Acute and Sub-acute Toxicity Studies of Sweetsop Starch in Female Sprague-Dawley Rats
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Abstract
Using natural super disintegrants to develop fast-dissolving tablets (FDTs) is gaining attention. We aimed to extract the starch from the pulp of Annona squamosa. L (sweetsop) fruit and explore its potential as a super-disintegrant in designing FDTs. This study evaluated the oral acute and sub-acute toxicity of the sweetsop starch. In the acute toxicity assay, sweetsop starch was administered orally to female rats at 2000 mg/kg per body weight. In the sub-acute toxicity study, sweetsop starch was administered orally to female rats at 10, 100, and 1000 mg/kg doses. In the acute toxicity study, the starch did not produce any behavioural changes, signs of toxicity, or mortality at 2000 mg/kg in female rats. Also, in the sub-chronic toxicity (28-days) study, sweetsop starch did not produce any signs of toxicity or changes in behavioural parameters up to 2000 mg/kg in the experimental animals. The starch did not significantly change haematological, biochemical, or histopathological parameters in the treated rats. The oral acute and sub-acute toxicity evaluation results in female rats revealed that the starch extracted from the pulp of Sweetsop does not produce any significant toxic effects in the experimental animals. Therefore, sweetsop starch can be considered safe in the pharmaceutical industry.
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