Functional Category
Coating agent; extended-release agent; tablet binder.
Applications in Pharmaceutical Formulation
Zein is used as a tablet binder in wet-granulation processes or as a tablet-coating agent mainly as a replacement for shellac. It is used primarily as an enteric-coating agent or in extended-release oral tablet formulations and other delivery systems.(1–3) Zein is also used in food applications as a coating agent.
Description
Zein is a prolamin obtained from corn (Zea mays Linne´ (Fam. Gramineae)). It occurs as a granular, straw- to pale yellow-colored amorphous powder or fine flakes and has a characteristic odor and bland taste.
Stability and Storage Conditions
Zein should be stored in an airtight container, in a cool, dry place. It has not been reported to polymerize.(4,5
Incompatibilities
Incompatible with oxidizing agents.
Safety
Zein is used in oral pharmaceutical formulations and food products, and is generally regarded as an essentially nontoxic and nonirritant material at the levels employed as an excipient. However, it may be harmful if ingested in large quantities. See also Section 18.