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)

XRQ165498B

Preferred Substance Name (FDA)

Polyglyceryl-3 oleate

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

3

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.

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…