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||
Lauroyl Polyoxyl-32 glycerides
Lauroyl Macrogol-32 glycerides
|UNII Code (FDA)||
|Preferred Substance Name (FDA)||
LAUROYL PEG-32 GLYCERIDES
|Handbook of Pharmaceutical Excipients||
Consists of a small fraction of mono, di- and triglycerides and mainly PEG-32 (MW 1500) mono- and diesters of lauric acid (C12)
Solubilizer for poorly-soluble APIs and bioavailability enhancer. Single excipient formulation system: self-emulsifies in aqueous fluid into microemulsion—LFCS Type III (SMEDDS). Wetting agent. Lipid binder in melt processes. Safety of use is inferred by extensive toxicological evaluations and precedence of use in approved pharmaceutical products.
Main formulation technologies
Self-emulsifying lipid formulation for oral applications. Melt processes: granulation and capsule molding. Wet granulation and compression.