Formulation And Evaluation Of Bi-Layer Tablets Of Ketoprofen And Omeprazole Using Box-Behnken Design

Abstract

The present study aims to develop and optimize bi-layer tablets containing Ketoprofen and Omeprazole using the Box-Behnken Design (BBD). Ketoprofen, a non-steroidal anti-inflammatory drug (NSAID), was formulated for sustained release, whereas Omeprazole, a proton pump inhibitor (PPI), was included in the immediate-release layer to counteract gastrointestinal side effects. The Box-Behnken Design was applied to optimize key formulation parameters such as polymer concentration, binder concentration, and filler concentration for the Ketoprofen layer. The Omeprazole layer was optimized for enteric coating using a similar design approach. The bi-layer tablets were prepared by compression using a bilayer tablet press, and their physical, chemical, and in-vitro dissolution characteristics were evaluated. The optimization process allowed for precise control of drug release kinetics, ensuring effective therapeutic outcomes. The final formulation exhibited desirable physical properties, drug release profiles, and stability. The sustained release of Ketoprofen over 12 hours provided prolonged anti-inflammatory action, while the immediate release of Omeprazole within 60 minutes ensured gastric protection. Furthermore, stability studies conducted under accelerated conditions demonstrated that the formulation retained its integrity over time. The application of the Box-Behnken Design facilitated an efficient experimental approach, reducing the number of trials while ensuring optimal formulation development. The study successfully demonstrates the feasibility of formulating a bi-layer tablet that enhances patient compliance by integrating an anti-inflammatory drug with a gastroprotective agent. The optimized formulation offers significant potential in the management of inflammatory disorders while minimizing adverse gastrointestinal effects associated with NSAID therapy. Future studies may focus on in-vivo pharmacokinetic and clinical evaluations to confirm therapeutic efficacy.