Food Additive---Polysorbate 80

Polysorbate 80, also known as Tween 80, is a synthetic nonionic surfactant commonly used in food, cosmetics, and drug formulations as a solubilizer, stabilizer, or emulsifier. Polysorbate 20 and 60 (Tween 20 and 60) are also included in this family of surfactants. It has also been used to prevent protein adsorption and/or aggregation. A wide range of pharmaceutical agents are available in formulations that contain polysorbate 80, including amiodarone, vitamin K, etoposide, docetaxel, various vaccines, protein biotherapeutics, erythropoietin-stimulating agents , and fosaprepitant. 

Metabolism

Polysorbates undergo degradation by auto-oxidation, producing reactive peroxides, in addition to hydrolysis. Exposure to light of polysorbate 80 aqueous solution leads autoxidation of the alkyl polyoxyethylene chain leading to the production of hydroperoxide derivatives. The peroxides cause oxidative damage to the protein molecule that makes up the formulation. The residual peroxides and the rate of peroxide generation as a result of light exposure are found to vary for polysorbate 80 of different grades/from different sources.

Uses

Polysorbate 80 is a hydrophilic nonionic surfactant. It is utilized as a surfactant in soaps and cosmetics and also as a lubricant in eye drops. In food or pharmaceutical products, it can act as an emulsifier. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration or vaccinations.

Various products formulated with polysorbate 80 are used in the oncology setting for chemotherapy, supportive care, or prevention, including docetaxel, epoetin/darbepoetin, and fosaprepitant. However, polysorbate 80, like some other surfactants, is not an inert compound and has been implicated in a number of systemic and injection- and infusion-site adverse events (ISAEs).