A Quality By Design Approach to Scale-Up of High Shear Wet Granulation Process
High-shear wet granulation is a complex process that, in turn, makes scale-up a challenging task. Scale-up of high-shear wet granulation process has been studied extensively in the past with various different methodologies being proposed in the literature.
This review article discusses existing scale-up principles and categorizes the various approaches into two main scale-up strategies: parameter-based and attribute-based. With the advent of the quality by design (QbD) principle in drug product development process, an increased emphasis toward the latter approach may be needed to ensure product robustness. In practice, a combination of both scale-up strategies is often utilized. In a QbD paradigm, there’s also a need for an increased fundamental and mechanistic understanding of the process. This can be achieved either by increased experimentation that comes at higher costs, or by using modeling techniques, that are also discussed as part of this review.
Article Information: Preetanshu Pandey, Sherif I.F. Badawy; Sciencedirect