Development of a multidisciplinary optimization process for designing optimal pharmaceutical formulations with constrained experimental regions

Pharmaceutical formulation design with the development of analytical technologies and methodologies is an integral part of a drug’s research and development. Conventional pharmaceutical formulation design problems are typically studied under the assumption of an unconstrained experimental region with a single quality characteristic. In real world pharmaceutical formulation design problems, however, we are often faced with multiple quality characteristics with a constrained experimental region due to physical limitations. In order to address these needs, we propose a multidisciplinary optimization process for the optimal design of pharmaceutical formulations by developing a response surface simplex design (RSSD) and a response surface D-optimal design (REDD) for experimental modeling and by developing a partitioned composite desirability function (PCDF) for multidisciplinary optimization. Two actual case studies are also presented here for model verification purposes.