Labrafil® M 2125 CS

A liquid 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).

Names and synonyms

USP NF Name

Linoleoyl Polyoxyl-6 glycerides

EP Name

Linoleoyl Macrogol-6 glycerides

UNII Code (FDA)

1U4409FY0P

Preferred Substance Name (FDA)

CORN 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 linoleic (C18:2) acid

Key characteristics

Product form

Liquid

Viscosity (mPa.s)

70 – 90 (20°C)

HLB

9

Main functionalities

Solubilizer for poorly-soluble APIs 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).
Safety of use is inferred by substantial toxicological data and precedence of use in approved pharmaceutical products.