Biowaiver monographs for immediate release solid oral dosage forms: Isoniazid A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs .

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dc.contributor.author Becker, C. en_US
dc.contributor.author Dressman, J. B. en_US
dc.contributor.author Amidon, G. L. en_US
dc.contributor.author Junginger, H. E. en_US
dc.contributor.author Kopp, S. en_US
dc.contributor.author Midha, K. K. en_US
dc.contributor.author Shah, V. P. en_US
dc.contributor.author Stavchansky, S. en_US
dc.contributor.author Barends, D. M. en_US
dc.date.accessioned 2007-09-20T18:09:35Z
dc.date.available 2008-04-03T18:49:00Z en_US
dc.date.issued 2007-03 en_US
dc.identifier.citation Becker, C.; Dressman, J.B.; Amidon, G.L.; Junginger, H.E.; Kopp, S.; Midha, K.K.; Shah, V.P.; Stavchansky, S.; Barends, D.M. (2007). "Biowaiver monographs for immediate release solid oral dosage forms: Isoniazid A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs . ." Journal of Pharmaceutical Sciences 96(3): 522-531. <http://hdl.handle.net/2027.42/55934> en_US
dc.identifier.issn 0022-3549 en_US
dc.identifier.issn 1520-6017 en_US
dc.identifier.uri http://hdl.handle.net/2027.42/55934
dc.identifier.uri http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17117431&dopt=citation en_US
dc.description.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 isoniazid as the only active pharmaceutical ingredient (API) are reviewed. Isoniazid's solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Isoniazid is “highly soluble” but data on its oral absorption and permeability are inconclusive, suggesting this API to be on the borderline of BCS Class I and III. For a number of excipients, an interaction with the permeability is extreme unlikely, but lactose and other deoxidizing saccharides can form condensation products with isoniazid, which may be less permeable than the free API. A biowaiver is recommended for IR solid oral drug products containing isoniazid as the sole API, provided that the test product meets the WHO requirements for “very rapidly dissolving” and contains only the excipients commonly used in isoniazid products, as listed in this article. Lactose and/or other deoxidizing saccharides containing formulations should be subjected to an in vivo BE study. © 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci en_US
dc.format.extent 146064 bytes
dc.format.extent 3118 bytes
dc.format.mimetype application/pdf
dc.format.mimetype text/plain
dc.publisher Wiley Subscription Services, Inc., A Wiley Company en_US
dc.subject.other Chemistry en_US
dc.subject.other Food Science, Agricultural, Medicinal and Pharmaceutical Chemistry en_US
dc.title Biowaiver monographs for immediate release solid oral dosage forms: Isoniazid A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs . en_US
dc.type Article en_US
dc.rights.robots IndexNoFollow en_US
dc.subject.hlbsecondlevel Pharmacy and Pharmacology en_US
dc.subject.hlbtoplevel Health Sciences en_US
dc.description.peerreviewed Peer Reviewed en_US
dc.contributor.affiliationum College of Pharmacy, University of Michigan, Ann Arbor, Michigan en_US
dc.contributor.affiliationother Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main, Germany en_US
dc.contributor.affiliationother Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main, Germany en_US
dc.contributor.affiliationother Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand en_US
dc.contributor.affiliationother World Health Organization, Geneva, Switzerland en_US
dc.contributor.affiliationother University of Saskatchewan, Saskatoon, Saskatchewan, Canada en_US
dc.contributor.affiliationother International Pharmaceutical Federation FIP, Den Haag, The Netherlands en_US
dc.contributor.affiliationother Pharmaceutical Division, College of Pharmacy, University of Texas at Austin, Austin, Texas en_US
dc.contributor.affiliationother RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands ; This article reflects the scientific opinion of the authors and not the policies of regulating agencies. ; RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Telephone: +31 30 2744209; Fax: +31 30 274462 en_US
dc.identifier.pmid 17117431 en_US
dc.description.bitstreamurl http://deepblue.lib.umich.edu/bitstream/2027.42/55934/1/20765_ftp.pdf en_US
dc.identifier.doi http://dx.doi.org/10.1002/jps.20765 en_US
dc.identifier.source Journal of Pharmaceutical Sciences en_US
dc.owningcollname Interdisciplinary and Peer-Reviewed
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