Clinical Research

Davis- 5-Loxin® Water Sol American Society for Nutrition (ASN) Poster

Plasma Concentrations of Boswellic Acids in Fasting Healthy Humans Supplemented with a Water-Soluble Boswellia Extract (78% AKBA) vs. Reference Boswellia Extract (30% AKBA)

Barbara Davis* , Jennifer Murphy, Venkata Krishnaraju Alluri, Trimurtulu Golakoti, Krishanu Sengupta
1. PLT Health Solutions Inc., Morristown, New Jersey

2. Laila Impex R&D Center, Jawahar Autonagar, Vijayawada, 520 007, India

* Presenting Author

Objectives: A randomized, open label, balanced, two-way crossover study compared the oral bioavailability and pharmacokinetic profiles of two Boswellia products standardized to 3-O-acetyl-11-Keto-β-boswellic acid (AKBA).

Methods: Twenty-two fasted male participants completed the study. They received a single oral-dose of water-soluble Boswellia extract 78% (LI51202F1) or to the standard Boswellia extract 30% (5-Loxin) at 30 mg AKBA equivalent with 240 mL water on 2 separate occasions 12 days apart. Plasma AKBA and KBA were analyzed using a LC-MS/MS in pre- (0 hours) and post-dose (0.5, 1, 1.5, 2, 2.5, 3, 4, 8, 12 and 24 hours) blood samples. Pharmacokinetic analysis was performed using WinNonlin® version 7.0 (Pharsight corporation, USA).

Results: Comparative analysis of the pharmacokinetic parameters showed LI51202F1 had higher (111.11%) Cmax for AKBA vs. 5-Loxin. The bioavailability indicated by Geometric means of AUC0-t and AUC0-∞ were 25.49 % and 16.13% higher in LI51202F1 than 5-Loxin.

Conclusions: The present study demonstrates that oral ingestion of water soluble and standard Boswellia extracts resulted in similar bioavailability of AKBA. Interestingly, the water-soluble version exhibited higher Cmax and AUC values, which could be attributed to the improved solubility of LI51202F1.

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