Croscarmellose sodium

Structural formula
General
Surname	Croscarmellose Sodium ( INN , modified)
other names	Cross-linked carboxymethyl cellulose, sodium salt; Cross-linked carboxymethyl cellulose, sodium salt; Carmellosum natricum conexum; NaCMC-CL; E 468 ; CROSCARMELLOSE ( INCI ) ;
CAS number	74811-65-7
Monomers / partial structures	carboxymethylated cellobiose
properties
solubility	practically insoluble in water
safety instructions
GHS labeling of hazardous substances	no classification available
	no classification available
H and P phrases	H: see above
	P: see above
As far as possible and customary, SI units are used. Unless otherwise noted, the data given apply to standard conditions .

Croscarmellose sodium is a water-insoluble, swellable polysaccharide that is used as an excipient in drug production and food technology.

Chemically, it is the sodium salt of cross-linked carboxymethyl cellulose .

Manufacturing

As described for carboxymethyl cellulose, production begins with the conversion of ground cellulose. The crosslinking of the carboxymethyl cellulose polymer chains takes place with the aid of glycolic acid , which is formed from excess chloroacetic acid from the previous process step. Deprotonation of the carboxy groups by the acid formed then enables the formation of bonds to other polymer chains. The degree of crosslinking can be controlled via pH and temperature. Crosslinking agents are not used. The average degree of substitution, the number of replaced hydroxyl groups per cellulose unit, is 0.7.

properties

Due to the cross-linking of the polymer chains, croscarmellose sodium - unlike the sodium salt of uncrosslinked carmellose - is practically insoluble in water. However, it has a high water-binding capacity and swells to 4 to 8 times its volume when water is absorbed. Croscarmellose sodium is also practically insoluble in acetone , ethanol , toluene and diethyl ether .

Croscarmellosis is not absorbed.

use

Croscarmellose sodium is used as a disintegrant (" pill disintegrant ") for tablets, capsules and granules. It causes the drug form to rapidly disintegrate in the gastrointestinal tract , which is the prerequisite for the release of the drug or drugs. In terms of processing technology, croscarmellose sodium is suitable for both direct tableting and wet granulation. The use concentrations are 0.5–5% for tablets and 10–25% for capsules, based on the weight of the tablet or capsule.

In special processes, croscarmellose sodium is also used as a taste masking additive.

Trade names

Ac-Di-Sol, Disolcel, Explocel, Nymcel, Pharmacel, Primellose, Solutab, Vivasol

Individual evidence

↑ Entry on E 468: Cross-linked sodium carboxy methyl cellulose in the European database for food additives, accessed on August 6, 2020.
↑ Entry on CROSCARMELLOSE in the CosIng database of the EU Commission, accessed on August 6, 2020.
↑ ^a ^b ^c Commentary on the European Pharmacopoeia 6.0, loose-leaf collection, 30th edition 2008.
↑ This substance has either not yet been classified with regard to its hazardousness or a reliable and citable source has not yet been found.
↑ Analysis and characterization according to USP
^ ^A ^b Handbook of Pharmaceutical Excipients, 5th Edition (2006). Ray C. Rowe (Editor), Paul J. Sheskey (Editor), PJ Weller (Editor).

[E-Nummer468-1] Entry on E 468: Cross-linked sodium carboxy methyl cellulose in the European database for food additives, accessed on August 6, 2020.

[CosIng-2] Entry on CROSCARMELLOSE in the CosIng database of the EU Commission, accessed on August 6, 2020.

[ABK-3] Commentary on the European Pharmacopoeia 6.0, loose-leaf collection, 30th edition 2008.

[NV-4] This substance has either not yet been classified with regard to its hazardousness or a reliable and citable source has not yet been found.

[5] Analysis and characterization according to USP

[HPE-6] A ^b Handbook of Pharmaceutical Excipients, 5th Edition (2006). Ray C. Rowe (Editor), Paul J. Sheskey (Editor), PJ Weller (Editor).