Assessment of Tween 80 Safety Limits in Beagle Dogs and Cynomolgus Monkeys for Injectable Formulations

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August 08,2025

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Polysorbates, such as Tween 80, are valuable solubilisers used in injectable formulations. They assist in dissolving hydrophobic drugs, stabilising protein-based drugs, improving the uniformity and stability of formulations, and reducing surface tension to prevent active ingredients from adhering to containers. However, there have been some reports of low blood pressure and severe allergic reactions following intravenous (IV) administration in dogs, with unclear details regarding doses and safety limits. This study aims to determine safe concentration and volume limits for Tween 80 in Beagle dogs (via IV and SC routes) and to compare tolerance profiles with cynomolgus monkeys (via IV).

Assessment of Tween 80 Safety Limits in Beagle Dogs and Cynomolgus Monkeys for Injectable Formulations

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