A glyceride with a high melting point used as a modified release agent or lubricant in tablets. Can also be used in lipid coating technologies and as lipid carrier for nanoparticles.
Names & synonyms
| USP NF Name | Glyceryl dibehenate |
|---|---|
| EP Name | Glycerol dibehenate |
| UNII Code (FDA) | R8WTH25YS2 |
| Preferred Substance Name (FDA) | GLYCERYL DIBEHENATE |
| Handbook of Pharmaceutical Excipients | Glyceryl Behenate |
| Chemical description | Consists of mono-, di- and triesters of behenic acid (C22), the diester fraction being predominant. |
Key characteristics
| Product form | Powder |
|---|---|
| Melting range (°C) | 65 - 77 |
| HLB | 2 |
Main functionalities
Modified release matrix former for tablet. Lubricant for tablet—independent of mixing time and speed. Lipid carrier former for solid lipid nanoparticle (SLN) and nanostructured lipid carrier (NLC). Coating agent for taste masking and protection of sensitive APIs.
Listed in the European STEP database for excipients in pediatric medicines.
Safety of use is inferred by GRAS status and precedence of use in approved pharmaceutical products.
Main formulation technologies
Tablet compression (direct and wet granulation). Melt processes: granulation, extrusion, coating, prilling, spray congealing. Nanoparticle, nanocarrier formulation.
Documentation
Documentation technique
Brochures
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Gattefosse brochure Compritol 888 ATO a smart solution to sustain drug release (En)
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Gattefosse brochure Compritol 888 ATO The lubricant for challenging pharmaceutical tablets (En)
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Gattefosse brochure Gattefosse products in pediatric dosage forms
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Gattefosse brochure Oral drug delivery with lipid excipients
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Gattefosse brochure veterinary medicines with Lipid excipients
Scientific document
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Poster AAPS 2013: High Drug Load Lipid Matrix Tablets Prepared by Wet Granulation Part I Formulation Parameters
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Poster AAPS 2013: High Drug Load Lipid Matrix Tablets Prepared by Wet Granulation Part II Process Parameters
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Poster AAPS 2013: Percolation threshold of Compritol 888 in matrix tablet
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Poster AAPS 2014: Ethanol Resistant Extended Release Matrix Tablets with Compritol 888 Ato
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Poster AAPS 2014: Is Compritol 888 Ato Chemically Stable in Hot Melt Extrusion Processed at High Temperature
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Poster AAPS 2016: Compritol 888 ATO A Sustained Release Lipid Matrix for Once a Day Aceclofenac Tablets
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Poster AAPS 2017 QbD: How particle size and glyceryde composition affect performance of sustained release tablets with Compritol 888 ATO
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Poster CRS 2014: Estimating in vivo drug release from a new theophylline Compritol matrix using biorelevant methods
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Poster CRS 2014: Streamlining the design of sustained release matrix tablets using mathematical modeling for drug release optimization
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Poster CRS 2015: New Insights into Stability of SR lipid matrix Tablets
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Poster CRS 2016: Impact of hot and wet granulation on Compritol 888 ATO lipid matrices for extended release of highly water soluble high dose API
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Poster CRS 2021: Selecting efficient pharmaceutical binder for developing robust extended-release matrices of Compritol 888ATO prepared using wet granulation technique: Part 2
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Poster CRS 2021: Selecting efficient pharmaceutical binder for developing robust extended-release matrices of Compritol®888ATO prepared using wet granulation technique: Part 1
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Poster CRS 2022 Abuse deterrent SR tablets with Compritol 888 ATO
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2022 AAPS Poster_Impact of Granulation Solvent on Release Performance of Dual sustained release Matrix
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Poster AAPS 2014: Compritol 888 Ato Vs Precirol Ato 5 in Hot Melt Extrusion Investigation of Operating Window Limits
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Poster AAPS 2009: Vaginal cream formulations for the prevention of HIV infection for women in developing countries
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Poster PBP 2024 - Advantages of combining polymers and lipids in extrusion processes
Associated content
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