Ceratonia

Category

Controlled-release Agents; Stabilizing Agents; Suspending Agents; Tablet Binder; Viscosity-increasing Agents

Grade

Pharmceutical Excipients

Description

Ceratonia occurs as a yellow-green or white colored powder. Although odorless and tasteless in the dry powder form, ceratonia acquires a leguminous taste when boiled in water.

UNII

V4716MY704

Chemical Name

Carob gum

CAS Number

9000-40-2

Synonyms

Algaroba; carob bean gum; carob flour; ceratonia gum; ceratonia siliqua; ceratonia siliqua gum; Cheshire gum; E410; gomme de caroube; locust bean gum; Meyprofleur; St John’s bread

Administration route

Oral

Dosage Form

oral tablet

Stability and Storage Conditions

The bulk material should be stored in a well-closed container in a cool, dry place. Ceratonia loses not more than 15% of its weight on drying.

Source and Preparation

Ceratonia is a naturally occurring material obtained from the ground endosperms separated from the seeds of the locust bean tree, Ceratonia siliqua (Leguminosae). The tree is indigenous to southern Europe and the Mediterranean region.

Applications

Ceratonia is a naturally occurring material generally used as a substitute for tragacanth or other similar gums. A ceratonia mucilage that is slightly more viscous than tragacanth mucilage may be prepared by boiling 1.0-1.5% of powdered ceratonia with water. As a viscosity-increasing agent, ceratonia is said to be five times as effective as starch and twice as effective as tragacanth. Ceratonia has also been used as a tablet binder and is used in oral controlled-release drug delivery systems approved in Europe and the USA. Ceratonia is widely used as a binder, thickening agent, and stabilizing agent in the cosmetics and food industry. In foods, 0.15-0.75% is used. Therapeutically, ceratonia mucilage is used orally in adults and children to regulate intestinal function.

Safety

Ceratonia is generally regarded as an essentially noncarcinogenic, nontoxic and nonirritant material. Therapeutically, it has been used in oral formulations for the control of vomiting and diarrhea in adults and children; 20-40 g daily in adults has been used dispersed in liquid. As an excipient, ceratonia is used in oral controlledrelease formulations approved in Europe and the USA. Ceratonia is also widely used in food products. The WHO has not specified an acceptable total daily intake for ceratonia as the total daily intake arising from its use at the levels necessary to achieve the desired effect, and from its acceptable background in food, was not considered to represent a hazard to health.Ceratonia hypersensitivity has been reported, in a single case report, in an infant. However, ceratonia is said to be nonallergenic in children with known allergy to peanuts. LD50 (hamster, oral): 10.0 g/kg LD50 (mouse, oral): 13.0 g/kg LD50 (rabbit, oral): 9.1 g/kg LD50 (rat, oral): 13.0 g/kg

Incompatibilities

The viscosity of xanthan gum solutions is increased in the presence of ceratonia. This interaction is used synergistically in controlledrelease drug delivery systems.