Critical aspects in dissolution testing of nanomaterials in the oro-gastrointestinal tract: the relevance of juice composition for hazard identification and grouping

Luisana Di Cristo, Johannes G. Keller, Luca Leoncino, Valentina Marassi, Frederic Loosli, Didem Ag Seleci, Georgia Tsiliki, Agnes G. Oomen, Vicki Stone, Wendel Wohlleben*, Stefania Sabella*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

The dissolution of a nanomaterial (NM) in an in vitro simulant of the oro-gastrointestinal (OGI) tract is an important predictor of its biodurability in vivo. The cascade addition of simulated digestive juices (saliva, stomach and intestine), including inorganic/organic biomacromolecules and digestive enzymes (complete composition, referred to as “Type 1 formulation”), strives for realistic representation of chemical composition of the OGI tract. However, the data robustness requires consideration of analytical feasibility, such as the use of simplified media. Here we present a systematic analysis of the effects exerted by different digestive juice formulations on the dissolution% (or half-life values) of benchmark NMs (e.g., zinc oxide, titanium dioxide, barium sulfate, and silicon dioxide). The digestive juices were progressively simplified by removal of components such as organic molecules, enzymes, and inorganic molecules (Type 2, 3 and 4). The results indicate that the “Type 1 formulation” augments the dissolution via sequestration of ions by measurable factors compared to formulations without enzymes (i.e., Type 3 and 4). Type 1 formulation is thus regarded as a preferable option for predicting NM biodurability for hazard assessment. However, for grouping purposes, the relative similarity among diverse nanoforms (NFs) of a NM is decisive. Two similarity algorithms were applied, and additional case studies comprising NFs and non NFs of the same substance were included. The results support the grouping decision by simplified formulation (Type 3) as a robust method for screening and grouping purposes.

Original languageEnglish
Pages (from-to)798-815
Number of pages18
JournalNanoscale Advances
Volume6
Issue number3
Early online date8 Dec 2023
DOIs
Publication statusPublished - 7 Feb 2024

Keywords

  • General Engineering
  • General Materials Science
  • General Chemistry
  • Atomic and Molecular Physics, and Optics
  • Bioengineering

ASJC Scopus subject areas

  • General Engineering
  • Bioengineering
  • Atomic and Molecular Physics, and Optics
  • General Chemistry
  • General Materials Science

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