Publication: Biowaiver monographs for immediate release solid oral dosage forms: Mefloquine hydrochloride
Issued Date
2011-01-01
Resource Type
ISSN
15206017
00223549
00223549
Other identifier(s)
2-s2.0-78650067024
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Mahidol University
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SCOPUS
Bibliographic Citation
Journal of Pharmaceutical Sciences. Vol.100, No.1 (2011), 11-21
Suggested Citation
S. Strauch, E. Jantratid, J. B. Dressman, H. E. Junginger, S. Kopp, K. K. Midha, V. P. Shah, S. Stavchansky, D. M. Barends Biowaiver monographs for immediate release solid oral dosage forms: Mefloquine hydrochloride. Journal of Pharmaceutical Sciences. Vol.100, No.1 (2011), 11-21. doi:10.1002/jps.22249 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/12833
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Title
Biowaiver monographs for immediate release solid oral dosage forms: Mefloquine hydrochloride
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. © 2010 Wiley-Liss, Inc.
