Biowaiver monographs for immediate release solid oral dosage forms: Rifampicin
Identifieur interne : 002454 ( Istex/Corpus ); précédent : 002453; suivant : 002455Biowaiver monographs for immediate release solid oral dosage forms: Rifampicin
Auteurs : C. Becker ; J. B. Dressman ; H. E. Junginger ; S. Kopp ; K. K. Midha ; V. P. Shah ; S. Stavchansky ; D. M. BarendsSource :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 2009-07.
Abstract
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing rifampicin as the only Active Pharmaceutical Ingredient (API) are reviewed. Rifampicin's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and absolute BA data indicate that rifampicin is a BCS Class II drug. Of special concern for biowaiving is that many reports of failure of IR solid oral dosage forms of rifampicin to meet BE have been published and the reasons for these failures are yet insufficiently understood. Moreover, no reports were identified in which in vitro dissolution was shown to be predictive of nonequivalence among products. Therefore, a biowaiver based approval of rifampicin containing IR solid oral dosage forms cannot be recommended for either new multisource drug products or for major scale‐up and postapproval changes (variations) to existing drug products. © 2009 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2252–2267, 2009
Url:
DOI: 10.1002/jps.21624
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ISTEX:32253E0C22887116A6012BDF437360E2D43D6538Le document en format XML
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Rifampicin's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and absolute BA data indicate that rifampicin is a BCS Class II drug. Of special concern for biowaiving is that many reports of failure of IR solid oral dosage forms of rifampicin to meet BE have been published and the reasons for these failures are yet insufficiently understood. Moreover, no reports were identified in which <i>in vitro</i> dissolution was shown to be predictive of nonequivalence among products. Therefore, a biowaiver based approval of rifampicin containing IR solid oral dosage forms cannot be recommended for either new multisource drug products or for major scale‐up and postapproval changes (variations) to existing drug products. © 2009 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2252–2267, 2009</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>A project of the International Pharmaceutical Federation FIP, Group BCS, <url href="http://www.fip.org/bcs">www.fip.org/bcs</url>.</p></note><note xml:id="fn2"><p>This article reflects the scientific opinion of the authors and not necessarily the policies of Bayer Technology Services; regulatory agencies; the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO).</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Biowaiver monographs for immediate release solid oral dosage forms: Rifampicin</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>BIOWAIVER MONOGRAPH FOR RIFAMPICIN</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Biowaiver monographs for immediate release solid oral dosage forms: Rifampicin</title></titleInfo><name type="personal"><namePart type="given">C.</namePart><namePart type="family">Becker</namePart><affiliation>Institute of Pharmaceutical Technology, J.W. 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Telephone: 31 30 2744209; Fax: 31 30 2744462.</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="brief-communication" displayLabel="shortCommunication" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-S9SX2MFS-0">brief-communication</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2009-07</dateIssued><dateCaptured encoding="w3cdtf">2008-06-24</dateCaptured><dateValid encoding="w3cdtf">2008-10-13</dateValid><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">3</extent><extent unit="tables">3</extent><extent unit="references">140</extent><extent unit="words">9707</extent></physicalDescription><abstract lang="en">Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of new multisource and reformulated immediate release (IR) solid oral dosage forms containing rifampicin as the only Active Pharmaceutical Ingredient (API) are reviewed. Rifampicin's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and absolute BA data indicate that rifampicin is a BCS Class II drug. Of special concern for biowaiving is that many reports of failure of IR solid oral dosage forms of rifampicin to meet BE have been published and the reasons for these failures are yet insufficiently understood. Moreover, no reports were identified in which in vitro dissolution was shown to be predictive of nonequivalence among products. Therefore, a biowaiver based approval of rifampicin containing IR solid oral dosage forms cannot be recommended for either new multisource drug products or for major scale‐up and postapproval changes (variations) to existing drug products. © 2009 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:2252–2267, 2009</abstract><note type="content">*A project of the International Pharmaceutical Federation FIP, Group BCS, www.fip.org/bcs.</note><note type="content">*This article reflects the scientific opinion of the authors and not necessarily the policies of Bayer Technology Services; regulatory agencies; the International Pharmaceutical Federation (FIP) and the World Health Organization (WHO).</note><subject lang="en"><genre>keywords</genre><topic>absorption</topic><topic>dissolution</topic><topic>biopharmaceutics classification system (BCS)</topic><topic>permeability</topic><topic>regulatory science</topic><topic>rifampicin</topic><topic>solubility</topic></subject><relatedItem type="host"><titleInfo><title>Journal of Pharmaceutical Sciences</title></titleInfo><titleInfo type="abbreviated"><title>J. 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