WEI MING PHARMACEUTICAL MFG. CO., LTD.

Cyclocel Microcrystalline Cellulose

Microcrystalline cellulose (MCC) is a versatile pharmaceutical and food aid. It is derived from a special grade of purified alpha wood cellulose by severe acid hydrolysis to remove the amorphous cellulose portions, yielding particles consisting of bundle of needle-like microcrystals. MCC is a white, odorless, tasteless, free-flowing powder that is relatively free from organic and inorganic contaminants.

Features of MCC
excellent compressibility rapid disintegration free flowing freedom from chemical reaction with all other ingredients good moisture stability excellent in absorbing water, oil and solvents excellent initial color and long-term stability excellent microbiological qualities

Pharmaceutical & Health Food Uses of Microcrystalline Cellulose

Microcrystalline cellulose is a product designed primarily for pharmaceutical solid dosage formulation Tableting with MCC The suitability of MCC for tableting operations is proven by the numbers and variety of functions it can perform: __Direct Compression ___ binder Lubricant Disintegrant filler flow aid __________Wet Granulation __ _________ Binder Permits fast addition Rapid wicking action of granulation fluid

Encapsulation with MCC The newer technology for manufacturing capsule dosage forms has created another area for the application of MCC. As a binder, MCC is especially useful in formulations which are compressed before insertion into the hard gelatin capsule. Drying or Absorbing Agent MCC can be used to dry or absorb active ingredients that are viscous or oily to produce relatively free-flowing forms.


WEI MING PHARMACEUTICAL MFG. CO., LTD. Tableting Uses of Microcrystalline Cellulose
IN DIRECT COMPRESSION Microcrystalline cellulose can be used in all methods of tableting, it is most effectively used in direct compression. Performance of MCC in direct compression: Dry Binder Disintegrant Co-lubricant Free Flowing Whiteness High hardness level, low friability, excellent compression Promotes rapid disintegration and dissolution. Aid to dry lubrication Efficient dry blending of ingredients, enable direct compression of many formulations Tablets of superior whiteness and color stability.

The amount of MCC used in direct compression tableting depends on the flow and compression characteristics of the other formulations ingredients. Normally, about 20 percent of the formulation is MCC, but the range is from 10 to 50 percent. IN WET GRANULATION MCC often added to both the dried granulation before compression and to the wet mass. MCC is used by the amount of 10~30% of the formulations. IN SLUGGING METHOD Generally, 20 percent or less of MCC is used. It is normally added into dried granulation before compression, but in some formulation it is beneficial to add a small percentage.

Food Uses of Microcrystalline Cellulose

Tableting binder Micro Dispersant Hydration aid Carrier Cellulose Component Anti-caking agent Quick Drying Non-Nutritive Bulking Emulsion Stabilizer Disintegrant Texture Modification Heat Stabilizer

Application : Beverages, Sauces, Salad Dressing, High Fiber Beverages, Frozen Dairy Desserts, Canned Food.


WEI MING PHARMACEUTICAL MFG. CO., LTD. Grades of Microcrystalline Cellulose
ALL GRADES of MCC have good compressibility and disintegration. The detailed application as below: 101 standard grade and most widely used, especially for wet granulation 102 better flowability than 101, good for direct compression. 200 bigger particle size than 102, better flowability than 102, good for direct compression 301 same particle size as 101, but better flowability and higher bulk density 302 same particle size as 102, but better flowability and higher bulk density L-101 very low bulk density, super compactible dry binder, excellent loading capacity Average Particle Particle Size Size () Specification ________________ ________________ ________________ + 60 mesh 1.0% 101 50 + 200 mesh30.0% + 60 mesh 8.0% 102 100 + 200 mesh45.0% +60 mesh10.0% 200 180 +100mesh50.0% + 60 mesh 1.0% 301 50 + 200 mesh30.0% + 60 mesh 8.0% 302 100 + 200 mesh45.0% + 60 mesh 0.5% L-101 50 + 100 mesh5.0%

Grade

Bulk Density (g/ml) _______________ 0.26~0.31 0.28~0.33 0.29~0.36 0.34~0.45 0.35~0.46 0.13~0.23

+200 mesh 5-30% Bulk density determined with JAPAN Tsutsui A.B.D. powder tester All the specifications are according to Pharm. Eur 4.7 and USP 26 - N.F. 21.

REMARK:
The information contained in this bulletin is correct to the best of our knowledge. The recommendations or suggestions herein are made without guarantee or representation as to result, since the conditions of use are beyond our control. We suggest that you evaluate the recommendations contained in this bulletin in your own laboratory prior to use. No statement is to be construed as violating any copyright or patent. They are intended only as a source of information.