Preparation and optimization of multi-functional directly compressible excipient: an integrated approach of principal component analysis and design of experiments.

Developing a new excipient and obtaining its market approval is an expensive, time-consuming, and complex process. The application of a multivariate analytical approach principal component analysis (PCA) - in combination with the design of experiments (DoE) approach can make the process of developing co-processed excipient cost-effective and rapid. The present investigation was aimed to demonstrate the applicability of the DoE approach and PCA in developing a co-processed excipient by using the spray drying technique. The preliminary studies suggested a significant effect of inlet air temperature ( ) and polymer ratio [chitosan chlorhydrate (CC): mannitol - ) on critical product characteristics so they were selected as independent variables in 3 full factorial design. The result of regression analysis suggested a significant effect of both independent variables on all response variables. The PCA of practically obtained value suggested a strong effect of all the selected response variables on the model. The prepared co-processed excipient had better tableting properties compared to the physical mixture of excipients and was able to accommodate more than 80% drug without compromising the flow property and compressibility. The present investigation successfully proved the applicability PCA and DoE approach as an effective and rapid tool for optimizing process parameters and formulation composition for preparing a directly compressible co-processed excipient.