Dextrose-Based Coated Pellets are pharmaceutical excipient-based multiparticulate pellets developed using dextrose as a principal pellet-forming component and subsequently coated with a suitable functional or protective coating system. Dextrose may be present as dextrose monohydrate or anhydrous dextrose, and the final pellet composition depends on the intended formulation and coating process. USP identifies dextrose as either the monohydrate or anhydrous form, with an assay requirement of 97.5%–102.0% calculated on the anhydrous basis.
The coated multiparticulate structure can provide a uniform platform for further pharmaceutical formulation development. Depending on the coating material and coating level, coated pellets can be designed for protective coating, modified release, delayed release, or other formulation-specific release requirements. Published pellet technology demonstrates that polymer coatings can be applied to pellet cores to modify release characteristics.
Dextrose-based pellet systems can be manufactured for applications including capsule filling, multiparticulate oral formulations, formulation development and other pharmaceutical manufacturing requirements.
Dextrose-Based Coated Pellets can be considered for:
Dextrose pellet cores have also been described in published pharmaceutical research involving polymer-coated pellet systems.
The final characteristics of Dextrose-Based Coated Pellets depend on the dextrose form, pellet composition, binder system, coating polymer, coating weight gain, pellet size and manufacturing process. Therefore, coating thickness, coating weight gain, release profile and finished-pellet assay should be treated as product-specific parameters rather than universal specifications.
Dextrose-Based Coated Pellets can be supplied in packaging configurations suitable for pharmaceutical manufacturing and bulk formulation requirements. Pellet size, coating system, composition, packaging quantity and finished-product specifications should be confirmed against the applicable product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.5%–102.0% |
| Loss on Drying | NMT 5.0% |
| Residue on Ignition | NMT 0.5% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |