Biowaiver Monographs for Immediate Release Solid Oral Forms: Acetazolamide

G.E. GRANERO, M.R. LONGHI, C. BECKER, H.E. JUNGINGER, S. KOPP, K.K. MIDHA, V.P. SHAH,

Wiley InterScience

Año: 2008 p. 3691 - 3691

font face="AdvP0DE0" color="#231f20" size="1"> Literature data relevant to the decision to allow a waiver of in vivoin vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing acetazolamide are reviewed. Acetazolamide’s solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) problems are taken into consideration. The available data on solubility, on oral absorption and permeability a