Hollow-fiber flow field-flow fractionation and multi-angle light scattering as a new analytical solution for quality control in pharmaceutical nanotechnology

摘要: Abstract The rapid development of nanoproducts in pharmaceutical field highlights the need for robust analytical methods to ensure their quality and stability. Nanoparticles different nature composition (NPs) are employed many purposes, such as improvement drug solubility/bioavailability controlled delivery drugs. Among NPs features, particle size distribution (PSD) plays a fundamental role determining properties. Nevertheless high NPs, authorities FDA European Union highlight lack characterization control nanomaterials. techniques size-characterization particles, Field-Flow Fractionation (FFF) represents competitive choice: due absence stationary phase, separation mechanism is gentle with total maintenance native properties analytes. In this paper microcolumn variant FFF, Hollow-Fiber Flow FFF (HF5), coupled on-line Multi-Angle Light Scattering (MALS) new field. HF5-MALS was applied c haracterization preservation conditions silver polyvinylpyrrolidone-stabilized (AgPVP) used antimicrobial activity. ratio gyration hydrodynamic radii AgPVP evaluated fresh aged suggesting case aggregation rearrangement. influence PVP coating dilution factor also studied. Finally metal ion release determined relationship these shape modifications. method reproducible it can be considered an important tool platform NPs.