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Characterization and Quantitation of Carbon Black Nanomaterials in Polymeric and Biological Aqueous Dispersants by Asymmetrical Flow Field Flow Fractionation.

ABSTRACT: Characterization of carbon black (CB) nanomaterials is required in industrial and research areas. Hence, in this study, asymmetrical flow field flow fractionation coupled to UV-vis and DLS detectors in series (AF4-UV-vis-DLS) was studied to evaluate the CB dispersion behavior in polymeric and biological dispersants, given the relevance of these media in practical applications. Under the experimental conditions, the results indicated that polymeric and biological dispersions showed size distributions with hydrodynamic diameters of 404 and 175 nm, respectively, for a particle core diameter of 40 nm. The polymeric dispersant provided lower stability as a function of time than that achieved by the biological dispersant. AF4 allowed separation of different core-sized CB (40, 69, and 72 nm) according to their hydrodynamic size using cross-flow rates of 0.5 mL·min^-1 and 1 mL·min^-1 for polymeric and biological dispersants, respectively. The dilution of the polymeric dispersion with different real water matrices produced a dramatic loss of dispersion stability, this effect being negligible in the case of biological dispersions.

SUBMITTER: Sanjuan-Navarro L

PROVIDER: S-EPMC8637946 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature

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Characterization and Quantitation of Carbon Black Nanomaterials in Polymeric and Biological Aqueous Dispersants by Asymmetrical Flow Field Flow Fractionation.

Sanjuan-Navarro Lorenzo L Moliner-Martínez Yolanda Y Campíns-Falcó Pilar P

ACS omega 20211118 47

Characterization of carbon black (CB) nanomaterials is required in industrial and research areas. Hence, in this study, asymmetrical flow field flow fractionation coupled to UV-vis and DLS detectors in series (AF4-UV-vis-DLS) was studied to evaluate the CB dispersion behavior in polymeric and biological dispersants, given the relevance of these media in practical applications. Under the experimental conditions, the results indicated that polymeric and biological dispersions showed size distribut ...[more]

PMID: 34870005

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Project description:Liposomal formulations for the treatment of cancer and other diseases are the most common form of nanotechnology enabled pharmaceuticals (NEPs) submitted for market approval and in clinical application today. The accurate characterization of their physical-chemical properties is a key requirement; in particular, size, size distribution, shape, and physical-chemical stability are key among properties that regulators identify as critical quality attributes. Here we develop and validate an optimized method, based on multi-detector asymmetrical-flow field flow fractionation (MD-AF4) to accurately and reproducibly separate liposomal drug formulations into their component populations and to characterize their associated size and size distribution, whether monomodal or polymodal in nature. In addition, the results show that the method is suitable to measure liposomes in the presence of serum proteins and can yield information on the shape and physical stability of the structures. The optimized MD-AF4 based method has been validated across different instrument platforms, three laboratories, and multiple drug formulations following a comprehensive analysis of factors that influence the fractionation process and subsequent physical characterization. Interlaboratory reproducibility and intra-laboratory precision were evaluated, identifying sources of bias and establishing criteria for the acceptance of results. This method meets a documented high priority need in regulatory science as applied to NEPs such as Doxil and can be adapted to the measurement of other NEP forms (such as lipid nanoparticle therapeutics) with some modifications. Overall, this method will help speed up development of NEPS, and facilitate their regulatory review, ultimately leading to faster translation of innovative concepts from the bench to the clinic. Additionally, the approach used in this work (based on international collaboration between leading non-regulatory institutions) can be replicated to address other identified gaps in the analytical characterization of various classes of NEPs. Finally, a plan exists to pursue more extended interlaboratory validation studies to advance this method to a consensus international standard.

Dataset Information

Characterization and Quantitation of Carbon Black Nanomaterials in Polymeric and Biological Aqueous Dispersants by Asymmetrical Flow Field Flow Fractionation.

Publications

Characterization and Quantitation of Carbon Black Nanomaterials in Polymeric and Biological Aqueous Dispersants by Asymmetrical Flow Field Flow Fractionation.

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