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Croscarmellose Sodium is internally cross linked sodium Carboxy Methyl Cellulose for use as a disintegrant in pharmaceutical formulations. The cross linking reduces water solubility while still allowing the material to swell and absorb many times its weight in water. As a result, it provides superior drug dissolution and disintegration characteristics, thus improving formula's subsequent bioavailability. Croscarmellose Sodium also resolves formulators concerns over long term functional stability, reduced effectiveness at high tablet hardness levels, and similar problems associated with other products. Croscarmellose Sodium is developed to enhance drug dissolution. Croscarmellose Sodium is a very commonly used, FDA approved pharmaceutical additive. Its purpose in most tablets including dietary supplements - is to assist the tablet in disintegrating in the intestinal tract at the required area too slowly, or in the wrong part of the intestine or not at all thereby reducing the efficacy of the active ingredients. Croscarmellose sodium is a stable though hygroscopic material. It should be stored in a well-closed container in a cool & dry place.
Applications : 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. Concentrations of upto 5% w/w of Croscarmellose Sodium may be used as a tablet disintegrant although normally 2% w/w is used in tablets prepared by direct compression and 3% w/w in tablets prepared by a wet granulation process.