Mannitol Pellets are pharmaceutical excipient-based multiparticulate pellets manufactured using D-mannitol as the principal pellet-forming material. Mannitol is a polyol widely used in pharmaceutical formulations and is available as a crystalline, water-soluble excipient. Pharmaceutical mannitol has a well-established compendial profile and can be used as a core material for pellet and multiparticulate formulation development.
Mannitol has the molecular formula C₆H₁₄O₆, molecular weight 182.17 g/mol, and CAS number 69-65-8. The USP-NF monograph specifies mannitol at 97.0%–102.0% on a dried basis.
Mannitol-based starter pellets can provide a sugar-free pellet core for subsequent coating, layering or multiparticulate formulation processes. Commercial pharmaceutical mannitol pellets are available as spherical starter cores with controlled particle-size distributions for downstream processing.
Mannitol Pellets can be considered for:
Published pharmaceutical pellet technology describes mannitol as a suitable excipient for starter pellets/cores, including pellets consisting predominantly of mannitol.
Mannitol Pellets are designed as a particulate excipient platform rather than as a conventional powdered mannitol material. Important finished-pellet properties include particle-size distribution, spherical geometry, moisture, mechanical strength, friability and bulk density.
These parameters should be specified according to the actual pellet grade because raw-material monograph limits do not automatically represent finished Mannitol Pellet specifications.
Mannitol Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Pellet size, particle-size distribution, 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 0.3% |
| Residue on Ignition | NMT 0.1% |
| Specific Rotation | +137° to +145° |
| Melting Point | 164–169°C |