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Description

Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the manufacture of the popular antiarrhythmic amiodarone. Polysorbate 80 is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 25 μg of polysorbate 80 per dose. Polysorbate 80 is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb. In Europe and America, people eat about 100 mg of polysorbate 80 in foods per day on average. Polysorbate 80 has not been found to be carcinogenic. Rats fed with diets containing up to 5% polysorbate 80 by volume for 12 weeks showed no toxic effects.

Originator

Approval Year

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Unknown

PubMed

Patents

Sample Use Guides

In Vivo Use Guide
The Joint FAO / WHO Expert Committee on Food Additives (JECFA) established in 197, based on data on the absence of adverse effects at doses up to 2500 mg / kg / day and safety factor 100, the maximum allowable daily intake of polysorbates in 25 mg / Kg.
Route of Administration: Oral
In Vitro Use Guide
For 1-day and 5-day cultures, Caco-2 cells were seeded into regular 96-well tissue culture plates at 2 × 104 cells per well in 200 μL of growth medium, and, for 21–23 daymonolayer cultures, the cellswere seeded at the same density into 96-well transwell plates. After being cultured for indicated periods of time, Caco-2 cells were treated with individual test formulations (containing Polysorbate 80) in a final volume of 200 μL per well in 96-well plates at specified concentrations diluted with culture medium for two hours. Immediately after treatment, cytotoxicity was evaluated using MTT cell viability assay
Substance Class Polymer
Record UNII
6OZP39ZG8H
Record Status Validated (UNII)
Record Version