Publication: Biowaiver monographs for immediate release solid oral dosage forms: Lamivudine
Issued Date
2011-01-01
Resource Type
ISSN
15206017
00223549
00223549
Other identifier(s)
2-s2.0-79954613321
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Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Journal of Pharmaceutical Sciences. Vol.100, No.6 (2011), 2054-2063
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: Lamivudine. Journal of Pharmaceutical Sciences. Vol.100, No.6 (2011), 2054-2063. doi:10.1002/jps.22449 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/12834
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Title
Biowaiver monographs for immediate release solid oral dosage forms: Lamivudine
Abstract
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing lamivudine as the only active pharmaceutical ingredient were reviewed. The solubility and permeability data of lamivudine as well as its therapeutic index, its pharmacokinetic properties, data indicating excipient interactions, and reported BE/bioavailability (BA) studies were taken into consideration. Lamivudine is highly soluble, but its permeability characteristics are not well-defined. Reported BA values in adults ranged from 82% to 88%. Therefore, lamivudine is assigned to the biopharmaceutics classification system (BCS) class III, noting that its permeability characteristics are near the border of BCS class I. Lamivudine is not a narrow therapeutic index drug. Provided that (a) the test product contains only excipients present in lamivudine IR solid oral drug products approved in the International Conference on Harmonization or associated countries in usual amounts and (b) the test product as well as the comparator product fulfills the BCS dissolution criteria for very rapidly dissolving; a biowaiver can be recommended for new lamivudine multisource IR products and major post-approval changes of marketed drug products. © 2011 Wiley-Liss, Inc.