Dextrose-Loaded Pellets are pharmaceutical excipient-based multiparticulate pellets in which dextrose is intentionally incorporated at a defined loading level within the pellet formulation. The term “loaded” describes the incorporation of dextrose into the pellet matrix and does not by itself establish a particular dextrose concentration.
Dextrose is available as dextrose monohydrate and anhydrous dextrose. USP specifies Dextrose Excipient at 97.5%–102.0% dextrose calculated on an anhydrous basis. Dextrose monohydrate is associated with CAS 77938-63-7, while anhydrous dextrose is CAS 50-99-7.
The finished Dextrose-Loaded Pellet formulation can contain additional excipients required for pellet formation and processing. Consequently, the finished-product assay, moisture, pellet size, density and mechanical properties should be established from the actual formulation specification rather than applying the raw-material specification directly.
Dextrose-Loaded Pellets can be considered for:
The final characteristics depend on the dextrose form, loading level, other excipients, binder system and pelletization process.
Parameters including dextrose loading, moisture, pellet size, bulk density, friability and mechanical strength should therefore be controlled according to the applicable finished-product specification.
Dextrose-Loaded Pellets can be supplied for pharmaceutical formulation and bulk manufacturing requirements. The dextrose loading, pellet size, formulation composition, packaging configuration and applicable quality parameters should be confirmed against the relevant product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |