphiza-tion formation methods on the properties of the amorphous drug including the stability of the amor-phous state,dissolution/solubility,supersaturation,and"spring-parachute"process is still poorly understood,particularly for certain amorphous supersaturating drug delivery systems(aSDDS).The present work aimed to explore the detailed merit of current attractive amorphization manufacturing methods(i.g.,hot-melt extrusion(HME)technique)on the property improvement of aSDDS in form of amorphous solid dispersion microparticles by employing a model Bcs II drug nitrendipine and a polyvinylpyrrolidone-based model polymer *** asDDS systems were developed by various methods,and their physicochemical properties were characterized by SEM,PXRD and ***-triggered amorphization induced superior supersaturation by the observation of the highest dissolution and *** induced the optimal supersaturation duration by the observed greatest extension of"spring-parachute"process(e.g,maximum AUCspring-parachute).HME technique is comparable with other techniques for the stabilization of amorphous state during *** aSDDS systems by HME and other methods showed improved long-term stability of the amorphous state in comparison to the pure amorphous *** transformation infrared spectroscopy,Noyes-Whitney equation,nucleation theory and Gibbs free energy of transfer(△G)were used to analyze the underlying ***-lecular mechanism studies indicated that HME caused a stronger crystallization inhibition effect in the asDDS systems than other methods,but molecular interaction is not a dominant mechanism for property enhancement caused by *** the mechanism associated with the polymer itself(PVPVA64),it could inhibit the drug recrystallization,solubilize the drug spontaneously and cause the improved molecular interactions in all aSDDS *** study provided

关键词： Hot-melt extrusion-triggered amorphization Extensionof"spring-parachute"process promotion of dissolution/solubility Inhibition of crystallization from a supersaturated state Amorphism-based supersaturating drug microparticle systems

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