Mannitol-Coated Pellets are pharmaceutical excipient-based multiparticulate pellets in which D-mannitol forms the pellet core or principal pellet component and a suitable coating system is applied to the pellet surface. Mannitol is a water-soluble polyol used as a pharmaceutical excipient and provides a sugar-free alternative to conventional sucrose-based pellet cores. Commercial pharmaceutical mannitol pellets are specifically described as starter cores suitable for layering and functional coating.
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% calculated on the dried basis. This value applies to the mannitol component and should not automatically be used as the assay specification for finished Mannitol-Coated Pellets.
The coating system can be selected according to the intended formulation. Published pharmaceutical research and formulation examples demonstrate the use of mannitol-containing pellet cores with polymeric coatings, including functional coatings designed to modify formulation performance.
Mannitol-Coated Pellets can be considered for:
Mannitol pellet cores are commercially used as platforms for active-ingredient layering and functional coating.
The final characteristics of Mannitol-Coated Pellets depend on the mannitol grade, pellet-core composition, coating polymer, coating level, coating process and intended application.
Important finished-product parameters such as pellet size, moisture, bulk density, friability, coating weight gain, coating thickness and release profile should therefore be established according to the actual product specification.
Mannitol-Coated Pellets can be supplied for pharmaceutical formulation 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 |