Chemistry name: Microcrystalline cellulose; MCC

CAS No.: 9004-34-6

EINECS No.: 232-674-9

Chemical formula:  (C6H10O5)n

Molecular mass: 160.255 g/mol

Definition:

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EXCfiller®Microcrystalline cellulose (MCC) is a white, odourless and tasteless crystalline powder obtained by physicochemical processing of natural cellulose. Its chemical structure consists of linear polysaccharides linked by β-1,4-glucosidic bonds, typically with a degree of polymerisation ranging from 100 to 300 (significantly lower than that of natural cellulose). As a vital, multifunctional food industry additive, MCC serves multiple purposes, including acting as a filler, thickener, stabiliser, disintegrator and fat replacement. It is a quintessential multipurpose additive and excipient in both the food and pharmaceutical industries.

■ Source

EXCfiller®Microcrystalline cellulose is produced from natural, renewable cellulose. Plant materials with a high purity level and a cellulose content of at least 90% are prioritised. Common sources include coniferous woods, such as spruce and pine, and broadleaf woods, such as birch and poplar. These woods have a high cellulose content (92-95%) and low impurity levels. Cotton linters, a by-product of cotton processing, have the highest cellulose purity (95-98%) and are the preferred feedstock for high-end MCC. Agricultural by-products such as wheat straw, corn cobs and sugarcane bagasse can be used as low-cost feedstocks after undergoing delignification and hemicellulose removal processes.

Particularities of EXCfiller®Microcrystalline cellulose:

Product Specifications:

EXCfiller®Microcrystalline cellulose is available in the following specification and contents:

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☑ EXCfiller®Microcrystalline cellulose retained 60 mesh≤1.0%, 200 mesh≤30.0%

Product quality standards:

● USP, EP, BP, CP, Food grade, In-house

EXCfiller®Microcrystalline cellulose Applications:

EXCfiller®Microcrystalline cellulose is one of the most widely used multifunctional excipients in pharmaceutical formulations. It is listed in the Pharmacopoeia of the People's Republic of China (ChP 2020), the United States Pharmacopeia (USP 45-NF 40) and the European Pharmacopoeia (Ph. Eur. 10.0). It is classified as a 'filler, disintegrant and flow aid'. Its key advantages are excellent biocompatibility, stable physicochemical properties, non-sensitising characteristics and direct compressibility. This makes it suitable for various dosage forms, including oral and topical preparations.

Microcrystalline cellulose is primarily used in oral solid dosage forms, such as tablets and capsules. Its functional roles include acting as a bulking agent, disintegrant and flow enhancer. Standard tablets (e.g. vitamin C tablets) use a combination of microcrystalline cellulose (MCC) at 30-50% and lactose at 20-30% for direct compression, achieving a tablet weight variation of ≤±3%. Sustained-release tablets utilise MCC at 40-60%+hydroxypropyl methylcellulose (HPMC) at 10-20%, leveraging MCC's porous structure to absorb drugs and prolong release time. Dispersible tablets use MCC at 15-20% and cross-linked polyvinylpyrrolidone (PVPP) at 5-10%. These tablets have a disintegration time of ≤3 minutes and a dissolution rate of ≥85% after 30 minutes. To prevent localized concentration spikes that could impair disintegration, ensure ≥95% uniformity in mixing with drug powder during processing. For highly adhesive drugs (e.g. traditional Chinese medicine extract tablets), use MCC at 5-8%+micronised silica at 0.5-1% to prevent sticking and cracking during tableting. Suspension formulations, such as oral suspensions and eye drops, are also widely used. The compounding process uses microcrystalline cellulose (MCC) and xanthan gum (0.1-0.3%) together to enhance the stability of the suspension, achieving a sedimentation volume ratio of at least 0.95. Dispersion via high-speed stirring (1500 rpm) is required to prevent agglomeration during the process. For topical formulations such as ointments, gels and suppositories, the formulation uses MCC (3%), Vaseline (20%) and lanolin (5%) to create a W/O emulsion system that remains stable for at least six months when subjected to accelerated testing at 40°C. For gels (e.g. moisturising gels), the formulation combines MCC with 0.5% carbomer and adjusts the pH to 6-7. The resulting gel has a smooth texture with no granular sensation.

​​​​​​​The core application of food-grade microcrystalline cellulose (MCC) lies in its multifunctional versatility. By adjusting parameters such as particle size, crystallinity and degree of polymerisation, it can be adapted to meet the textural, stability and functional requirements of various products, while also aligning with clean label trends (natural origin and residue-free). Its common functions include bulking, thickening, stabilising, disintegrating, replacing fat, and retaining moisture and oil. In health supplements and functional foods such as tablets, capsules, probiotic formulations and meal replacements, microcrystalline cellulose is used as a filler and disintegrant to enhance formability at a concentration of 20%-50%.

■ Production technology characteristics

After pulverising plant materials (such as cotton fibres), refined cellulose with a purity of at least 98% is obtained through alkali cooking to remove lignin and hemicellulose, followed by bleaching using hydrogen peroxide or chlorine dioxide (with a residual bleaching agent of no more than 50 mg/kg). The refined cellulose is then hydrolysed using a dilute hydrochloric acid solution (2-6% concentration) or sulfuric acid at 90-110°C, breaking the glycosidic bonds in the amorphous regions while preserving the crystalline areas (crystallinity ≥70%). An alkaline solution (e.g. sodium hydroxide) is then added to neutralise to a pH of 4-6. Separate by centrifugation, then wash to remove salts and oligosaccharides (conductivity ≤50 μS/cm) and filter. Use spray drying or drum drying at a temperature of ≤120°C to prevent cellulose degradation. Grind the product and pass it through a grading sieve (200-400 mesh) to control the particle size distribution. The finished product must undergo microbial and residual solvent testing to meet food-grade standards.

☑ EXCfiller®Microcrystalline cellulose retained 60 mesh≤8.0%, 200 mesh≥45.0%

☑ EXCfiller®Microcrystalline cellulose retained 120 mesh≤5.0%, 200 mesh≥50.0%