Interchangeability among carbamazepine formulations: the impact over epilepsy patients

The treatment of epilepsy is complex and a matter of concern is the interchangeability among different formulations available for antiepileptic drugs. To evaluate the effects of interchangeability among carbamazepine formulations on patients with epilepsy. This is a prospective cohort study that inc...

Full description

Bibliographic Details
Authors: Frade, Virgínia Paula, Nunes Paiva, Maria Jose, Martins, Isarita, de Castro, Whocely Victor, Belo, Vinicius Silva, Baldoni, Andre Oliveira, Freitas-Lima, Priscila, Sanches, Cristina
Format: article
Status:Published version
Publication Date:2022
Country:Brasil
Institution:Universidade de São Paulo (USP)
Repository:Brazilian Journal of Pharmaceutical Sciences
Language:English
OAI Identifier:oai:revistas.usp.br:article/204749
Online Access:https://www.revistas.usp.br/bjps/article/view/204749
Access Level:Open access
Keyword:Antiepilepticdrugs
Carbamazepine
Epilepsy
Genericmedications
Interchangeability
id BR_44fd39f8733ddc4378883ff23cdccdfc
oai_identifier_str oai:revistas.usp.br:article/204749
network_acronym_str BR
network_name_str Brasil
repository_id_str
spelling Interchangeability among carbamazepine formulations: the impact over epilepsy patientsAntiepilepticdrugsCarbamazepineEpilepsyGenericmedicationsInterchangeabilityThe treatment of epilepsy is complex and a matter of concern is the interchangeability among different formulations available for antiepileptic drugs. To evaluate the effects of interchangeability among carbamazepine formulations on patients with epilepsy. This is a prospective cohort study that included adult outpatients diagnosed with epilepsy and under pharmacological treatment with carbamazepine. Before switching the brand/manufacturer, the “Interchangeable Pharmaceutical Product in the Treatment of Epilepsies” questionnaire was applied. The questionnaires “Adverse Events Profile” and Quality of Life in Epilepsy-31, so as the plasma carbamazepine concentrations, were evaluated before and after the brand/ manufacturer switch. Physical-chemical tests aiming to assess tablets quality were performed in accordance with the Brazilian Pharmacopoeia 5th edition. The study population was composed by 14 patients (mean age: 44.6 years), with 10 of females. From those interviewed, 10 had no knowledge about the three antiepileptic drugs formulations available. The frequency of adverse event “problems with skin” incresead (p=0.023) and “upset stomach” decreased (p=0.041) after the changeover. The adverse events profile was associated with only two quality of life domains: “energy/fatigue” (p=0.048) and “total score” (p=0.018). Divergent results between generic and reference formulations were observed in purity-water test (reference: 1.96%, generic: 4.84%) and dissolution test, in which the generic formulation presented 66.27 to 85.77% of carbamazepine dissolved after the third level.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2022-11-23info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/20474910.1590/s2175-97902022e19594Brazilian Journal of Pharmaceutical Sciences; Vol. 58 (2022)Brazilian Journal of Pharmaceutical Sciences; v. 58 (2022)Brazilian Journal of Pharmaceutical Sciences; Vol. 58 (2022)2175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/204749/196191Copyright (c) 2022 Brazilian Journal of Pharmaceutical Scienceshttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessFrade, Virgínia PaulaNunes Paiva, Maria JoseMartins, Isaritade Castro, Whocely VictorBelo, Vinicius SilvaBaldoni, Andre OliveiraFreitas-Lima, PriscilaSanches, Cristina2023-08-21T18:32:40Zoai:revistas.usp.br:article/204749Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2023-08-21T18:32:40Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Interchangeability among carbamazepine formulations: the impact over epilepsy patients
title Interchangeability among carbamazepine formulations: the impact over epilepsy patients
spellingShingle Interchangeability among carbamazepine formulations: the impact over epilepsy patients
Frade, Virgínia Paula
Antiepilepticdrugs
Carbamazepine
Epilepsy
Genericmedications
Interchangeability
