Innovation and Assessment of Specialized Tablets Leveraging Box Behnken Design

Abstract

Hypertension, a leading cause of global mortality, affects over one billion individuals and necessitates effective and patient-friendly therapeutic solutions. T his study focuses on the development of a mucoadhesive bilayer tablet formulation of propranolol hydrochloride, a beta-blocker widely used to manage hypertension. The proposed tablet design integrates an instant release layer for rapid therapeutic effect and a mucoadhesive extended-release layer for prolonged drug delivery. Both layers were prepared using the direct compression method, a cost-effective and scalable manufacturing process. Comprehensive evaluations of pre- and post-compressional parameters confirmed the tablets met the requisite quality standards. The study also employed the Box-Behnken design, a response surface methodology, to optimize the formulation. The optimized batch, MBT 16, exhibited desirable outcomes, demonstrating effective drug release for immediate and sustained action. This novel dual-layer approach enhances the pharmacokinetic profile of propranolol hydrochloride, potentially improving patient compliance by reducing dosing frequency while maintaining stable blood pressure control throughout the day. The incorporation of natural excipients further highlights the cost-effectiveness and safety of the formulation. This study paves the way for advanced hypertension management through innovative drug delivery systems, combining therapeutic efficiency with improved patient adherence.