Mannitol-Based Coated Pellets are pharmaceutical excipient-based multiparticulate systems prepared using D-mannitol as the principal pellet-forming component and subsequently processed with a suitable coating system. Mannitol is a water-soluble polyol used as a pharmaceutical excipient and can be incorporated into pellet cores intended for further coating, layering and multiparticulate formulation development.
D-Mannitol has CAS 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. These values describe the mannitol component and should not automatically be treated as specifications for the complete coated-pellet formulation.
The coating system can be selected according to the intended formulation requirement. Depending on the coating material and process, coated pellets may be developed for protective coating, functional coating or formulation-specific release characteristics. Final coating weight gain, coating thickness, pellet size and release performance are product-specific.
Mannitol-Based Coated Pellets can be considered for:
The final characteristics depend on the mannitol grade, pellet composition, binder system, coating material, coating level and manufacturing process.
Finished-product parameters such as particle-size distribution, moisture, bulk density, friability, coating weight gain, coating thickness and release profile should therefore be controlled according to the applicable product specification.
Mannitol-Based Coated Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Pellet size, coating system, coating weight gain, 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% |
| Specific Rotation | +137° to +145° |
| Melting Point | 164–169°C |