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MICRO CRYSTALLINE CELLULOSE POWDER

Micro Crystalline Cellulose is a mechanically disintegrated level of Alpha Cellulose. It comprises purified, de-polymerized, Micro Crystalline sub-micron size colloidal particles. It is produced by treating Alfa Cellulose obtained as a pulp from fibrous plants with minerals acid. As the name implies, Micro Crystalline Cellulose is basically Cellulose and is derived from high quality wood pulp and Cotton Linters. While cellulose is the most abundant organic material, Micro Crystalline Cellulose can only be derived by Hydrolysis from a special grade of Alpha Cellulose.

It is a white to off-white, odorless, tasteless, extra freeflowing powder which is relatively free from organic and non-organic contaminants. It is metabolically inert, stable, and safe and has excellent water absorptive, swelling & dispersion properties, is insoluble in water, dilute acid, in almost all common organic solvents and oils. It is partially soluble in dilute alkali.

Micro Crystalline Cellulose is used as a texturizer, an anti-caking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production.The most common form is used in Pharmaceuticals. It is also used as an alternative to Carboxymethyl Cellulose.
In many ways, cellulose makes the ideal excipient. A naturally occurring polymer, it is composed of glucose units connected by a 1-4 beta glycosidic bond. These linear cellulose chains are bundled together as micro fibril spiraled together in the walls of plant cell. Each microfibril exhibits a high degree of three-dimensional internal bonding resulting in a crystalline structure that is insoluble in water and resistant to reagents. There are, however, relatively weak segments of the microfibril with weaker internal bonding. These are called amorphous regions; some argue that they are more accurately called dislocations, because of the single-phase structure of microfibrils. The crystalline region is isolated to produce Micro Crystalline Cellulose.

Micro Crystalline Cellulose revolutionized tableting because of its unique compressibility and carrying capacity. It exhibits excellent properties as an excipient for solid dosage forms. It compacts well under minimum compression pressures, has high binding capability, and creates tablets that are extremely hard, stable, yet disintegrate rapidly. Other advantages include low friability, inherent lubricity, and the highest dilution potential of all binders. These properties make Micro Crystalline Cellulose particularly valuable as a filler and binder for formulations prepared by direct compression, though it also is used in wet or dry granulation and for pelletisation.Micro Crystalline Cellulose Powder has found extensive use as an excipient and diluent. It has replaced competitive products because of its uniqueness. For instance – In tableting, Starch is a good disintegrator but a poor binder, Lactose is a good binder but a poor disintegrator. Micro Crystalline Cellulose is an excellent binder and a good disintegrator.

 

Brand

Micro Crystalline Cellulose Powder is offered under the brand name “SHACEL”.

 

Process

Rayon Grade wood pulp/Cotton Linters, the main raw material are hydrolyzed with suitable Mineral Acidunder very carefully controlled conditions. This is followed by thorough washing with
de-mineralized water. The depathogenised slurry prepared is dried, blended and finally packed.

 

Product Benefit / Advantages

Direct Compressible Grade of Micro Crystalline cellulose performs as an excipient to assist in the flow, lubrication and binding properties of the ingredients to be tableted and improves stability of drugs. Facilitate rapid disintegration of the tablet. It can be used in direct compression of most drugs. Although SHACEL can be used in all methods of tableting, it is most effectively used in direct compression. When using SHACEL only a simple three step procedure of weighing, mixing and compressing is required to prepare a wide variety of tablets. Because of its high chemical purity and low moisture content, improved chemical and colour stability of the tablets can result with the use of SHACEL. It is also best suited for preparation of capsules.

Detailed tests and experiments by various agencies for the use of Direct Compressible Grade Micro Crystalline Cellulose Powder in tableting have shown the following results.

• Excellent Compression & Hardness
• No Sign of Lubrication Difficulties
• Good Flowing Properties
• Reduces Friability & Weight Loss
• Excellent Binder and Filler

SPECIFICATIONS
Description Fine or Granular Crystalline, Odorless, Tasteless, Free Flowing Powder, Non Fibrous, Organic, Carbohydrate
Color White to off- white
Solubility Insoluble in water, slightly soluble in dilute Sodium Hydroxide solution, insoluble in dilute Acids and most Organic Solvents.
Identification Tests A, B, C Complies
Degree of polymerization NMT 350
Assay 97.00% – 102.00%
pH 5.0 to 7.5
Conductivity NMT 75 µS
Water soluble substance NMT 0.20% w/w
Ether soluble substance NMT 0.05% w/w
Residue on ignition NMT 0.2% w/w
Loss on drying NMT 6.00% w/w
Heavy metals NMT 10 PPM
Arsenic NMT 2 PPM
Organic Impurities NIL
Starch&Dextrins NIL

 

MICROBIAL LIMITS
Total Aerobic Microbial Count NMT 1000 CFU/G
Total Yeast &Mold Count NMT 100 CFU/G
Escherichia Coli Absent
Staphylococcus Aureus Absent
Salmonella Species Absent
Pseudomonas Aeruginosa Absent

 

Presently we are manufacturing the following Grades

 

PARTICLE SIZE / MOISTURE CONTENTS
Grade Particle Size Standards Average Particles Size Bulk Density GM/CC Moisture (%W/W)
SHACEL 101 +60 Mesh NMT 1%+200 Mesh NMT 30% 50 Micron 0.26 to 0.31 NMT 6.00
SHACEL 102 +60 Mesh NMT 8%+200 Mesh NMT 45% 90 Micron 0.28 to 0.33 NMT 6.00
SHACEL 103 +60 Mesh NMT 1%+200 Mesh NMT 30% 50 Micron 0.26 to 0.31 NMT 3.00

Packing

Packing is done in poly laminated 25 Kg HDPE bags with 2 (Two) Liners inside. Any modifications in packing can be made as per the customer’s requirement. Microcrystalline Cellulose Powder is
non – hygroscopic and considered to be stable product and is packaged in a sealed manner. The product has no specific requirement for storage, and there is no expiration date. However, it may absorb moisture if exposed to the atmosphere with a relative humidity higher than 65%.

Disclaimer

Because of the numerous factors affecting results, and being used in numerous Industries, Suhal Cellulose LLP products are sold on the understanding that purchasers will make their own tests to determine the suitability of this product for their particular purpose. The several uses suggested by us are presented only to assist our customers in exploring possible applications. All information and data presented are believed to be accurate and reliable but are presented without the assumption of any liability of Suhal Cellulose LLP. The information contained is intended to be general in nature.