A 28-Day Oral Toxicity Study in Wistar Rats for a Highly Bioavailable Curcumin Preparation, CAVACURMIN®

Curcumin is widely used for its antioxidant and anti-inflammatory properties, but its poor oral bioavailability has driven the development of advanced formulations such as CAVACURMIN®, a gamma-cyclodextrin-based curcumin complex with enhanced absorption. Given recent regulatory scrutiny of high-bioavailability curcumin products, we evaluated the subacute oral safety of CAVACURMIN® in Wistar rats. Animals received 2000 mg/kg/day (low dose) or 3500 mg/kg/day (high dose) for 28 days, with controls receiving vehicle or γ-cyclodextrin alone. No mortality or systemic toxicity occurred, except for one incidental death unrelated to treatment. Dose-dependent local, transient post-dosing signs (salivation, bedding displacement) were attributed to sensory or irritant effects. Clinical chemistry showed modest, non-adverse shifts—including decreased urea (up to −25 % in males) and increased albumin (up to +9 % in females)—that may indicate favourable pharmacological effects such as enhanced nitrogen retention and mild anti-inflammatory modulation. All other parameters, including body weight, food intake, haematology, organ weights (except a small, non-adverse liver weight increase in high-dose females), and gross pathology, were comparable to controls. These findings demonstrate that CAVACURMIN® was well tolerated at doses up to 3500 mg/kg/day, supporting its safety and suitability for further evaluation in an OECD 408-compliant 90-day toxicity study.