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 & synonyms
|USP NF Name||
Polyoxyl-32 stearate (type I) NF
Macrogol-32 stearate (type I) EP
|UNII Code (FDA)||
|Preferred Substance Name (FDA)||
|Handbook of Pharmaceutical Excipients||
Consists of PEG-32 (MW 1500) esters of palmitic (C16) and stearic (C18) acids
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.
Main formulation technologies
Self-emulsifying lipid formulation for oral applications. Melt processes: granulation, extrusion, capsule molding, and compression. Wet granulation and compression.