Acute and Sub-Acute Toxicity Studies of Soursop Starch in Swiss Mice and Wistar Rats
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Abstract
The recent utilization of natural superdisintegrants in the development of fast-dissolving tablets (FDTs) is becoming increasingly common. The starch from the Annona muricata (soursop) fruit was isolated and assessed for its potential as a new natural superdisintegrant for formulating FDTs. The acute and sub-acute toxicity of the isolated soursop starch and the dosage level in the final formulation were investigated. In the acute toxicity study, Swiss mice were given orally the maximum dose of 2000 mg/kg of soursop starch. In the sub-acute toxicity study, 50, 300, 1000 and 2000 mg/kg doses were administered to Wistar rats for 28 days. The results showed that soursop starch did not induce any behavioural changes, signs of toxicity, or mortality at the 2000 mg/kg dose in mice during the acute toxicity study. Similarly, in the 28-day oral toxicity study, soursop starch did not cause any toxicity or alterations in behavioural parameters up to the 2000 mg/kg dose in Wistar rats. Also, no significant changes were observed in haematological, biochemical, or histopathological parameters in rats administered soursop starch. Overall, the findings from the oral acute and sub-acute toxicity assessments in mice and rats at the maximum dose of 2000 mg/kg revealed that the starch derived from soursop pulp is relatively safe for oral consumption.
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