QUALITY ASSURANCE AND INTERCHANGEABILITY OF DIFFERENT BRANDS OF ESOMEPRAZOLE MARKETED IN NIGERIA
Ukwueze S. E.* and Eguzoikpe U. D.
ABSTRACT
Esomeprazole is a highly marketed anti-ulcer drug across Nigeria other sub-Saharan regions. The pharmaceutical
quality of the various generics of esomeprazole sold in these regions becomes of utmost importance in ensuring
that optimal therapeutic benefits were obtaining after administering any of the available brands in clinical practice.
This study was therefore aimed at evaluating the pharmaceutical profile and interchangeability of the different
brands of esomeprazole marketed in Nigeria. Six brands of esomeprazole (coded A1-A6) were subjected to official
and non-official tests as specified in the USP and BP. These tests were hardness/crushing strength, friability,
disintegration time, dissolution and weight uniformity tests. The content of active ingredient was determined using
the UV -Visible spectrophotometry at a maximum wavelength of 295 nm. Beer’s law was obeyed at a
concentration range of 0.2-1.2 μg/ml. Fit factor was calculated to determine in vitro bioequivalence of the brands
against the innovator brand (A1). The results showed that all the tablet brands (A1-A5) passed the hardness and
friability tests, while all the brands (A1-A6) passed the disintegration, dissolution and content uniformity tests
according to the USP and BP standards. Only sample A3 failed the weight uniformity test. Also, all the brands
showed F2 values greater than 50, indicating acceptable similarities in their dissolution curves. Hence, these brands
could be used interchangeably with one another leading to better availability, patient compliance and overall
improvement in therapeutic outcome of esomeprazole products in the country.
Keywords: Esomeprazole, interchangeability, gastro-esophageal reflux disease, spectrophotometer, bioequivalence.
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