Lauroyl polyoxylglycerides

• BPLauroyl Macrogolglycerides
• Ph. Eur.Lauroyl Macrogolglycerides
• USP–NFLauroyl Polyoxylglycerides

Gelucire 44/14; lauroyl macrogol-32 glycerides; lauroyl macrogolglycerides; PEG-32 glyceryl laurate

Mixture of mono-, di- and triglycerides and mono- and di-fatty acid esters of polyethylene glycol, mainly of lauric acid · [—]

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

Solubilising agent, Surfactant, emulsifier

Typical concentrations: — · Dosage forms: Solid, Liquid

A nonionic, water-dispersible surfactant used in oral formulations to improve the solubility and bioavailability of poorly water-soluble drugs. It is used as a semi-solid vehicle for melt-filling into hard capsules, in self-emulsifying and self-microemulsifying drug delivery systems, and as a carrier in solid dispersions made by melt methods. The concentration ranges from a minor solubilising component to the main constituent of a capsule fill.

A pale yellow, waxy semi-solid. It consists of a mixture of glycerides and polyethylene glycol esters, mainly of lauric acid, together with some free polyethylene glycol; the pharmacopoeial material is defined by the mean molecular mass of the polyethylene glycol (300–1500).

Melting point

about 44 °C (Gelucire 44/14)

HLB

about 14 (Gelucire 44/14)

Behaviour in water

disperses in water to form a fine micellar dispersion or microemulsion

Physical form

waxy semi-solid at room temperature; filled into capsules in the molten state

Stable when stored in the original airtight container, protected from light and moisture, in a cool place. Like other lipid excipients it can undergo slow physical changes on ageing that may alter drug release, which should be checked in stability studies. Avoid prolonged heating of the molten material.

Incompatible with strong oxidising agents. Peroxides and aldehydes from the polyethylene glycol fraction may degrade oxidation-sensitive drugs, and water migration between fill and shell can affect hard gelatin capsules.

Prepared by partial alcoholysis of vegetable oils rich in lauric acid (such as hydrogenated palm kernel or coconut oil) with polyethylene glycol, or by esterification of glycerol and polyethylene glycol with the fatty acids.

Used in marketed oral medicines and generally regarded as of low toxicity at the levels used. Large amounts may cause gastrointestinal disturbance.

Observe normal precautions for the quantity handled. Eye protection and gloves are recommended; take care when handling the hot molten material.

Included in the FDA Inactive Ingredient Database (oral capsules) and in medicines licensed in Europe.

Caprylocaproyl polyoxylglycerides; linoleoyl polyoxylglycerides; oleoyl polyoxylglycerides; stearoyl polyoxylglycerides.

In the Gelucire naming system the two numbers give the approximate melting point (°C) and the HLB, so Gelucire 44/14 melts at about 44 °C and has an HLB of about 14.