E468 – Crosslinked Sodium Carboxymethylcellulose
E468 is a crosslinked sodium carboxymethylcellulose derivative used as a food additive and pharmaceutical excipient, primarily as a bulking and separating agent.
Things worth knowing about "E468"
E468 is a crosslinked sodium carboxymethylcellulose derivative used as a food additive and pharmaceutical excipient, primarily as a bulking and separating agent.
What is E468?
E468 refers to crosslinked sodium carboxymethylcellulose, also known as croscarmellose sodium. It is a synthetically modified cellulose derivative produced by chemically crosslinking sodium carboxymethylcellulose. Cellulose is a naturally occurring polysaccharide found in plant cell walls. The crosslinking process creates an insoluble, highly swellable polymer.
Production and Chemical Properties
E468 is produced by treating cellulose with sodium hydroxide and chloroacetic acid, followed by chemical crosslinking. The resulting product is a white to off-white, odorless powder that swells strongly in water but does not dissolve. This unique property makes it especially valuable as a tablet disintegrant in pharmaceutical formulations and as a functional additive in the food industry.
Use as a Food Additive
As a food additive classified under bulking and separating agents, E468 is used in processed foods to prevent clumping and improve texture. Typical applications include:
- Powdered foods and seasoning blends
- Dietary supplements in capsule or tablet form
- Dietetic food products
- Processed foods requiring improved texture
Use in the Pharmaceutical Industry
In the pharmaceutical industry, E468 (croscarmellose sodium) is widely used as a tablet disintegrant. It ensures that tablets break apart rapidly after ingestion, enabling the active ingredient to be released quickly. This significantly improves the bioavailability of medications. Typical concentrations in tablet formulations range from 0.5% to 5% of total weight.
Safety and Tolerability
E468 is considered safe for consumption based on current scientific assessments. The European Food Safety Authority (EFSA) has reviewed the substance and found no significant safety concerns at the levels used in food and pharmaceutical applications. Since E468 is not meaningfully absorbed in the gastrointestinal tract, the risk of systemic side effects is very low. In rare cases, sensitive individuals may experience mild gastrointestinal discomfort such as bloating.
Approval and Regulation
E468 is approved in the European Union under Regulation (EC) No 1333/2008 on food additives. Its use is restricted to specific food categories, and maximum permitted levels apply depending on the application. The substance is also approved as a food and pharmaceutical additive in many other countries worldwide.
References
- European Food Safety Authority (EFSA): Re-evaluation of cellulose (E 460(i)), powdered cellulose (E 460(ii)), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), methyl ethyl cellulose (E 465), sodium carboxy methyl cellulose (E 466), enzymatically hydrolysed carboxymethylcellulose (E 469) as food additives. EFSA Journal, 2018.
- European Commission: Regulation (EC) No 1333/2008 on food additives. Official Journal of the European Union, 2008.
- Rowe R.C., Sheskey P.J., Quinn M.E. (eds.): Handbook of Pharmaceutical Excipients, 6th edition. Pharmaceutical Press, London, 2009.
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Related search terms: E468-en