Polyoxyl 40 hydrogenated castor oil

• Ph. Eur.Macrogolglycerol Hydroxystearate
• USP–NFPolyoxyl 40 Hydrogenated Castor Oil

Cremophor RH 40; glycerol polyethylene glycol oxystearate; Kolliphor RH 40; macrogolglyceroli hydroxystearas; PEG-40 hydrogenated castor oil

Polyethoxylated hydrogenated castor oil (hydrogenated castor oil reacted with about 40 moles of ethylene oxide per mole) · [61788-85-0]

Polymer, mixture or material of variable composition — no single molecular formula applies.

Solubilising agent, Surfactant, emulsifier

Typical concentrations: — · Dosage forms: Liquid, Semi-solid

A nonionic solubiliser and emulsifier used to solubilise fat-soluble vitamins, essential oils, flavours, fragrances and lipophilic drugs in aqueous oral and topical preparations, and as a surfactant in self-emulsifying (microemulsion) drug delivery systems such as some oral ciclosporin formulations. It is less bitter-tasting and less irritant than polyoxyl 35 castor oil, which makes it popular in oral liquids. Use levels vary with the load to be solubilised, commonly from a few percent up to about 20–25% in liquid formulations and higher in lipid-based concentrates.

A mixture obtained by ethoxylating hydrogenated castor oil. The hydrophobic part consists mainly of glycerol polyethylene glycol hydroxystearate and the hydrophilic part of free polyethylene glycols and glycerol ethoxylates. It is a white to yellowish paste at room temperature.

Physical form

white to yellowish paste at room temperature that liquefies at about 30 °C; faint characteristic odour, almost tasteless

HLB

about 14–16

Solubility

soluble in water, ethanol, 2-propanol and fatty oils; aqueous solutions are clear

Composition

mainly glycerol polyethylene glycol 12-hydroxystearate with free polyethylene glycols and ethoxylated glycerol

Stable. Aqueous solutions can be heat sterilised, although they may become turbid at high temperature and clear again on cooling. Store in a well-closed container in a cool, dry place, protected from light.

Like other polyethoxylated surfactants, it can reduce the activity of some preservatives, such as parabens, through micellar binding, and it may be incompatible with phenolic compounds and strong oxidising agents.

Prepared by reacting hydrogenated castor oil with ethylene oxide in a molar ratio of about 1:40.

Generally regarded as non-toxic and non-irritant in oral and topical use. Hypersensitivity reactions have been reported with polyethoxylated castor oils, mainly after intravenous use of the non-hydrogenated material, and should be borne in mind.

Observe normal precautions for the quantity handled. Eye protection and gloves are recommended.

Included in the FDA Inactive Ingredient Database (oral capsules, solutions and tablets; ophthalmic and topical preparations) and in non-parenteral medicines licensed in Europe.

Polyoxyl 35 castor oil; polyoxyl 60 hydrogenated castor oil; polysorbate 80.

To solubilise an oil or lipophilic drug, it is usually best to mix the active thoroughly with the warmed surfactant before slowly adding water. The material should be warmed and homogenised before sampling, because components can separate in the paste.