REVIEW ARTICLE ON QBD APPROACHES TO IMPROVE NANOTECHNOLOGY BASED DRUG PRODUCT

Quality by Design (QbD) is a systematic approach in pharmaceutical development that focuses on predefined objectives, scientific understanding and quality risk management. It involves defining a Quality Target Product Profile (QTPP), identifying Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs). It is implemented for control strategies to ensure product quality, safety and efficacy by using tools such as risk assessment, Design of Experiments (DoE), Process Analytical Technology (PAT) and Ishikawa diagrams support QbD throughout the product lifecycle. Simultaneously, Nanotechnology has revolutionized drug delivery by improving solubility, bioavailability and targeted delivery. Nano-pharmaceuticals like liposomes, polymeric nanoparticles and nanosuspensions benefit greatly from QbD principles. Integrating QbD into nano-drug development enables better control of particle size, zeta potential, drug loading, and release kinetics, which are critical for performance and safety. Computational tools and design optimization techniques further streamline this development. The integration of QbD and nanotechnology enhances the reliability, effectiveness, and regulatory compliance of advanced drug products. This synergy not only accelerates innovation and improves therapeutic outcomes but also ensures consistent quality and supports efficient approval and lifecycle management in line with global regulatory standards.