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Ingredients & Excipients Used


Microcrystalline Cellulose I.P.

THE EXCIPIENT OF CHOICE

Microcrystalline Cellulose is hardly a new product. As a naturally occurring substance, it has proven to be stable, safe and physiologically inert.

Microcrystalline Cellulose revolutionized tablet making 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 Microcrystalline 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 spheronisation/pelletisation.

WHAT IS MICROCRYSTALLINE CELLULOSE?

As the name implies, Microcrystalline Cellulose is basically cellulose and is derived from high quality wood pulp. While cellulose is the most abundant organic material, Microcrystalline Cellulose can only be derived from a special grade of alpha cellulose.

In many ways, Cellulose makes the ideal excipient. A naturally occurring polymer, it is comprised of glucose units connected by a 1-4 beta glycosidic bond. These linear cellulose chains are bundled together as microfibril spiralled 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 but are more accurately called dislocations since microfibril containing single-phase structure. The crystalline region is isolated to produce Microcrystalline Cellulose.

NB's SANCEL CONSISTENTLY RELIABLE MICROCRYSTALLINE CELLULOSE

Processing of the cellulose microfibrils begins with shredding the sheets of high purity alpha grade pulp. The shredded pulp is immersed in hot bath of mineral acid that dissolves the amorphous regions of the microfibrils while leaving the microcrystalline segments intact. The object is to break down the long polymer chains. Hydrolysis is carried to the point where a leveling off degree of polymerization (LODP) is achieved. Consistency in LODP is checked routinely by quality control personnel.

Following hydrolysis, chemicals and impurities are removed through a water-washing step. This is followed by Spray drying. The slurry is sprayed through hot air jets to evaporate the water. This process produces particles of the desired size and moisture content.
While the process of producing Microcrystalline Cellulose appears to be relatively straight, the product quality is directly tied to various parametesr of the process in terms of time, temperature, pressure and purity of materials and the manufacturing environment.

THE SANCEL ADVANTAGE FACILITATION PHARMACEUTICAL MANUFACTURING SUCCESS

Presently, three types of Sancel is produced: Sancel 101Sancel 102 & Sancel 112. Each corresponds to 50 micron, 90 micron and low moisture, respectively. SANCEL is purified partially depolymerized ALPHA CELLULOSE. It is White, Odorless and Tasteless, and free from organic and inorganic contaminations. It is insoluble in Water, Dilute Acids, and in mostly all organic solvents. Practically insoluble in Sodium Hydroxide solution: SANCEL, which has now become a synonymous name in pharmaceutical industries, is a must for quality as well as quantity products. The different grades are produced during final stages of the Sancel manufacturing process by altering the spray drying conditions.

Rapid drying produces aggregates of microcrystals with many dislocations and slip planes that can fracture and realign during tableting. This deformation is primarily plastic, so bonds formed under pressure remain formed after pressure is released, making for a strong, dense tablet with no capping. Microcrystalline Cellulose also is highly absorptive due to the capillary action of its surface porosity, making it possible to act as a carrier for liquids and yet retain free flowing and compression properties. Its porosity promotes easy wetting and rapid drying of wet granulation and exhibits good volumetric flow characteristic with low lubricant demand.

Microcrystalline Cellulose Sancel-102

Parameters IP USP26 - NF21
Appearance Fine or granular, white or almost white powder, free flowing Fine or granular, white or almost white powder, free flowing
Identification    
A Comply Comply
B + C Comply Not Applicable
B Degree of Polymerization Not Applicable < 350
pH 5 - 7.5 5 - 7
Starch and Dextrins Absent Not Applicable
Organic Impurities Comply Not Applicable
Organic Volatile Impurities Not Applicable Comply
Water Soluble Substances, %NMT 0.2 0.24
Ether Soluble Substances, % NMT Not Applicable 0.05
Arsenic, PPM, NMT 2 Not Applicable
Heavy Metal, PPM, NMT 10 10
Residue on Ignition, % NMT 0.2 0.5
Loss on Drying, % NMT 6 6
Assay, % 97 - 102 Not Applicable
Conductivity, µS / cm,not exceed than water by Not Applicable 75
Microbiology Analysis    
Total Aerobic Microbial Count, CFU/g, NMT 1000 1000
Total Yeast and Mold Count, CFU/g, NMT 100 100
Pseudomonas aeruginosa, per 10 g Absent Absent
Escherichia coli, per 10 g Absent Absent
Staphylococcus aureus, per 10 g Absent Absent
Salmonella sp. per 10 g Absent Absent
Inhouse Specifications    
Screen Analysis % Retention    
60 Mesh, NMT 8
200 Mesh, NLT 45
Bulk Density, g/cc 0.28 - 0.33