Toxicological evaluation of xanthan gum based hydrogel formulation in Wistar rats using single dose study

Xanthan gum-based hydrogel formulation FXG3 was prepared by a free radical polymerization technique. To assess safety of FXG3 hydrogel for potential application as new drug delivery system, a single oral dose toxicity study was conducted according to OECD guidelines. Female adult rats of Wistar strain were divided into group A and group B. Group A served as the control and was given 1mL/100 g body weight 0.9% saline. Group B received a dose of 5g/kg body weight of FXG3 hydrogel. Rats were observed continuously for 14 days for clinical signs, and prior to terminal sacrifice, blood samples were taken to assess for haematology and biochemical parameters. Selected organs (heart, liver, lung, kidneys, spleen, and stomach) were removed and examined macroscopically, washed, sliced and stained with haematoxylin-eosin for histopathological investigation. No mortality or any signs of acute toxicity was observed during the observation period. No macroscopic alteration was found in the selected organs. Histopathological examination did not show any pathological changes. Thus, the maximal tolerated dose of FXG3 was calculated to be higher than 5g/kg body weight. It can be concluded that FXG3, a xanthan gum-based hydrogel formulation, was non-toxic after acute oral administration at 5g/kg body weight, and thus may be a promising candidate in controlled drug delivery system.