Polyoxyethylene Castor Oil Derivatives

Synonyms: Synonyms applicable to polyoxyethylene castor oil derivatives are shown below. See Table I for information on specific materials. Acconon; Arlatone; Cremophor; Etocas; Eumulgin; Jeechem; Lipocol; macrogolglyceroli hydroxystearas; macrogolglyceroli ricinoleas; Mapeg; Marlowet; Nikkol; Protachem; Simulsol.

Description: Polyoxyl 35 castor oil occurs as a pale yellow, oily liquid that is clear at temperatures above 26C. It has a faint but characteristic odor and can be completely liquefied by heating to 26C. Polyoxyl 40 hydrogenated castor oil occurs as a white to yellowish, semisolid paste at 20C that liquefies at 30C. It has a very faint characteristic odor and is almost tasteless in aqueous solution. Polyoxyl 60 hydrogenated castor oil occurs as a white paste at room temperature. It has little taste or odor in aqueous solution.

Chemical Name: Polyethoxylated castor oil

Emulsifying agent; solubilizing agent; wetting agent.

• Polyoxyethylene castor oil derivatives are nonionic solubilizers and emulsifying agents used in oral, topical, and parenteral pharmaceutical formulations.

• Polyoxyl 35 castor oil is mainly used as an emulsifing and solubilizing agent, and is particularly suitable for the production of aqueous liquid preparations containing volatile oils, fat-soluble vitamins, and other hydrophobic substances.

• Cremophor EL emulsifies or solubilizes the fat-soluble vitamins A, D, E, and K in aqueous solutions for oral and topical administration; in 1 mL of a 25% v/v aqueous solution it is possible to incorporate approximately 10 mg of vitamin A palmitate, approximately 10 mg of vitamin D, approximately 120 mg of vitamin E acetate, or approximately 120 mg of vitamin K1. In aqueous alcoholic solutions, it also very readily solubilizes essential oils.

• Aqueous solutions of hydrophobic drugs (e.g. miconazole, hexetidine, clotrimazole, benzocaine) can be prepared with Cremophor EL, which has also been used as a solubilizing agent for drugs like cyclosporin A, paclitaxel, and cisplatin.

• Cremophor ELP is manufactured by purifying Cremophor EL and is therefore suitable for parenteral applications, e.g. Taxol preparations.

• In oral formulations, the taste of polyoxyl 35 castor oil can be masked by a banana flavor.

• Polyoxyl 35 castor oil has also been used as a solvent in proprietary injections of diazepam, propanidid, and alfaxalone with alfadolone acetate.

• A self-microemulsifying drug delivery system (SMEDDS) for oral bioavailability, and the enhancement of halofantrine, and simvastatin, have been prepared.

• Polyoxyl 35 castor oil has been used as a buffering agent for aqueous tropicamide eyedrops.

• It has also been used in an aqueous mixture together with caprylic/capric glyceride for mucosal vaccination, providing a potential alternative to parenteral vaccination.

• Polyoxyl 35 castor oil has been used to enhance the permeability of peptides across monolayers of Caco-2 cells by inhibiting the apically polarized efflux system, enhancing intestinal absorption of some drugs.

• Cremophor has been used as a vehicle for boron neutron-capture therapy in mice, which is a form of radiation therapy used in the treatment of glioblastoma multiforme.

• Polyoxyl 35 castor oil is also used in the production of glycerin suppositories.

In strongly acidic or alkaline solutions, the ester components of polyoxyethylene hydrogenated castor oil are liable to saponify. In aqueous solution, polyoxyl 35 castor oil is stable toward most electrolytes in the concentrations normally employed. However, it is incompatible with mercuric chloride since precipitation occurs.

Polyoxyethylene castor oil derivatives are used in a variety of oral, topical, and parenteral pharmaceutical formulations

Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended.

Polyoxyethylene alkyl ethers; polyoxyethylene stearates.