Tween 80

Absorption

Poorly absorbed .

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 .

Characteristics

Tween 80, commercially known as Polysorbate-80, is a viscous, water-soluble Yellow to amber liquid derived from polyethoxylated sorbitan and oleic acid. It is structurally similar to the (polyethylene) glycols and used both in injections (0.8-8.0%) and in oral suspension (0.375% w/v). A number of anticancer drugs can be formulated by Tween 80. Typical examples include etoposide and minor groove-binding cyclopropylpyrroloindole analogues like carzelesin.

Chemical properties

Tween 80 has a faint, characteristic odor and a warm, somewhat bitter taste. It is a mixture of oleate partial esters of sorbitol and sorbitol anhydrides condensed with approximately 20 mole of ethylene oxide (C2H4O) for each mole of sorbitol and its mono- and dianhydrides.

The Uses of Tween 80

Tween 80 is a general purpose medium HLB ethoxylated nonionic surfactant. It is also a detergent that can be used to identify Mycobacterium species, which have a lipase enzyme that breaks down compounds into oleic acid and polyoxyethylene sorbitol. It is used as an emulsifier and lubricant in textile chemicals; as an oil-in-water emulsifier and viscosity modifier in food and cosmetic formulations; and as a solubiliser and dispersant in pickles and special vitamin-mineral formulations. It is also used as an antistatic agent for PVC, as an anti-fogging agent for PP, PE, PVC, PS and as an additive in cell culture media.

What are the applications of Application

Polysorbate 80 is a non ionic detergent for cell lysis

Background

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.
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.

Indications

It is used as a solubilizer, antimicrobial preservative and disinfectant .

Definition

ChEBI: A polymer composed of PEG-ylated sorbitan, where the total number of poly(ethylene glycol) units is 20 (w + x + y + z = 20) and a single terminal is capped by an oleoyl group.

brand name

Sorlate (Abbott); Tween 80 (ICI Americas).

General Description

Amber-colored viscous liquid. pH (5% aqueous solution) 5-7. Faint odor and bitter taste.
Polysorbate 80 (Tween 80) is a synthetic surfactant composed of fatty acid esters of polyoxyethylene sorbitan. Polysorbate 80 is usually available as a chemically diverse mixture of different fatty acid esters, with the oleic acid comprising?>?58% of the mix. However, the main component of polysorbate 80 is polyoxyethylene-20-sorbitan monooleate, which is structurally similar to polyethylene glycols. Polysorbate 80 has a molecular weight of 1309.7 Da and a 1.064 g/ml density[1].

Reactivity Profile

Tween 80 is incompatible with strong alkalis and oxidizers.

Fire Hazard

Tween 80 is probably combustible.

Biochem/physiol Actions

Tween 80 is used as emulsifiers, dissolving agents and stabilizer for essential oils, topical application and medical infusions including intravenous, subcutaneous or intramuscular administration.

Pharmacokinetics

Polysorbates are widely used to protect biological drug products from protein unfolding, aggregation, and precipitation during both shipping and handling. The polysorbates are amphipathic, nonionic surfactants made of fatty acid esters of polyoxyethylene sorbitan. Polysorbate 80 is one of the most common surfactants currently used in the formulation of protein-based biopharmaceuticals .

Pharmacokinetics

Polysorbate 80 (Tween 80) is rapidly removed from systemic circulation. The polysorbate 80 plasma concentration-time curve (AUC) in a patient administered an intravenous (IV) infusion of docetaxel 35 mg/m2 (polysorbate 80 1.75 g) showed a polysorbate 80 peak concentration of 304 μg/ml. The AUC for polysorbate 80 was 321.7 mg h/ml, with a short disposition half-life of 1.07 h and a total plasma clearance of 5.44 l/h. The distribution of polysorbate 80 at steady state was similar to the total blood volume (4.16 l), suggesting that polysorbate 80 circulates as large micelles and does not significantly distribute outside the central compartment. In vitro studies suggest that polysorbate 80 is metabolized by rapid carboxylesterase-mediated hydrolysis[1].

Safety Profile

Moderately toxic by intravenous route. Mildly toxic by ingestion. Experimental reproductive effects. Questionable carcinogen with experimental tumorigenic data. Human mutation data reported. An eye irritant. When heated to decomposition it emits acrid smoke and irritating fumes.

Metabolism

Polysorbates undergo degradation by auto-oxidation, producing reactive peroxides, in addition to hydrolysis . Exposure to light of polysorbate 80 aqueous solution leads autoxidation of the alkyl polyoxyethylene chain leading to the production of hydroperoxide derivatives. The peroxides cause oxidative damage to the protein molecule that makes up the formulation. The residual peroxides and the rate of peroxide generation as a result of light exposure are found to vary for polysorbate 80 of different grades/from different sources .