title: Biowaiver monographs for immediate release solid oral dosage forms: ciprofloxacin hydrochloride.
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.
authors.affiliation: Faculty of Chemical Sciences, Pharmacy Department, CONICET, National University of Córdoba, Córdoba, Argentina.
authors.forename: M E
authors.initials: ME
authors.lastname: Olivera
authors.forename: R H
authors.initials: RH
authors.lastname: Manzo
authors.forename: H E
authors.initials: HE
authors.lastname: Junginger
authors.forename: K K
authors.initials: KK
authors.lastname: Midha
authors.forename: V P
authors.initials: VP
authors.lastname: Shah
authors.forename: S
authors.initials: S
authors.lastname: Stavchansky
authors.forename: J B
authors.initials: JB
authors.lastname: Dressman
authors.forename: D M
authors.initials: DM
authors.lastname: Barends
mesh_terms: D000284:Administration, Oral; D000818:Animals; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics* / Q000627:therapeutic use; D001682:Biological Availability; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics* / Q000627:therapeutic use; D004304:Dosage Forms; D017277:Drug Approval; D005079:Excipients; D006801:Humans; D007408:Intestinal Absorption; D010539:Permeability; D012995:Solubility; D013810:Therapeutic Equivalency
chemical_list: D000900:Anti-Bacterial Agents; D004304:Dosage Forms; D005079:Excipients; D002939:Ciprofloxacin