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.
Main formulation technologies
Self-emulsifying lipid formulation for oral applications. Melt processes: granulation and capsule molding.
