Recent trends and future perspective of pharmaceutical wet granulation for better process understanding and product development

Abstract

Current trends in pharmaceutical wet granulation have been shifted from traditional approach to systematic and modern approaches, enabling the production of highly engineered product. In this context, quality by design (QbD), modelling, and simulation gradually become important tools in the pharmaceutical industry. In this review, several aspects of high-shear wet granulation (HSWG), such as process and formulation variables are introduced and discussed. In addition, potential critical process parameters of various granulation technologies, such as HSWG, twin-screw granulation (TSG), fluid-bed granulation (FBG), and fluid-bed melt granulation, are introduced. The significance of various off-line and on-line/in-line tools for the characterization of granules and tablet attributes are also highlighted along with their application. Moreover, various mechanistic and semi-mechanistic models that are used to improve the granulation process have been summarized as the predictive models. Overall, this review may inform and guide formulation scientists about the systematic approaches of pharmaceutical wet granulation process to improve the formulation and process design. (C) 2018 Elsevier B.V. All rights reserved.