title_short Interchangeability among carbamazepine formulations: the impact over epilepsy patients
title_full Interchangeability among carbamazepine formulations: the impact over epilepsy patients
title_fullStr Interchangeability among carbamazepine formulations: the impact over epilepsy patients
title_full_unstemmed Interchangeability among carbamazepine formulations: the impact over epilepsy patients
title_sort Interchangeability among carbamazepine formulations: the impact over epilepsy patients
dc.creator.none.fl_str_mv Frade, Virgínia Paula
Nunes Paiva, Maria Jose
Martins, Isarita
de Castro, Whocely Victor
Belo, Vinicius Silva
Baldoni, Andre Oliveira
Freitas-Lima, Priscila
Sanches, Cristina
author Frade, Virgínia Paula
author_facet Frade, Virgínia Paula
Nunes Paiva, Maria Jose
Martins, Isarita
de Castro, Whocely Victor
Belo, Vinicius Silva
Baldoni, Andre Oliveira
Freitas-Lima, Priscila
Sanches, Cristina
author_role author
author2 Nunes Paiva, Maria Jose
Martins, Isarita
de Castro, Whocely Victor
Belo, Vinicius Silva
Baldoni, Andre Oliveira
Freitas-Lima, Priscila
Sanches, Cristina
author2_role author
author
author
author
author
author
author
dc.subject.por.fl_str_mv Antiepilepticdrugs
Carbamazepine
Epilepsy
Genericmedications
Interchangeability
topic Antiepilepticdrugs
Carbamazepine
Epilepsy
Genericmedications
Interchangeability
description The treatment of epilepsy is complex and a matter of concern is the interchangeability among different formulations available for antiepileptic drugs. To evaluate the effects of interchangeability among carbamazepine formulations on patients with epilepsy. This is a prospective cohort study that included adult outpatients diagnosed with epilepsy and under pharmacological treatment with carbamazepine. Before switching the brand/manufacturer, the “Interchangeable Pharmaceutical Product in the Treatment of Epilepsies” questionnaire was applied. The questionnaires “Adverse Events Profile” and Quality of Life in Epilepsy-31, so as the plasma carbamazepine concentrations, were evaluated before and after the brand/ manufacturer switch. Physical-chemical tests aiming to assess tablets quality were performed in accordance with the Brazilian Pharmacopoeia 5th edition. The study population was composed by 14 patients (mean age: 44.6 years), with 10 of females. From those interviewed, 10 had no knowledge about the three antiepileptic drugs formulations available. The frequency of adverse event “problems with skin” incresead (p=0.023) and “upset stomach” decreased (p=0.041) after the changeover. The adverse events profile was associated with only two quality of life domains: “energy/fatigue” (p=0.048) and “total score” (p=0.018). Divergent results between generic and reference formulations were observed in purity-water test (reference: 1.96%, generic: 4.84%) and dissolution test, in which the generic formulation presented 66.27 to 85.77% of carbamazepine dissolved after the third level.
publishDate 2022
dc.date.none.fl_str_mv 2022-11-23
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.revistas.usp.br/bjps/article/view/204749
10.1590/s2175-97902022e19594
url https://www.revistas.usp.br/bjps/article/view/204749
identifier_str_mv 10.1590/s2175-97902022e19594
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/bjps/article/view/204749/196191
dc.rights.driver.fl_str_mv Copyright (c) 2022 Brazilian Journal of Pharmaceutical Sciences
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2022 Brazilian Journal of Pharmaceutical Sciences
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
publisher.none.fl_str_mv Universidade de São Paulo. Faculdade de Ciências Farmacêuticas
dc.source.none.fl_str_mv Brazilian Journal of Pharmaceutical Sciences; Vol. 58 (2022)
Brazilian Journal of Pharmaceutical Sciences; v. 58 (2022)
Brazilian Journal of Pharmaceutical Sciences; Vol. 58 (2022)
2175-9790
1984-8250
reponame:Brazilian Journal of Pharmaceutical Sciences
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Brazilian Journal of Pharmaceutical Sciences
collection Brazilian Journal of Pharmaceutical Sciences
repository.name.fl_str_mv Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)
repository.mail.fl_str_mv bjps@usp.br||elizabeth.igne@gmail.com
_version_ 1853675624916320256
score 15,300719

Similar Items