In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs

This study evaluates in vivo the drug absorption profiles from potato starch-methyl methacrylate matrices∗ using theophylline as a model drug. Healthy beagle dogs under fasting conditions were used for in vivo studies and plasma samples were analyzed by a fluorescence polarization immunoassay analys...

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Authors: Fernández-Campos F., Ferrero Rodríguez, Carmen, Colom H., Jiménez-Castellanos Ballesteros, María Rosa
Format: article
Status:Versión aceptada para publicación
Publication Date:2015
Country:España
Institution:Universidad de Sevilla (US)
Repository:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/152926
Online Access:https://hdl.handle.net/11441/152926
https://doi.org/10.1016/j.ijpharm.2014.11.071
Access Level:Open access
Keyword:Potato starch-methyl methacrylate copolymers
Anhydrous theophylline
Sustained-release matrix tablet
Beagle dog
Pharmacokinetics
IVIVC
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repository_id_str
spelling In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogsFernández-Campos F.Ferrero Rodríguez, CarmenColom H.Jiménez-Castellanos Ballesteros, María RosaPotato starch-methyl methacrylate copolymersAnhydrous theophyllineSustained-release matrix tabletBeagle dogPharmacokineticsIVIVCThis study evaluates in vivo the drug absorption profiles from potato starch-methyl methacrylate matrices∗ using theophylline as a model drug. Healthy beagle dogs under fasting conditions were used for in vivo studies and plasma samples were analyzed by a fluorescence polarization immunoassay analysis (FPIA method). Non-compartmental and compartmental (population approach) analysis was performed to determine the pharmacokinetic parameters. The principle of superposition was applied to predict multiple dose plasma concentrations from experimental single dose data. An in vitro-in vivo correlation (IVIVC) was also assessed. The sustained absorption kinetics of theophylline from these formulations was demonstrated by comparison with two commercially available oral sustained-release theophylline products (Theo-Dur® and Theolair®). A one-compartment model with first order kinetics without lag-time best describes the absorption/disposition of theophylline from the formulations. Results revealed a theophylline absorption rate in the order FD-HSMMA Theo-Dur®OD-CSMMA > Theolair®FD-CSMMA. On the basis of simulated plasma theophylline levels, a twice daily dosage (every 12 h) with the FD-CSMMA tablets should be recommended. A Level C IVIVC was found between the in vitro t50% and the in vivo AUC/D, although further optimization of the in vitro dissolution test would be needed to adequately correlate with in vivo data.Ministerio de Educación y Ciencia MAT2004-01599ElsevierFarmacia y Tecnología FarmacéuticaMinisterio de Educación y Ciencia (MEC). España2015info:eu-repo/semantics/articleinfo:eu-repo/semantics/acceptedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/152926https://doi.org/10.1016/j.ijpharm.2014.11.071reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésInternational Journal of Pharmaceutics, 478 (2), 684-692.MAT2004-01599https://doi.org/10.1016/j.ijpharm.2014.11.071info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1529262026-06-17T12:51:07Z
dc.title.none.fl_str_mv In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
title In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
spellingShingle In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
Fernández-Campos F.
Potato starch-methyl methacrylate copolymers
Anhydrous theophylline
Sustained-release matrix tablet
Beagle dog
Pharmacokinetics
IVIVC
title_short In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
title_full In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
title_fullStr In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
title_full_unstemmed In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
title_sort In vivo absorption behaviour of theophylline from starch-methyl methacrylate matrix tablets in beagle dogs
dc.creator.none.fl_str_mv Fernández-Campos F.
Ferrero Rodríguez, Carmen
Colom H.
Jiménez-Castellanos Ballesteros, María Rosa
author Fernández-Campos F.
author_facet Fernández-Campos F.
Ferrero Rodríguez, Carmen
Colom H.
Jiménez-Castellanos Ballesteros, María Rosa
author_role author
author2 Ferrero Rodríguez, Carmen
Colom H.
Jiménez-Castellanos Ballesteros, María Rosa
author2_role author
author
author
dc.contributor.none.fl_str_mv Farmacia y Tecnología Farmacéutica
Ministerio de Educación y Ciencia (MEC). España
dc.subject.none.fl_str_mv Potato starch-methyl methacrylate copolymers
Anhydrous theophylline
Sustained-release matrix tablet
Beagle dog
Pharmacokinetics
IVIVC
topic Potato starch-methyl methacrylate copolymers
Anhydrous theophylline
Sustained-release matrix tablet
Beagle dog
Pharmacokinetics
IVIVC
description This study evaluates in vivo the drug absorption profiles from potato starch-methyl methacrylate matrices∗ using theophylline as a model drug. Healthy beagle dogs under fasting conditions were used for in vivo studies and plasma samples were analyzed by a fluorescence polarization immunoassay analysis (FPIA method). Non-compartmental and compartmental (population approach) analysis was performed to determine the pharmacokinetic parameters. The principle of superposition was applied to predict multiple dose plasma concentrations from experimental single dose data. An in vitro-in vivo correlation (IVIVC) was also assessed. The sustained absorption kinetics of theophylline from these formulations was demonstrated by comparison with two commercially available oral sustained-release theophylline products (Theo-Dur® and Theolair®). A one-compartment model with first order kinetics without lag-time best describes the absorption/disposition of theophylline from the formulations. Results revealed a theophylline absorption rate in the order FD-HSMMA Theo-Dur®OD-CSMMA > Theolair®FD-CSMMA. On the basis of simulated plasma theophylline levels, a twice daily dosage (every 12 h) with the FD-CSMMA tablets should be recommended. A Level C IVIVC was found between the in vitro t50% and the in vivo AUC/D, although further optimization of the in vitro dissolution test would be needed to adequately correlate with in vivo data.
publishDate 2015
dc.date.none.fl_str_mv 2015
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/acceptedVersion
format article
status_str acceptedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/152926
https://doi.org/10.1016/j.ijpharm.2014.11.071
url https://hdl.handle.net/11441/152926
https://doi.org/10.1016/j.ijpharm.2014.11.071
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv International Journal of Pharmaceutics, 478 (2), 684-692.
MAT2004-01599
https://doi.org/10.1016/j.ijpharm.2014.11.071
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,300719

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