Polysorbate 80

This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon.


Polysorbate 80
Accession Number
Small Molecule

Polysorbate 80 is a hydrophilic nonionic surfactant derived from polyethoxylated sorbitan and oleic acid. 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 [14].

A solubilizing agent acts as a surfactant and increases the solubility of one agent in another. A substance that would not normally dissolve in a particular solution is able to dissolve with the use of a solubilizing agent [14].

Polysorbate 80 is used as a solubilizing agent in IV infusions of the antiarrhythmic drug amiodarone. Rare case reports of liver toxicity have been published suggesting polysorbate 80 may contribute to liver toxicity with the IV formulation of amiodarone. The package labeling of amiodarone warns that polysorbate 80 is also known to leach DEHP (dioctyl phthalate) from PVC and dosing recommendations should be followed closely [14].

It is also known as an emulsifier, which helps ingredients mix together and prevent separation, and water-containing small amounts of salts, and is included in several vaccines licensed in the USA [8].

  • polyoxyethylene-sorbitan-20 mono-oleate
  • Tween 80
Over the Counter Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
AvitearsSolution / drops10 mg/mLTopicalPinnacle Science, L Lc2009-07-17Not applicableUs
PolysorbateSolution0.8 %Ophthalmic; TopicalEberth Pharmaceuticals Inc1994-12-31Not applicableCanada
VivaSolution / drops100 mg/10mLOphthalmicDakota Laboratories, Llc1987-02-19Not applicableUs
Mixture Products
NameIngredientsDosageRouteLabellerMarketing StartMarketing End
Clear Eyes Complete 7 Symptom ReliefPolysorbate 80 (1.25 mL/mL) + Hypromellose (.5 mL/mL) + Naphazoline hydrochloride (.0625 mL/mL) + Zinc sulfate (.625 mL/mL)LiquidOphthalmicPrestige Brands Holdings, Inc.2010-03-01Not applicableUs
Clear Eyes Complete 7 Sympton ReliefPolysorbate 80 (1.25 mg/mL) + Hypromellose (.5 mg/mL) + Naphazoline hydrochloride (.0625 mg/mL) + Zinc sulfate (.625 mg/mL)LiquidOphthalmicPrestige Brands Holdings, Inc.2013-06-12Not applicableUs
OtovelPolysorbate 80 (6250 ug/.25mL) + Ciprofloxacin (872.5 ug/.25mL) + Fluocinolone Acetonide (62.5 ug/.25mL)For solutionAuricular (otic)Arbor Pharmaceuticals2016-04-29Not applicableUs
REFRESH OPTIVE AdvancedPolysorbate 80 (5 mg/mL) + Carboxymethylcellulose sodium (5 mg/mL) + Glycerin (10 mg/mL)Solution / dropsOphthalmicAllergan2011-11-30Not applicableUs
REFRESH OPTIVE AdvancedPolysorbate 80 (0.5 %) + Carboxymethylcellulose sodium (0.5 %) + Glycerin (1.0 %)SolutionOphthalmicAllergan2013-03-06Not applicableCanada
REFRESH OPTIVE AdvancedPolysorbate 80 (5 mg/mL) + Carboxymethylcellulose sodium (5 mg/mL) + Glycerin (10 mg/mL)Solution / dropsOphthalmicAllergan2013-01-15Not applicableUs
Refresh Optive Advanced SensitivePolysorbate 80 (0.5 %) + Carboxymethylcellulose sodium (0.5 %) + Glycerin (1.0 %)EmulsionOphthalmicAllergan2014-10-14Not applicableCanada
REFRESH OPTIVE Mega-3Polysorbate 80 (5 mg/mL) + Carboxymethylcellulose sodium (5 mg/mL) + Glycerin (10 mg/mL)Solution / dropsOphthalmicAllergan2017-05-30Not applicableUs
Rohto Beauty SecretPolysorbate 80 (2 mg/mL) + Naphazoline hydrochloride (.12 mg/mL)LiquidOphthalmicThe Mentholatum Company2017-10-01Not applicableUs
Rohto CoolPolysorbate 80 (2 mg/mL) + Naphazoline hydrochloride (.12 mg/mL)LiquidOphthalmicThe Mentholatum Company2001-08-21Not applicableUs
CAS number
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Chemical Formula
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InChI Key
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Structured Indications
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It has been listed as a solubilizer, antimicrobial preservative and disinfectant [15]. PS80 is comprised of mixtures of structurally-related fatty acid esters of polyoxyethylene sorbitan and lauric acid or oleic acid, respectively [].

