Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Furosemide

G. GRANERO; M. LONGHI; M. MORA; H. JUNGINGER; K. MIDHA; V. SHAH; S. STANVCHANSKY; J. DRESSMAN; D. BARENDS

JOURNAL OF PHARMACEUTICAL SCIENCES

JOHN WILEY & SONS INC

Lugar: Lawrence, Kansas, USA; Año: 2010 vol. 99 p. 2544 - 2556

0022-3549

Literature and new experimental data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing furosemide are reviewed. The available data on solubility, oral absorption, and permeability are sufficiently conclusive to classify furosemide into Class IV of the Biopharmaceutics Classification System (BCS). Furosemide’s therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) problems are also taken into consideration. In view of the data available, it is concluded that the biowaiver procedure cannot be justified for either the registration of new multisource drug products or major postapproval changes (variations) to existing drug products.