Abstract

Graphene family materials (GFMs) are extensively explored for various biomedical applications due to their unique physical properties. The prime challenge is to establish a conclusive safety profile of these nanomaterials and their respective products or devices. Formulating GFMs with appropriate ingredients (e.g., surfactant/compatibilizer) will help to disperse them homogeneously (i.e., within the polymer matrix in the case of polymer–graphene nanocomposites) and aid in good interfacial interaction to achieve the desired properties. However, no cytotoxicity report is available on the effects of the additives on graphene and its incorporated materials. Here, we report in vitro cytotoxicity of formulated FLG (FLG-C), i.e., a mixture of FLG, melamine, and sodium poly(naphthalene sulfonate) (SPS), along with natural rubber (NR) latex and FLG-C-included NR latex nanocomposite (FLG-C-NR) thin films on human vaginal epithelial (HVE) cells. FLG-C shows reduced cellular proliferation (∼55%) only at a longer exposure time (72 h) even at a low concentration (50 μg/mL). It also displays significant down- and upregulation in mitochondrial membrane potential (MMP) and reactive oxygen species (ROS), respectively, whereas no changes are observed in lactate dehydrogenase (LDH), propidium iodide (PI), uptake, and cell cycle analysis at 48 h. In vitro experiments on NR latex and FLG-C-NR latex thin films demonstrate that the incorporation of FLG-C does not compromise the biocompatibility of the NR latex. Further substantiation from the in vivo experiments on the thin films recommends that FLG-C could be suitable to prepare a range of biocompatible rubber latex nanocomposites-based products, viz., next-generation condoms (male and female), surgical gloves, catheters, vaginal rings, bladder–rectum spacer balloon, etc.

Highlights

  • Graphene family materials (GFMs) should be formulated with suitable additives, which helps in achieving excellent interfacial adhesion, to accomplish the most sought properties, but, no toxicity reports are available on the formulated GFM

  • Dispersion in deionized water and cell culture medium besides Raman imaging of FLG-C-natural rubber (NR) latex thin films are shown in Figure 1b presents the high-resolution (HR)-Transmission electron microscopy (TEM) image of FLG-C dispersed in deionized water, and it shows an overlapped flat structure with observable edges, indicating the optimum dispersion of FLG-C

  • To further probe the structural information of FLG-C dispersion, we present selected area diffraction (SAED) patterns, which reveal the presence of bilayer graphene with a typical hexagonal symmetry.[49]

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Summary

■ INTRODUCTION

Because of the unique and exceptional physical properties besides the potential to tailor microstructural diversities [hydrophobic to hydrophilic and functionalized with −NH2, −COOH, poly(ethylene glycol), −SH, etc.], graphene, an sp2-. The surfactant releases a dose-dependent ROS (i.e., 40 and 58% of ROS with the doses of 50 and 100 μg/mL, respectively) (Figure S14a), not affecting the HVE cell proliferation Both NR latex and FLG-C incorporated NR latex thin film extracts show similar levels of ROS production (11.1−15.6%) (Figure 4a) and do not show any dose dependency, which suggests that the leachables from both the materials may be identical (in terms of quality and quantity). The performed in vivo experiments clearly show that both NR latex- and FLGC-incorporated NR latex thin film nanocomposites have no clinical sign or overt toxicity, no skin irritation/sensitization, and no irritation to vaginal and penile tissues. These experiments further prove that FLG-C incorporation into NR latex does not compromise its biocompatibility

■ CONCLUSIONS
■ ACKNOWLEDGMENTS
■ REFERENCES
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