Chapter 3 - Application of Design of Experiments (DoE) in Pharmaceutical Product and Process Optimization

Abstract

The development of pharmaceutical drug products involves a multitude of functional and nonfunctional excipients, a series of processes, and manufacturing steps. Hence, the product development verily involves a series of factors, which needs to be rationally optimized for achieving the desired product quality. The traditional one-factor-at-a-time (OFAT) approach is having limited importance nowadays due to several shortcomings like the huge investment of time, efforts, resources, and inability to establish a cause-and-effect relationship. On the contrary, the systematic design of experiments (DoE) is a multifactorial approach of optimizing the product quality by minimal experimentation and investment of resources. The DoE approach has been immensely used in the technology-driven industry for the development of optimized products with significantly improved quality, resource economics, process capability, and prognostic ability. The immense utility of such rational approaches has led to its wider acceptance in developing the breakthrough systems. This chapter, therefore, endeavors to provide an overview account on the fundamentals of experimental designs and their applications in the development of pharmaceutical products.