Optimization of Spray-Dried Co-Processed Excipients Using Design of Experiments: A Mixture Design Approach

Co-processed excipient (CPE) are widely recognized for their ability to enhance the functional properties of pharmaceutical formulations, providing superior performance compared to unprocessed physical mixtures. They improve flowability and compactibility when combined with active pharmaceutical ingredients (API). In this study, Design of Experiments (DoE) was employed to revisit the spray-dried production of CPEs composed of microcrystalline cellulose (MCC), lactose (LAC), and povidone (POV). The responses evaluated were compressibility index (CI), hardness, yield, and moisture content (MC). A mixture design was utilized to assess the interactions between these excipients and their effects on the responses, with response surface methodology (RSM) used to model the data via Design-Expert software. The optimization process identified an optimal formulation composed of 90% MCC and 10% POV, achieving a hardness value of 7.39 kgf, CI of 30.37%, MC of 3.73%, and a yield of 57.97%. This study demonstrates that DoE can be effectively utilized to develop promising CPE formulations.