Related Experiment Video
Updated: Jun 11, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
Published on: August 22, 2017
Biowaiver monographs for immediate release solid oral dosage forms: ciprofloxacin hydrochloride
M E Olivera1, R H Manzo, H E Junginger
1Faculty of Chemical Sciences, Pharmacy Department, CONICET, National University of Córdoba, Córdoba, Argentina.
Abstract:
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing ciprofloxacin hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ciprofloxacin hydrochloride's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and BA data indicate that ciprofloxacin hydrochloride is a BCS Class IV drug. Therefore, a biowaiver based approval of ciprofloxacin hydrochloride containing IR solid oral dosage forms cannot be recommended for either new multisource drug products or for major scale-up and postapproval changes (variations) to existing drug products.
Related Concept Videos
Bioequivalence studies: Biowaivers
Inhibitors of Bacterial DNA Synthesis
Drug Product Performance: In Vitro–In Vivo Correlation
Oral Drug Delivery Systems: Continuous-Release Systems
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
Drug Delivery Systems: Different Types
