Investigation of the influence of critical process parameters in roller compaction process on physical properties of granules and tablets using design of experiments

Abstract

Different granulation methods are used in the pharmaceutical industry, mainly divided as wet or dry granulation. Although roller compaction is a widely used dry granulation process, the evaluation of critical process parameters has proven challenging because of the complex interactions among each parameter. Ribbons with different properties based on the variation of the input parameters are the result of roller compaction process. The properties of the final product are directly related to process parameters used during dry granulation. Understanding the interaction between the roller compaction parameters will allow accurate control of the process. The study aims to present the applicability of design of experiments (DoE) approach in the development of the roller compaction process. For this purpose, the two-level full factorial design was used to evaluate the influence of process parameters as roll pressure and speed, vertical feed screw speed and mill speed on the intermediate and final product physical properties. The results revealed that roll speed is the variable having the most impact on the density of the granules. The granules particle size is mostly dependent on variation in roll pressure, roll speed, and mill speed. Increasing the milling speed will create more uniform particles in the aspect of span distribution. After the process of compression of granules into tablets and assessing the data, roll speed was identified as the most influencing factor regarding tablet hardness.