Quality by Design in Nanoparticle Drug Delivery Systems
Summary
Quality by Design in nanoparticle drug delivery integrates principles from engineering, material science and regulatory guidance to establish robust development pathways for lipid-, polymer- and hybrid-based carriers. By defining a quality target product profile at the outset, researchers identify critical material attributes and process parameters that influence safety, efficacy and manufacturability. Systematic risk assessment and design of experiments build a design space within which formulations consistently meet predefined performance metrics such as particle size distribution, surface charge, drug release kinetics and stability. This approach enhances global regulatory alignment, accelerates translation of bench-scale research into scalable processes and supports the production of reliable, patient-centric nanomedicines for oncology, infectious diseases and precision therapies.
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Quality by Design in Nanoparticle Drug Delivery Systems publication trend
The graph below shows the total number of articles in quality by design in nanoparticle drug delivery systems across all publications each year (not limited to Nature Index journals).
Technical terms
Quality by Design (QbD): A systematic approach to pharmaceutical development that emphasises predefined objectives and risk management to ensure product quality.
Critical Quality Attributes (CQAs): The physical, chemical or biological properties of a formulation that must be controlled to ensure desired product performance.
Design of Experiments (DoE): A structured statistical technique for planning, conducting and analysing experiments to identify key factors influencing product attributes.
Liposome: A spherical vesicle composed of lipid bilayers used to encapsulate and deliver therapeutic agents.
Polymeric Micelle: A nanoscale assembly of amphiphilic block copolymers that can solubilise hydrophobic drugs within its core.
Zeta Potential: The electrostatic potential at the slipping plane of a particle in suspension, indicative of colloidal stability.
References
- Quality by Design-Driven Zeta Potential Optimisation Study of Liposomes with Charge Imparting Membrane Additives. Pharmaceutics (2022).
- Pharmaceutical Development and Design of Thermosensitive Liposomes Based on the QbD Approach. Molecules (2022).
- A Systematic, Knowledge Space-Based Proposal on Quality by Design-Driven Polymeric Micelle Development. Pharmaceutics (2021).
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