Dextrose-Based Pellets are pharmaceutical excipient-based multiparticulate pellets formulated with dextrose as a principal pellet-forming component. Dextrose is available in monohydrate and anhydrous forms, and the choice of form affects moisture content, processing characteristics and the final product specification.
Dextrose monohydrate is recognized as Dextrose Excipient in USP, with the dextrose content specified at 97.5%–102.0% calculated on an anhydrous basis. The finished pellet composition, however, can contain additional excipients or processing materials, so the finished-pellet assay should be controlled according to the applicable product specification rather than automatically using the raw-material assay.
Dextrose-Based Pellets can be considered for pharmaceutical formulation development, multiparticulate oral formulations, capsule-filling applications and other applications where a dextrose-based pellet platform is required.
Dextrose-Based Pellets may be used for:
The characteristics of Dextrose-Based Pellets depend on the dextrose form, formulation composition, binder system, pelletization process and intended application.
Important finished-product parameters such as pellet size, bulk density, moisture, friability, mechanical strength and dextrose loading should therefore be established according to the actual product specification.
Dextrose-Based Pellets can be supplied for pharmaceutical formulation and bulk manufacturing requirements. Packaging configuration, pellet size, composition, dextrose loading and applicable quality specifications should be confirmed against the relevant 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% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Water Content | NMT 5.0% |