Croscarmellose Sodium
Croscarmellose sodium is a crosslinked polymer of carboxymethyl-cellulose sodium. Croscarmellose sodium is known as Tablet and capsule disintegrant. This item is available in Arvin Kala’s product portfolio.
Description
Croscarmellose sodium appears as an odorless, white or grayish-white powder.
Applications in Pharmaceutical Formulation or Technology
Croscarmellose sodium is utilized in oral pharmaceutical formulations as a disintegrant for capsules and granules.
In tablet formulations, croscarmellose sodium can be used in both direct-compression and wet-granulation processes. For wet granulations, it should be added during both the wet and dry stages (intra- and extra-granularly) to maximize its wicking and swelling capabilities. Croscarmellose sodium can be used as a tablet disintegrant at concentrations up to 5% w/w, though typically 2% w/w is used for tablets made by direct compression and 3% w/w for those made by wet granulation.
Stability and Storage Conditions
Croscarmellose sodium is a stable but hygroscopic material. A model tablet formulation prepared by direct compression, using croscarmellose sodium as a disintegrant, showed no significant change in drug dissolution after being stored at 30°C for 14 months. Croscarmellose sodium should be stored in a well-sealed container in a cool, dry place.
Method of Manufacture
Alkali cellulose is produced by soaking cellulose, derived from wood pulp or cotton fibers, in a sodium hydroxide solution. This alkali cellulose is then reacted with sodium monochloroacetate to form carboxymethylcellulose sodium. Once the substitution reaction is complete and all sodium hydroxide is consumed, the excess sodium monochloroacetate gradually hydrolyzes to glycolic acid. The glycolic acid converts some sodium carboxymethyl groups to free acid and catalyzes crosslink formation, resulting in croscarmellose sodium. The croscarmellose sodium is then extracted with aqueous alcohol to remove any remaining sodium chloride or sodium glycolate. After purification, croscarmellose sodium with a purity greater than 99.5% is obtained. The croscarmellose sodium may be milled to shorten the polymer fibers, enhancing its flow properties.
Safety
Croscarmellose sodium is primarily used as a disintegrant in oral pharmaceutical formulations and is generally considered nontoxic and nonirritant. However, consuming large amounts of croscarmellose sodium orally may have a laxative effect, though the quantities used in solid dosage forms are unlikely to cause such issues.
In the UK, croscarmellose sodium is approved for use in dietary supplements. The WHO has not established an acceptable daily intake for carboxymethylcellulose sodium, a related substance used as a food additive, because the amounts needed to achieve the desired effect are not considered a health hazard.
Handling Precautions
Follow standard precautions based on the circumstances and amount of material being handled. Croscarmellose sodium can irritate the eyes, so it is recommended to use eye protection.
Chemical-physical values
| Test Item | Unit | Specification |
|---|---|---|
|
DESCRIPTION |
|
White powder |
|
PH |
% |
between 5-7 |
|
SODIUM CHLORIDE SODIUM GLYCOLLATE & |
w/w |
Max 22% |
|
LOSS ON DRYING |
w/w |
Max 3.15% |
| Test Item | Unit | Specification |
|---|---|---|
|
WATER SOLUBLE MATTER |
%w/w |
Max 10 |
|
SETTLING VOLUME (I H) |
ml |
Min 10 &
Max 30
|
|
HEAVY METALS |
ppm |
Max 20 |
|
BULKD ENSITY (I H) |
gr/ml |
Min 0.35 &
Max 0.55
|
|
TAPPEDD ENSITY (I H) |
gr/ml |
Min 0.55 &
Max 0.75
|
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