Microcrystalline Cellulose-Coated Pellets are pharmaceutical excipient-based multiparticulate pellets in which microcrystalline cellulose (MCC) forms the pellet core or principal pellet component and the pellets are subsequently coated with a suitable coating system.
MCC is a partially depolymerized cellulose material used as a pharmaceutical excipient. It has CAS Number 9004-34-6 and polymeric formula (C₆H₁₀O₅)n. The International Pharmacopoeia describes MCC as practically insoluble in water and most organic solvents and specifies a pH range of 5.0–7.5, loss on drying of NMT 6.0%, sulfated ash of NMT 0.1%, and heavy metals of NMT 10 ppm for the MCC material.
Commercial MCC starter pellets are available as highly spherical cores in different size fractions, including 100–200 µm, 150–300 µm, 200–355 µm, 350–500 µm, 500–710 µm, 700–1000 µm and 1000–1400 µm. These cores can subsequently undergo coating or layering processes.
For Microcrystalline Cellulose-Coated Pellets, the coating material, coating weight gain, coating thickness and final performance are product-specific. These parameters should be established according to the actual formulation rather than assigning a generic value.
Microcrystalline Cellulose-Coated Pellets can be considered for:
The final characteristics depend on the MCC grade, core size, coating material, coating level, coating process and intended formulation.
Commercial MCC starter pellets are reported to have high sphericity and low friability, with commercial particle-size classes extending from approximately 100 µm to 1400 µm.
Microcrystalline Cellulose-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) | 95.0% – 105.0% |
| Loss on Drying | NMT 6.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.0–7.5 |
| Water Content | NMT 0.20% |