This article reflects the scientific opinion of the authors and not necessarily the policies of regulating agencies, the International Pharmaceutical Federation (FIP), and the World Health Organization (WHO).
Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride†
Article first published online: 2 JUL 2010
Copyright © 2010 Wiley-Liss, Inc.
Journal of Pharmaceutical Sciences
Volume 100, Issue 1, pages 11–21, January 2011
How to Cite
Strauch, S., Jantratid, E., Dressman, J.B., Junginger, H.E., Kopp, S., Midha, K.K., Shah, V.P., Stavchansky, S. and Barends, D.M. (2011), Biowaiver monographs for immediate release solid oral dosage forms: mefloquine hydrochloride. J. Pharm. Sci., 100: 11–21. doi: 10.1002/jps.22249
- Issue published online: 8 DEC 2010
- Article first published online: 2 JUL 2010
- Manuscript Accepted: 27 APR 2010
- Manuscript Revised: 23 APR 2010
- Manuscript Received: 18 FEB 2010
- Biopharmaceutics Classification System (BCS);
- mefloquine hydrochloride;
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing mefloquine hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. The solubility and permeability data of mefloquine hydrochloride as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability studies were taken into consideration. Mefloquine hydrochloride is not a highly soluble API. Since no data on permeability are available, it cannot be classified according to the Biopharmaceutics Classification System with certainty. Additionally, several studies in the literature failed to demonstrate BE of existing products. For these reasons, the biowaiver cannot be justified for the approval of new multisource drug products containing mefloquine hydrochloride. However, scale-up and postapproval changes (HHS-FDA SUPAC) levels 1 and 2 and most EU type I variations may be approvable without in vivo BE, using the dissolution tests described in these regulatory documents. © 2010 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 100:11–21, 2011