Corn Starch-Coated Pellets are pharmaceutical-grade excipient-based multiparticulate pellets incorporating corn starch within the pellet system and a coating layer designed according to the intended formulation application. They can be used in pellet coating, layering and oral multiparticulate formulation development.
Corn starch is a pharmaceutical excipient commonly used in solid oral formulation development. Starch-based pellet systems can be used as cores for subsequent coating processes, including enteric and release-modifying coating applications where required.
The performance of coated pellets depends on the pellet-core composition, particle size, coating material, coating level, coating uniformity and processing conditions. Therefore, the final specifications should be established according to the particular Corn Starch-Coated Pellets product.
Corn Starch-Coated Pellets can be considered for:
Corn starch is represented by (C₆H₁₀O₅)n and has CAS Number 9005-25-8. It is a polymeric carbohydrate material rather than a single low-molecular-weight compound.
For Corn Starch-Coated Pellets, the finished product should be evaluated using both core/excipient quality parameters and coating-related characteristics. Coating weight gain, coating uniformity and release performance are formulation-specific and should not be assigned universal numerical values without an approved product specification.
Corn Starch-Coated Pellets can be supplied according to the required particle-size range, coating requirements, quantity, packaging configuration and applicable product specification. Suitable packaging should protect the pellets from moisture and environmental exposure.
| 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% |
| pH (1% Solution) | 4.0–7.0 |
| Water Content | NMT 6.0% |