Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios
Autor(a) principal: | |
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Data de Publicação: | 2019 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Health Review |
Texto Completo: | https://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/3770 |
Resumo: | This study was carried out in order to compare the relative bioavailability of two different formulations containing 2.00 mg of dexchlorpheniramine maleate + 0.25 mg of bethametasona, test formulation (Dexmine®) and reference formulation (Celestamine®) in healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 2 x 2. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical method employed the ultra-performance liquid chromatography triple quadrupole tandem mass spectrometry, using as the internal standard brompheniramine. Non-compartmental model was applied to determine different pharmacokinetic parameters and these were calculated from the plasma concentrations obtained from the volunteer samples. Bioequivalence between test and reference formulation were demonstrated as the calculated 90 % confidence interval for the corresponding ratios of log transformed pharmacokinetic parameters (Cmax, AUC0-t and AUC0-?) fell within the 80–125 % range, the predetermined criterion for therapeutic equivalence. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable. |
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Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadiosDexchlorpheniramineBethametasoneBioequivalenceUPLC-MS/MSThis study was carried out in order to compare the relative bioavailability of two different formulations containing 2.00 mg of dexchlorpheniramine maleate + 0.25 mg of bethametasona, test formulation (Dexmine®) and reference formulation (Celestamine®) in healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 2 x 2. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical method employed the ultra-performance liquid chromatography triple quadrupole tandem mass spectrometry, using as the internal standard brompheniramine. Non-compartmental model was applied to determine different pharmacokinetic parameters and these were calculated from the plasma concentrations obtained from the volunteer samples. Bioequivalence between test and reference formulation were demonstrated as the calculated 90 % confidence interval for the corresponding ratios of log transformed pharmacokinetic parameters (Cmax, AUC0-t and AUC0-?) fell within the 80–125 % range, the predetermined criterion for therapeutic equivalence. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable.Brazilian Journals Publicações de Periódicos e Editora Ltda.2019-10-11info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/377010.34119/bjhrv2n5-039Brazilian Journal of Health Review; Vol. 2 No. 5 (2019); 4371-4385Brazilian Journal of Health Review; v. 2 n. 5 (2019); 4371-43852595-6825reponame:Brazilian Journal of Health Reviewinstname:Federação das Indústrias do Estado do Paraná (FIEP)instacron:BJRHenghttps://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/3770/3572Copyright (c) 2019 Brazilian Journal of Health Reviewinfo:eu-repo/semantics/openAccessSantos, Alessandra Ferreira dosFrancisco, Quevellin Alves dos SantosCorrea, Carlos Eduardo MeloMarques, Vanessa Bergamin Boralli2019-11-07T12:55:53Zoai:ojs2.ojs.brazilianjournals.com.br:article/3770Revistahttp://www.brazilianjournals.com/index.php/BJHR/indexPRIhttps://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/oai|| brazilianjhr@gmail.com2595-68252595-6825opendoar:2019-11-07T12:55:53Brazilian Journal of Health Review - Federação das Indústrias do Estado do Paraná (FIEP)false |
dc.title.none.fl_str_mv |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios |
title |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios |
spellingShingle |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios Santos, Alessandra Ferreira dos Dexchlorpheniramine Bethametasone Bioequivalence UPLC-MS/MS |
title_short |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios |
title_full |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios |
title_fullStr |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios |
title_full_unstemmed |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios |
title_sort |
Quantification of dexchlorpheniramine and betamethasone in human plasma by the uplc-ms/ms method and its application in a bioequivalence study containing the two drugs in combination, administered as a single dose in healthy volunteers/ Quantificação de dexclorfeniramina e betametasona em plasma humano pelo método clue-em/em e sua aplicação em um estudo de bioequivalência contendo os dois fármacos em associação, administrados em dose única em voluntários sadios |
author |
Santos, Alessandra Ferreira dos |
author_facet |
Santos, Alessandra Ferreira dos Francisco, Quevellin Alves dos Santos Correa, Carlos Eduardo Melo Marques, Vanessa Bergamin Boralli |
author_role |
author |
author2 |
Francisco, Quevellin Alves dos Santos Correa, Carlos Eduardo Melo Marques, Vanessa Bergamin Boralli |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Santos, Alessandra Ferreira dos Francisco, Quevellin Alves dos Santos Correa, Carlos Eduardo Melo Marques, Vanessa Bergamin Boralli |
dc.subject.por.fl_str_mv |
Dexchlorpheniramine Bethametasone Bioequivalence UPLC-MS/MS |
topic |
Dexchlorpheniramine Bethametasone Bioequivalence UPLC-MS/MS |
description |
This study was carried out in order to compare the relative bioavailability of two different formulations containing 2.00 mg of dexchlorpheniramine maleate + 0.25 mg of bethametasona, test formulation (Dexmine®) and reference formulation (Celestamine®) in healthy volunteers of both sexes under fasting conditions. The study was conducted in a single dose, randomized, open-label, crossover 2 x 2. The tolerability was evaluated by the monitoring of adverse events and vital signs, results of clinical and laboratory tests. Plasma concentrations were quantified by validated bioanalytical method employed the ultra-performance liquid chromatography triple quadrupole tandem mass spectrometry, using as the internal standard brompheniramine. Non-compartmental model was applied to determine different pharmacokinetic parameters and these were calculated from the plasma concentrations obtained from the volunteer samples. Bioequivalence between test and reference formulation were demonstrated as the calculated 90 % confidence interval for the corresponding ratios of log transformed pharmacokinetic parameters (Cmax, AUC0-t and AUC0-?) fell within the 80–125 % range, the predetermined criterion for therapeutic equivalence. It can be concluded that the two formulations were bioequivalent in terms of rate and absorption extent and thus interchangeable. |
publishDate |
2019 |
dc.date.none.fl_str_mv |
2019-10-11 |
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://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/3770 10.34119/bjhrv2n5-039 |
url |
https://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/3770 |
identifier_str_mv |
10.34119/bjhrv2n5-039 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://ojs.brazilianjournals.com.br/ojs/index.php/BJHR/article/view/3770/3572 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2019 Brazilian Journal of Health Review info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2019 Brazilian Journal of Health Review |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Brazilian Journals Publicações de Periódicos e Editora Ltda. |
publisher.none.fl_str_mv |
Brazilian Journals Publicações de Periódicos e Editora Ltda. |
dc.source.none.fl_str_mv |
Brazilian Journal of Health Review; Vol. 2 No. 5 (2019); 4371-4385 Brazilian Journal of Health Review; v. 2 n. 5 (2019); 4371-4385 2595-6825 reponame:Brazilian Journal of Health Review instname:Federação das Indústrias do Estado do Paraná (FIEP) instacron:BJRH |
instname_str |
Federação das Indústrias do Estado do Paraná (FIEP) |
instacron_str |
BJRH |
institution |
BJRH |
reponame_str |
Brazilian Journal of Health Review |
collection |
Brazilian Journal of Health Review |
repository.name.fl_str_mv |
Brazilian Journal of Health Review - Federação das Indústrias do Estado do Paraná (FIEP) |
repository.mail.fl_str_mv |
|| brazilianjhr@gmail.com |
_version_ |
1797240048680173568 |