Year: 2026 | Month: September | Volume: 13 | Issue: 9 | Pages: 79-86
DOI: https://doi.org/10.52403/ijrr.20260910
Quality by Design (QbD) in Novel Drug Delivery Systems: A Review Integrating Pharmaceutics and Regulatory Affairs
Vishwa M. Patel1, Nihar A. Patel2
1Student, Master of Pharmacy in Pharmaceutics, Dharamsinh Desai University, Nadiad, Gujarat, India
2Student, Master of Pharmacy in Regulatory Affairs, Dharamsinh Desai University, Nadiad, Gujarat, India
Corresponding Author: Vishwa M. Patel
ABSTRACT
Quality by Design (QbD) has evolved from a regulatory aspiration into a foundational scientific framework for the development of novel drug delivery systems (NDDS), including lipid-based nanocarriers, polymeric nanoparticles, self-nanoemulsifying drug delivery systems (SNEDDS), liposomes, and mRNA-lipid nanoparticle (LNP) platforms. Rooted in the International Council for Harmonisation (ICH) Q8-Q12 guideline series, QbD replaces traditional quality-by-testing paradigms with a systematic, risk-based approach built around the Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Design of Experiments (DoE), design space definition, and lifecycle-oriented control strategies. This review integrates the pharmaceutical science underlying QbD implementation in NDDS - including formulation optimization, risk-assessment tools, and process analytical technology (PAT) - with the regulatory affairs perspective governing its application, spanning FDA and EMA expectations, post-approval change management under ICH Q12, and unresolved translational gaps for complex nanopharmaceuticals. Representative case studies across lipid nanosystems, polymeric nanoparticles, and nanoemulsion-based ocular delivery illustrate practical QbD implementation. The review concludes with a discussion of emerging directions, including artificial-intelligence-assisted design-space modelling and analytical QbD (AQbD), and highlights the continuing need for harmonized regulatory frameworks specific to nanopharmaceutical complexity.
Keywords: Quality by Design; ICH Q8-Q12; novel drug delivery systems; nanopharmaceuticals; Design of Experiments; Critical Quality Attributes; regulatory affairs; pharmaceutical development
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