Dextrose-Containing Pellets are pharmaceutical excipient-based multiparticulate pellets in which dextrose is one component of the pellet formulation. Unlike a pure Dextrose Pellet system, the term “Dextrose-Containing Pellets” does not indicate that the finished pellets consist predominantly of dextrose. The actual dextrose percentage depends on the formulation.
Dextrose is available in both monohydrate and anhydrous forms. USP identifies Dextrose as containing NLT 97.5% and NMT 102.0% dextrose, calculated on the anhydrous basis. Dextrose monohydrate has CAS 77938-63-7, while anhydrous dextrose has CAS 50-99-7.
Because Dextrose-Containing Pellets may contain other excipients, the finished pellet specifications should be based on the actual formulation and manufacturing process. USP also notes that excipient performance characteristics can vary according to formulation and processing conditions.
Dextrose-Containing Pellets can be considered for:
The final characteristics depend on the percentage of dextrose, other excipients, binder system, pelletization process and intended application.
Therefore, parameters such as dextrose loading, moisture, pellet size, bulk density, friability and dissolution/release behavior should be established according to the specific finished-product specification.
Dextrose-Containing Pellets can be supplied for pharmaceutical formulation and bulk manufacturing requirements. Pellet composition, dextrose percentage, particle-size range, packaging quantity and applicable quality specifications should be confirmed against the relevant product specification and COA.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |