Biowaiver monographs for immediate release solid oral dosage forms: Isoniazid A project of the International Pharmaceutical Federation FIP, Groupe BCS, www.fip.org/bcs .
dc.contributor.author | Becker, C. | en_US |
dc.contributor.author | Dressman, Jennifer B. | en_US |
dc.contributor.author | Amidon, Gordon L. | en_US |
dc.contributor.author | Junginger, H. E. | en_US |
dc.contributor.author | Kopp, S. | en_US |
dc.contributor.author | Midha, Kamal 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 | https://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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