Corn Starch-Based Pellets are pharmaceutical-grade excipient pellets formulated with corn starch as a major pellet-core component. They are used as multiparticulate excipient systems and can serve as starter cores for subsequent coating, layering and formulation processes.
Corn starch is recognized as a pharmaceutical excipient, and starch-based pellets have been investigated for extrusion-spheronization and multiparticulate formulation development. Research has demonstrated the use of corn starch as a pellet-formulation component and cofiller.
Commercial pharmaceutical corn starch pellets are described as pellet cores for enteric-coated, sustained-release and controlled-release pellet manufacturing. A reported commercial specification gives starch content above 95%, with defined limits for loss on drying, sulphated ash, heavy metals and pH.
Corn Starch-Based Pellets can be considered for:
Corn starch consists of starch granules obtained from mature corn. USP-NF recognizes Corn Starch as a pharmaceutical excipient monograph.
Corn starch can also function as a filler/cofiller in pelletization processes. Published research has evaluated ordinary and waxy corn starch in extrusion-spheronization with microcrystalline cellulose.
For finished Corn Starch-Based Pellets, physical and chemical specifications should be established specifically for the pellet product. The commercial pellet specification reported for pharmaceutical corn starch pellets includes starch content >95%, LOD ≤6.0%, sulphated ash ≤0.6%, heavy metals ≤10 ppm and pH 4.0–7.0.
Corn Starch-Based Pellets can be supplied according to the required particle-size range, quantity, packaging configuration and applicable product specification. The material should be stored in tightly closed packaging in a dry environment.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 95.0% |
| Loss on Drying | NMT 6.0% |
| Residue on Ignition | NMT 0.6% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0–7.0 |