polysorbate 80
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. — NCATS
Clinical trial activity
4 trials · 4 clinical orgs · 0 marketing orgs
Earliest trial started Nov 1, 2006 (NCT00366548)
Timeline
2000s
- Jan 1, 2006
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Lubricant
Also used as an excipient.
JAK1 other
Also used as an excipient.
- Unspecified targetSurfactant
surfactant
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- Yes
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaPolysorbate 80 ↗
- NCATS6OZP39ZG8H ↗
- ChEMBLCHEMBL1697847 ↗
Also known as
- e494
- e494
- polyethoxylated sorbitan monooleate
- polyoxyethylene-sorbitan-20 mono-oleate
- polysorbate 80
- polysorbate 80
- polysorbate 80
- polysorbate 80
- polysorbate 80
- polysorbate 80
- polysorbate 80
- polysorbate 80
- sorlate
- tween 80
- tween 80
- tween 80
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04035070 | Phase 4 | May 31, 2020 | Cairo University |
| NCT01010282 | N/A | Nov 1, 2009 | Allergan |
| NCT00932477 | N/A | Aug 1, 2009 | Allergan |
| NCT00366548 | Phase 3 | Nov 1, 2006 | Pfizer, Wyeth |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Allergan | For profit | 2 | 2 | 1 | 2009 |
| Cairo University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Pfizer | For profit | 1 | 1 | 1 | 2006 |
| Wyeth | For profit | 1 | 0 | 1 | 2006 |