Biowaiver monographs for immediate release solid oral dosage forms: Aciclovir
Identifieur interne : 001A24 ( Istex/Corpus ); précédent : 001A23; suivant : 001A25Biowaiver monographs for immediate release solid oral dosage forms: Aciclovir
Auteurs : J. Arnal ; I. Gonzalez-Alvarez ; M. Bermejo ; G. L. Amidon ; H. E. Junginger ; S. Kopp ; K. K. Midha ; V. P. Shah ; S. Stavchansky ; J. B. Dressman ; D. M. BarendsSource :
- 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
Links to Exploration step
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<front><div type="abstract" xml:lang="en">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</div>
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<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">M.</namePart>
<namePart type="family">Bermejo</namePart>
<affiliation>Facultad de Farmacia, Universidad de Valencia, Burjassot 46100, Valencia, Spain</affiliation>
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</name>
<name type="personal"><namePart type="given">G.L.</namePart>
<namePart type="family">Amidon</namePart>
<affiliation>College of Pharmacy, University of Michigan, Ann Arbor, Michigan</affiliation>
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<name type="personal"><namePart type="given">H.E.</namePart>
<namePart type="family">Junginger</namePart>
<affiliation>Faculty of Pharmaceutical Sciences, Naresuan University, Phitsanulok, Thailand</affiliation>
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<affiliation>World Health Organization, Geneva, Switzerland</affiliation>
<description>This article reflects the scientific opinion of the authors and not the policies of regulating agencies.</description>
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</name>
<name type="personal"><namePart type="given">K.K.</namePart>
<namePart type="family">Midha</namePart>
<affiliation>University of Saskatchewan, Saskatoon, Saskatchewan, Canada</affiliation>
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<namePart type="family">Shah</namePart>
<affiliation>International Pharmaceutical Federation FIP, Den Haag, The Netherlands</affiliation>
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<namePart type="family">Stavchansky</namePart>
<affiliation>Pharmaceutical Division, College of Pharmacy, University of Texas at Austin, Austin, Texas</affiliation>
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<name type="personal"><namePart type="given">J.B.</namePart>
<namePart type="family">Dressman</namePart>
<affiliation>Institute of Pharmaceutical Technology, J.W. Goethe University, Frankfurt am Main, Germany</affiliation>
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<name type="personal"><namePart type="given">D.M.</namePart>
<namePart type="family">Barends</namePart>
<affiliation>RIVM, National Institute for Public Health and the Environment, Bilthoven, The Netherlands</affiliation>
<description>This article reflects the scientific opinion of the authors and not the policies of regulating agencies.</description>
<affiliation>E-mail: dirk.barends@rivm.nl</affiliation>
<affiliation>Correspondence address: RIVM, National Institute for Public Health and the Environment, Bilthoven, The Netherlands. Telephone: +31‐30‐2744209; Fax: +31‐30‐2744462.</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<typeOfResource>text</typeOfResource>
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<originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher>
<place><placeTerm type="text">Hoboken</placeTerm>
</place>
<dateIssued encoding="w3cdtf">2008-12</dateIssued>
<dateCaptured encoding="w3cdtf">2008-01-30</dateCaptured>
<dateValid encoding="w3cdtf">2008-02-25</dateValid>
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<physicalDescription><extent unit="figures">1</extent>
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<abstract lang="en">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</abstract>
<subject lang="en"><genre>keywords</genre>
<topic>absorption</topic>
<topic>aciclovir</topic>
<topic>bioequivalence</topic>
<topic>biopharmaceutics classification system (BCS)</topic>
<topic>permeability</topic>
<topic>solubility</topic>
<topic>regulatory science</topic>
</subject>
<relatedItem type="host"><titleInfo><title>Journal of Pharmaceutical Sciences</title>
</titleInfo>
<titleInfo type="abbreviated"><title>J. Pharm. Sci.</title>
</titleInfo>
<genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre>
<subject><genre>article-category</genre>
<topic>Commentary</topic>
<topic>Commentaries</topic>
</subject>
<identifier type="ISSN">0022-3549</identifier>
<identifier type="eISSN">1520-6017</identifier>
<identifier type="DOI">10.1002/(ISSN)1520-6017</identifier>
<identifier type="PublisherID">JPS</identifier>
<part><date>2008</date>
<detail type="volume"><caption>vol.</caption>
<number>97</number>
</detail>
<detail type="issue"><caption>no.</caption>
<number>12</number>
</detail>
<extent unit="pages"><start>5061</start>
<end>5073</end>
<total>13</total>
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