Super Refined™ Polysorbate 80

Croda Pharma’s Super Refined™ Polysorbate 80 is an extremely mild and effective oil-in-water emulsifier and solubilising agent. It can be used to stabilise and solubilise active ingredients across a variety of administration forms, such as injectable and oral formulations. The Super Refining™ process removes polar impurities, including primary and secondary oxidation products, making it suitable for formulation with highly sensitive and unstable active pharmaceutical ingredients (APIs). 

Benefits of Croda Pharma’s Super Refined™ Polysorbate 80

Croda Pharma’s Super Refined™ Polysorbate 80 is a stable, colourless and high purity form of polysorbate 80 suited for use in formulation with highly sensitive and unstable APIs. It offers additional benefits such as decreased cellular irritation, improved API stability and formulation integrity, and prevention of protein aggregation.

Polysorbate 80 as an excipient in drug formulation 

Polysorbate 80 is one of the most widely used surfactants in pharmaceutical drug development. Its mechanism of action in protein formulations prevents API loss through adsorption onto surfaces, and protects them against degradation (Yi et al., 2020). It can be used as an excipient in oral, injectable, topical, pulmonary and ophthalmic formulations. Polysorbates are ubiquitous in the pharmaceutical industry: a study showed that more than 90% biopharmaceutical companies use polysorbates 80 in their product portfolios (Wuchner et al., 2022).