Labrasol® ALF

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 fine dispersion, i.e., microemulsion (SMEDDS).

Names and synonyms

USP NF Name

Caprylocaproyl Polyoxyl-8 glycerides

EP Name

Caprylocaproyl macrogol-8 glycerides

UNII Code (FDA)

00BT03FSO2

Preferred Substance Name (FDA)

PEG-8 CAPRYLIC/CAPRIC GLYCERIDES

Handbook of Pharmaceutical Excipients

Polyoxylglycerides

Chemical description

Consists of a small fraction of mono-, di- and triglycerides and mainly PEG-8 (MW 400) mono- and diesters of caprylic (C8) and capric (C10) acids

Key characteristics

Product form

Liquid

Viscosity (mPa.s)

80 – 110 (20°C)

CMC (mg/L, 25°C)

42 ±24

HLB

12

Main functionalities

Solubilizer for poorly-soluble APIs and bioavailability enhancer.
Single excipient formulation system: self-emulsifies in aqueous fluid into microemulsion—LFCS Type III (SMEDDS).
High purity guaranteed for stability and capsule compatibility.
Safety of use is inferred by extensive toxicological data and precedence of use in approved pharmaceutical products.