Mannitol-Loaded Pellets are pharmaceutical excipient-based multiparticulate pellets in which D-mannitol is incorporated at a defined formulation level. The term “loaded” describes the incorporation of mannitol into the pellet system; it does not by itself specify a particular concentration.
D-Mannitol has CAS Number 69-65-8, molecular formula C₆H₁₄O₆, and molecular weight 182.17 g/mol. The USP-NF monograph specifies mannitol at 97.0%–102.0% on a dried basis for the mannitol excipient. This is a raw-material/compendial requirement and should not be presented as the assay of the complete finished pellet.
Mannitol can be incorporated into multiparticulate pellet formulations together with other pharmaceutical excipients. Published formulation research has demonstrated that changing the proportion of mannitol can influence pellet characteristics such as morphology, mechanical properties and release behavior.
Mannitol-Loaded Pellets can be considered for:
The finished characteristics depend on the mannitol loading, other excipients, binder system, pelletization process and intended application.
Consequently, finished-product parameters such as mannitol loading, pellet size, moisture, bulk density, friability and mechanical strength should be established according to the actual product specification.
Mannitol-Loaded Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Mannitol loading, pellet size, formulation composition, packaging configuration 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) | 97.0–102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Water Content | NMT 0.5% |
| Melting Point | 165–170°C |