QbD Assisted Approach for studying the impact of Formulation and Process Variables on Release Kinetic of Antiepileptic Formulation

Abstract

The present study adopts a Quality by Design (QbD) assisted approach to systematically evaluate the impact of formulation and process variables on the release kinetics of antiepileptic drug formulations, specifically sublingual and bilayer tablets. Two distinct formulations strategies were developed: a sublingual tablet for rapid onset of action and a bilayer tablet designed to deliver both immediate and sustained release profiles. Critical formulation variables, including the concentration of superdisintegrants (Crospovidone), binders (PVP K30), and diluents (Microcrystalline Cellulose), along with key process parameters, were identified through risk assessment and optimized using Design of Experiments (DoE). Response surface methodology and contour plots were utilized to investigate the interaction effects on critical quality attributes, including friability and in vitro drug release. The drug release profiles from both formulations were analyzed using different kinetic models, namely zero-order, first-order, Higuchi, and Korsmeyer-Peppas to better understand the underlying release mechanisms.