Key Benefits & Why Formulators Choose NBE SANCEL® Silicified Microcrystalline Cellulose (SMCC)
Enhanced Flowability:
The colloidal SiO2 coating reduces inter-particle friction and cohesion, delivering better flow than standard MCC — especially critical for sticky or cohesive APIs.
Superior Compactibility:
SMCC demonstrates higher tensile strength tablets at equivalent compression forces compared to plain MCC, enabling harder tablets or reduced tablet weight.
Improved Lubrication Sensitivity:
SMCC maintains compactibility even in the presence of magnesium stearate, overcoming one of the biggest challenges in direct compression formulation.
Moisture Buffering:
The silicon dioxide component reduces moisture sensitivity, making SMCC ideal for moisture-sensitive active pharmaceutical ingredients.
Better API Distribution:
The uniform particle structure of SMCC promotes even API distribution throughout the tablet matrix.
Single-Step Advantage:
Replaces separate MCC + glidant additions, simplifying the formulation and reducing the number of excipients.
Pharmacopeial Specifications
| Parameters | I.P. | B.P. / Ph.Eur. | U.S.P. – N.F. |
|---|---|---|---|
| Appearance | White or almost White, Fine or Granular Powder | ||
| Odour | Odourless | N.A. | N.A. |
| Solubility | N.A. | Comply | N.A. |
| Identification | A+B+C | Comply | A+B |
| pH Value | 5.0 to 7.5 | 5.0 to 7.5 | 5.0 to 7.5 |
| Loss on Drying, % NMT | 6 | 7 | 7 |
| Sulphated Ash, % NMT | 0.20 | 0.10 | 0.10 |
| Assay, % | 97 – 102 | N.A. | N.A. |
| Conductivity, µS / cm, not exceed than water by | N.A. | 75 | 75 |
| Water Soluble substances, % NMT | 0.20 | 0.25 | 0.25 |
| Ether Soluble Substances, % NMT | N.A. | 0.05 | 0.05 |
| Heavy Metals, PPM NMT | 10 | 10 | 10 |
| Arsenic, PPM, NMT | 2 | N.A. | N.A. |
| Starch and Dextrins | Absent | N.A. | N.A. |
| Microbiology Limits | |||
| Total Aerobic Microbial Count, CFU/g, NMT | 1,000 | 1,000 | 1,000 |
| Total Yeast and Mold Count, CFU/g, NMT | 100 | 100 | 100 |
| Pseudomonas Aeruginosa, per g | Absent | Absent | Absent |
| Escherichia Coli, per g | Absent | Absent | Absent |
| Staphylococcus Aureus, per g | Absent | Absent | Absent |
| Salmonella Sp., per 10 g | Absent | Absent | Absent |
Note: This product meets the requirements for Residual Solvents in the United States Pharmacopeia <467> and complies with the ICH Guide Q3C for Residual Solvents.
Storage Conditions: Store Protected from Light and Moisture.
Re-evaluation Date: Four (4) years from date of manufacture, if storage conditions stated above are observed.
| Application | Binder | Compression Agent | Flow Aid | Disintegration and Dissolution Aid | Diluent | Reduces Friability | Facilitates Addition of Granulation Solution | Carrier for Drugs in Liquid Form | Oil Adsorption | Vegetable Extract Carrier | Facilitates Extrusion |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Tablets by Direct Compaction | Y | Y | Y | Y | Y | Y | |||||
| Tablets by Wet Granulation | Y | Y | Y | Y | Y | ||||||
| Capsules (Automatic Machine) | Y | Y | Y | ||||||||
| Capsules (Semi Automatic Machine) | Y | Y | |||||||||
| Granules | Y | Y | Y | Y | Y | Y | Y | Y | Y | ||
| Pellets and Spheres | Y | Y | Y | ||||||||
| API Adsorption | Y | Y | Y | ||||||||
| API Absorption | Y | Y |
| Types of SANCEL™ Microcrystalline Cellulose | SANCEL™ 101 | SANCEL™ 102 | SANCEL™ 112 | SANCEL™ 200 |
|---|---|---|---|---|
| Wet Granulation | Y | Y | ||
| Direct Compaction | Y | Y | Y | |
| Poor Flowing API | Y | Y | ||
| API Adsorption/Absorption | Y | Y | Y | Y |
| Vegetable Extract Adsorption/Absorption | Y | Y | Y | Y |
| Capsules (Automatic Filling) | Y | |||
| Capsules (Semi Automatic Filling) | Y | Y | ||
| Pellet & Spheronization | Y |
| Differential Parameters | SANCEL™ 101 | SANCEL™ 102 | SANCEL™ 112 | SANCEL™ 200 |
|---|---|---|---|---|
| Average Particle Size (Micron) | 50 | 100 | 160 | 180 |
| Weight retained on 60 Mesh (%) | NMT 1 | NMT 8 | NLT 10 | NLT 10 |
| Weight retained on 100 Mesh (%) | – | – | NLT 40 | NLT 50 |
| Weight retained on 200 Mesh (%) | NMT 30 | NLT 45 | – | – |
| Loss on Drying | NMT 7 | NMT 7 | NMT 7 | NMT 7 |
Frequently Asked Questions
What is silicified microcrystalline cellulose (SMCC)?
Silicified Microcrystalline Cellulose (SMCC) is a co-processed excipient made from approximately 98% MCC and 2% colloidal silicon dioxide.
How is SMCC different from a physical mixture of MCC and silicon dioxide?
SMCC is produced by co-processing MCC and colloidal SiO2 during manufacture, creating a uniform, intimate mixture at the particle level.
When should I use SMCC instead of standard MCC?
SMCC is the preferred choice when your API has poor flow properties or requires higher tablet tensile strength.
