Box–Behnken Designs and Their Applications in Pharmaceutical Product Development

Box–Behnken designs (BBDs) are the very efficient response surface design which provides information exclusively on the effect of experiment variables and overall experimental error in a minimum number of required runs. These designs possess very good symmetry and rotatability and also produce minimal experimental runs, as compared to the popular CCD and deliver maximal information. As a response surface design, BBD requires three levels (−1, 0, 1) and can be applicable for number of factors ranging between 3 and 21. It is possible to use both numerical and categorical factors for optimization in a BBD, but use of categorical factors tends to increase the number of runs. Due to high resolution of CCDs, these can be efficiently useful for a variety of drug product and process optimization. This chapter provides complete details regarding the application of BBD in pharmaceutical drug product development and optimization.