Polysorbate 80
Polysorbate 80 Uses, Dosage, Side Effects, Food Interaction and all others data.
Polysorbate, a substance formulated by the reaction of sorbitan fatty acid ester (a nonionic surfactant) with ethylene oxide, is used in many foreign countries, including the U.S. and the EU, where it acts as an emulsifier, a solubilizer in many foods, including bread, cake mix, salad dressing, shortening oil and chocolate .
Polysorbate 80 is a hydrophilic nonionic surfactant. 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.
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.
| Trade Name | Polysorbate 80 |
| Generic | Polysorbate 80 |
| Polysorbate 80 Other Names | Polysorbate 80, Tween 80 |
| Type | |
| Groups | Approved |
| Therapeutic Class | |
| Manufacturer | |
| Available Country | |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
It is used as a solubilizer, antimicrobial preservative and disinfectant .
Polysorbate 80 is also used to associated treatment for these conditions: Eye lubrication, Eye discomfort
How Polysorbate 80 works
Polysorbate 80 is one of the primary components of protein formulations. This drug inhibits interfacial damage of the protein molecule that undergoes mechanical stress during shipping and handling. Polysorbate 80 also affects the formulation photostability. Exposure to light of polysorbate 80 aqueous solution results in peroxide generation, which in turn may lead to oxidation of the susceptible amino acid residues in the protein molecule .
One study on rats found that Polysorbate 80 increased apical to basolateral membrane permeability of digoxin in Caco-2 cells suggesting that Ps 80 is an in vitro inhibitor of P-glycoprotein. It concluded that PS 80 may influence in vivo absorption of P-gp substrates, and this could be translated to human applications .
Toxicity
Acute oral toxicity (LD50): 25000 mg/kg in Mouse
In general, study results of the polysorbates demonstrated no carcinogenicity and genotoxicity. In repeated-dose toxicity studies, diarrhea was observed as the major symptom of toxicity . Some studies, however, show conflicting findings.
In a 2-year dietary study of polysorbate 80 in rats, a higher incidence of adrenal medullary pheochromocytomas was found, mainly in male rats .
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 must be followed closely .
It was found that maternal toxicities such as loose stool, suppression of weight gain and reduced intake were seen, and poor lactation was noted in some studies of mother rats administered 7.5% solutions of polysorbates .
Food Interaction
No interactions found.Elimination Route
Poorly absorbed .
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