Gelucire® 48/16

A non-ionic pure surfactant for lipid-based formulation to solubilize and increase oral bioavailability of poorly soluble API. Forms micellar solution in aqueous media.

Names and synonyms

USP NF Name

Polyethylene glycol monostearate

EP Name

Macrogol stearate (pending)

UNII Code (FDA)

33GX5WQC0M

Preferred Substance Name (FDA)

PEG-32 STEARATE

Handbook of Pharmaceutical Excipients

Polyoxylethylene stearates

Chemical description

Consists of PEG-32 (MW 1500) esters of palmitic (C16) and stearic (C18) acids

Key characteristics

Product form

Pellets

Melting range (°C)

46-50

HLB

12

CMC (mg/L, 25°C)

153 ± 31

Main functionalities

Solubilizer for low log P APIs and bioavailability enhancer.
Single excipient formulation system: self-emulsifies in aqueous fluid into micellar solution—LFCS Type IV.
Use in melt processes (granulation, extrusion), granulation, and compression.
Wetting agent.
Safety of use is inferred by precedence of use in approved pharmaceutical products.