Lipid nanoparticles (LNPs) and liposomes are lipid-based drug carriers that differ in internal formation. Liposomes have a phospholipid membrane surrounding an aqueous inner core mimicking natural cell walls. LNPs encompass nano-emulsions, micelles, and solid lipid nanoparticles (SLNs).
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Liposomes and lipid nanoparticles (LNPs) are versatile drug delivery systems that allow precise control over composition, morphology, and structure, tailoring these features to meet specific pharmaceutical applications. Thorough particle characterization is essential for accelerating pharmaceutical product development and achieving regulatory approval. Key characteristics that require detailed assessment include size and payload distribution. Additionally, understanding internal structure, drug incorporation mechanisms, loading efficiency, and release kinetics is critical for developing effective drug delivery systems.
Field-flow fractionation combined with multi-angle light scattering and dynamic light scattering (FFF-MALS-DLS) provides a highly adaptable and precise approach for separating and analyzing LNPs. This technique delivers comprehensive, quantitative size distributions while avoiding biases associated with small ensemble methods like electron microscopy (EM) and nanoparticle tracking analysis (NTA), or the tendency of batch DLS and NTA to favor larger particles.
Figure 1. AF4-DLS (QELS) fractogram of lipid nanoparticles incubated with serum. Compared to the original sample, the peak becomes narrower. These slight changes cannot be detected by DLS or NTA. (Figure adapted from Ref. 4)
FFF-MALS-DLS integrates size-based separation via FFF with absolute size and structural determination using online MALS and DLS. Furthermore, additional online detectors, such as UV/Vis, fluorescence, and refractive index, enhance functionality, creating a robust analytical platform for characterizing drug delivery nanoparticles.
The capabilities of FFF-MALS-DLS are particularly valuable for meeting regulatory requirements related to the enhanced characterization of liposomal drug formulations and other nanoparticle delivery systems. These advancements have contributed to the development of global standards for nanoparticle characterization, including ISO/TS 21362 and ASTM WK 68060, as well as techniques outlined by the NCI-NCL and EU-NCL.
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This information has been sourced, reviewed and adapted from materials provided by Waters | Wyatt Technology.
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