Biopharmaceutical Quality Assessment of Multisource Ciprofloxacin 500 mg Tablets Circulating in the Federal Capital Territory, Nigeria
DOI:
https://doi.org/10.51412/psnnjp.2026.004Keywords:
Ciprofloxacin, Dissimilarity Factor, Similarity Factor, Dissolution Efficiency, Mean Dissolution TimeAbstract
Background: The quality of ciprofloxacin generics in Nigeria is a concern due to the potential for therapeutic failure and antimicrobial resistance.
Objectives: This study evaluated the pharmaceutical equivalence of nineteen (19) brands of ciprofloxacin, 500 mg tablets marketed within the Federal Capital Territory (FCT), Abuja, Nigeria. The samples were purposively collected from registered retail community pharmacies following WHO guidelines for medicine quality surveillance.
Methodology: Methodology involved assessing physicochemical properties, dissolution profiles, similarity factor (f2), dissimilarity factor (f1), dissolution efficiency (DE), and mean dissolution time (MDT).
Results: While all brands met pharmacopeial standards for an immediate-release solid oral dosage form, only one brand met both f1 and f2 similarity requirements. Although most brands achieved DE values > 80 %.
Conclusions: While many generics eventually release their full drug content, they do not do so at a rate similar to the reference brand, which is critical for concentration-dependent antibiotics. Similarity and dissimilarity factors can be useful for regulatory purposes; they may not provide the same level of insight as mean dissolution time and dissolution efficiency.
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Copyright (c) 2026 Durojaye Aishat Bisoye, Galadima Isa Hayatu, Omachoko Sunday Odoma, Isaac Johnson Ajeh
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