Starch-Coated Pellets are pharmaceutical multiparticulate pellets incorporating a starch-based coating layer over a suitable pellet core. The core and coating system can be selected according to the intended formulation, processing requirements and desired physical characteristics.
Starch is a naturally derived carbohydrate polymer identified by CAS 9005-25-8 and represented by the general formula (C₆H₁₀O₅)n. Because starch is polymeric, it does not have one fixed molecular weight.
Starch-based pellet systems have been studied for pharmaceutical applications, including the use of spherical starch pellets as cores for subsequent coating and formulation processing. Published research also indicates that the surface characteristics of starch-containing pellets can influence their interaction with coating dispersions.
For a Starch-Coated Pellets product, the coating composition, coating level, thickness, uniformity and final performance are formulation-specific. Therefore, these parameters should be controlled according to the actual finished-product specification rather than applying generic numerical values.
Starch-Coated Pellets can be considered for:
Starch-based pellet cores can also be designed for subsequent coating processes, with particle size and surface characteristics influencing coating performance.
The final characteristics of Starch-Coated Pellets depend on:
A commercial pharmaceutical starch-pellet reference reports 0.30–1.50 mm particle size, 0.40–0.60 g/mL bulk density, 0.60–0.80 g/mL tapped density, ≤5.0% moisture, pH 5.0–7.0 and ≤0.5% ash. These are reference values for a starch-pellet product and should not automatically be treated as SDP's finished Starch-Coated Pellets specifications.
Starch-Coated Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Core composition, starch coating composition, coating weight gain, coating thickness, particle size, moisture and packaging configuration should be confirmed against the applicable SDP product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |