Sodium lauryl sulfate (SLS) is a frequently used tabletting aid that works as a wetting agent, lubricant or solubilizer.
GRAS status is recognition that Texapon K 12 P PH can now be used for dietary supplements in the USA and that it has been shown to be safe under the conditions of intended use.
Cognis said that Texapon K12 P PH is particularly efficient in tabletting processes due to its small and consistent particle size.
Cognis claimed that Texapon K12 P PH exhibits a performance profile that makes it ideal for the manufacture of tablets and capsules. Cognis self-affirmed Texapon K12 as GRAS on March 31 in consultation with a panel of independent experts.
The dietary supplement and food manufacturers can now use SLS in two daily doses of up to 30mg/day. Texapon K 12 P PH also meets other international regulations, including USP/NF, Ph Eur and JP standards, and is kosher certified.
Cognis stated that because of its very low particle size, Texapon K 12 P PH is efficient in the tabletting process. In addition, it offers a range of new options to formulators and manufacturers of dietary supplements, as they are more stable with some actives than competing products.
Thomas Rosen, global product line manager of pharmaceuticals and healthcare at Cognis, said: “Texapon K 12 P PH can help manufacturers them to improve tablet quality while also ensuring high efficiency. Their wetting capabilities, low particle size and uniform quality that our production processes ensure are key to providing these benefits.”
John Giannone, marketing and business manager of pharmaceuticals and healthcare North America at Cognis, said: “Now that we have gained GRAS status, formulators and manufacturers of dietary supplement tablets and capsules can use them in the US and other countries. As these SLS-based wetting agents are very effective, we believe they will be a key advantage in this market.”