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 | Lauroyl Polyoxyl-32 glycerides |
|---|---|
| EP Name | Lauroyl Macrogol-32 glycerides |
| UNII Code (FDA) | H5ZC52369M |
| Preferred Substance Name (FDA) | LAUROYL PEG-32 GLYCERIDES |
| Handbook of Pharmaceutical Excipients | Polyoxylglycerides |
| Chemical description | Consists of a small fraction of mono, di- and triglycerides and mainly PEG-32 (MW 1500) mono- and diesters of lauric acid (C12) |
Key characteristics
| Product form | Waxy solid |
|---|---|
| Melting range (°C) | 42.5 - 47.5 |
| HLB | 11 |
| CMC (mg/L, 25°C) | 72 ± 53 |
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). Wetting agent. Lipid binder in melt processes. Safety of use is inferred by extensive toxicological evaluations and precedence of use in approved pharmaceutical products.
Main formulation technologies
Self-emulsifying lipid formulation for oral applications. Melt processes: granulation and capsule molding. Wet granulation and compression.
Resources
Technical documentation
Brochures
Scientific document
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Poster AAPS 2016: Solid State Structural Aspects of Solid Self-microemulsifying Drug Delivery Systems during Digestion
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Poster AAPS 2021: GELUCIRE 44/14® FOR TYPE-IV LIPID BASED FORMULATIONS AND THEIR IN VITRO IN VIVO PERFORMANCE EVALUATION
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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 AAPS 2014: Formulation of a Self Emulsifying Lipid Formulation of Curcumin
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Poster AAPS 2017: Macrogol esters influence of in vitro and in vivo dissolution of a poorly soluble drug (En)
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,…