An Open Label, Randomized, Comparative Bioavailability Study of BioTurm™ Extract Versus Curcuma longa Extract With...

Introduction Curcumin (95%) from Curcuma longa rhizomes holds significant therapeutic promise, but its clinical efficacy is limited by poor oral bioavailability due to rapid metabolism, poor solubility, and quick elimination. This study compared the pharmacokinetics of BioTurm™, a novel standardized extract, with the market standards of Curcuma longa (95% curcumin) with piperine extract, a known bioavailability enhancer. Methods A single-dose, open-label, randomized, three-arm, comparative study was conducted in 14 healthy volunteers (aged 21-30 years). Participants were randomized into three groups: group A - BioTurm^TM extract (standardized to 45% curcuminoids and 4.5% ar-turmerone, n = 5), group B (95% curcuminoidswith 1% piperine, n = 4), and group C (95% curcuminoidswith 10% piperine, n = 5). Following single oral dose administration, blood samples were collected at multiple time points over eight hours. Plasma concentrations were analyzed using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS), and pharmacokinetic (PK) parameters were determined. Results BioTurm™ (group A) achieved significantly higher bioavailability than market-standard group B, with a C_max of 647.97 ng/mL vs. 10.94 ng/mL. Group C, containing 10% piperine, achieved a comparable C_max (663.60 ng/mL) and area under the curve (AUC₀-₂₄: 1479.89 ng·hr/mL). Ar-turmerone from BioTurm™ was detectable throughout the sampling period, peaking at two hours. No adverse events were reported. Conclusion BioTurm™ showed significantly enhanced bioavailability over the standard curcumin-piperine (1%) combination, without requiring additional enhancers. Only a high dose of piperine (10%) could match its PK profile. The presence of ar-turmerone and curcuminoids in BioTurm™ suggests a synergistic effect, offering a simplified and effective alternative to piperine-based formulations with potential therapeutic advantages.