Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina

ilustraciones, diagramas

Autores:
Carvajal Barbosa, Laura
Tipo de recurso:
Fecha de publicación:
2024
Institución:
Universidad Nacional de Colombia
Repositorio:
Universidad Nacional de Colombia
Idioma:
spa
OAI Identifier:
oai:repositorio.unal.edu.co:unal/86344
Acceso en línea:
https://repositorio.unal.edu.co/handle/unal/86344
https://repositorio.unal.edu.co/
Palabra clave:
540 - Química y ciencias afines::542 - Técnicas, procedimientos, aparatos, equipos, materiales
610 - Medicina y salud::615 - Farmacología y terapéutica
Carbamazepina/síntesis química
Disolución
Técnicas In Vitro/métodos
Carbamazepine/chemical synthesis
Dissolution
In Vitro Techniques/methods
Correlación in vivo in vitro
Carbamazepina
Método de disolución
Liberación modificada
Aparato de disolución USP 4
Celda de flujo
In vivo in vitro correlation
Carbamazepine
Dissolution method
Modified release
Dissolution apparatus USP 4
Flow-through cell
Rights
openAccess
License
Atribución-NoComercial-SinDerivadas 4.0 Internacional
id UNACIONAL2_cb4874e98e4dc045258d0bcd97579d2f
oai_identifier_str oai:repositorio.unal.edu.co:unal/86344
network_acronym_str UNACIONAL2
network_name_str Universidad Nacional de Colombia
repository_id_str
dc.title.spa.fl_str_mv Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
dc.title.translated.eng.fl_str_mv Two-Step In Vitro-In Vivo Correlation for the Development a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified Release Tablet
title Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
spellingShingle Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
540 - Química y ciencias afines::542 - Técnicas, procedimientos, aparatos, equipos, materiales
610 - Medicina y salud::615 - Farmacología y terapéutica
Carbamazepina/síntesis química
Disolución
Técnicas In Vitro/métodos
Carbamazepine/chemical synthesis
Dissolution
In Vitro Techniques/methods
Correlación in vivo in vitro
Carbamazepina
Método de disolución
Liberación modificada
Aparato de disolución USP 4
Celda de flujo
In vivo in vitro correlation
Carbamazepine
Dissolution method
Modified release
Dissolution apparatus USP 4
Flow-through cell
title_short Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
title_full Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
title_fullStr Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
title_full_unstemmed Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
title_sort Contribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepina
dc.creator.fl_str_mv Carvajal Barbosa, Laura
dc.contributor.advisor.spa.fl_str_mv Aragón Novoa, Diana Marcela
dc.contributor.author.spa.fl_str_mv Carvajal Barbosa, Laura
dc.contributor.researchgroup.spa.fl_str_mv Sistemas Para Liberación Controlada de Moléculas Biológicamente Activas
dc.subject.ddc.spa.fl_str_mv 540 - Química y ciencias afines::542 - Técnicas, procedimientos, aparatos, equipos, materiales
610 - Medicina y salud::615 - Farmacología y terapéutica
topic 540 - Química y ciencias afines::542 - Técnicas, procedimientos, aparatos, equipos, materiales
610 - Medicina y salud::615 - Farmacología y terapéutica
Carbamazepina/síntesis química
Disolución
Técnicas In Vitro/métodos
Carbamazepine/chemical synthesis
Dissolution
In Vitro Techniques/methods
Correlación in vivo in vitro
Carbamazepina
Método de disolución
Liberación modificada
Aparato de disolución USP 4
Celda de flujo
In vivo in vitro correlation
Carbamazepine
Dissolution method
Modified release
Dissolution apparatus USP 4
Flow-through cell
dc.subject.decs.spa.fl_str_mv Carbamazepina/síntesis química
Disolución
Técnicas In Vitro/métodos
dc.subject.decs.eng.fl_str_mv Carbamazepine/chemical synthesis
Dissolution
In Vitro Techniques/methods
dc.subject.proposal.spa.fl_str_mv Correlación in vivo in vitro
Carbamazepina
Método de disolución
Liberación modificada
Aparato de disolución USP 4
Celda de flujo
dc.subject.proposal.eng.fl_str_mv In vivo in vitro correlation
Carbamazepine
Dissolution method
Modified release
Dissolution apparatus USP 4
Flow-through cell
description ilustraciones, diagramas
publishDate 2024
dc.date.accessioned.none.fl_str_mv 2024-07-02T18:54:10Z
dc.date.available.none.fl_str_mv 2024-07-02T18:54:10Z
dc.date.issued.none.fl_str_mv 2024
dc.type.spa.fl_str_mv Trabajo de grado - Maestría
dc.type.driver.spa.fl_str_mv info:eu-repo/semantics/masterThesis
dc.type.version.spa.fl_str_mv info:eu-repo/semantics/acceptedVersion
dc.type.content.spa.fl_str_mv Text
dc.type.redcol.spa.fl_str_mv http://purl.org/redcol/resource_type/TM
status_str acceptedVersion
dc.identifier.uri.none.fl_str_mv https://repositorio.unal.edu.co/handle/unal/86344
dc.identifier.instname.spa.fl_str_mv Universidad Nacional de Colombia
dc.identifier.reponame.spa.fl_str_mv Repositorio Institucional Universidad Nacional de Colombia
dc.identifier.repourl.spa.fl_str_mv https://repositorio.unal.edu.co/
url https://repositorio.unal.edu.co/handle/unal/86344
https://repositorio.unal.edu.co/
identifier_str_mv Universidad Nacional de Colombia
Repositorio Institucional Universidad Nacional de Colombia
dc.language.iso.spa.fl_str_mv spa
language spa
dc.relation.indexed.spa.fl_str_mv Bireme
