Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride

Autores
Olivera, Maria Eugenia; Manzo, Ruben Hilario; Junginger, H. E.; Midha, K. K.; Shah, V. P.; Stavchansky, S; Dressman, J.B.; D.M. Barends.
Año de publicación
2011
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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 ciprofloxacin hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ciprofloxacin hydrochloride's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and BA data indicate that ciprofloxacin hydrochloride is a BCS Class IV drug. Therefore, a biowaiver based approval of ciprofloxacin hydrochloride 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.
Fil: Olivera, Maria Eugenia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
Fil: Manzo, Ruben Hilario. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
Fil: Junginger, H. E.. Naresuan University; Tailandia
Fil: Midha, K. K.. University of Saskatchewan; Canadá
Fil: Shah, V. P.. International Pharmaceutical Federation; Países Bajos
Fil: Stavchansky, S. University of Texas at Austin. Oden Institute for Computational Engineering and Sciences; Estados Unidos
Fil: Dressman, J.B.. Goethe Universitat Frankfurt; Alemania
Fil: D.M. Barends.. National Institute for Public Health and the Environment; Países Bajos
Materia
ABSORPTION
BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)
CIPROFLOXACIN
DISSOLUTION
PERMEABILITY
REGULATORY SCIENCE
SOLUBILITY
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/131969
Acceder
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network_name_str CONICET Digital (CONICET)
spelling Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochlorideOlivera, Maria EugeniaManzo, Ruben HilarioJunginger, H. E.Midha, K. K.Shah, V. P.Stavchansky, SDressman, J.B.D.M. Barends.ABSORPTIONBIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)CIPROFLOXACINDISSOLUTIONPERMEABILITYREGULATORY SCIENCESOLUBILITYhttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Literature 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 ciprofloxacin hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ciprofloxacin hydrochloride's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and BA data indicate that ciprofloxacin hydrochloride is a BCS Class IV drug. Therefore, a biowaiver based approval of ciprofloxacin hydrochloride 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.Fil: Olivera, Maria Eugenia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; ArgentinaFil: Manzo, Ruben Hilario. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; ArgentinaFil: Junginger, H. E.. Naresuan University; TailandiaFil: Midha, K. K.. University of Saskatchewan; CanadáFil: Shah, V. P.. International Pharmaceutical Federation; Países BajosFil: Stavchansky, S. University of Texas at Austin. Oden Institute for Computational Engineering and Sciences; Estados UnidosFil: Dressman, J.B.. Goethe Universitat Frankfurt; AlemaniaFil: D.M. Barends.. National Institute for Public Health and the Environment; Países BajosJohn Wiley & Sons Inc2011-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/131969Olivera, Maria Eugenia; Manzo, Ruben Hilario; Junginger, H. E.; Midha, K. K.; Shah, V. P.; et al.; Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride; John Wiley & Sons Inc; Journal of Pharmaceutical Sciences; 100; 1; 1-2011; 22-330022-3549CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://jpharmsci.org/article/S0022-3549(15)32338-8/fulltextinfo:eu-repo/semantics/altIdentifier/doi/10.1002/jps.22259info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-29T10:18:53Zoai:ri.conicet.gov.ar:11336/131969instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-09-29 10:18:53.679CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
title Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
spellingShingle Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
Olivera, Maria Eugenia
ABSORPTION
BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)
CIPROFLOXACIN
DISSOLUTION
PERMEABILITY
REGULATORY SCIENCE
SOLUBILITY
title_short Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
title_full Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
title_fullStr Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
title_full_unstemmed Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
title_sort Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride
dc.creator.none.fl_str_mv Olivera, Maria Eugenia
Manzo, Ruben Hilario
Junginger, H. E.
Midha, K. K.
Shah, V. P.
Stavchansky, S
Dressman, J.B.
D.M. Barends.
author Olivera, Maria Eugenia
author_facet Olivera, Maria Eugenia
Manzo, Ruben Hilario
Junginger, H. E.
Midha, K. K.
Shah, V. P.
Stavchansky, S
Dressman, J.B.
D.M. Barends.
author_role author
author2 Manzo, Ruben Hilario
Junginger, H. E.
Midha, K. K.
Shah, V. P.
Stavchansky, S
Dressman, J.B.
D.M. Barends.
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv ABSORPTION
BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)
CIPROFLOXACIN
DISSOLUTION
PERMEABILITY
REGULATORY SCIENCE
SOLUBILITY
topic ABSORPTION
BIOPHARMACEUTICS CLASSIFICATION SYSTEM (BCS)
CIPROFLOXACIN
DISSOLUTION
PERMEABILITY
REGULATORY SCIENCE
SOLUBILITY
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv 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 ciprofloxacin hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ciprofloxacin hydrochloride's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and BA data indicate that ciprofloxacin hydrochloride is a BCS Class IV drug. Therefore, a biowaiver based approval of ciprofloxacin hydrochloride 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.
Fil: Olivera, Maria Eugenia. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
Fil: Manzo, Ruben Hilario. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Córdoba; Argentina. Universidad Nacional de Córdoba. Facultad de Ciencias Químicas. Departamento de Farmacia; Argentina
Fil: Junginger, H. E.. Naresuan University; Tailandia
Fil: Midha, K. K.. University of Saskatchewan; Canadá
Fil: Shah, V. P.. International Pharmaceutical Federation; Países Bajos
Fil: Stavchansky, S. University of Texas at Austin. Oden Institute for Computational Engineering and Sciences; Estados Unidos
Fil: Dressman, J.B.. Goethe Universitat Frankfurt; Alemania
Fil: D.M. Barends.. National Institute for Public Health and the Environment; Países Bajos
description 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 ciprofloxacin hydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ciprofloxacin hydrochloride's solubility and permeability, its therapeutic use and index, pharmacokinetics, excipient interactions and reported BE/bioavailability (BA) problems were taken into consideration. Solubility and BA data indicate that ciprofloxacin hydrochloride is a BCS Class IV drug. Therefore, a biowaiver based approval of ciprofloxacin hydrochloride 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.
publishDate 2011
dc.date.none.fl_str_mv 2011-01
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/131969
Olivera, Maria Eugenia; Manzo, Ruben Hilario; Junginger, H. E.; Midha, K. K.; Shah, V. P.; et al.; Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride; John Wiley & Sons Inc; Journal of Pharmaceutical Sciences; 100; 1; 1-2011; 22-33
0022-3549
CONICET Digital
CONICET
url http://hdl.handle.net/11336/131969
identifier_str_mv Olivera, Maria Eugenia; Manzo, Ruben Hilario; Junginger, H. E.; Midha, K. K.; Shah, V. P.; et al.; Biowaiver monographs for immediate release solid oral dosage forms: Ciprofloxacin hydrochloride; John Wiley & Sons Inc; Journal of Pharmaceutical Sciences; 100; 1; 1-2011; 22-33
0022-3549
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://jpharmsci.org/article/S0022-3549(15)32338-8/fulltext
info:eu-repo/semantics/altIdentifier/doi/10.1002/jps.22259
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv John Wiley & Sons Inc
publisher.none.fl_str_mv John Wiley & Sons Inc
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
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score 13.070432

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