A winterized oil composed of long-chain mono-, di-, and triglycerides for lipid-based formulations to solubilize and increase oral bioavailability of poorly water-soluble lipophilic APIs. Used in self-emulsifying lipid formulations (SEDDS and SMEDDS) as an oily vehicle.

Names & synonyms

USP NF Name

Glyceryl monolinoleate

EP Name

Glycerol monolinoleate

UNII Code (FDA)

4763AXI84L

Preferred Substance Name (FDA)

GLYCERYL MONOLINOLEATE

Handbook of Pharmaceutical Excipients

Glyceryl monolinoleate

Chemical description

Consists of mono-, di- and triglycerides of mainly linoleic (C18:2) and oleic (C18:1) acids, the diester fraction being predominant

Key characteristics

Product form

Liquid

Viscosity (mPa.s)

120 (20°C)

HLB

1

oil_molecule

Main functionalities

Solubilizer for lipophilic API and bioavailability enhancer. Oily vehicle for LFCS Type I (oily), Type II (SEDDS) and Type III (SMEDDS), associated with lymphatic absorption. Safety of use is inferred by GRAS status and precedence of use in approved pharmaceutical products.

Main formulation technologies

Oily and self-emulsifying lipid formulation for oral applications. Soft/hard gelatin capsule filling.

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