An oily vehicle used as solubilizer for lipophilic APIs in oral and topical formulations.
Names & synonyms
USP NF Name | Glyceryl monooleate (Type 40) |
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EP Name | Glycerol mono-oleates (Type 40) |
UNII Code (FDA) | 4PC054V79P |
Preferred Substance Name (FDA) | GLYCERYL OLEATE |
Handbook of Pharmaceutical Excipients | Glyceryl monooleate |
Chemical description | Consists of mono-, di- and triglycerides of oleic (C18:1) acid, the monoester fraction being predominant |
Key characteristics
Product form | Liquid |
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Viscosity (mPa.s) | 220 (20°C) |
HLB | 1 |
Main functionalities
Solubilizer for lipophilic APIs and bioavailability enhancer. Oily vehicle containing long-chain fatty acids (C18:1) for LFCS Type I (oily), Type II (SEDDS), and Type III (SMEDDS), associated with lymphatic absorption. Oily vehicle for topical formulations. Safety of use is inferred by GRAS status and precedence of use in approved pharmaceutical products.
Main formulation technologies
Soft and hard gelatin capsule filling. Topical emulgel and ointment.
Documentation
Documentation technique
Brochures
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
Associated content
Excipients for solubility and bioavailability enhancement
Poor solubility, poor permeability, and pre-systemic elimination are factors that…
Providing emolliency with oily vehicles
By their intrinsic lipid nature, oily vehicles bring emollient properties to…