Microcrystalline Cellulose (MCC) is white powder, insoluble in organic solvents or oil, can be partially soluble in alkaline solution, swell and absorbs water 2-3 times, oil 1.1-1.4 times of its own volume. As an excipient for tablet, MCC is highly porous particle, easy to transform and accommodate pharmaceutical ingredients. It has good bonding property in dry form and disintegration property, can be used in hard tablets. MCC also can be used in food additives.
Comply with USP, EP and CP.
| Appearance | – | White or quasi-white powder |
| Odour | – | Odourless and tasteless |
| pH | – | 5.0-7.5 |
| Water Soluble Substances | % | ≤0.25 |
| Loss on drying | % | ≤5.0 |
| Residue on ignition | % | ≤0.1 |
| Conductivity | ppm | ≤75us/cm |
| Ether-Soluble Substances | % | ≤0.05 |
| Heavy metals | ppm | ≤10 |
| Specification | Pellet Diameter (μm) | Loss on drying (<%) | Bulk density (g/ml) |
| PH-101 | 50 | 5% | 0.29 |
| PH-102 | 90 | 5% | 0.29 |
Features:
(1) The most significant characteristic of microcrystalline cellulose in solid dosage forms is its high compressibility. Compared to other solid pharmaceutical excipients, this is due to the hydrogen bonds between microcrystalline cellulose molecules. Under pressure, these hydrogen bonds form associations, thereby conferring high compressibility and enhancing tablet hardness. Consequently, it is frequently employed as a dry binder. Simultaneously, when compressed tablets encounter liquids, moisture rapidly penetrates the microcrystalline cellulose-containing tablet interior, causing the hydrogen bonds to break instantly. This property also renders it suitable as a disintegrant. Thus, it is extensively utilised in tablet manufacturing.
(2) Microcrystalline cellulose exhibits high water absorption capacity. On the one hand, this property facilitates superior slurry absorption during wet granulation, affording ample scope for binders/wetting agents or the incorporation of additional functional excipients within the binder formulation, thereby enhancing process controllability. On the other hand, its excellent wettability improves uniformity of material wetting in wet granulation processes, consequently benefiting both granule uniformity and the consistency of final product content.
(3) Microcrystalline cellulose, being insoluble in water, exhibits a ‘settling phenomenon’ during dissolution, wherein microcrystals accumulate at the bottom of the dissolution vessel during the latter stages. This leads to incomplete API release. Consequently, for poorly soluble drugs, the recommended microcrystalline proportion should generally not exceed 30%. Should settling occur, the microcrystalline proportion may be reduced, or the dissolution speed increased (50–75 rpm).
