Design and Evaluation of Controlled Release Drug Delivery System of Generic Drug

Objective: Metoprolol succinate, an off-patent generic drug, is an ideal model drug for incorporation into an extended-release dosage form owing to its short half-life (3-7 hrs), low plasma protein binding (12%), and high solubility. The main objective of this study was to develop metoprolol succinate extended-release tablets based on the monolithic matrix technology for once-daily administration. The developed formulation has an in vitro release profile similar to the FDA approved target in vitro release profile while conforming to the USP limits. Methods: Metoprolol succinate matrix tablet formulations were prepared with different compositions employing different excipients, different polymers, and different concentration of polymers. Finally, one optimized formula with optimum hardness and coating parameters for the matrix tablet was selected and studied. Findings: Drug release from the formulated products was deemed acceptable, matching the release from the marketed formulation and falling within the limits set by the USP. Novelty: The formulations that were developed remained stable even after undergoing three months of accelerated stability studies. The manufacturing process was found to be consistent, cost-effective, and suitable for large-scale production using conventional tablet machines. Keywords: Extended release, Metoprolol succinate, Formulation, Physical parameters, Invitro release, Stability