Polysorbate 80

cid3

20

Category

Surfactant; Emulsifier; Solubilizer; Humectants

Molecular Formula

C64H124O26

Molecular Weight

1309.63

Grade

Pharmceutical Excipients

Description

This product is a pale yellow to amber oily viscous liquid.

UNII

6OZP39ZG8H

Chemical Name

Polyoxyethylene 20 sorbitan monolaurate

CAS Number

9005-65-6

Synonyms

Tween 80; polyoxyethylene 20 oleate; polysorbatum 80; (Z)-sorbitan mono-9-octadecenoate poly(oxy1, 2-ethanediyl) derivatives

Administration route

Intramuscular, intravenous, oral, topical, rectal, vaginal

Dosage Form

Intramuscular injection, intravenous injection, oral, topical, rectal, vaginal preparations

Stability and Storage Conditions

Polysorbate is stable to electrolytes, weak acids and weak bases; it will gradually saponify in case of strong acids and strong bases. Its oleate is susceptible to oxidation. Polysorbate is hygroscopic, check its moisture content before use, and dry if necessary. Polysorbate, like other polyoxyethylene surfactants, will produce peroxides when stored for too long. Polysorbate should be stored in a sealed container, away from light, in a cool and dry place.

Commonly used amount and the maximum amount

The World Health Organization has evaluated the acceptable daily intake of polysorbate 20, 40, 60, 65, and 80. Calculated on the basis of total polysorbate, the daily intake can be as high as 25mg per kilogram of body weight. The marketed topical emulsion, the maximum dosage in the cream is 6.00%.

Source and Preparation

This product is polyoxyethylene 20 laurel sorbitan polymerized from laurel sorbitan and ethylene oxide. Polysorbate is prepared from pear (sugar) alcohol through a three-step reaction. First, sorbitol is dehydrated to form sorbitan (cyclic sorbitan); sorbitan is esterified with fatty acids, such as oleic acid or stearic acid, to form hexose esters; finally, it reacts with ethylene oxide under the action of a catalyst Generate polysorbate.

Applications

Polysorbates containing 20 oxyethylene units are hydrophilic nonionic surfactants widely used as emulsifiers for stable oil-in-water pharmaceutical emulsions. Polysorbates are also used as solubilizers for various substances, including essential oils and oil-soluble vitamins, and as wetting agents for oral or parenteral suspensions. Polysorbates have been found to help increase the oral bioavailability of drug molecules that are substrates of p-glycoprotein.

Safety

Polysorbates are widely used in cosmetics, foods, and preparations for oral, parenteral, and topical administration, and are generally considered to be non-toxic and non-irritating materials. There have been occasional reports of hypersensitivity to polysorbates when used topically and intramuscularly. Polysorbates have also been associated with some serious adverse effects, including death, reported in low-birth-weight newborns when vitamin E preparations containing a mixture of polysorbate 20 and polysorbate 80 were administered intravenously. When heated to decomposition, polysorbate emits acrid and pungent fumes. Moderate toxicity in intravenous injection, moderate ingestion toxicity in gastrointestinal tract, irritating to eyes. It is an experimental carcinogen and has an effect on reproduction. Mutagenicity has been reported. LD50 (mouse, IP): 7.6g/kg LD50 (mouse, IV): 4.5g/kg LD50 (mouse, oral): 25g/kg LD50 (rat, IP): 6.8g/kg LD50 (rat, IV): 1.8g/kg Polysorbate 40 and polysorbate 80 are not toxic to CaCo-2 cells

Incompatibilities

Polysorbate reacts discoloration and/or precipitation with various substances, especially phenol, tannin, tar and tar-like substances. In the presence of polysorbates, the antimicrobial activity of the preservative parabens was reduced.