Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ciprofloxacin Hydrochloride |
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| Authors: | ME Olivera RH Manzo HE Junginger KK Midha VP Shah S Stavchansky JB Dressman DM Barends |
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| Institution: | 1. Faculty of Chemical Sciences, Pharmacy Department, CONICET, National University of Córdoba, Córdoba, Argentina;2. Faculty of Pharmaceutical Sciences, Department of Pharmaceutics, Naresuan University, Phitsanulok, Thailand;3. University of Saskatchewan, Division of Pharmacy, Saskatoon, Saskatchewan, Canada;4. International Pharmaceutical Federation FIP, The Hague, The Netherlands;5. Pharmaceutics Division, College of Pharmacy, University of Texas at Austin, Austin, Texas;6. Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt, Germany;7. RIMV – National Institute for Public Health and the Environment, Bilthoven, The Netherlands |
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| 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. |
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