QUALITY EVALUATION OF MARKETED BRANDS OF CIPROFLOXACIN TABLETS: IN VITRO EQUIVALENCE

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Maaike Dijkstra
Mathilde Delacroix
Elena Vitale

Abstract

Ciprofloxacin tablets are sold under many brand names, and clinicians assume that they can be interchanged. This narrative review examines how the published literature judges that assumption in vitro. It covers the biopharmaceutical properties of the drug, pharmacopoeial and physical tests, dissolution profile comparison and the similarity factor, biowaiver and correlation concepts, and evidence on substandard antimicrobials. It reports no new laboratory data and names no brand. The literature supports multi-medium dissolution testing with validated assays and several batches per brand, while showing that many evaluations rely on single-medium, single-batch designs. In vitro similarity is consistent with, but does not prove, bioequivalence, and reporting standards need to improve.

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