Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats

Detalhes bibliográficos
Autor(a) principal: Solon, Lílian Grace da Silva
Data de Publicação: 2010
Outros Autores: Guerra, Gerlane Bernardo Coelho, Araújo, Aurigena Antunes de, Barichello, José Mário, Pérez Urizar, José, Soares, Luiz Alberto Lira
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UFBA
Texto Completo: http://www.repositorio.ufba.br/ri/handle/ri/12925
Resumo: p.48-54
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spelling Solon, Lílian Grace da SilvaGuerra, Gerlane Bernardo CoelhoAraújo, Aurigena Antunes deBarichello, José MárioPérez Urizar, JoséSoares, Luiz Alberto LiraSolon, Lílian Grace da SilvaGuerra, Gerlane Bernardo CoelhoAraújo, Aurigena Antunes deBarichello, José MárioPérez Urizar, JoséSoares, Luiz Alberto Lira2013-09-12T17:06:42Z2013-09-12T17:06:42Z20102176-9451http://www.repositorio.ufba.br/ri/handle/ri/12925v. 2, n. 2p.48-54The purpose of this study was to determine naproxen concentrations in rat plasma samples by HPLC and to compare the bioavailability of a generic and two compounded naproxen sodium suspensions (test 1 and test 2). Analysis was run at a fl ow rate of 1.2 mL.min-1 with a mobile phase of acetonitrile: NaH2PO4 0.01 M pH 4.00 (50:50, v/v) at 280 nm, using a C18 column (150 mm x 4.6 mm, 5 μm). The calibration curve was linear (R2 = 0.9987) over the range of 0.25 - 200 μg.mL-1. The precision for inter and intra-day analysis ranged from 2.46% to 12.39%. Cmax, Tmax and AUCt were 191.25 ± 11.17 μg.mL-1, 1.00 ± 0.106 h and 2438.16 ± 291.34 μg.h.mL-1 for the reference drug, 188.22 ± 24.78 μg.mL-1, 1.06 ± 0.092 h and 1755.02 ± 228.90 μg.h.mL-1 for test 1, and 160.50 ± 10.58 μg.mL-1, 0.66 ± 0.102 h and 1955.28 ± 142.80 μg.h.mL-1 for test 2. No signifi cant differences were found based on analysis of variance, with mean values and 90% CI of test2/reference ratio (Cmax 83.92% and AUCt 80.19%). For test1/reference ratio, the result was Cmax 98.41% and AUCt 71.98%. Based on these results, it can be concluded that the validated method was successfully applied to this study; the test 1 formulation failed to demonstrate a bioequivalence to the reference drug; however, the test 2 and reference naproxen sodium suspension were bioequivalent in terms of the rate and extent of absorption under these conditions.Submitted by Suelen Reis (suziy.ellen@gmail.com) on 2013-09-04T14:24:11Z No. of bitstreams: 1 JBABM-02-048.pdf: 1188444 bytes, checksum: 13bad23cb399c52a37a8ec07c39b2b48 (MD5)Approved for entry into archive by Alda Lima da Silva(sivalda@ufba.br) on 2013-09-12T17:06:42Z (GMT) No. of bitstreams: 1 JBABM-02-048.pdf: 1188444 bytes, checksum: 13bad23cb399c52a37a8ec07c39b2b48 (MD5)Made available in DSpace on 2013-09-12T17:06:42Z (GMT). No. of bitstreams: 1 JBABM-02-048.pdf: 1188444 bytes, checksum: 13bad23cb399c52a37a8ec07c39b2b48 (MD5) Previous issue date: 2010http://dx.doi.org/10.4172/1948-593X.1000021reponame:Repositório Institucional da UFBAinstname:Universidade Federal da Bahia (UFBA)instacron:UFBABioavailability studiesValidationHPLCPharmacokineticsCompounded naproxen sodium suspensionComparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to ratsDental Press Journal of Orthodonticsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleenginfo:eu-repo/semantics/openAccessORIGINALJBABM-02-048.pdfJBABM-02-048.pdfapplication/pdf1188444https://repositorio.ufba.br/bitstream/ri/12925/1/JBABM-02-048.pdf13bad23cb399c52a37a8ec07c39b2b48MD51LICENSElicense.txtlicense.txttext/plain1762https://repositorio.ufba.br/bitstream/ri/12925/2/license.txt1b89a9a0548218172d7c829f87a0eab9MD52TEXTJBABM-02-048.pdf.txtJBABM-02-048.pdf.txtExtracted texttext/plain37261https://repositorio.ufba.br/bitstream/ri/12925/3/JBABM-02-048.pdf.txt17504e9c6ecd172e68019b92bfac5ae1MD53ri/129252022-07-05 14:02:49.574oai:repositorio.ufba.br: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Repositório InstitucionalPUBhttp://192.188.11.11:8080/oai/requestopendoar:19322022-07-05T17:02:49Repositório Institucional da UFBA - Universidade Federal da Bahia (UFBA)false
dc.title.pt_BR.fl_str_mv Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
dc.title.alternative.pt_BR.fl_str_mv Dental Press Journal of Orthodontics
title Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
spellingShingle Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
Solon, Lílian Grace da Silva
Bioavailability studies
Validation
HPLC
Pharmacokinetics
Compounded naproxen sodium suspension
title_short Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
title_full Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
title_fullStr Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
title_full_unstemmed Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
title_sort Comparative bioavailability of a generic and two compounded naproxen sodium suspensions administered to rats
author Solon, Lílian Grace da Silva
author_facet Solon, Lílian Grace da Silva
Guerra, Gerlane Bernardo Coelho
Araújo, Aurigena Antunes de
Barichello, José Mário
Pérez Urizar, José
Soares, Luiz Alberto Lira
author_role author
author2 Guerra, Gerlane Bernardo Coelho
Araújo, Aurigena Antunes de
Barichello, José Mário
Pérez Urizar, José
Soares, Luiz Alberto Lira
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Solon, Lílian Grace da Silva
Guerra, Gerlane Bernardo Coelho
Araújo, Aurigena Antunes de
Barichello, José Mário
Pérez Urizar, José
Soares, Luiz Alberto Lira
Solon, Lílian Grace da Silva
Guerra, Gerlane Bernardo Coelho
Araújo, Aurigena Antunes de
Barichello, José Mário
Pérez Urizar, José
Soares, Luiz Alberto Lira
dc.subject.por.fl_str_mv Bioavailability studies
Validation
HPLC
Pharmacokinetics
Compounded naproxen sodium suspension
topic Bioavailability studies
Validation
HPLC
Pharmacokinetics
Compounded naproxen sodium suspension
description p.48-54
publishDate 2010
dc.date.issued.fl_str_mv 2010
dc.date.accessioned.fl_str_mv 2013-09-12T17:06:42Z
dc.date.available.fl_str_mv 2013-09-12T17:06:42Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://www.repositorio.ufba.br/ri/handle/ri/12925
dc.identifier.issn.none.fl_str_mv 2176-9451
dc.identifier.number.pt_BR.fl_str_mv v. 2, n. 2
identifier_str_mv 2176-9451
v. 2, n. 2
url http://www.repositorio.ufba.br/ri/handle/ri/12925
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.source.pt_BR.fl_str_mv http://dx.doi.org/10.4172/1948-593X.1000021
dc.source.none.fl_str_mv reponame:Repositório Institucional da UFBA
instname:Universidade Federal da Bahia (UFBA)
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instname_str Universidade Federal da Bahia (UFBA)
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reponame_str Repositório Institucional da UFBA
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