Glyceryl Behenate

Category

Binder Excipients

Molecular Weight

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Grade

Pharmceutical Excipients

Description

Glyceryl behenate occurs as a fine white-yellow powder, as a hard waxy mass or pellet, or as white or almost white unctuous flakes. It has a faint odor.

UNII

NA

Chemical Name

Docosanoic acid, monoester with glycerin [30233-64-8] (glyceryl behenate)

CAS Number

30233-64-8

Synonyms

Compritol 888 ATO; 2, 3-dihydroxypropyl docosanoate; docosanoic acid, 2, 3-dihydroxypropyl ester; E471; glycerol behenate; glyceroli dibehenas; glyceryl monobehenate.

Administration route

Oral

Dosage Form

Oral capsules, tablets, and suspensions

Stability and Storage Conditions

Glyceryl behenate should be stored in a tightly closed container, at a temperature less than 35℃.

Source and Preparation

Glyceryl behenate is prepared by the esterification of glycerin by behenic acid (C22 fatty acid) without the use of catalysts. In the case of Compritol 888 ATO (Gattefosse'), raw materials used are of vegetable origin, and the esterified material is atomized by spray cooling.

Applications

Glyceryl behenate is used in cosmetics, foods, and oral pharmaceutical formulations.In pharmaceutical formulations, glyceryl behenate is mainly used as a lubricant in the preparation of oral tablets and capsules. It has good binding properties, it does not affect tablet hardness and is unaffected by mixing or production parameters. Glyceryl behenate has been investigated for the encapsulation of various drugs such as retinoids. It has also been investigated for use in the preparation of sustained-release tablets; as a matrix-forming agent for the controlled release of water-soluble drugs; and it can also be used as a hot-melt coating agent sprayed onto a powder or drug-loaded sugar beads and granules. It may also be incorporated via extrusion/spheronization into pellets, which can be further compressed into tablets.

Safety

Glyceryl behenate is used in cosmetics, foods and oral pharmaceutical formulations, and is generally regarded as a relatively nonirritant and nontoxic material. The US Cosmetic Ingredients Review Expert Panel evaluated glyceryl behenate and concluded that it is safe for use in cosmetic formulations in present practices of use and concentration. LD50 (mouse, oral): 5 g/kg

Incompatibilities

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