Macrogol 15 hydroxystearate

• BPMacrogol 15 Hydroxystearate
• Ph. Eur.Macrogol 15 Hydroxystearate
• USP–NFPolyoxyl 15 Hydroxystearate

Kolliphor HS 15; Solutol HS 15; polyethylene glycol 660 12-hydroxystearate; polyoxyl 15 hydroxystearate; macrogoli 15 hydroxystearas

Mixture of mono- and di-esters of 12-hydroxystearic acid with polyethylene glycol (about 15 ethylene oxide units), containing about 30% free polyethylene glycol · [70142-34-6]

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

Solubilising agent, Surfactant, emulsifier

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

A non-ionic solubiliser and emulsifier used to dissolve poorly water-soluble drugs in parenteral (including intravenous) injections, and in oral liquids and capsules; it is also used in some ophthalmic and topical preparations. The amount used depends on the drug load; it is often chosen as a lower-histamine-release alternative to polyoxyl castor oils.

A yellowish-white paste or waxy mass at room temperature that becomes a clear liquid at about 30 °C. It has a faint characteristic odour.

HLB

about 14–16

Physical state

paste at room temperature; liquefies at about 25–30 °C

Critical micelle concentration

about 0.005–0.02% w/v

Solubility

soluble in water, ethanol and 2-propanol, giving clear solutions; insoluble in liquid paraffin

Chemically stable. Aqueous solutions can be heat-sterilised; temporary cloudiness or phase separation during autoclaving reverses on cooling and shaking. On storage the paste may separate physically and should be melted and mixed before use. Store in an airtight container in a cool place, protected from light.

Incompatible with strong oxidising agents. As a polyethylene glycol ester it may contain peroxide and aldehyde impurities that can degrade sensitive drugs, and it can reduce the activity of some preservatives by micellar binding.

Produced by reacting 12-hydroxystearic acid with ethylene oxide (about 15 moles per mole of acid).

Regarded as having low toxicity. In parenteral use it causes less histamine release than polyoxyl 35 castor oil, but hypersensitivity reactions are still possible and should be considered with intravenous products.

Observe normal precautions for the quantity handled. Eye protection and gloves are recommended. Warm gently to liquefy before dispensing.

Included in parenteral and oral medicinal products marketed in Europe and elsewhere, and described in the Ph. Eur. and USP–NF.

Polyoxyl 35 castor oil; polyoxyl 40 hydrogenated castor oil; polysorbate 80; tocofersolan.

Because it is a paste at room temperature, it is usually melted (at about 60 °C) and the drug dissolved in the molten surfactant before dilution with water. Dilution of drug–surfactant solutions should be checked for drug precipitation.