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 | Caprylocaproyl Polyoxyl-8 glycerides |
|---|---|
| EP Name | Caprylocaproyl macrogol-8 glycerides |
| UNII Code (FDA) | 00BT03FSO2 |
| Preferred Substance Name (FDA) | PEG-8 CAPRYLIC/CAPRIC GLYCERIDES |
| Handbook of Pharmaceutical Excipients | Polyoxylglycerides |
| Chemical description | Consists of a small fraction of mono-, di- and triglycerides and mainly PEG-8 (MW 400) mono- and diesters of caprylic (C8) and capric (C10) acids |
Key characteristics
| Product form | Liquid |
|---|---|
| Viscosity (mPa.s) | 80 - 110 (20°C) |
| CMC (mg/L, 25°C) | 42 ±24 |
| HLB | 12 |
Main functionalities
Solubilizer for poorly-soluble APIs and bioavailability enhancer. Single excipient formulation system: self-emulsifies in aqueous fluid into microemulsion—LFCS Type III (SMEDDS). High purity guaranteed for stability and capsule compatibility. Safety of use is inferred by extensive 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.
Resources
Technical documentation
Brochures
Scientific document
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Poster Dublin 2019 :Investigation of Labrasol ALF as an intestinal permeation enhancer Ussing chambers and intestinal instillations
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Poster PBP 2016: Solidification of liquid self-emulsifying lipid formulations by loading on solid mesoporous carriers
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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 PBP 2024 - Advantages of combining polymers and lipids in extrusion processes
Associated content
Lipid-based formulations
Lipid-based formulations are a powerful tool to increase oral bioavailability of…
Excipients for solubility and bioavailability enhancement
Poor solubility, poor permeability, and pre-systemic elimination are factors that…
Capsule filling and molding
Capsule filling and molding are common technologies suitable for powder, liquid,…