biowaiver monographs for immediate release solid oral dosage.pdfVIP

1 Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Diclofenac Sodium and Diclofenac Potassium B. CHUASUWAN,1,2 V. BINJESOH,1,3 J.E. POLLI,1 H. ZHANG,4 G.L. AMIDON,5 H.E. JUNGINGER,6 K.K. MIDHA,7 V.P. SHAH,9 S. STAVCHANSKY,9 J.B. DRESSMAN,10 D.M. BARENDS11 1 Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, Maryland 2 Research and Development Institute, The Government Pharmaceutical Organization, Bangkok, Thailand 3 Faculty of Pharmacy, Rangsit University, Pathumtani, Thailand 4AstraZeneca Pharmaceuticals LP, Wilmington, Delaware 5College of Pharmacy, University of Michigan, Ann Arbor, Michigan 6 Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand 7 University of Saskatchewan, Saskatoon, Saskatchewan, Canada 8 International Pharmaceutical Federation FIP, The Hague, The Netherlands 9 Pharmaceutical Division, College of Pharmacy, University of Texas at Austin, Austin, Texas 10Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt, Germany 11RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands Received 23 May 2008; accepted 3 July 2008 Published online 27 August 2008 in Wiley InterScience (). DOI 10.1002/jps.21525 ABSTRACT: Literature data are reviewed regarding the scientific advisability of allow- ing a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing either diclofenac potassium and diclofenac sodium. Within the biopharmaceutics classification system (BCS), diclofenac potassium and diclofenac sodium are each BCS class II active pharmaceutical ingredients (APIs). However, a biowaiver can be recommended for IR drug products of each salt form, due to their therapeutic