Quality by Design based Optimization of Spironolactone Immediate-Release Tablets.

Abstract

The development of pharmaceutical formulations demands a quality-driven approach to ensure therapeutic efficacy, safety, and patient compliance. This study focuses on the quality-based development of spironolactone immediate-release tablets, an essential medication for managing hypertension, heart failure, and hyperaldosteronism. A systematic approach incorporating Quality by Design (QbD) principles was employed to optimize the formulation and manufacturing processes.Critical quality attributes (CQAs) such as dissolution rate, disintegration time were identified through risk assessment and targeted for optimization. Key formulation variables, including binder concentration, lubrication level and disintegrant levels, were systematically varied using a design of experiments (DoE) approach. The optimized formulation demonstrated rapid disintegration and consistent drug release, meeting the predefined quality criteria. This study highlights the importance of a quality-driven development framework for achieving a robust and patient-centric spironolactone immediate-release tablet formulation. The findings underscore the potential of applying QbD principles to improve formulation efficiency, reduce development timelines, and ensure regulatory compliance, ultimately benefiting patients and the pharmaceutical industry. The target goals for each of the response variable were provided, which included enhancing of % drug release NLT 75% in 60 min and reducing disintegration time less than 8 min f3, f10 and f11 batches shoes maximum f2 factor with comparable disintegrant time.