Food additives Europe numbers: E471
Functional Category
Coating agent; tablet binder; tablet and capsule lubricant; thickening agent; viscosity-increasing agent.
Applications in Pharmaceutical Formulation
Glyceryl behenate is used in cosmetics, foods, and oral pharmaceutical formulations; see Table I. In pharmaceutical formulations, glyceryl behenate is mainly used as a lubricant in the preparation of oral tablets and capsules.(1–3) 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.(4) It has also been investigated for use in the preparation of sustained-release tablets;(5–10) as a matrix-forming agent for the controlled release of water-soluble drugs;(10) and it can also be used as a hot-melt coating agent sprayed onto a powder or drug-loaded sugar beads and granules.(11,12) It may also be incorporated via extrusion/spheronization into pellets, which can be further compressed into tablets. Glyceryl behenate is used in oral enteric-coated pellets, powders and suspensions. It is also used in controlled, extended-release and orally disintegrating tablets. For oral preparations, glyceryl behenate forms a lipidic matrix for sustained-release formulations. It has been used along with acid-soluble or swellable polymers to mask the bitter or unpleasant taste of the medicament with improved palatability.(13) Glyceryl behenate has been used for the preparation of ophthalmic inserts.(14,15) In cosmetics, glyceryl behenate is used as a skin conditioning agent, emollient and viscosity-increasing agent in emulsions. It also improves the heat stability of emulsions and is a gelifying agent for various oils. For topical formulations, it is used as a thickening agent for oily phases. It is also used as a surfactant or emulsifying agent.
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.
Stability and Storage Conditions
Glyceryl behenate should be stored in a tightly closed container, at a temperature less than 358C
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(16