Labrafil® M 1944 CS

A nonionic water-dispersible surfactant for lipid-based formulations to solubilize and increase oral bioavailability of poorly water-soluble APIs. Self-emulsifies in aqueous media forming a coarse dispersion, i.e., emulsion (SEDDS). Co-emulsifier in topical formulations to improve stability of emulsions.

Names and synonyms

USP NF Name

Oleoyl polyoxyl-6 glycerides

EP Name

Oleoyl macrogol-6 glycerides

UNII Code (FDA)

DRG3KJZ1TJ

Preferred Substance Name (FDA)

APRICOT KERNEL OIL PEG-6 ESTERS

Handbook of Pharmaceutical Excipients

Polyoxylglycerides

Chemical description

Consists of mono-, di- and triglycerides and PEG-6 (MW 300) mono- and diesters of oleic (C18:1) acid

Key characteristics

Product form

Liquid

Viscosity (mPa.s)

75 – 95 (20°C)

HLB

9

Main functionalities

Solubilizer for poorly-soluble API and bioavailability enhancer
Single excipient formulation system: self-emulsifies in aqueous fluid into emulsion – LFCS type II (SEDDS)
Combine with Labrasol®ALF or Gelucire® 44/14 for LFCS Type III (SMEDDS)
Co-emulsifier in topical formulations often associated with Tefose® 63 in antifungal cream
Safety of use is supported by substantial toxicological data and precedence of use in approved pharmaceutical products.

Main formulation technologies