Mechanism of action

Tween 80 increased apical to basolateral permeability of digoxin in Caco-2 cells suggesting that Tween 80 is an in vitro inhibitor of P-gp. The overall objective of the present study was to investigate whether an inhibition of P-gp by Tween 80 can potentially influence in vivo absorption of P-gp substrates by evaluating the effect of Tween 80 on the disposition of digoxin (a model P-gp substrate with minimum metabolism) after oral administration in rats [A33231].

It has long been known that polysorbates undergo intrinsic degradation via auto oxidation yielding reactive peroxides, as well as by hydrolysis (12-17). Less attention has been paid to the formation of reactive aldehydes such as formaldehyde and acetaldehyde (18) known to induce immunogenicity of soluble proteins [12].

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Volume of distribution
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Protein binding
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Route of elimination
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Half life
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Acute oral toxicity (LD50): 25000 mg/kg in Mouse [MSDS]

Affected organisms
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Pharmacogenomic Effects/ADRs
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Drug Interactions
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Food Interactions
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General References
  1. Coors EA, Seybold H, Merk HF, Mahler V: Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions. Ann Allergy Asthma Immunol. 2005 Dec;95(6):593-9. doi: 10.1016/S1081-1206(10)61024-1. [PubMed:16400901]
  2. Sun W, Xie C, Wang H, Hu Y: Specific role of polysorbate 80 coating on the targeting of nanoparticles to the brain. Biomaterials. 2004 Jul;25(15):3065-71. doi: 10.1016/j.biomaterials.2003.09.087. [PubMed:14967540]
  3. Zhao YM, Xia AX, Wei YH, Ruan YP, Li FZ: [Polysorbate-80 modified neurotoxin nanoparticle with its transport and cytotoxicity against blood-brain barrier]. Yao Xue Xue Bao. 2010 Oct;45(10):1312-6. [PubMed:21348312]
  4. van Tellingen O, Beijnen JH, Verweij J, Scherrenburg EJ, Nooijen WJ, Sparreboom A: Rapid esterase-sensitive breakdown of polysorbate 80 and its impact on the plasma pharmacokinetics of docetaxel and metabolites in mice. Clin Cancer Res. 1999 Oct;5(10):2918-24. [PubMed:10537361]
  5. Zhang H, Yao M, Morrison RA, Chong S: Commonly used surfactant, Tween 80, improves absorption of P-glycoprotein substrate, digoxin, in rats. Arch Pharm Res. 2003 Sep;26(9):768-72. [PubMed:14560928]
  6. Polysorbate 80 [Link]
  7. Code of Federal Regulation [Link]
  8. Common Ingredients in U.S. Licensed Vaccines [Link]
  9. NTP Toxicology and Carcinogenesis Studies of Polysorbate 80 (CAS No. 9005-65-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). [Link]
  10. Polysorbate 80 and Helicobacter pylori: a microbiological and ultrastructural study [Link]
  11. Food Emulsifier Polysorbate 80 Increases Intestinal Absorption of Di-(2-Ethylhexyl) Phthalate in Rats [Link]
  12. Polysorbates, peroxides, protein aggregation, and immuno- genicity – a growing concern. [Link]
  13. In uence of excipients on drug absorption via modulation of intestinal transporters activity [Link]
  14. Polysorbate 80 [Link]
  15. Overview of pharmaceutical excipients used in tablets and capsules [Link]
External Links
PubChem Substance
AHFS Codes
  • 52:13.00* — Artificial Tears
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Clinical Trials

Clinical Trials
3CompletedTreatmentDry Eye Syndromes1
4CompletedTreatmentDry Eye Syndromes1
4CompletedTreatmentPsoriasis / Sleep Apnea, Obstructive1


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Dosage forms
Solution / dropsTopical10 mg/mL
For solutionAuricular (otic)
SolutionOphthalmic; Topical0.8 %
Solution / dropsOphthalmic
Solution / dropsOphthalmic100 mg/10mL
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Patent NumberPediatric ExtensionApprovedExpires (estimated)


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Experimental Properties
melting point (°C)-20.556MSDS
boiling point (°C)100MSDS
water solubilityEasily soluble in cold water, hot waterMSDS
Predicted Properties
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Predicted ADMET features
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Mass Spec (NIST)
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Not classified

Drug created on December 03, 2015 09:51 / Updated on March 23, 2018 15:45