Preparation, Characterization, and Pharmacokinetic Evaluation of BerbiQ: An Advanced Bioavailable Berberine Formulation Using OMICS Technology by Synergistic Complexation

Abstract

A novel bioavailable berberine formulation, BerbiQ, was developed using OMICS technology by complexing berberine hydrochloride with synergistic molecules, particularly silymarin, to enhance its therapeutic efficacy. The formulation incorporated coconut milk containing proteins and lipids through an advanced bionanotechnology approach. Morphological analysis via scanning electron microscope (SEM) and transmission electron microscopy (TEM) confirmed that BerbiQ consists of spherical, well-dispersed particles with smooth surfaces and no aggregation, indicative of successful berberine complexation. Additional characterization using Fourier transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), and differential scanning calorimetry (DSC) analyses, along with stability studies, validated the effective complexation and stability of berberine hydrochloride within the BerbiQ formulation. Pharmacokinetic studies revealed that BerbiQ significantly enhances the oral bioavailability of berberine compared to conventional formulations, demonstrating a 4.26-fold increase in area under the curve (AUC) and a 4.10-fold increase in maximum plasma concentration (Cmax). Moreover, BerbiQ exhibited a shorter time to reach the maximum plasma concentration (Tmax), a lower elimination rate constant (Kel), and an extended terminal half-life (t1/2), indicating sustained release and prolonged systemic availability of berberine. These improvements are attributed to the advanced complexation and sustained-release properties enabled by OMICS technology. The enhanced bioavailability and pharmacokinetic profile of BerbiQ suggest it as an efficient delivery system for berberine, potentially reducing the required dosage and minimizing side effects. These findings position BerbiQ as a promising candidate for various therapeutic applications, offering improved efficacy and therapeutic potential.