Abstract

The aim of this present study was to develop and formulate sustained release coated metoprolol tartrate matrix granules and to design an in-vitro in-vivo correlation (IVIVC) tool based on bioavailability data available from human volunteers. USP apparatus II, paddle type was used for generation of in-vitro drug release data for each formulation. The similarity factor (f2) was determined using dissolution data parameters of the formulations. Twenty-four healthy male volunteers participated in the two-way crossover bioequivalent study where the volunteers were treated in a completely randomized fashion. The percent drug dissolved in the dissolution test and percent absorbed data shows a ‘level A’ IVIVC was achieved with a good linear regression relation. Different release rate formulation including Fast, Moderate and Slow release formulations exhibited an excellent covenant between the three dosage forms.

Key words: Sustained-release capsules, metoprolol tartrate, bioavailability, in-vitro in-vivo correlation (IVIVC), humans.