Biowaiver monographs for immediate release solid oral dosage forms: Isoniazid
Identifieur interne : 001B79 ( Main/Exploration ); précédent : 001B78; suivant : 001B80Biowaiver monographs for immediate release solid oral dosage forms: Isoniazid
Auteurs : C. Becker [Allemagne] ; J. B. Dressman [Allemagne] ; G. L. Amidon [États-Unis] ; H. E. Junginger [Thaïlande] ; S. Kopp [Suisse] ; K. K. Midha [Canada] ; V. P. Shah [Pays-Bas] ; S. Stavchansky [États-Unis] ; D. M. Barends [Pays-Bas]Source :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 2007-03.
English descriptors
- Teeft :
- Barends, Bioavailability, Bioequivalence, Biopharmaceutics, Biopharmaceutics system, Biowaiver, Biowaiver monograph, Biowaiver monographs, Clin pharmacol, Clogp1, Combination treatment, Deoxidizing, Deoxidizing saccharides, Dosage, Dosage forms, Dose combination, Drug products, Essential medicines, Excipient, Excipients, Glucose, Glucose isonicotinylhydrazone, Goethe university, Healthy volunteers, Immediate release, Isoniazid, Isoniazid formulations, Junginger, Lactose, Literature data, Logp, Midha, Monograph, Oral absorption, Oral administration, Oral application, Oral dosage forms, Permeability, Pharm, Pharmaceutical, Pharmaceutical sciences, Pharmaceutical technology, Public health, Pyrazinamide, Rifampicin, Saccharide, Solubility, Therapeutic index, Urinary, Urinary excretion, Urinary recovery, World health organization.
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
Url:
DOI: 10.1002/jps.20765
Affiliations:
- Allemagne, Canada, Pays-Bas, Suisse, Thaïlande, États-Unis
- District de Darmstadt, Hesse (Land), Hollande-Méridionale, Michigan, Texas
- Francfort-sur-le-Main, La Haye
Links toward previous steps (curation, corpus...)
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- to stream Main, to step Merge: 001B90
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Le document en format XML
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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</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Canada</li><li>Pays-Bas</li><li>Suisse</li><li>Thaïlande</li><li>États-Unis</li></country><region><li>District de Darmstadt</li><li>Hesse (Land)</li><li>Hollande-Méridionale</li><li>Michigan</li><li>Texas</li></region><settlement><li>Francfort-sur-le-Main</li><li>La Haye</li></settlement></list><tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Becker, C" sort="Becker, C" uniqKey="Becker C" first="C." last="Becker">C. Becker</name></region><name sortKey="Dressman, J B" sort="Dressman, J B" uniqKey="Dressman J" first="J. B." last="Dressman">J. B. Dressman</name></country><country name="États-Unis"><region name="Michigan"><name sortKey="Amidon, G L" sort="Amidon, G L" uniqKey="Amidon G" first="G. L." last="Amidon">G. L. Amidon</name></region><name sortKey="Stavchansky, S" sort="Stavchansky, S" uniqKey="Stavchansky S" first="S." last="Stavchansky">S. Stavchansky</name></country><country name="Thaïlande"><noRegion><name sortKey="Junginger, H E" sort="Junginger, H E" uniqKey="Junginger H" first="H. E." last="Junginger">H. E. Junginger</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Kopp, S" sort="Kopp, S" uniqKey="Kopp S" first="S." last="Kopp">S. Kopp</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Midha, K K" sort="Midha, K K" uniqKey="Midha K" first="K. K." last="Midha">K. K. 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