(189o) Development of an Expanded Parametric PBE Using Experimental Data from a High Shear Wet Granulation Process

Wet granulation process is widely used in the pharmaceutical industry to increase the particle size distribution of a solid formulation as liquid binder is applied. Even though this process is considered as one of the most complex processes currently performed in the manufacturing process, it can help in improving the blend flow properties, to minimize cross contamination, and dust accumulation in the room. As the effect of the blade angle and its RPM, the massing time, and the addition of a hydrophobic agent to the initial formulation were studied, more insights of the final PSD of a high shear batch wet granulation process were obtained. The objective was to expand the PBE to include explicitly the operating parameters. This expanded model could be used to predict on real time the PSD behavior and control the granulation process. For the PBE development, the experimental data were fit using the GSolids program. The expanded PBE obtained was able predict the PSD behavior of particles below 1218 μm. To increase the particle size range of the PBE, a suitable agglomeration kernel is needed, which should consider the agglomeration of larger particles.