The independently conducted safety evaluation sought to establish the safety of the formulation using a standard series of in vitro and in vivo safety studies
A recently published research study has provided evidence for the long-term safety of Dolcas Biotech’s Curcugen curcumin formulation. With multiple scientific evaluations supporting the oleoresin-based turmeric (Curcuma longa-L.) formulation’s bioefficacy and high bioavailability, the company says, this recent preclinical safety evaluation reportedly demonstrated zero indication of general toxicity, genotoxicity or adverse events associated with long-term use.
The independently conducted safety evaluation, published in the Hindawi Journal of Biomedical Research International sought to establish the safety of the formulation using a standard series of in vitro and in vivo safety studies, in accordance with OECD guidelines. This included the toxicological assessment of acute, oral, and 90-day repeated dosing.
The single dose of Curcugen administered orally to Sprague-Dawley (SD) rats demonstrated a non-lethal dose of as high as 5,000 mg/kg body weight. A sub chronic assessment of the ingredient, as administered to SD rats over 90 days resulted in a no observed adverse effect level (NOAEL) at a dose of 2,000 mg/kg body weight/day. This was confirmed through comprehensive screening of blood serum markers encompassing organ function and urine analysis. Moreover the ingredient did not elicit any genotoxic or mutagenic abnormalities with long-term use.
Dolcas Biotech president K. G. Rao said: “Not only does the knowledgeable, label-reading consumer of today demand to know what’s in the products they consume, they want to be reassured of their impeccable safety.”
The ingredient is a 100% turmeric-derived, bioavailability-enhanced, water-dispersible curcuminoids active patented for its unique, clean-label coextraction of polar-type resins from the oleoresin. According to Dolcas, its proprietary manufacturing process does not remove, further refine, and then reconstitute these active compounds. Instead, the process optimises their interaction – particularly with water – so that the otherwise lipid-soluble curcuminoids disperse for heightened functional and biological activity.
Curcugen has already attained Self-GRAS status, and the recent study positions the company to apply for full FDA GRAS status later this year, it says. “The enhanced bioavailability of Curcugen, with its 39-times greater free curcumin absorption profile, allows the consumer to feel confident knowing the product is completely safe and fully clean label,” Rao concluded.