Preparation of a Unique Bioavailable Bacoside Formulation (Cognique®) Using Polar-Nonpolar-Sandwich (PNS) Technology and Its Characterization, In Vitro Release Study, and Proposed Mechanism of Action

Bacopa monnieri Linn. (B. monnieri) is a medicinal herb that has been utilized as a traditional medicine to improve memory and learning. Bacosides, the important components of B. monnieri, are used in Ayurvedic herbal formulation to improve cognitive and neuroprotective action and as therapeutics for the management of many central nervous disorders. A novel bioavailable bacoside formulation, Cognique®, was prepared through the preservation of bacosides with complete multiple natural matrix including gingerols and rosemary extracts containing rosemary essential oil, rosmarinic acid, and carnosic acid using Polar-Nonpolar-Sandwich (PNS) technology. The successful PNS formulation of Cognique® was confirmed by different instrumental methods. The SEM images clearly indicated that Cognique® was almost well dispersed and has hollow core nest-like spherical structure with porous nature and rough surface due to the interaction between the polar-bacosides-nonpolar matrixes. IR, XRD, and DSC studies also confirmed the existence of bacosides in Cognique® with high stability due to the PNS formulation. The stability and in vitro drug release studies revealed that the PNS technology is an advanced technology to preserve the bioactive components, particularly bacosides, and they are capable of maintaining the sustained release of bacosides at target sites. The existence of synergistic effects of bacosides, extracts of rosemary, and gingerols in Cognique® can be utilized as a natural nutritional supplement for supporting neuroprotective effect and cognition improvement through maintenance of gut-brain axis. This study demonstrated a novel bioavailable bacoside formulation—Cognique®—through the preservation of bacosides with multiple natural matrix. Future study will investigate the efficacy, safety, and improvement of normal cognitive function in human volunteers.