Development and evaluation of synchronized and sustained release Tripergium Wilfordii tablets based hot-melt extrusion and direct powder compression

Abstract Development of synchronized and sustained release preparations for herbal medicines is still a vast challenge due to their complicated components with different physicochemical properties. In this study, tablets were developed to achieve synchronized and sustained release of the multi-components in Tripergium Wilfordii (TMW). TMW solid dispersions (TMW SD) based on Kollidon® VA64 and glyceryl monostearate (GMS) were first prepared by hot-melt extrusion (HME), and then the TMW tablets consisted of pulverized TMW SD, Ludipress® and talc were prepared by direct powder compression (DPC). The physical property was characterized by differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD), and the results showed that drug existed in a molecular or amorphous state. The in vitro release profile was evaluated using similarity factor f2, and the results demonstrated that synchronized and sustained release of the multi-components in TMW tablets were achieved. The release kinetics, erosion and hydration studies indicated that the drug release was mainly controlled by bulk erosion. Therefore, the combination of HME and DPC is a potential strategy to accomplish synchronized and sustained release of the multi-components in herbal medicines.