Labrafil® M 2130 CS

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

Names and synonyms

USP NF Name

Lauroyl polyoxyl-6 glycerides

EP Name

Lauroyl macrogol-6 glycerides

UNII Code (FDA)

8EPU9MJ01K

Preferred Substance Name (FDA)

HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS

Handbook of Pharmaceutical Excipients

Polyoxylglycerides

Chemical description

Consists mainly of mono-, di- and triglycerides and PEG-6 (MW 300) mono- and diesters of lauric (C12) and stearic (C18) acids

Key characteristics

Product form

Waxy solid

Melting Point (°C)

33 – 38

HLB

9

Main functionalities

Co-emulsifier in topical formulations often associated with Tefose® 63.

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.