Biowaiver monographs for immediate release solid oral dosage forms: Aciclovir
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Auteurs : J. Arnal [Espagne] ; I. Gonzalez-Alvarez [Espagne] ; M. Bermejo [Espagne] ; 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] ; J. B. Dressman [Allemagne] ; D. M. Barends [Pays-Bas]Source :
- Journal of Pharmaceutical Sciences [ 0022-3549 ] ; 2008-12.
English descriptors
- Teeft :
- Aciclovir, Acyclovir, Acyclovir merck, Acyclovir sandoz, Amidon, Barends, Bioavailability, Bioequivalence, Bioinequivalence, Biopharmaceutics, Biopharmaceutics system, Biowaiver, Biowaiver monograph, Biowaiver monographs, Cmax, Comprimidos, December, Different formulations, Dosage, Dosage forms, Dressman, Drug products, Essential medicines, Excipient, Excipients, February, Immediate release, Junginger, Literature data, Magnesium, Midha, Mono, Monograph, Oral administration, Oral dosage forms, Oral drug products, Permeability, Pharm, Pharmaceutical, Pharmaceutical sciences, Pharmacokinetic, Shah, Sodium starch glycolate, Solubility, Solubility values, Stavchansky, Tablet, Tablet strengths, Tabletten, Tabletten acyclovir, Tabletter, Tabletti, Test formulation, Test product, Tmax, Valaciclovir, World health organization, Zovirax.
Abstract
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing (biowaiver) for the approval of immediate release (IR) solid oral dosage forms containing aciclovir are reviewed. Aciclovir therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) studies were also taken into consideration in order to ascertain whether a biowaiver can be recommended. According to the Biopharmaceutics Classification System (BCS) and considering tablet strengths up to 400 mg, aciclovir would be BCS Class III. However, in some countries also 800 mg tablets are available which fall just within BCS Class IV. Aciclovir seems not to be critical with respect to a risk for bioinequivalence, as no examples of bioinequivalence have been identified. It has a wide therapeutic index and is not used for critical indications. Hence, if: (a) the test product contains only excipients present in aciclovir solid oral IR drug products approved in ICH or associated countries, for instance as presented in this article; and (b) the comparator and the test product both are very rapidly dissolving, a biowaiver for IR aciclovir solid oral drug products is considered justified for all tablet strengths. © 2008 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:5061–5073, 2008
Url:
DOI: 10.1002/jps.21392
Affiliations:
- Allemagne, Canada, Espagne, Pays-Bas, Suisse, Thaïlande, États-Unis
- District de Darmstadt, Hesse (Land), Hollande-Méridionale, Michigan, Texas
- Francfort-sur-le-Main, La Haye
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Aciclovir therapeutic use and therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) studies were also taken into consideration in order to ascertain whether a biowaiver can be recommended. According to the Biopharmaceutics Classification System (BCS) and considering tablet strengths up to 400 mg, aciclovir would be BCS Class III. However, in some countries also 800 mg tablets are available which fall just within BCS Class IV. Aciclovir seems not to be critical with respect to a risk for bioinequivalence, as no examples of bioinequivalence have been identified. It has a wide therapeutic index and is not used for critical indications. Hence, if: (a) the test product contains only excipients present in aciclovir solid oral IR drug products approved in ICH or associated countries, for instance as presented in this article; and (b) the comparator and the test product both are very rapidly dissolving, a biowaiver for IR aciclovir solid oral drug products is considered justified for all tablet strengths. © 2008 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:5061–5073, 2008</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Canada</li><li>Espagne</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="Espagne"><noRegion><name sortKey="Arnal, J" sort="Arnal, J" uniqKey="Arnal J" first="J." last="Arnal">J. Arnal</name></noRegion><name sortKey="Bermejo, M" sort="Bermejo, M" uniqKey="Bermejo M" first="M." last="Bermejo">M. Bermejo</name><name sortKey="Gonzalez Lvarez, I" sort="Gonzalez Lvarez, I" uniqKey="Gonzalez Lvarez I" first="I." last="Gonzalez-Alvarez">I. Gonzalez-Alvarez</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. 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