POLYSORBATE 80

US Approved OTC

First approved in 1949

Description
Sources: https://www.drugs.com/inactive/polysorbate-80-372.html

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

Condition	Modality	Targets	Highest Phase	Product
Dry eye syndrome 21 Sources: https://clinicaltrials.gov/ct2/show/NCT01339936	Primary		Approved 8583	Unknown Approved Use Unknown

PubMed

Title	Date	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 Created by `admin` on `Mon Mar 31 18:16:05 GMT 2025` Edited by `admin` on `Mon Mar 31 18:16:05 GMT 2025`
Record UNII	6OZP39ZG8H
Record Status	`Validated (UNII)`
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Name

Type

Language

PEG-20 SORBITAN OLEATE

Preferred Name

English

POLYSORBATE 80

Official Name

English

POLYOXYETHYLENE 20 SORBITAN MONOOLEATE [WHO-IP]

Common Name

English

POLYSORBATE 80 [JAN]

Common Name

English

Polyoxyethylene 20 sorbitan monooleate

Common Name

English

MF59 COMPONENT TWEEN 80

Common Name

English

POLYSORBATE 80 [VANDF]

Common Name

English

POLYSORBATE 80 [FCC]

Common Name

English

INS NO.433

Code

English

Polysorbate 80 [WHO-DD]

Common Name

English

POLYSORBATE 80 [USP-RS]

Common Name

English

POLYSORBATE 80 [MART.]

Common Name

English

E-433

Code

English

POLYSORBATE 80 [FHFI]

Common Name

English

FEMA NO. 2917

Code

English

INS-433

Code

English

SORBIMACROGOL OLEATE 300

Common Name

English

POLYSORBATE 80 [WHO-IP]

Common Name

English

POLYSORBATE 80 [USAN]

Common Name

English

POLYSORBATE 80 [EP MONOGRAPH]

Common Name

English

SORBAX PMO-20

Brand Name

English

TWEEN-80

Brand Name

English

POLYOXYETHYLENE(20)SORBITAN MONOOLEATE

Common Name

English

POLYSORBATE 80 [HSDB]

Common Name

English

POLYSORBATE 80 [MI]

Common Name

English

POLYSORBATA 80 [WHO-IP LATIN]

Common Name

English

TWEEN 80

Brand Name

English

POLYSORBATE 80 [II]

Common Name

English

Classification Tree Code System Code

NCI_THESAURUS

C83486