Abstract
In this study, we present a dissolution test system that allows for the testing of dissolution of nano- and micrometer size materials under highly controlled atmospheric composition (O2 and CO2), temperature, and pH. The system enables dissolution testing in physiological simulant fluids (here low-calcium Gamble’s solution and phagolysosomal simulant fluid) and derivation of the temporal dissolution rates and reactivity of test materials. The system was validated considering the initial dissolution rates and dissolution profiles using eight different materials (γ-Al2O3, TiO2 (NM-104 coated with Al2O3 and glycerin), ZnO (NM-110 and NM-113, uncoated; and NM-111 coated with triethoxycaprylsilane), SiO2 (NM-200—synthetic amorphous silica), CeO2 (NM-212), and bentonite (NM-600) showing high intra-laboratory repeatability and robustness across repeated testing (I, II, and III) in triplicate (replicate 1, 2, and 3) in low-calcium Gamble’s solution. A two-way repeated-measures ANOVA was used to determine the intra-laboratory repeatability in low-calcium Gamble’s solution, where Al2O3 (p = 0.5277), ZnO (NM-110, p = 0.6578), ZnO (NM-111, p = 0.0627), and ZnO (NM-113, p = 0.4210) showed statistical identical repeatability across repeated testing (I, II, and III). The dissolution of the materials was also tested in phagolysosomal simulant fluid to demonstrate the applicability of the ATempH SBR system in other physiological fluids. We further show the uncertainty levels at which dissolution can be determined using the ATempH SBR system.
Highlights
Manufactured nanomaterials (NMs) have increasingly been produced for a few decades [1,2] and are used in multiple industrial sectors [3,4,5,6] as nanotechnology inspires new solutions and products [2,5,7]
Al2 O3 was identified as G-aluminum oxide by the supplier [54], which was supported in a study conducted by Krause et al (2018) [61]
The ATempH SBR system was capable of controlling the temperature, pH, gas flow, and composition during testing in order to lock the conditions relevant for human lungs
Summary
Manufactured nanomaterials (NMs) have increasingly been produced for a few decades [1,2] and are used in multiple industrial sectors [3,4,5,6] as nanotechnology inspires new solutions and products [2,5,7]. Compared to the bulk material, NMs demonstrate distinct properties utilized to solve existing problems (e.g., material durability and strength, rheology, catalysis, optics, drug delivery, and food packing) [3,4,5,6]. A “particle” is defined as a minute piece of matter with defined physical boundaries, which could, e.g., be spheres, flakes, and fibers. This definition is applied for defining substances in nanoform in the European chemical regulations [9]. NMs may have higher human [2] and environmental toxicity [10,11] when compared to Nanomaterials 2022, 12, 517.
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