A non-ionic pure surfactant for lipid-based formulation to solubilize and increase oral bioavailability of poorly soluble API. Forms micellar solution in aqueous media.
Names & synonyms
| USP NF Name | Polyoxyl-32 stearate (type I) NF |
|---|---|
| EP Name | Macrogol-32 stearate (type I) EP |
| UNII Code (FDA) | 33GX5WQC0M |
| Preferred Substance Name (FDA) | PEG-32 STEARATE |
| Handbook of Pharmaceutical Excipients | Polyoxylethylene stearates |
| Chemical description | Consists of PEG-32 (MW 1500) esters of palmitic (C16) and stearic (C18) acids |
Key characteristics
| Product form | Pellets |
|---|---|
| Melting range (°C) | 46 - 50 |
| HLB | 12 |
| CMC (mg/L, 25°C) | 153 ± 31 |
Main functionalities
Solubilizer for low log P APIs and bioavailability enhancer. Single excipient formulation system: self-emulsifies in aqueous fluid into micellar solution—LFCS Type IV. Use in melt processes (granulation, extrusion), granulation, and compression. Wetting agent. Safety of use is inferred by precedence of use in approved pharmaceutical products.
Main formulation technologies
Self-emulsifying lipid formulation for oral applications. Melt processes: granulation, extrusion, capsule molding, and compression. Wet granulation and compression.
Resources
Technical documentation
Brochures
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Gattefosse brochure Selecting the best excipients to optimize drug delivery
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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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Brochure Gattefosse Lipid-based formulations Bio-enhancers by nature
Scientific document
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Poster CRS 2018 : Bioavailable Curcumin A Type 4 Lipid Based Drug Delivery System using Gelucire 48 16 As Solid Solubilizer
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Poster CRS 2019 : Understanding The Role Of In Vitro And In Vivo Evaluation Techniques In determining the performance of LBF
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Poster CRS 2022 Gelucire® 4816 a safe wetting agent for fenofibrate tablet
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Poster PharmSci 2019: Gelucire 4816 for type IV LBF and their in vitro in vivo performance evaluation
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Poster_AAPS 2012_Characterization of new self excipient GELUCIRE 4816 to expand formulation options for poorly soluble drugs
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Introducing Gelucire® 48/16 A solid solution for solubility enhancement (En)
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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: 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)
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Poster PBP 2024 - Advantages of combining polymers and lipids in extrusion processes
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Poster CRS 2024 - Comparing the effect of adding Gelucire® 48/16 and 50/13 in an amorphous solid dispersion: a case study with ticagrelor
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…