Polysorbate 80

Products

Polysorbate 80 is present in many drugs as an excipient. These include tablets, injectables (e.g., amiodarone), biologics (therapeutic proteins, vaccines), and solutions. It is also used in personal care products and in foods.

Structure and properties

Polysorbate 80 is a mixture of partial esters of fatty acids, mainly oleic acid, with sorbitol and its anhydrides ethoxylated with about 20 moles of ethylene oxide for each mole of sorbitol and sorbitol anhydride. It exists as an oily, colorless to brownish yellow, clear or slightly opalescent liquid that is dispersible in water. Polysorbate 80 belongs to the group of non-ionic emulsifiers. Like other surface-active substances, it contains hydrophilic and hydrophobic portions.

Effects

Polysorbate 80 has emulsifying, stabilizing and surface-active properties. It can form micelles.

Fields of application

Polysorbate 80 is a pharmaceutical excipient used as a solubilizer, emulsifier, stabilizer and penetration enhancer. Its main functions include solubilization. Polysorbate 80, for example, is present in many tablets. It allows lipophilic active ingredients to dissolve (dissolve) and be absorbed upon release in the gastrointestinal tract. Polysorbate 80 also performs this function in liquid and semisolid drugs and in soft capsules.

Adverse effects

Polysorbate 80 is associated with several adverse effects. These include hypersensitivity reactions, administration site reactions, undesirable distribution of the active ingredient, and gastrointestinal disturbances. Another concern is that peroxides with oxidizing properties can form during storage.