Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Mefloquine Hydrochloride |
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| Authors: | S Strauch E Jantratid JB Dressman HE Junginger S Kopp KK Midha VP Shah S Stavchansky DM Barends |
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| Institution: | 1. Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany;2. Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand;3. World Health Organization (WHO), Geneva, Switzerland;4. University of Saskatchewan, Saskatoon, Saskatchewan, Canada;5. International Pharmaceutical Federation (FIP), The Hague, The Netherlands;6. Pharmaceutics Division, College of Pharmacy, University of Texas at Austin, Austin, Texas;7. RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands |
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| Abstract: | 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. |
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