Evaluation of properties of granules and tablets prepared by twin-screw continuous granulation and comparison of their properties with those by batch fluidized-bed and high shear granulations

Abstract

This study aims to evaluate granules and tablets properties prepared by twin-screw continuous granulation (TSG) by comparing with those by fluidized-bed granulation (FBG) and high shear granulation (HSG). During FBG, mass median diameter increased in proportional to moisture content of wet granules. In HSG and TSG, granules growth was observed with an increase in mass ratio of liquid to solid. The mass median diameter was affected by the blade rotation speed at higher level of water content in HSG. By contrast, granule growth was less affected by the screw rotation speed in TSG. Friability and density of granules prepared by TSG remained between FBG and HSG. Scanning electron microscopy and cross-sectional 3D X-ray tomography images suggested that granules prepared by TSG did not receive high shear force as HSG during the granulation. The tablet strength and the percentage of dissolution were similar with those by FBG. It was because granules prepared by TSG had relatively porous structure as FBG. Under practical operation conditions, the tablet properties were comparable with those by FBG and HSG.