Advanced 3D and 4D microstructure study of single granule formation for pharmaceutical powders using synchrotron x‐ray imaging

Abstract

AbstractMonitoring the microstructure of the granule in the wet granulation process could play a decisive role in obtaining high‐quality granules. Due to the complex, fast and opaque nature of wet granulation, it cannot be captured by conventional methods. In this study, synchrotron x‐ray imaging was employed for the first time to investigate the internal real‐time pore evolution during the granule formation process, based on the single droplet impact method. It was found that granules from coarser and more homogenous powders experienced a higher rate of pore evolution during nucleation with a more uniform pore distribution. Dynamic wetting studies showed the granule formation mechanisms, the crater mechanism was found for most binary mixtures with 50 wt. % excipients. According to the physical tests, the granules with lower porosity and finer pores exhibited higher hardness and a slower dissolution rate.