Dissolution studies of generic medications: New evidence of deviations from the transitivity principle

Autores
Ruiz, María Esperanza; Gregorini, Anabella; Talevi, Alan; Volonté, Maria Guillermina
Año de publicación
2012
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
Current international criteria to guarantee that two equivalent pharmaceutical medications are interchangeable establish that substitution may be done whenever studies indicate that a generic or similar product is bioequivalent to the reference product. The principle of transitivity defines interchangeability between approved pharmaceutical equivalents (i.e., given two generic products B and C and a reference A, if B and C are bioequivalent to A, then B and C are assumed to be bioequivalent although bioequivalence between them has not been actually assessed). In this study, the goal was to test the applicability of the transitivity principle in establishing interchangeability between pharmaceutical equivalents. We obtained the dissolution profiles of all the products corresponding to tablets of ranitidine 300 mg and cephalexin 500 mg (Biopharmaceutics Classification System Class III), furosemide 40 mg (Class IV), and ibuprofen 400 mg and 600 mg (BCS Class II) available in the Argentinean pharmaceutical market. Dissolution profiles of all possible pairs were compared through similarity factor f2. The results obtained bring into question the general validity of the transitivity principle, as many examples were observed to have dissolution profiles similar to the reference product, yet were not equivalent. Although this has only been assessed through in vitro tests, our results are potentially important, as a number of recent reports have suggested the extension of biowaivers to certain BCS Class II and Class III products, including ranitidine hydrochloride and ibuprofen.
Fil: Ruiz, María Esperanza. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina
Fil: Gregorini, Anabella. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; Argentina
Fil: Talevi, Alan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Química Medicinal; Argentina
Fil: Volonté, Maria Guillermina. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; Argentina
Materia
TRANSITIVITY PRINCIPLE
BIOEQUIVALENCE
DISSOLUTION PROFILES
SIMILARITY FACTOR F2
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:11336/246202
Acceder
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oai_identifier_str oai:ri.conicet.gov.ar:11336/246202
network_acronym_str CONICETDig
repository_id_str 3498
network_name_str CONICET Digital (CONICET)
spelling Dissolution studies of generic medications: New evidence of deviations from the transitivity principleRuiz, María EsperanzaGregorini, AnabellaTalevi, AlanVolonté, Maria GuillerminaTRANSITIVITY PRINCIPLEBIOEQUIVALENCEDISSOLUTION PROFILESSIMILARITY FACTOR F2https://purl.org/becyt/ford/1.7https://purl.org/becyt/ford/1https://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Current international criteria to guarantee that two equivalent pharmaceutical medications are interchangeable establish that substitution may be done whenever studies indicate that a generic or similar product is bioequivalent to the reference product. The principle of transitivity defines interchangeability between approved pharmaceutical equivalents (i.e., given two generic products B and C and a reference A, if B and C are bioequivalent to A, then B and C are assumed to be bioequivalent although bioequivalence between them has not been actually assessed). In this study, the goal was to test the applicability of the transitivity principle in establishing interchangeability between pharmaceutical equivalents. We obtained the dissolution profiles of all the products corresponding to tablets of ranitidine 300 mg and cephalexin 500 mg (Biopharmaceutics Classification System Class III), furosemide 40 mg (Class IV), and ibuprofen 400 mg and 600 mg (BCS Class II) available in the Argentinean pharmaceutical market. Dissolution profiles of all possible pairs were compared through similarity factor f2. The results obtained bring into question the general validity of the transitivity principle, as many examples were observed to have dissolution profiles similar to the reference product, yet were not equivalent. Although this has only been assessed through in vitro tests, our results are potentially important, as a number of recent reports have suggested the extension of biowaivers to certain BCS Class II and Class III products, including ranitidine hydrochloride and ibuprofen.Fil: Ruiz, María Esperanza. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; ArgentinaFil: Gregorini, Anabella. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; ArgentinaFil: Talevi, Alan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Química Medicinal; ArgentinaFil: Volonté, Maria Guillermina. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; ArgentinaDissolution Technologies, Inc2012-02info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/246202Ruiz, María Esperanza; Gregorini, Anabella; Talevi, Alan; Volonté, Maria Guillermina; Dissolution studies of generic medications: New evidence of deviations from the transitivity principle; Dissolution Technologies, Inc; Dissolution Technologies; 19; 1; 2-2012; 13-241521-298XCONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://dissolutiontech.com/DTresour/201202Articles/DT201202_A02.pdfinfo:eu-repo/semantics/altIdentifier/doi/10.14227/DT190112P13info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-sa/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-09-03T10:05:09Zoai:ri.conicet.gov.ar:11336/246202instacron: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:34982025-09-03 10:05:10.078CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
title Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
spellingShingle Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
Ruiz, María Esperanza
TRANSITIVITY PRINCIPLE
BIOEQUIVALENCE
DISSOLUTION PROFILES
SIMILARITY FACTOR F2
