Microcrystalline Cellulose-Loaded Pellets are pharmaceutical excipient-based multiparticulate pellets in which microcrystalline cellulose (MCC) is incorporated at a defined level within the pellet formulation. The term “loaded” describes the incorporation of MCC into the formulation and does not by itself indicate a specific MCC concentration.
Microcrystalline cellulose is a purified, partially depolymerized cellulose excipient identified by CAS Number 9004-34-6 and polymeric formula (C₆H₁₀O₅)n. Because MCC is polymeric, it does not have one fixed molecular weight.
The International Pharmacopoeia specifies MCC with a degree of polymerization NMT 350, loss on drying NMT 6.0%, sulfated ash NMT 0.1%, heavy metals NMT 10 ppm and pH 5.0–7.5 under the specified test conditions. These are specifications for MCC itself and should not automatically be transferred to the complete finished pellet.
Microcrystalline Cellulose-Loaded Pellets can be considered for:
The finished characteristics depend on the MCC loading, other excipients, binder system, pelletization process and intended application.
Consequently, MCC loading, pellet size, moisture, bulk density, friability and mechanical strength should be established according to the actual finished-product specification.
Microcrystalline Cellulose-Loaded Pellets can be supplied for pharmaceutical formulation development and bulk manufacturing requirements. MCC loading, pellet size, 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 0.5% |
| Residue on Ignition | NMT 0.1%. |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 0.5% |