Enhancing Therapeutic Outcomes with Novel Drug Delivery Systems: Challenges and the Role of Quality by Design

Novel Drug Delivery Systems (NDDS) have significantly improved pharmaceutical science by addressing the drawbacks of traditional drug delivery methodssuch as low bioavailability, ineffective targeted delivery and rapid degradation. These advanced systems like nanoparticles, liposomes, micelles, and nanocapsules enable drug release in controlled manner, enhanced stability, and precise targeting to specific tissues or cells, thereby better therapeutic efficacy and patient compliance. The complex and multivariate nature of NDDS development demands a systematic approach to ensure consistent quality and optimal performance. QbD offers a science-based framework that integrates risk management, understanding the process, and control of CQAs and CPPs throughout the lifecycle of the product. By incorporating tools such as DoE and PAT, that facilitates robust formulation and manufacturing processe while reducing development time and costs. This review highlights the role of QbD in overcoming the challenges associated with NDDS, illustrates its application across various drug carriers and its impact on enhancing drug delivery efficiency, safety, and regulatory compliance. The integration of QbD into NDDS development promises to advance personalized medicine and promote innovation in pharmaceutical therapeutics.