Preclinical Safety Assessment of Starch Humate: Acute and Sub-Acute Oral Toxicity Studies in Rats

Starch humate is a new superdisintegrant prepared from sorghum starch and humic acid. It has been developed for use as excipient in fast-dissolving tablets. Prior to its use in solid dosage form, it is crucial to assess its safety and toxicity profile. This study aimed to evaluate the acute and sub-acute toxicity of starch humate in Swiss mice, and Wistar rats. The acute toxicity study was done by single oral administration of starch humate to Swiss mice at doses of 50, 300, 1000, and 2000 mg/kg body weight. To evaluate the sub-acute toxicity, Wistar rats were administered starch humate at doses of 50, 300, 1000, and 2000 mg/kg body weight over a 28-day period. Throughout the study, the body weight, food and water consumption, hematological and biochemical parameters, and organ weights were monitored. The results showed no sign of toxicity or mortality in the mice up to the highest dose of 2,000 mg/kg in the acute toxicity test. Similarly, for the sub-acute toxicity test, results showed no significant alterations in body weight, hematological and biochemical markers, or organ weights in the groups treated with starch humate compared to the control group. These findings suggest that starch humate is a safe excipient for pharmaceutical use. However, additional research into its long-term safety and effectiveness in drug formulations is necessary.