Meta-Analysis of Pharmacokinetic Studies of Nanobiomaterials for the Prediction of Excretion Depending on Particle Characteristics.

The growth in development and use of nanobiomaterials (NBMs) has raised questions regarding their possible distribution in the environment. Because most NBMs are not yet available on the market and exposure monitoring is thus not possible, prospective exposure modeling is the method of choice to get information on their future environmental exposure. An important input for such models is the fraction of the NBM excreted after their application to humans. The aim of this study was to analyze the current literature on excretion of NBMs using a meta-analysis. Published pharmacokinetic data from animal experiments was collected and compiled in a database, including information on the material characteristics. An evaluation of the data showed that there is no correlation between the excretion (in % of injected dose, ID) and the material type, the dose, the zeta potential or the size of the particles. However, the excretion is dependent on the type of administration with orally administered NBMs being excreted to a larger extent than intravenously administered ones. A statistically significant difference was found for IV vs. oral and oral vs. inhalation. The database provided by this work can be used for future studies to parameterize the transfer of NBMs from humans to wastewater. Generic probability distributions of excretion for oral and IV-administration are provided to enable excretion modeling of NBMs without data for a specific NBM.