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 & synonyms
|USP NF Name||
Stearoyl polyoxyl-32 glycerides
Stearoyl macrogol-32 glycerides
|UNII Code (FDA)||
|Preferred Substance Name (FDA)||
PEG-32 HYDROGENATED PALM GLYCERIDES
|Handbook of Pharmaceutical Excipients||
Consists of mono, di- and triglycerides and PEG-32 (MW 1500) mono- and diesters of palmitic (C16) and stearic (C18) acids
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.