Microcrystalline Cellulose (MCC) – Versatile Filler-Binder Excipient for Direct Compression Tablets

1. General Introduction to Microcrystalline Cellulose (MCC)

Microcrystalline Cellulose (MCC) is one of the most widely used pharmaceutical excipients. Owing to its excellent compressibility, good flowability, chemical inertness, and disintegration-enhancing properties, MCC is extensively used in tablets, hard capsules, chewable tablets, orally disintegrating tablets (ODTs), and many other solid dosage forms.

MCC is available in a wide range of grades with different particle sizes and bulk densities, making it suitable for various active pharmaceutical ingredients (APIs) and manufacturing processes:

• MCC 101: Fine particle size, ideal for wet granulation and dry granulation processes.
• MCC 102: Larger particle size with improved flowability, recommended for direct compression.
• MCC 112: Larger particle size with low moisture content, designed for direct compression of formulations containing moisture-sensitive APIs.
• MCC 200: Larger particle size than MCC 102, offering superior flowability, making it ideal for high-speed tableting and high drug-load formulations.

Manufactured under stringent quality control from purified wood pulp to the finished product, ensuring uniform particle size distribution, optimal moisture content, and high purity for consistent performance in pharmaceutical and nutraceutical production.

2. Microcrystalline Cellulose Material Information

• Material Name: Microcrystalline Cellulose (MCC)
• Origin: India
• Material Group: Pharmaceutical Excipient / Food Additive
• Function: Diluent/ Filler, Binder, Disintegrant, Anti-caking agent, and flowability enhancer in tablet and hard capsule formulas.
• Appearance: Fine crystalline powder, porous granules, white or almost white, practically odorless and tasteless.
• Solubility: Practically insoluble in water, dilute acids, and most organic solvents.
• Quality Standards: Complies with strict international pharmacopoeia standards (USP / EP / BP / JP).

Specifically strictly controlled for:

• Particle Size Distribution (PSD): Ensures uniform particle size for optimized blending performance and excellent batch-to-batch consistency.
• Loss on Drying (LOD):Tightly controlled moisture content helps maintain tablet hardness and stability throughout storage.
• Heavy Metals: Strictly controlled to ensure very low levels of inorganic impurities and toxic heavy metals.
• Microbial Limits:Complies with pharmacopeial microbial limit requirements to ensure product safety.

3. Advantages of Microcrystalline Cellulose

• Excellent Compressibility and Tableting Performance: MCC exhibits outstanding compressibility, enabling the production of tablets with high hardness even at low compression forces.
• Low Friability: Its plastic deformation properties produce tablets with excellent mechanical strength and low friability.
• Promotes Rapid Tablet Disintegration: The porous capillary structure facilitates rapid water uptake, allowing the tablet to disintegrate quickly and ensuring optimal drug release.
• Good Flowability:The engineered particle morphology promotes smooth powder flow through the tablet press hopper, ensuring consistent die filling and uniform tablet weight.
• Low Bulk Density: MCC can be incorporated at high concentrations, providing improved powder properties and enhanced tablet performance.
• Excellent Chemical Inertness and Safety: MCC is highly stable, chemically inert toward most active pharmaceutical ingredients (APIs), and minimizes the risk of incompatibilities, contributing to long-term product stability.
• Wide Range of Grades: Available in various particle sizes, bulk densities, and moisture levels to meet diverse formulation and manufacturing requirements.

4. Applications of Microcrystalline Cellulose

In Pharmaceuticals

• Tablets: Filler, binder, disintegration aid, and powder property enhancer.
• Hard capsules:Filler to improve fill weight uniformity.
• Chewable tablets and ODTs: Filler providing a smooth and pleasant mouthfeel.
• Extrusion–Spheronization: Forms a structural framework that promotes the production of spherical pellets with high mechanical strength and a narrow particle size distribution.

In Health Supplements and Food Industry

• Health Supplement Tablets: Used as a safe base and filler for vitamins, minerals, and herbal extracts.
• Food Additive: Acts as an anti-caking agent, stabilizer, emulsifier, and texture improver in processed food products.

5. Commercial Products Utilizing Microcrystalline Cellulose

6. Product Contact Information

To find out more about the supply chain, specifications of Microcrystalline Cellulose (MCC), or to place an order, please contact us:

• Consultation Hotline: +84 (0) 834 560 500
• Email: director@biorichgroup.com
• Website: www.biorichgroup.com
• Sample/COA Request: Please contact us via email to request samples and the latest Certificate of Analysis (COA) of the raw material from the manufacturer.