International Numbering System (INS) for Food Additives 1400
Food additives Europe numbers: E1400
Functional Category
Stiffening agent; suspending agent; tablet binder; tablet and capsule diluent.
Applications in Pharmaceutical Formulation
Dextrin is a dextrose polymer used as an adhesive and stiffening agent for surgical dressings. It is also used as a tablet and capsule diluent; as a binder for tablet granulation; as a sugar-coating ingredient that serves as a plasticizer and adhesive; and as a thickening agent for suspensions. Additionally, dextrin has been used as a source of carbohydrate by people with special dietary requirements because it has a low electrolyte content and is free of lactose and sucrose.(1) Dextrin is also used in cosmetics.
Description
Dextrin is partially hydrolyzed maize (corn), potato or cassava starch. It is a white, pale yellow or brown-colored powder with a slight characteristic odor
Stability and Storage Conditions
Physical characteristics of dextrin may vary slightly depending on the method of manufacture and on the source material. In aqueous solutions, dextrin molecules tend to aggregate as density, temperature, pH, or other characteristics change. An increase in viscosity is caused by gelation or retrogradation as dextrin solutions age, and is particularly noticeable in the less-soluble maize starch dextrins. Dextrin solutions are thixotropic, becoming less viscous when sheared but changing to a soft paste or gel when allowed to stand. However, acids that are present in dextrin as residues from manufacturing can cause further hydrolysis, which results in a gradual thinning of solutions. Residual acid, often found in lesssoluble dextrins such as pyrodextrin, will also cause a reduction in viscosity during dry storage. To eliminate these problems, dextrin manufacturers neutralize dextrins of low solubility with ammonia or sodium carbonate in the cooling vessel. The bulk material should be stored in a well-closed container in a cool, dry place.
Incompatibilities
Incompatible with strong oxidizing agents.
Safety
Dextrin is generally regarded as a nontoxic and nonirritant material at the levels employed as an excipient. Larger quantities are used as a dietary supplement without adverse effects, although ingestion of very large quantities may be harmful. LD50 (mouse, IV): 0.35 g/kg(2)