A nonionic water-insoluble surfactant used as cosurfactant in oral lipid-based formulation SEDDS and SMEDDS. Cosurfactant and solubilizer in topical dosage forms.
Names & synonyms
| USP NF Name | Polyglyceryl-3 dioleate |
|---|---|
| EP Name | / |
| UNII Code (FDA) | D08AL46IU2 |
| Preferred Substance Name (FDA) | Polyglyceryl-3 dioleate |
| Handbook of Pharmaceutical Excipients | / |
| Chemical description | Consists of polyglyceryl-3 esters of oelic acid (C18:1), the diester fraction being predominant. |
Key characteristics
| Product form | Oily liquid |
|---|---|
| Viscosity (mPa.s) | 3000 (20°C) |
| HLB (PIT method) | 5 ± 1 |
Main functionalities
Solubilizer for poorly-soluble APIs and bioavailability enhancer. Co-surfactant in LFCS Type II (SEDDS) and Type III (SMEDDS) formulations.
Solubilizer and Solubilizer and skin penetration enhancer. Co-surfactant for microemulsion in topical formulations.
Safety of use is inferred by precedence of use in approved pharmaceutical products.
Main formulation technologies
Self-emulsifying lipid formulation for oral applications. Topical emulgel, microemulsion, and foam.
Documentation
Documentation technique
Brochures
Scientific document
-
Poster AAPS 2014: Establishment of a Binary Phase Diagrams Database for the Development of Self Emulsifying Lipid Based Formulations
-
Poster CRS 2024 - Rheology as a tool for characterizing topical product formulations: impact of solubilizer variation on stability and structure
-
Poster Skin Formulation 2023 - Advanced rheological characterization of topical products
Associated content
Excipients for solubility and bioavailability enhancement
Poor solubility, poor permeability, and pre-systemic elimination are factors that…
Selecting penetration enhancers, for transdermal delivery
To overcome the skin barrier properties, many strategies exist, among which the use…