Quality-by-design approach as a systematic tool for the development of nanopharmaceutical products

•QbD is an integrated science and risk-based approach of developing drug products.•It facilitates manufacturing improved product and process understanding.•Quality of nanopharmaceuticals is challenging due to material behaviour.•Application of QbD for helps in optimizing their product performance.•Regulatory flexibility and accelerated approval are other vital merits of QbD. In recent decades, extensive emphasis has been given on developing nanopharmaceutical products for improving the therapeutic performance of drugs, resulting in an increasing number of product approvals by drug regulatory agencies. Although nanopharmaceuticals are subjected to the same regulatory pathways as conventional pharmaceutical products, their biopharmaceutical characteristics at the nanoscale make them vulnerable to high variability in quality. Positive effects on drug quality assurance have resulted from adopting systematic quality-by-design (QbD) principles, boosting pharmaceutical manufacturing with improvements in the quality, safety, and efficacy of drugs. This article provides insights into the QbD-based development of nanopharmaceuticals with robust quality, efficacy, and safety features for their successful translation to the clinic.