title_short Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
title_full Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
title_fullStr Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
title_full_unstemmed Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
title_sort Dissolution studies of generic medications: New evidence of deviations from the transitivity principle
dc.creator.none.fl_str_mv Ruiz, María Esperanza
Gregorini, Anabella
Talevi, Alan
Volonté, Maria Guillermina
author Ruiz, María Esperanza
author_facet Ruiz, María Esperanza
Gregorini, Anabella
Talevi, Alan
Volonté, Maria Guillermina
author_role author
author2 Gregorini, Anabella
Talevi, Alan
Volonté, Maria Guillermina
author2_role author
author
author
dc.subject.none.fl_str_mv TRANSITIVITY PRINCIPLE
BIOEQUIVALENCE
DISSOLUTION PROFILES
SIMILARITY FACTOR F2
topic TRANSITIVITY PRINCIPLE
BIOEQUIVALENCE
DISSOLUTION PROFILES
SIMILARITY FACTOR F2
purl_subject.fl_str_mv https://purl.org/becyt/ford/1.7
https://purl.org/becyt/ford/1
https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv Current international criteria to guarantee that two equivalent pharmaceutical medications are interchangeable establish that substitution may be done whenever studies indicate that a generic or similar product is bioequivalent to the reference product. The principle of transitivity defines interchangeability between approved pharmaceutical equivalents (i.e., given two generic products B and C and a reference A, if B and C are bioequivalent to A, then B and C are assumed to be bioequivalent although bioequivalence between them has not been actually assessed). In this study, the goal was to test the applicability of the transitivity principle in establishing interchangeability between pharmaceutical equivalents. We obtained the dissolution profiles of all the products corresponding to tablets of ranitidine 300 mg and cephalexin 500 mg (Biopharmaceutics Classification System Class III), furosemide 40 mg (Class IV), and ibuprofen 400 mg and 600 mg (BCS Class II) available in the Argentinean pharmaceutical market. Dissolution profiles of all possible pairs were compared through similarity factor f2. The results obtained bring into question the general validity of the transitivity principle, as many examples were observed to have dissolution profiles similar to the reference product, yet were not equivalent. Although this has only been assessed through in vitro tests, our results are potentially important, as a number of recent reports have suggested the extension of biowaivers to certain BCS Class II and Class III products, including ranitidine hydrochloride and ibuprofen.
Fil: Ruiz, María Esperanza. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina
Fil: Gregorini, Anabella. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; Argentina
Fil: Talevi, Alan. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - La Plata; Argentina. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Química Medicinal; Argentina
Fil: Volonté, Maria Guillermina. Universidad Nacional de La Plata. Facultad de Ciencias Exactas. Departamento de Ciencias Biológicas. Cátedra de Control de Calidad de Medicamentos; Argentina
description Current international criteria to guarantee that two equivalent pharmaceutical medications are interchangeable establish that substitution may be done whenever studies indicate that a generic or similar product is bioequivalent to the reference product. The principle of transitivity defines interchangeability between approved pharmaceutical equivalents (i.e., given two generic products B and C and a reference A, if B and C are bioequivalent to A, then B and C are assumed to be bioequivalent although bioequivalence between them has not been actually assessed). In this study, the goal was to test the applicability of the transitivity principle in establishing interchangeability between pharmaceutical equivalents. We obtained the dissolution profiles of all the products corresponding to tablets of ranitidine 300 mg and cephalexin 500 mg (Biopharmaceutics Classification System Class III), furosemide 40 mg (Class IV), and ibuprofen 400 mg and 600 mg (BCS Class II) available in the Argentinean pharmaceutical market. Dissolution profiles of all possible pairs were compared through similarity factor f2. The results obtained bring into question the general validity of the transitivity principle, as many examples were observed to have dissolution profiles similar to the reference product, yet were not equivalent. Although this has only been assessed through in vitro tests, our results are potentially important, as a number of recent reports have suggested the extension of biowaivers to certain BCS Class II and Class III products, including ranitidine hydrochloride and ibuprofen.
publishDate 2012
dc.date.none.fl_str_mv 2012-02
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/11336/246202
Ruiz, María Esperanza; Gregorini, Anabella; Talevi, Alan; Volonté, Maria Guillermina; Dissolution studies of generic medications: New evidence of deviations from the transitivity principle; Dissolution Technologies, Inc; Dissolution Technologies; 19; 1; 2-2012; 13-24
1521-298X
CONICET Digital
CONICET
url http://hdl.handle.net/11336/246202
identifier_str_mv Ruiz, María Esperanza; Gregorini, Anabella; Talevi, Alan; Volonté, Maria Guillermina; Dissolution studies of generic medications: New evidence of deviations from the transitivity principle; Dissolution Technologies, Inc; Dissolution Technologies; 19; 1; 2-2012; 13-24
1521-298X
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://dissolutiontech.com/DTresour/201202Articles/DT201202_A02.pdf
info:eu-repo/semantics/altIdentifier/doi/10.14227/DT190112P13
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
application/pdf
dc.publisher.none.fl_str_mv Dissolution Technologies, Inc
publisher.none.fl_str_mv Dissolution Technologies, 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
_version_ 1842269896278278144
score 13.13397

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