Application of Design of Experiment to Demonstrate Equivalency of Two Multi Layer Compression Process for an Extended Release Tablets Product

Abstract

Abstract ― A design of experiment (DOE) was performed to a multi layer compression process that is going to be transferred from facility A to facility B. This study demonstrates and compared the equivalence of the compression process of a non-validated process site with a validated process from the original site. The relevance of this project is to demonstrate the equivalence of the process to ensure the robustness, and quality of the product. During the compression process, the weight of multiple stages, thickness, and hardness were collected in both machine. The data collected was analyzed using One-Way-ANOVA and Kruskal-Wallis test. Based on the results obtained from the data, it was concluded that both multi layer compression process are equivalent. Key Terms ― Design of Experiment, Extended Release Tablets, Multi Layer Compression Process, One – Way – ANOVA.