Croscarmellose Sodium

Synonyms:  Ac-Di-Sol; carmellosum natricum conexum; crosslinked carboxymethylcellulose sodium; Explocel; modified cellulose gum; Nymcel ZSX; Pharmacel XL; Primellose; Solutab; Vivasol.

Description:  Croscarmellose sodium occurs as an odorless, white or grayishwhite powder. 

Chemical Name: Cellulose, carboxymethyl ether, sodium salt, crosslinked

Tablet and capsule disintegrant.

• 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 should be added in both the wet and dry stages of the process (intra- and extragranularly) so that the wicking and swelling ability of the disintegrant is best utilized.

• Croscarmellose sodium at concentrations up to 5% w/w 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.

The efficacy of disintegrants, such as croscarmellose sodium, may be slightly reduced in tablet formulations prepared by either the wet-granulation or direct-compression process that contain hygroscopic excipients such as sorbitol. Croscarmellose sodium is not compatible with strong acids or with soluble salts of iron and some other metals such as aluminum, mercury, and zinc.

Croscarmellose sodium is mainly used as a disintegrant in oral pharmaceutical formulations and is generally regarded as an essentially nontoxic and nonirritant material. However, oral consumption of large amounts of croscarmellose sodium may have a laxative effect, although the quantities used in solid dosage formulations are unlikely to cause such problems.

Observe normal precautions appropriate to the circumstances and quantity of material handled. Croscarmellose sodium may be irritant to the eyes; eye protection is recommended.

Carboxymethylcellulose calcium; carboxymethylcellulose sodium.