Microcrystalline Cellulose-Based Pellets are pharmaceutical excipient-based multiparticulate pellets formulated with microcrystalline cellulose (MCC) as the principal pellet-forming material. MCC is a purified, partially depolymerized cellulose excipient widely used in pharmaceutical pelletization because it can form mechanically stable, spherical pellet cores.
Microcrystalline cellulose is identified by CAS Number 9004-34-6 and has the polymeric formula (C₆H₁₀O₅)n. Because MCC is a polymeric material, it does not have a single fixed molecular weight. Pharmacopoeial specifications include degree of polymerization, loss on drying, pH, residue on ignition and elemental impurity controls.
Commercial MCC-based pellets are available as spherical starter cores. Established commercial grades include 100–200 µm, 150–300 µm, 200–355 µm, 350–500 µm, 500–710 µm, 700–1000 µm and 1000–1400 µm size ranges. These are useful reference ranges for pellet technology but should not automatically be presented as SDP's specifications.
Microcrystalline Cellulose-Based Pellets can be considered for:
MCC-based pellets are particularly useful where spherical geometry, controlled particle size and mechanical integrity are required. Commercial MCC starter pellets demonstrate high sphericity and controlled particle-size distributions.
The actual MCC percentage, pellet size, moisture, bulk density and friability should be established from the specific finished-product specification. A commercial 100% MCC starter-pellet product cannot automatically be treated as the specification for every Microcrystalline Cellulose-Based Pellet.
Microcrystalline Cellulose-Based Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. Pellet size, MCC loading, composition, 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% – 103.0% |
| Loss on Drying | NMT 7.0% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Water Content | NMT 7.0% |