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Crosslinked sodium carboxy methyl cellulose is a cross-linked polymer of carboxymethylcellulose sodium, commonly used as a disintegrant in pharmaceutical formulations.
Crosslinked sodium carboxy methyl cellulose appears as a white to off-white powder and is highly soluble in water, forming a gel-like consistency that facilitates the rapid disintegration of tablets and capsules upon contact with moisture.
This property enhances the bioavailability of active pharmaceutical ingredients by promoting their release in the gastrointestinal tract.
CAS: 74811-65-7
EINECS: 1312995-182-4
Synonyms
Sodiumcroscarmellose;CROSCARMELLOSE SODIUM;MODIFIED CELLULOSE GUM;PRIMELLOSE(R);Crosscarmelosesodium;Croscarmellose natrium;Cross-linked carboxymethylcellulose sodium;Unii-m28ol1hh48
Crosslinked sodium carboxy methyl cellulose is non-toxic and generally recognized as safe for use in food and pharmaceuticals.
Crosslinked sodium carboxy methyl cellulose is also characterized by its ability to swell significantly when hydrated, which aids in the breakdown of solid dosage forms.
Additionally, Crosslinked sodium carboxy methyl cellulose is stable under a wide range of pH conditions, making it versatile for various formulations.
Crosslinked sodium carboxy methyl cellulose's effectiveness as a disintegrant is influenced by factors such as particle size and concentration, and it is often used in combination with other excipients to optimize the performance of drug delivery systems.
Crosslinked sodium carboxy methyl cellulose Chemical Properties
Melting point: >205oC (dec.)
density: Bulk density (g/cc) 0.48
storage temp.: Hygroscopic, -20°C Freezer, Under inert atmosphere
solubility: Practically insoluble in acetone, in anhydrous ethanol and in toluene.
form: Solid
color: White to Off-White
PH: 5-7 (20°C, 10g/L in H2O)
Odor: at 100.00%. odorless
Water Solubility: 30g/L
Major Application: pharmaceutical (small molecule)
EPA Substance Registry System: Crosslinked sodium carboxy methyl cellulose (74811-65-7)
Uses
Crosslinked sodium carboxy methyl cellulose is a super disintegrant used in pharmaceuticals in the synthesis of tablets for oral administration.
Pharmaceutical Applications
Crosslinked sodium carboxy methyl cellulose is used in oral pharmaceutical formulations as a disintegrant for capsules,tablets, and granules.
In tablet formulations, Crosslinked sodium carboxy methyl cellulose may be used in bothdirect-compressionandwet-granulationprocesses.
When used in wet granulations, the Crosslinked sodium carboxy methyl cellulose 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.
Crosslinked sodium carboxy methyl cellulose 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.
Production Methods
Alkali cellulose is prepared by steeping cellulose, obtained from wood pulp or cotton fibers, in sodium hydroxide solution.
The alkali cellulose is then reacted with sodium monochloroacetate to obtain carboxymethylcellulose sodium.
After the substitution reaction is completed and all of the sodium hydroxide has been used, the excess sodium monochloroacetate slowly hydrolyzes to glycolic acid.
The glycolic acid changes a few of the sodium carboxymethyl groups to the free acid and catalyzes the formation ofcrosslinkstoproducecroscarmellosesodium.
The Crosslinked sodium carboxy methyl cellulose is then extracted with aqueous alcohol and any remaining sodium chloride or sodium glycolate is removed.
After purification, Crosslinked sodium carboxy methyl cellulose of purity greater than 99.5% is obtained.
The Crosslinked sodium carboxy methyl cellulose may be milled to break the polymer fibers into shorter lengths and hence improve its flow properties.
