Microcrystalline Cellulose (MCC) — Practical Guide for Pharma, Food and Industrial Buyers
Overview
Microcrystalline cellulose (MCC, CAS 9004‑34‑6) is a purified, partially depolymerized cellulose widely used as a binder, filler/diluent, disintegrant and anti‑caking agent across pharmaceuticals, food, cosmetics and industrial formulations. Its combination of compressibility, porosity and particle‑size–dependent flow behavior makes grade selection (for example PH‑101 vs PH‑102) a critical decision for tablet manufacture, capsule filling and powder handling operations.
Key physicochemical considerations
- Critical attributes: particle size distribution (D50/D90), bulk and tapped density, loss on drying (LOD), porosity/specific surface area, and flowability. These drive die fill, compression behavior and dissolution.
- Typical commercial grades: PH‑101 (finer, ~45–60 μm; higher compressibility) and PH‑102 (coarser/agglomerated, ~80–120 μm; improved flow). Specialty grades (PH‑103, PH‑200/300 families) provide tailored moisture content or porosity for sensitive APIs.
Quick grade comparison
| Grade | Typical median particle size | Bulk density (g/mL) | Typical use |
|---|---|---|---|
| PH‑101 | ~45–60 μm | 0.20–0.35 | Direct compression where high tablet hardness is required |
| PH‑102 | ~80–120 μm | 0.30–0.45 | When flowability and uniform die fill are limiting |
Practical formulation guidance
- Use PH‑101 when compaction and interparticle bonding are primary objectives; use PH‑102 where powder flow and fill uniformity dominate process performance. Pilot trials are essential — small changes in API particle size or lubricant level can alter outcomes.
- Lubricant management: magnesium stearate coats MCC surfaces quickly; over‑lubrication reduces bonding and can slow tablet disintegration. Control mixing times and lubricant percentage strictly.
- Wet granulation: if capping or lamination occurs with direct compression, consider wet granulation or selecting a grade with higher porosity.
Procurement, QC and COA checklist
When sourcing MCC, require a Certificate of Analysis (COA) that at minimum includes:
- Identity (IR spectrum), loss on drying, sulfated ash
- Heavy metals specification (Pb, As, Cd, Hg) with test results and limits
- Microbial limits (TAMC/TYMC) and absence of specified pathogens
- Particle‑size distribution (D50/D90), bulk/tapped density
- Lot number, manufacturing date, origin and packaging details
Packaging is typically 20 kg woven bags; request sample lots and full COA before awarding production orders.
Storage and handling
Store sealed in a cool, dry environment (recommended <30% RH) to avoid moisture uptake that degrades compressibility. After opening, repack promptly and minimize exposure to humidity. Standard hygienic handling, dust control and EHS precautions apply.
Common formulation troubleshooting
- Poor flow or segregation: often caused by a very fine grade or electrostatic powders — switch to PH‑102 or add a small amount of glidant (colloidal silica).
- Low tablet hardness: check for over‑lubrication and evaluate PH‑101 or slightly higher compression forces.
- Slow disintegration: consider reducing lubricant, increasing porosity, or including a superdisintegrant.
Regulatory and safety notes
MCC is widely accepted for food and pharmaceutical use. EFSA’s re‑evaluation of celluloses concluded “ADI not specified” for many cellulose additives, supporting broad acceptance in food applications; for pharmaceuticals, USP/Ph. Eur. monographs define identity, LOD, particle‑size and impurity limits. Always confirm compliance with the compendial monograph required by the finished product market.
Selecting a supplier
Choose suppliers that provide complete COAs, traceability, GMP‑capable manufacturing, and audited quality systems (ISO9001, HACCP/HALAL/Kosher where relevant). Request technical datasheets and production samples for pilot runs; ask for audit reports if you plan long‑term sourcing.
Conclusion and next step
When grade, moisture control and QC are managed, MCC is a low‑risk, high‑utility excipient for tablets, capsules, food and cosmetics. To evaluate suitability, request samples, a full COA and technical support from your supplier. For sample requests and technical specifications, Shandong Shine Health can provide GMP‑capable MCC grades and COA support — email info@sdshinehealth.com.
References
Younes M., Aggett P., et al. (2018). Re‑evaluation of celluloses (E460 series). EFSA Journal. https://doi.org/10.2903/J.EFSA.2018.5047
Saigal N., Baboota S., Ahuja A., Ali J. (2009). Microcrystalline Cellulose as a Versatile Excipient. Journal of Young Pharmacists.
Chaerunisa A.Y., Sriwidodo S., Abdassah M. (2019). Microcrystalline Cellulose as Pharmaceutical Excipient. Pharmaceutical Formulation Design - Recent Practices. https://doi.org/10.5772/intechopen.88092
FDA EAFUS entry for microcrystalline cellulose: https://hfpappexternal.fda.gov/scripts/fdcc/index.cfm?id=CELLULOSEMICROCRYSTALLINE
Shandong Shine Health product and technical pages: https://www.sdshinehealth.com/microcrystalline/
Nissa R.C., Abdullah A.H.D. et al. (2023). Characterization of MCC from alternative sources. IOP Conf. Series: Earth and Environmental Science. https://doi.org/10.1088/1755-1315/1201/1/012101
