Abstract

Application of Multivariate Tools and Artificial Neural Networking in Science Based Development of Novel Drug Products in PAT and QbD Era

Asha Patel, Associate Professor, Parul University

In the pharmaceutical industry, chemometrics is rapidly establishing itself as a tool that can be used at every step of product development. This set of multivariate analysis methods allows the extraction of information contained in large, complex data sets thus contributing to increase product and process understanding through Process Analytical Tools (PAT). Multivariate analysis (MVA) tools, with the case study on experimental data of optimization of dosage forms like Polymeric micelles for lung delivery, Nanoemulsion for ocular delivery, Niosome based gel for topical application. The application of artificial neural networking in optimization of sacrificing excipients for solid dispersion would have been discussed in the paper. Use of chemometric tools in the development and optimization of above said dosage forms with research data treatment been summarized. MVA is now an important tool in the QbD toolkit. Research examples containing the QbD paradiagm by applying risk approach to process parameters, identification of QTPP, plotting Ishikawa Fish bone diagram using software, screening of product and process paramaters of formulation, optimization thorugh Partial least square regression (PLSR) using Minitab software with statistical data treatment. Overall justification for science based development of pharmaceutical dosage forms with their bioavailability aspects.