04.25.22
Curcugen, a water-soluble, oleoresin-based turmeric formulation marketed by Dolcas Biotech, saw positive results as the subject of a safety study, which included a standard series of in vitro and animal safety trials.
While multiple studies have established the formulations bioavailability and efficacy in humans, the recent preclinical safety evaluation had safety as its primary endpoint, and found that the ingredient had zero indication of general toxicity, genotoxicity, or adverse events associated with long-term use.
Appearing in the Hindawi Journal of Biomedical Research International, and led by Somashekara Nirvanashetty, PhD, the series of in vitro and in vivo safety studies sought to establish the safety guidelines of Curcugen in accordance with OECD (Organization for Economic Cooperation and Development) 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 5,000mg/kg body weight. A sub chronic assessment of Curcugen, as administered to SD rats over 90 days resulted in a no observed adverse effect level (NOAEL) at a dose of 2,000mg/kg body weight/day. This was confirmed through comprehensive screening of blood serum markers encompassing organ function and urine analysis. Moreover, Curcugen did not elicit any genotoxic or mutagenic abnormalities with long-term use.
“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,” K. G. Rao, Dolcas Biotech president, said.
Curcugen is protected by a patent for its unique, clean-label coextraction of polar-type resins from the turmeric oleoresin. The manufacturing process doesn’t remove, further refine, and then reconstitute these active compounds, as do other formulations on the market. Instead, the process optimizes their interaction, particularly with water, so that the otherwise lipid-soluble curcuminoids disperse for heightened functional and biological activity, according to the company.
Curcugen has been studied for its impact on joint function and pain secondary to inflammation. A study published last year also found that the ingredient supports mood and gut health, including helping to ease the symptoms of IBS. The ingredient is standardized to contain 50% curcuminoids, 1.5% retained turmeric essential oil, turmeric polysaccharides, and resins, and is formulated for a 500 mg daily dose.
While multiple studies have established the formulations bioavailability and efficacy in humans, the recent preclinical safety evaluation had safety as its primary endpoint, and found that the ingredient had zero indication of general toxicity, genotoxicity, or adverse events associated with long-term use.
Appearing in the Hindawi Journal of Biomedical Research International, and led by Somashekara Nirvanashetty, PhD, the series of in vitro and in vivo safety studies sought to establish the safety guidelines of Curcugen in accordance with OECD (Organization for Economic Cooperation and Development) 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 5,000mg/kg body weight. A sub chronic assessment of Curcugen, as administered to SD rats over 90 days resulted in a no observed adverse effect level (NOAEL) at a dose of 2,000mg/kg body weight/day. This was confirmed through comprehensive screening of blood serum markers encompassing organ function and urine analysis. Moreover, Curcugen did not elicit any genotoxic or mutagenic abnormalities with long-term use.
“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,” K. G. Rao, Dolcas Biotech president, said.
Curcugen is protected by a patent for its unique, clean-label coextraction of polar-type resins from the turmeric oleoresin. The manufacturing process doesn’t remove, further refine, and then reconstitute these active compounds, as do other formulations on the market. Instead, the process optimizes their interaction, particularly with water, so that the otherwise lipid-soluble curcuminoids disperse for heightened functional and biological activity, according to the company.
Curcugen has been studied for its impact on joint function and pain secondary to inflammation. A study published last year also found that the ingredient supports mood and gut health, including helping to ease the symptoms of IBS. The ingredient is standardized to contain 50% curcuminoids, 1.5% retained turmeric essential oil, turmeric polysaccharides, and resins, and is formulated for a 500 mg daily dose.
