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 coarse dispersion, i.e., emulsion (SEDDS). Co-emulsifier in topical formulations to improve stability of emulsions.
Names & synonyms
| USP NF Name | Oleoyl polyoxyl-6 glycerides |
|---|---|
| EP Name | Oleoyl macrogol-6 glycerides |
| UNII Code (FDA) | DRG3KJZ1TJ |
| Preferred Substance Name (FDA) | APRICOT KERNEL OIL PEG-6 ESTERS |
| Handbook of Pharmaceutical Excipients | Polyoxylglycerides |
| Chemical description | Consists of mono-, di- and triglycerides and PEG-6 (MW 300) mono- and diesters of oleic (C18:1) acid |
Key characteristics
| Product form | Liquid |
|---|---|
| Viscosity (mPa.s) | 75 - 95 (20°C) |
| HLB | 9 |
Main functionalities
Solubilizer for poorly-soluble API and bioavailability enhancer Single excipient formulation system: self-emulsifies in aqueous fluid into emulsion – LFCS type II (SEDDS) Combine with Labrasol®ALF or Gelucire® 44/14 for LFCS Type III (SMEDDS) Co-emulsifier in topical formulations often associated with Tefose® 63 in antifungal cream Safety of use is supported by substantial toxicological data and precedence of use in approved pharmaceutical products.
Main formulation technologies
Self-emulsifying lipid formulation for oral applications Soft/hard gelatin capsule filling and vials Topical and mucosal cream, emulgel, microemulsion and foam. Oily vehicle for injectable veterinary drugs.
Documentation
Documentation technique
Brochures
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Gattefosse brochure Gattefosse products in pediatric dosage forms
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Gattefosse brochure Lipid excipients for cannabinoid drug products
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Gattefosse brochure Oral drug delivery with lipid excipients
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Gattefosse Brochure Skin-Friendly Textures
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Gattefosse brochure veterinary medicines with Lipid excipients
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Brochure Gattefosse Lipid-based formulations Bio-enhancers by nature
Scientific document
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Poster AAPS 2013: Self formulation protocol I Solubiity determination in liquid and solid excipient
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Poster AAPS 2013: SELF formulation protocol II Excipient selection diagram design and selection of prototype formulations
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Poster AAPS 2013: SELF formulation protocol III Impact of lipolysis on prototype formulations
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Poster AAPS 2014: Establishment of a Binary Phase Diagrams Database for the Development of Self Emulsifying Lipid Based Formulations
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Poster CRS 2024 - Rheology as a tool for characterizing topical product formulations: impact of solubilizer variation on stability and structure
Associated content
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