Abstract
Polyethylene glycol (PEG) is a polymer used for surface modification of important substances in the modern pharmaceutical industry and biopharmaceutical fields. Despite the many benefits of PEGylation, there is also the possibility that the application and exposure of the substance may cause adverse effects in the body, such as an immune response. Therefore, we aimed to evaluate the sensitization responses that could be induced through the intercomparison of nanomaterials of the PEG-coated group with the original group. We selected gold/silver nanomaterials (NMs) for original group and PEGylated silver/gold NMs in this study. First, we measured the physicochemical properties of the four NMs, such as size and zeta potential under various conditions. Additionally, we performed the test of the NM’s sensitization potential using the KeratinoSens™ assay for in vitro test method and the LLNA: 5-bromo-2-deoxyuridine (BrdU)-FCM for in vivo test method. The results showed that PEGylated-NMs did not lead to skin sensitization according to OECD TG 442 (alternative test for skin sensitization). In addition, gold nanomaterial showed that cytotoxicity of PEGylated-AuNMs was lower than AuNMs. These results suggest the possibility that PEG coating does not induce an immune response in the skin tissue and can lower the cytotoxicity of nanomaterials.
Highlights
Polyethylene glycol (PEG) is composed of repeating ethylene glycol units and, when it is attached to a polypeptide or another molecule, the phenomenon is referred to as “PEGylation” [1]
PEGylation of NPs is utilized for messenger ribonucleic acid vaccines of Coronavirus disease 2019 (COVID-19) [7]
The COVID-19 vaccine manufactured by Pfizer and BioN-Tech delivers messenger ribonucleic acid (mRNA), packaged with a PEGylated lipid nanoparticle (LNP) to improve the effectiveness of a vaccine [7]
Summary
Polyethylene glycol (PEG) is composed of repeating ethylene glycol units and, when it is attached to a polypeptide or another molecule, the phenomenon is referred to as “PEGylation” [1]. PEGylation technique is commonly used in pharmaceuticals, performing an important role in nanoparticle (NP) stabilization [2]. NP is used to transport genes and drugs to target cells and tissues, and PEG prevents the NPs from opsonization, aggregation, and phagocytosis by altering NP’s size and solubility [2]. PEGylation of NPs is utilized for messenger ribonucleic acid (mRNA) vaccines of Coronavirus disease 2019 (COVID-19) [7]. The COVID-19 vaccine manufactured by Pfizer and BioN-Tech delivers mRNA, packaged with a PEGylated lipid nanoparticle (LNP) to improve the effectiveness of a vaccine [7]. Anaphylaxis has rarely been reported after vaccination, mRNA vaccines containing PEG are known to sometimes trigger anaphylaxis [7,8]. Concerns about PEG are increasing, and the importance of the safety assessment of PEG is being emphasized. Therfore, in this study, we aimed to analyze the skin sensitization by the PEGylated NPs based on the Organisation for Economic Cooperation and Development (OECD) Test Guideline (TG) of skin sensitization
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