Gelucire® 50/13

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

Stearoyl polyoxyl-32 glycerides

EP Name

Stearoyl macrogol-32 glycerides

UNII Code (FDA)

G6EP177239

Preferred Substance Name (FDA)

PEG-32 HYDROGENATED PALM GLYCERIDES

Handbook of Pharmaceutical Excipients

Polyoxylglycerides

Chemical description

Consists of mono, di- and triglycerides and PEG-32 (MW 1500) mono- and diesters of palmitic (C16) and stearic (C18) acids

Key characteristics

Product form

Pellets

Melting range (°C)

46-51

HLB

11

CMC (mg/L, 25°C)

100

Main functionalities

Solubilizer for poorly-soluble APIs and bioavailability enhancer.
Single excipient formulation system: self-emulsifies in aqueous fluid into coarse emulsion—LFCS Type III (SMEDDS).
Modulation of drug release.
Lipid binder in melt processes.
Safety of use is inferred by toxicological data and precedence of use in approved pharmaceutical products.