Response Surface Methodology: an Interesting Statistical Tool for Process Optimization and Validation: Example of Wet Granulation in a High-Shear Mixer

Abstract

The Response Surface Methodology is used to study the wet granulation in a high-speed mixer, granulator and dryer. By building sequential experimental designs, it is possible to quantify the influence of different process parameters on the characteristics of the final produced granules and tablets. The computed mathematical models are statistically tested and verified by experimentation. In order to facilitate the analysis of the regression coefficients, the response surfaces and the corresponding contourplots are drawn pointing out interesting levels for the operating conditions. Finally the chosen statististical approach appears to be efficient not only to optimize but also to validate the operation of wet granulation.