Corn Starch-Containing Pellets are pharmaceutical-grade excipient-based multiparticulate pellets containing corn starch as one of the formulation components. They can be developed for pellet-core applications, coating, layering and pharmaceutical multiparticulate formulation processes.
Corn starch is a widely used pharmaceutical excipient and can function as a filler, binder or disintegrant depending on the formulation. In pelletization, starch may be combined with other excipients to obtain the required pellet shape, mechanical strength, porosity and processing characteristics.
The properties of Corn Starch-Containing Pellets depend on the corn starch proportion, additional excipients, pelletization process, particle size and intended application. Therefore, the exact composition and finished-product specifications should be controlled according to the applicable product specification.
Corn Starch-Containing Pellets can be considered for:
Corn starch has CAS Number 9005-25-8 and is a polymeric carbohydrate represented by (C₆H₁₀O₅)n. Because this product is a corn-starch-containing formulation, rather than pure Corn Starch Pellets, the final composition can contain additional excipients.
Published pharmaceutical pellet information reports corn-starch pellet products with starch content above 95%, LOD not more than 6.0%, sulphated ash not more than 0.6%, heavy metals not more than 10 ppm and pH 4.0–7.0. These values can be used as a reference for a corn-starch pellet system, but should only be entered as SDP specifications when they match the actual SDP product specification or COA.
Corn Starch-Containing Pellets can be supplied according to the required composition, particle-size range, quantity, packaging configuration and applicable product specification. Appropriate 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% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0–7.0 |
| Water Content | NMT 6.0% |