Sucrose-Based Coated Pellets are pharmaceutical excipient-based multiparticulate pellets incorporating sucrose as a principal component of the pellet core or coating system and processed with a suitable coating layer. Sucrose-based spherical cores are widely used as starter substrates for subsequent layering and coating in multiparticulate formulations.
Sucrose is identified by CAS 57-50-1, has the molecular formula C₁₂H₂₂O₁₁, and a molecular weight of approximately 342.30 g/mol. Pharmaceutical sugar spheres can contain sucrose together with starch; therefore, the exact composition of a finished sucrose-based pellet should be determined from the applicable product specification rather than assuming a fixed sucrose percentage.
Sucrose-based pellet cores are particularly useful because their spherical geometry and controlled particle-size distribution provide a suitable substrate for subsequent coating and layering processes. Pharmaceutical literature describes sugar spheres as established starter cores for multiparticulate formulations and notes that particle size, sphericity, surface characteristics, density, moisture and friability are important quality attributes.
For Sucrose-Based Coated Pellets, the coating composition, coating weight gain, coating thickness, coating uniformity and final formulation performance are product-specific. These parameters should be established from the actual SDP product specification and should not be assigned unsupported numerical values.
Sucrose-Based Coated Pellets can be considered for:
Sugar spheres are established inert starter cores and can be further processed through layering and coating technologies.
The final characteristics depend on:
Commercial pharmaceutical sugar spheres are available in controlled particle-size grades. However, the exact particle-size range and composition for SDP Sucrose-Based Coated Pellets should be confirmed from the applicable product specification.
Sucrose-Based Coated Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Sucrose composition, pellet size, coating system, coating weight gain, 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) | 62.5–91.5% |
| Loss on Drying | NMT 4.0% |
| Residue on Ignition | NMT 0.25% |
| Heavy Metals | NMT 5 ppm |
| Water Content | NMT 4.0% |