TOXICOLOGICAL EVALUATION OF XANTHAN GUM BASED HYDROGEL FORMULATION IN WISTAR RATS USING SINGLE DOSE STUDY.

Autor: MALIK, NADIA SHAMSHAD, AHMAD, MAHMOOD, MINHAS, MUHAMAD USMAN, TULAIN, RUQIA, KHALID, IKRIMA, BARKAT, KASHIF, RASHID, AYESHA
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Zdroj: Acta Poloniae Pharmaceutica; Mar/Apr2020, Vol. 77 Issue 2, p353-360, 8p
Abstrakt: Xanthan gum-based hydrogel formulation FXG3 was prepared by a free radical polymerization technique. To assess the safety of FXG3 hydrogel for potential application as a 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 1 mL/100 g body weight 0.9% saline. Group B received a dose of 5 g/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 hematology and biochemical parameters. Selected organs (heart, liver, lung, kidneys, spleen, and stomach) were removed and examined macroscopically, washed, sliced and stained with hematoxylin-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 5 g/kg body weight. It can be concluded that FXG3, a xanthan gum-based hydrogel formulation, was non-toxic after acute oral administration at 5 g/kg body weight, and thus may be a promising candidate in controlled drug delivery system. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index