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Abstract

ASSESSMENT OF PHARMACEUTICAL QUALITY CONTROL AND BIOEQUIVALENCE OF VARIOUS BRANDS OF AMLODIPINE BESYLATE 10 MG TABLETS MARKETED IN SUDAN UNDER BIOWAIVER CONDITIONS

Manal AL-Yosofy* and Yasser AL-Domini

ABSTRACT

The aim of this study was to evaluate and compare two different Amlodipine Besylate 10 mg tablets brands commercially available in the Sudanese market with the Innovator. Amlodipine Besylate, a calcium channel blocker, is classified as BCS Class I and may be evaluated under biowaiver conditions. The pharmaceutical equivalence of two Amlodipine Besylate 10 mg tablets was evaluated using official and non-official standards according to USP37-2014 including weight variation, diameter, hardness, disintegration, friability, thickness, assay and dissolution rate. Dissolution profiles were studied using three different buffer solutions: pH 1.2, 4.5, and 6.8 and evaluated using the similarity factor f2 to predict the likely in vivo bioavailability and bioequivalence. All the tested three brands were complied with the official requirements according to USP37-2014. The dissolution profiles of brand A, B and Innovator in pH 1.2, 4.5 and brand A in pH 6.8 were found to be very rapidly dissolving (≥ 85% release in 15 minutes), while the brand B and Innovator in pH 6.8 could not fulfill biowaiver requirements. so they could not pass the WHO criteria ((≥ 85% release in 15 minutes). Similarity factor (f2) and difference factor (f1) were used to assess bioequivalency among the brand B and innovator in pH 6.8. For the brand B and innovator in pH 6.8 the similarity factor f2 value was 53 and difference factor f1 was 7. These results indicated that all generic Amlodipine Besylate tablets included in this investigation were bioequivalent with the chosen innovator brand and so may be used interchangeably.

Keywords: Biowaiver, Amlodipine Besylate, Tablet, Dissolution profiles, Similarity factor.


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