Corn Starch-Based Coated Pellets are pharmaceutical-grade excipient-based multiparticulate pellets in which corn starch forms an important part of the pellet core and a suitable coating system is applied to the pellet surface. These pellets can be developed for pharmaceutical coating, layering and oral multiparticulate formulation applications.
Corn starch is used in pharmaceutical pellet cores and can provide a suitable substrate for subsequent coating processes. Published pharmaceutical research has demonstrated the use of corn starch-based pellets and the application of enteric or release-controlling coatings to pellet cores.
The properties of coated pellets depend on the core composition, particle size, porosity, mechanical strength, coating material and coating level. These parameters influence coating uniformity and the final release characteristics of the formulation.
Corn Starch-Based Coated Pellets can be considered for:
Corn starch pellets are commercially described as cores for enteric-coated, sustained-release and controlled-release pellet manufacturing.
Corn starch has CAS Number 9005-25-8 and is a polymeric starch material represented by (C₆H₁₀O₅)n. Pharmaceutical research has specifically evaluated corn starch and waxy corn starch in pellet manufacturing, including their influence on pellet structure and release characteristics.
For Corn Starch-Based Coated Pellets, the finished product contains both a pellet core and a coating system. Therefore, finished-product quality should be assessed using product-specific parameters such as particle-size distribution, coating uniformity, moisture, mechanical properties and applicable release testing.
Corn Starch-Based Coated Pellets can be supplied according to the required particle size, coating specification, quantity, packaging configuration and applicable product specification. Packaging should provide suitable protection against moisture and environmental exposure.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |