polysorbate 80

Small moleculeexperimental

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

Phase 1
0
Phase 2
1
Phase 3
1
Phase 4
1

Earliest trial started Nov 1, 2006 (NCT00366548)

Timeline

2000s

  1. Jan 1, 2006

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Mechanism of action

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
Yes

Oral

No

Parenteral

No

Topical

No

Sources

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 IDPhaseStart dateSponsor(s)
NCT04035070Phase 4May 31, 2020Cairo University
NCT01010282N/ANov 1, 2009Allergan
NCT00932477N/AAug 1, 2009Allergan
NCT00366548Phase 3Nov 1, 2006Pfizer, Wyeth
Showing 4 of 4 trials
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Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit2212009
Cairo UniversityAcademic/Hospital1112020
PfizerFor profit1112006
WyethFor profit1012006
4 organizations
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