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 |
|---|---|
| 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.
Documentation
Documentation technique
Brochures
Associated content
Excipients for solubility and bioavailability enhancement
Poor solubility, poor permeability, and pre-systemic elimination are factors that…
Granulation
When powder properties are unsuitable for direct compression, a granulation step is…
Hot melt extrusion
Hot melt extrusion is a continuous solvent-free technology with precise process…