Glyceryl Behenate - Sustained-release matrix former, lubricant

1. General Introduction to Glyceryl Behenate

Glyceryl Behenate is a mixture of mono-, di-, and triglyceride esters of behenic acid (docosanoic acid). It is a widely used pharmaceutical excipient with the following key applications:

• Lipid matrix former for controlling the release rate of active pharmaceutical ingredients (APIs) in sustained-release tablet formulations.
• Lubricant that provides excellent lubrication without incompatibility issues while improving the appearance and surface finish of tablets.

Manufactured under a stringent quality control system, Glyceryl Behenate offers high purity, complies with applicable pharmacopeial quality standards, and is supported by comprehensive regulatory documentation to facilitate pharmaceutical product registration.

2. Detailed Material Specifications

• Product Name: Glyceryl Behenate
• Origin: China
• Main Ingredients: A mixture of mono-, di-, and triglyceride esters of behenic acid (docosanoic acid)
• Physical State: Powder or hard waxy flakes, white or off-white in color.
• Odor/Taste: Odorless or possessing a very faint fatty odor.
• Solubility: Practically insoluble in water and ethanol; soluble in chloroform and organic solvents upon heating.
• Quality Standards: Complies with international pharmacopeia standards (USP/NF, EP, ChP).

The material is rigorously controlled for the following parameters:

• Identification and fatty acid composition (specifically behenic acid content).
• Melting range (typically 65°C - 77°C).
• Acid value, iodine value, and saponification value.
• Limits for heavy metals and sulfated ash.
• Microbial limits for pharmaceutical manufacturing applications.

3. Application of Glyceryl Behenate in sustained-release tablet

Glyceryl dibehenate forms a hydrophobic lipid matrix and is typically used at concentrations of 15–50% w/w of the tablet, depending on the formulation and the aqueous solubility of the API. Key advantages of Glyceryl dibehenate in sustained-release tablet formulations include:

• 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.

4. Application of Glyceryl Behenate as 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.
• Facilitates scale-up

5. Commercial Products Utilizing Glyceryl Behenate

6. Product Contact Information

For further information regarding the supply chain and technical specifications of Glyceryl Behenate or to place an order, please contact:

• Consultation Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website:www.biorichgroup.com
• Sample/COA Requests: Please contact us via email to receive product samples, Certificates of Analysis (COA), and the latest technical documentation directly from the manufacturer.