Microcrystalline Cellulose-Based Coated Pellets are pharmaceutical excipient-based multiparticulate systems formulated using microcrystalline cellulose (MCC) as a principal pellet-forming component and subsequently provided with a suitable coating. MCC is a purified, partially depolymerized cellulose material widely used as a pharmaceutical excipient and as a pellet-core material.
Microcrystalline cellulose is identified by CAS Number 9004-34-6 and has the polymeric formula (C₆H₁₀O₅)n. Because MCC is polymeric, it does not have a single fixed molecular weight like a small-molecule ingredient. Pharmacopoeial MCC specifications include identification, degree of polymerization, loss on drying, residue on ignition and pH-related requirements.
MCC-based starter pellets are commercially used as cores for subsequent coating and layering. Commercial pellet grades are available in controlled particle-size fractions, making them suitable for multiparticulate formulation development.
The coating system for Microcrystalline Cellulose-Based Coated Pellets is formulation-specific. Coating material, coating level, coating thickness and release characteristics should be selected according to the intended pharmaceutical application.
Microcrystalline Cellulose-Based Coated Pellets can be considered for:
The final characteristics depend on the MCC grade, pellet composition, pellet size, coating polymer, coating weight gain and manufacturing process.
Commercial MCC starter-pellet grades demonstrate controlled particle-size distributions, including ranges such as 100–200 µm, 150–300 µm, 200–355 µm, 350–500 µm, 500–710 µm, 700–1000 µm and 1000–1400 µm. These are commercial reference grades and should not be presented as universal SDP specifications.
Microcrystalline Cellulose-Based Coated Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Pellet size, MCC composition, coating material, 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) | 100.0% |
| Loss on Drying | NMT 7.0% |
| Residue on Ignition | NMT 0.2% |
| pH (1% Solution) | 5.0–7.5 |
| Water Content | NMT 7.0% |