Starch-Based Coated Pellets are pharmaceutical excipient-based multiparticulate pellets prepared using starch as a principal pellet-forming component and subsequently covered with a suitable coating system. The coated format provides a platform for further pharmaceutical formulation development, capsule filling, layering and functional coating applications.
Starch is a naturally derived carbohydrate polymer represented by CAS 9005-25-8 and the polymeric formula (C₆H₁₀O₅)n. Because starch is a polymeric material, it does not have one fixed molecular weight.
Commercial pharmaceutical starch pellets are available as white spherical pellets. A current commercial reference specifies a typical particle-size range of 0.30–1.50 mm, bulk density of 0.40–0.60 g/mL, tapped density of 0.60–0.80 g/mL, moisture NMT 5.0%, pH 5.0–7.0 and ash NMT 0.5%. These values describe the pellet core reference and should not automatically be treated as the specifications of SDP's coated product.
The coating system, coating weight gain, coating thickness, coating uniformity and final release characteristics are product- and formulation-specific. They should therefore be established separately from the starch-pellet core specifications.
Starch-Based Coated Pellets can be considered for:
The final characteristics depend on the starch source, pelletization process, pellet size, coating material, coating level and formulation design.
A commercial starch-pellet reference identifies the pellets as white spherical particles and 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.
For coated pellets, additional controls should include:
These parameters should not be assigned numerical values without the actual SDP finished-product specification.
Starch-Based Coated Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Starch composition, pellet size, coating system, coating weight gain, moisture, density 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) | 97.0% – 103.0% |
| 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% |