In vitro and in vivo toxicological evaluation of zein/gum arabic nanoparticles loaded with pyridoxine and cyanocobalamin

Many nano-driven approaches have been made to improve the stability and bioavailability of vitamins, but limited information is available on safety of the nanoparticles. In this connection, the present work was aimed at safety assessment of pyridoxine and cyanocobalamin co-loaded zein/gum Arabic nanoparticles (PC-ZG NPs) using range of experiments. The cytotoxicity of nanoparticles was evaluated by performing WST assay in human Caco-2 cells over 24 h. The results demonstrated non-toxic effect of formulation with > 98% cell viability. Further, the nanoparticles exhibited a better hemocompatability with < 5% of released-heamoglobin from red blood cells incubated with nanoparticles over 4 h. In acute-toxicity study, Wistar rats were administered with single-dose of PC-ZG NPs at graded concentration of 0.6–24 mg/kg body weight (bw) and observed for 14 days. To evaluate the sub-acute toxicity, rats were repeatedly-dosed with varying concentrations (0.6–1.2 mg/kg bw) for 28 days. There were no observed variations in the physiology, appetite, and behaviour of rats in both the studies. The hematological and serum biochemical parameters didn’t exhibit any significant ( p > 0.05 ) difference between the treated and un-treated groups. No abnormalities were noticed in the histological-architecture of the vital organs, and at the levels of hepatic stress markers. Moreover, the bio-distribution of vitamins after repeated-dose period was 2–4 folds higher in intestine and liver samples of NPs-administered rats than the free-vitamin group. Taken together, the findings of the current study demonstrate the no adverse effect of single and repeated-dose of PC-ZG NPs up to 24 and 1.2 mg/kg bw, respectively.