Polyoxyl 35 castor oil

• Ph. Eur.Macrogolglycerol Ricinoleate
• USP–NFPolyoxyl 35 Castor Oil

Cremophor EL; Etocas 35; glycerol polyethylene glycol ricinoleate; Kolliphor EL; macrogolglyceroli ricinoleas; PEG-35 castor oil; polyethoxylated castor oil

Polyethoxylated castor oil (castor oil reacted with about 35 moles of ethylene oxide per mole) · [61791-12-6]

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

Solubilising agent, Surfactant, emulsifier

Typical concentrations: — · Dosage forms: Sterile (parenteral/ophthalmic), Liquid

A nonionic solubiliser and emulsifier used to dissolve poorly water-soluble drugs in intravenous concentrates, oral solutions and topical products, and to solubilise fat-soluble vitamins and essential oils. Well-known parenteral examples are paclitaxel concentrate (about 527 mg/mL of polyoxyl 35 castor oil with ethanol) and intravenous ciclosporin. In oral and topical formulations it is commonly used at a few percent up to about 10–20%, depending on the amount of drug to be solubilised.

A complex mixture obtained by ethoxylating castor oil. The main component is ricinoleic acid triglyceride whose hydroxyl groups and glycerol carry polyoxyethylene chains, together with free polyethylene glycols and ethoxylated glycerol. It is a pale yellow, oily liquid that is clear above about 26 °C.

Physical form

pale yellow, oily, viscous liquid with a faint characteristic odour; may become turbid or partly solidify below about 26 °C

HLB

about 12–14

Solubility

very soluble in water, giving clear solutions; miscible with ethanol; soluble in many organic solvents and miscible with castor oil

Composition

mainly glycerol polyethylene glycol ricinoleate (hydrophobic part) with free polyethylene glycols and ethoxylated glycerol (hydrophilic part)

Stable when stored in a well-filled, airtight container, protected from light, in a cool place. On cold storage it may separate or become cloudy; gentle warming and mixing restores it. Aqueous solutions can be heat sterilised, although they may become temporarily turbid.

It extracts the plasticiser di(2-ethylhexyl) phthalate (DEHP) from PVC infusion bags and sets, so non-PVC containers and administration sets are recommended for diluted parenteral solutions. Phenolic compounds can cause precipitation, and it may reduce the activity of some preservatives.

Prepared by reacting castor oil with ethylene oxide in a molar ratio of about 1:35, followed by purification.

Oral and topical use is generally well tolerated. After intravenous administration it has been associated with severe hypersensitivity (anaphylactoid) reactions, thought to involve complement activation, so patients receiving products such as paclitaxel are premedicated with corticosteroids and antihistamines. It can also alter the pharmacokinetics of co-administered drugs.

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

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

Castor oil; polyoxyl 40 hydrogenated castor oil; polyoxyl 60 hydrogenated castor oil; polysorbates.

Because of its hypersensitivity risk, newer parenteral formulations often replace it with other solubilisers or with nanoparticle and albumin-bound systems. It is also used in self-emulsifying and microemulsion drug delivery systems for oral use.