Preparation and antihepatotoxicity activity of Fagonia indica extract and its solid dispersion formulation

Abstract

This study aimed to evaluate and compare the antihepatotoxicity effect of Fagonia indica extract and its solid dispersion formulation (SD) against paracetamol-induced hepatotoxicity in rats. Dried Ethanolic plant extract was prepared by cold maceration in ethanol followed by solvent evaporation under reduced pressure. Quality control of crude extract was performed and the total phenolic and flavonoid contents were determined. Solid dispersion (SD) formulations were prepared by solvent evaporation technique and optimized with respect to drug solubility. Antihepatotoxicity activities of Fagonia indica extract and optimized solid dispersion were performed against paracetamol-induced hepatotoxicity in rats. Quality control parameters like total ash, acid insoluble ash, water soluble ash, crude fiber content and moisture content were within the acceptable limits. Total flavonoid and phenolic contents were found to be 31.289mg quercetin equivalents/g and 40.28mg gallic acid equivalent/g respectively. TLC Investigation of the plant extract revealed the presence of gallic acid, kaempferol and quarcetin. Optimized SD formulation with 200 mg of the dried extract, 350mg of PEG 4000 and 50mg of Tween 20 showed almost four-fold increasing in the solubility of the extract in water. The average hydrodynamic diameter of extract particles was reduced from 1972 nm to 437.6nm when prepared as SD. SD formulation showed highest antihepatotoxicity activity compared with plain plant extract at the same concentration. Optimized SD formulation at 500mg dose showed complete recovery from hepatotoxicity induced by paracetamol in rats. Therefore, SD is found to be one of the promising strategy to enhance the antihepatoxicity activity of Fagonia indica plant.