Mannitol-Containing Pellets are pharmaceutical excipient-based multiparticulate pellets in which D-mannitol is incorporated as one component of the pellet formulation. Unlike a pure Mannitol Pellet, the term “Mannitol-Containing” does not establish that mannitol is the major or only component. The actual mannitol percentage must therefore be defined by the finished formulation.
D-Mannitol has CAS 69-65-8, molecular formula C₆H₁₄O₆, and molecular weight 182.17 g/mol. The current USP-NF monograph specifies 97.0%–102.0% mannitol on a dried basis for the mannitol excipient itself.
Mannitol can be incorporated into pellet formulations together with other pharmaceutical excipients. Published research has evaluated mannitol-containing pellets prepared by extrusion-spheronization and demonstrated that changing the mannitol proportion can affect pellet properties and release behavior.
Mannitol-Containing Pellets can be considered for:
The finished characteristics depend on the mannitol percentage, other excipients, binder system, pelletization process and intended application.
Mannitol-containing pellet formulations have been investigated using extrusion-spheronization, with changes in mannitol content influencing pellet morphology, mechanical properties and release characteristics.
Therefore, the final pellet specification should be established for the actual formulation rather than applying the specification of pure mannitol to the complete pellet.
Mannitol-Containing Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Mannitol loading, pellet size, 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% – 103.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Water Content | NMT 0.5% |
| Specific Rotation | +23° to +25 |
| Melting Point | 165–170° |