Abstract

FORMULATION AND EVALUATION OF METOPROLOLOL SUCCINATE SUSTAINED RELEASE MATRIX TABLETS USING HPMC 100000 AND STEARIC ACID

Issa Alsalloum*, Fadi Abdulmassih and Kristina alsalloum

ABSTRACT

The objective of this study was to design and evaluate oral sustained drug delivery system for Metoprolol Succinate 50 mg, 100 mg, and 200 mg using hydrophilic polymers such as HPMC 100000 and hydrophobic excipient such as stearic acid. five batches were prepared by using Metoprolol Succinate 50 mg and HPMC 100000 in drug: polymer ratio of 1:0.5, 1:1, 1:1.5, 1:2, 1:2.5, and five batches were prepared by using Metoprolol Succinate 100 mg, HPMC 100000 and stearic acid in ratios : 1:2.5:0, 1:2.5:0.25, 1:2.5:0.5, 1:2.5:0.75, 1:2.5:1.and five batches were prepared by using Metoprolol Succinate 200 mg, HPMC 100000 and stearic acid in ratios : 1:2.5:0, 1:2.5:1, 1:2.5:1.25 1:2.75:1, 1:3:1. Matrix tablets were prepared by wet granulation method and evaluated for weight variation, content uniformity, friability, hardness, thickness and in vitro dissolution. Among the formulations studied, formulation F5 containing Metoprolol Succinate 50 mg and HPMC 100000 in drug: polymer ratio of (1:2.5) showed sustained release of drug for 10 h with cumulative percent release of 55% , formulation F6/4 Metoprolol Succinate 100 mg, HPMC 1000000 and stearic acid in ratio: (1:2.5:1) showed sustained release of drug for 10 h with cumulative percent release of 47,8%, formulation F7/4: Metoprolol Succinate 200 mg, HPMC 1000000 and stearic acid in ratios: (1:3:1) showed sustained release of drug for 10 h with cumulative percent release of 48,2%. Formulations with standard specifications were subjected to stability studies according to ICH Q1A guidelines. It was found that most of the formulations prepared conform to compendial specifications and there was no significant change in active content and dissolution profile in the accelerated stability studies.

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