अमूर्त

Formulation Development and Evaluation of Bi-Layer Sustained Release Tablets of Amlodipine and Metaprolol

Sindhu.P

Background and Objective: The objective of the present research, an attempt has been made to formulate bilayered tablets of Amlodipine besylate and Metoprolol succinate. The main objective for combination therapy is to encourage the use of lower doses of drug to reduce the patient’s blood pressure, to minimize dose dependent side effects and adverse reactions. When smaller doses of medication with different mechanism of action are combined, synergistic or additive effects on blood pressure are achieved. Methods: Nine different formulations of bilayered tablets were prepared with Amlodipine besylate as immediate release layer and Metoprolol succinate as Sustained release layer. Tablets were prepared by direct compression technique. Immediate release layer was prepared by using Super desintegrant CCS. Sustained release layer was prepared by different ratios of polymers like HPMC K100M, Acacia and Combination of both. The prepared tablets were evaluated for pre and post compression parameters, drug content, in vitro dissolution studies and stability studies. Results: All the evaluated parameters of the optimized formulation optimized formula showed the metaprolol succinate drug release over a period of 16 to 20 hours.and the amlodipine besilate (IR) release the max drug in 60 minutes showed compliance with pharmacopoeial standards. Interpretation and conclusion: The optimized formulation of bilayer tablets showed good release profile and are within pharmacopoeial limits. The extended release Metoprolol layer of optimized formulation follows first order and shows non-Fickian diffusion mechanism of release this formulation was subjected to stability studies. The stability studies were carried out for the optimized batch for three months and it showed acceptable results.