1/ Introduction
Glyceryl dibehenate, a mixture of mono-, di-, and triglycerides of behenic acid, is widely employed in pharmaceutical manufacturing as a sustained-release agent through the formation of a lipid matrix, or as a lubricant for tablet formulations.
2/ Key Advantages
Advantages in the role of sustained-release matrix:
- The lipid matrix does not swell or erode, thereby maintaining a diffusion-controlled drug release mechanism and preventing burst release within the first 60 minutes or upon tablet rupture.
- Applicable to various manufacturing processes such as direct compression, wet granulation, hot-melt extrusion, and solid dispersion systems.
- Eliminates the need for organic solvents, minimizing the risk of fire or explosion and avoiding the impact of alcohol on drug release behavior.
- Stable under physiological conditions (digestive enzymes, pH), reducing inter-patient variability in drug release profiles.
- Chemically inert and compatible with a wide range of active ingredients and excipients.
- Drug release performance is minimally affected during scale-up.
Advantages in the role of a lubricant:
- Being lipid-based, it provides a glossy tablet surface and reduces ejection force, thereby extending punch and die lifespan.
- Non-reactive lubricant suitable for formulations containing drug substances incompatible with magnesium stearate.
- Does not impart a metallic taste.
- Stable lubricant whose performance is less affected by variations in processing parameters such as blending time or lubricant concentration.
- Exhibits good binding properties, improving tablet cohesion and helping overcome hardness issues often observed with conventional lubricants.
Product complies with USP/EP/BP
The manufacturer has EXCIPACT GMP Certificate for Pharma application
Stock available at GSP/ GDP warehouse, prompt delivery, competitive price
3/ Applications
- Lipid matrix-forming agent for controlling the drug release rate in sustained-release tablets: 15–50%
- Non-reactive lubricant providing an aesthetically smooth tablet surface: 1–3%
4/ Commercial Products
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