Mannitol-Based Pellets are pharmaceutical excipient-based multiparticulate pellets formulated using D-mannitol as a principal pellet-forming component. Mannitol is a polyol excipient with good water solubility and is used in pharmaceutical formulation systems where a soluble, sugar-free pellet core is required.
D-Mannitol has CAS Number 69-65-8, molecular formula C₆H₁₄O₆, and molecular weight 182.17 g/mol. The USP-NF specification for mannitol is 97.0%–102.0% on a dried basis. This is the specification for the mannitol excipient and should not automatically be considered the assay of a finished Mannitol-Based Pellet formulation.
Mannitol-Based Pellets can be developed as pellet cores for pharmaceutical formulation, further coating, active-ingredient layering and multiparticulate dosage-form applications. The final composition and physical characteristics depend on the selected mannitol grade, pelletization process and other formulation components.
Mannitol-Based Pellets can be considered for:
The final characteristics of Mannitol-Based Pellets depend on the mannitol content, additional excipients, binder system, pelletization process and intended application.
Important finished-pellet parameters such as pellet size, bulk density, moisture, friability, mechanical strength and surface characteristics should therefore be established according to the actual product specification.
Mannitol-Based Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Pellet size, composition, mannitol loading, 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 3.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 3.0% |
| Melting Point | 164–169°C |