Starch-Based Pellets are pharmaceutical excipient-based multiparticulate pellets in which starch serves as the main pellet-forming or matrix component. Starch is a naturally derived carbohydrate polymer identified by CAS 9005-25-8 and represented by the general formula (C₆H₁₀O₅)n. Its molecular weight is polymeric and variable.
Starch-based pellet systems have been studied using extrusion-spheronization and other pelletization technologies. Research has demonstrated that modified starch can be used as a principal excipient for producing spherical pellets with controlled size, sphericity, friability and disintegration characteristics.
The properties of Starch-Based Pellets depend on the starch type, starch grade, binder system, water level, processing conditions and target particle size. Published research has evaluated corn, pea, potato and waxy-corn starch systems and found that starch type and formulation composition can influence pellet structure and release characteristics.
A current commercial pharmaceutical Starch Pellets specification 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 values are commercial reference values and should not automatically be treated as SDP's own COA specifications.
Starch-Based Pellets can be considered for:
Research has also demonstrated starch-based pellets prepared by extrusion-spheronization and evaluated their sphericity, friability and disintegration characteristics.
The final characteristics of Starch-Based Pellets depend on:
A commercial reference provides the following typical pellet parameters:
Starch-Based Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Starch grade, composition, particle size, moisture, density, packaging configuration and finished-product acceptance criteria 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) | 95.0% – 105.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 0.5% |