Abstract

Curcuminoids and their derivatives are known for numerous biological activities including antioxidant, anti-inflammatory, and wound healing properties. However, poor bioavailability of curcuminoids poses significant hurdle in its application as a dietary supplement to improve health conditions. Several commercial preparations have been developed to improve the oral bioavailability of curcumin using formulation technologies. Curcuwin Ultra+^TM (CU+) is a water dispersible curcumin formulation that has shown 144 times more bioavailability as compared to standard curcumin in humans. The present study was designed to demonstrate the safety of CU+ through comprehensive list of toxicity studies like acute and sub-chronic oral toxicity, mutagenicity and genotoxicity studies under Good Laboratory Practice (GLP) conditions using OECD guidelines. In an acute oral toxicity study, no lethality was observed in Sprague Dawley rats at dose as high as 2000 mg/kg body weight (b.w.) of CU+ with LD50 cut-off value of 5000 mg/kg b.w. Further, based on the 90-day repeat dose oral toxicity study followed by 28-day recovery period in Sprague Dawley rats, No Observed Adverse Effect Level (NOAEL) was noted to be 1000 mg/kg b.w./day. No mutagenicity due to CU+ was observed with reverse mutation (AMES) test in Salmonella typhimurium? and Escherichia coli strains and no genotoxicity was observed in studies that included micronucleus assay using erythrocytes from Swiss webster mice and, chromosomal aberrations test in Chinese hamster ovary cells. Overall CU+ was found to be safe in rodents, non-mutagenic, non-genotoxic, and had no observed adverse effects under experimental conditions tested.

Keywords:Curcuma longa; Turmeric; Curcumin; Curcuminoids; Demethoxycurcumin; Toxicity; Curcuwin Ultra+^TM