Acute and Sub-Acute Toxicity Studies of Starch Hyaluronate in Wistar Rats

Abstract

Starch hyaluronate is used as a new superdisintegrating agent in the development of fastdissolving tablets of poorly soluble drugs because of its improved biocompatibility, and hydrophilicity. The purpose of this study is to assess the acute and subacute toxicity profiles of starch hyaluronate in Wistar rats. The starch hyaluronate was administered to Wistar rats in a single-dose acute study and monitored for seven days. Wistar male and female rats were used in a 28-day sub-acute study that examined the effects of oral doses of 100, 200, and 600 mg/kg body weight/day on body weight, food intake, mortality, biochemical analysis, and histopathologicalevaluation. An acute study revealed that the synthesized starch hyaluronate minimal oral fatal dose for rats was larger than 2000 mg/kg body weight. The subacute toxicity evaluation found no significant changes when compared to the control group, and there was no change in hematological or biochemical parameters. The weights of the liver, kidneys, and pancreas remained constant. Based on the findings, it was concluded that starch hyaluronate at 600mg/kg body weight/day was neither immunogenic nor sensitizing, and was not a reproductive or developmental toxicant, implying that it is relatively safe when taken orally.&nbsp