|Applications||A cellulose-based superdisintegrant, providing excellent results in
tablet disintegration. Used at a level of 1 - 4 % only, it is one of the
most efficient superdisintegrants in pharmaceutical
technology. It can be used in all tableting processes, good for
medium soluble actives.
|Packing Type||25 Kgs Corrugated boxes / Fiber Drum|
|Particle size distribution (By Malvern)|
|D(v,0.1)||NMT 25 µm||In house method|
|D(v,0.9)||NLT 60 µm|
|PHARMACOPOEIAL TEST ITEMS||SPECIFICATION||REFERENCE|
|Loss on drying||NMT 10.0%||Ph. Eur., NF, JP|
|pH||5.0 - 7.0||Ph. Eur., NF, JP|
|Residue on Ethanol||max. 0.5%||In house method|
|The raw materials, manufacturing process and product do not contain any of the solvents listed in Residual Solvents (Ph. Eur. <5.4>, USP<467>) except for ethanol limited to < 0.5%|
Croscarmellose sodium is an internally cross-linked sodium carboxymethylcellulose for use as a superdisintegrant in pharmaceutical formulations.
Croscarmellose sodium, or sodium CMC, is a cross-linked polymer of carboxymethylcellulose sodium. It appears as white, fibrous, free-flowing powder.
Disintegrants facilitate the breakup of a tablet in the intestinal tract after oral administration. Cross-linking allows enhanced bioavailability of the drug through superior drug dissolution. Without a disintegrant, tablets may not dissolve appropriately and may effect the amount of active ingredient absorbed, thereby decreasing effectiveness
Croscarmellose sodium is used in oral pharmaceutical formulations as a disintegrant for Capsules, Tablets and Granules. In tablet formulations, Croscarmellose sodium may be used in both direct-compression and wet-granulation processes. When used in wet granulations the Croscarmellose sodium is best added in both the wet and dry stages of the process (intra- and extra granularly) so that the wicking and swelling ability of the disintegrant is best utilized.
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