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spelling Atribución-NoComercial-SinDerivadas 4.0 Internacionalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccesshttp://purl.org/coar/access_right/c_abf2Aragón Novoa, Diana Marcela4deaff341e3b3d3b4f981cdd720edd1d600Carvajal Barbosa, Laura10100c13d0ca8e085f36bf92601be738600Sistemas Para Liberación Controlada de Moléculas Biológicamente Activas2024-07-02T18:54:10Z2024-07-02T18:54:10Z2024https://repositorio.unal.edu.co/handle/unal/86344Universidad Nacional de ColombiaRepositorio Institucional Universidad Nacional de Colombiahttps://repositorio.unal.edu.co/ilustraciones, diagramasLos métodos de disolución in vitro posiblemente predictivos del comportamiento in vivo permiten evidenciar posibles problemas de biodisponibilidad y tomar decisiones oportunas desde las etapas de diseño y desarrollo de nuevas formulaciones. A su vez, las correlaciones in vivo in vitro (CIVIV) son herramientas principalmente útiles en el desarrollo de formulaciones, que consisten en un modelo matemático predictivo construido a partir de la relación entre una característica in vitro de la forma farmacéutica, con una variable respuesta in vivo. El objetivo de este trabajo fue desarrollar un método de disolución predictivo del comportamiento in vivo, empleando el Aparato celda de flujo, para tabletas de carbamazepina de liberación modificada (Tegretol® 200mg Liberación prolongada) en una compañía farmacéutica local interesada en desarrollar productos multifuente de carbamazepina. Con este fin, se empleó un diseño experimental Box-Behnken para optimizar el método de disolución minimizando el error en la predicción del Área Bajo la Curva (AUC0-t) y la Cmax (los datos in vivo se tomaron de la bibliografía). Se evaluaron tres factores en tres niveles: la concentración de laurilsulfato de sodio en el medio de disolución, la cantidad de microesferas de vidrio y la velocidad de flujo; los demás parámetros se mantuvieron constantes. La CIVIV se desarrolló utilizando una deconvolución con la ecuación de Wagner-Nelson, seguida por un escalamiento con enfoque en dos etapas y una reconvolución con la ecuación de Gohel et al. (2009). El enfoque en dos etapas se llevó a cabo construyendo un gráfico de Levy, escalando los perfiles de disolución y representándolos frente al perfil de absorción. Estos modelos CIVIV obtenidos se utilizaron para predecir las fracciones absorbidas. Siguiendo el diseño experimental, se obtuvieron quince perfiles de disolución y modelos CIVIV en diferentes condiciones, con errores de predicción de AUC0-t y Cmax que oscilaron entre -64% y -9%. Con el método de disolución optimizado, se logró una CIVIV con un r2= 0,9905, prediciendo errores de -6,09% para el AUC0-t y -1,94% para la Cmax. El método de disolución desarrollado y optimizado se puso a prueba con tabletas de carbamazepina de liberación inmediata (Tegretol® 200mg) y demostró ser discriminatorio. En conclusión, en una empresa farmacéutica local se desarrolló un método de disolución predictivo del comportamiento in vivo, empleando el Aparato celda de flujo, como herramienta para el desarrollo de productos multifuente de carbamazepina de liberación modificada. (Texto tomado de la fuente).In vitro dissolution methods, possibly predictive of in vivo behavior, make it possible to detect bioavailability problems and make timely decisions early in the design and development stages of new formulations. Furthermore, in vivo in vitro correlations (IVIVC) are mainly useful tools in the development of formulations, which consist of a predictive mathematical model built from the relationship between an in vitro characteristic of the dosage form with an in vivo response variable. The aim of this work was to develop an in vivo predictive flow-through cell dissolution method for a modified release carbamazepine tablet (Tegretol® 200mg prolonged release) in a local pharmaceutical company interested in developing carbamazepine generic products. For this purpose, a Box-Behnken experimental design was employed to optimize the dissolution method minimizing the prediction error of the Area Under the Curve (AUC0-t) and Cmax (in vivo data were taken from the literature). Three factors at three levels were evaluated: sodium lauryl sulfate concentration in dissolution media, the amount of glass beads, and flow rate; the other parameters were kept constant. The IVIVC was developed using a deconvolution with the Wagner-Nelson equation, followed by a two-step scaling approach, and a reconvolution with the equation from Gohel et al. (2009). The two-step approach was carried out by constructing a Levy plot, scaling up the dissolution profiles and plotting them against the absorption profile. The obtained IVIVC models were then used to predict the absorbed fractions. Following the experimental design, fifteen dissolution profiles and IVIVC models were obtained under different conditions, with AUC0-t and Cmax prediction errors ranging from -64% to -9%. With the optimized dissolution method, an IVIVC was achieved with an r2= 0.9905, predicting errors of -6.09% for the AUC0-t and -1.94% for Cmax. The developed and optimized dissolution method was challenged with immediate-release carbamazepine tablets (Tegretol® 200mg) and proved to be discriminative. In conclusion, an in vivo predictive flow-through cell dissolution method was developed in a local pharmaceutical company as a tool for the development of generic modified release carbamazepine products.Pharmetique LabsGrupo de Investigación: Sistemas para liberación controlada de moléculas biológicamente activas (SILICOMOBA)MaestríaMagíster en Ciencias FarmacéuticasFarmacocinética y estudios de biodisponibilidad y bioequivalenciax,x, 111 páginasapplication/pdfspaUniversidad Nacional de ColombiaBogotá - Ciencias - Maestría en Ciencias FarmacéuticasFacultad de CienciasBogotá, ColombiaUniversidad Nacional de Colombia - Sede Bogotá540 - Química y ciencias afines::542 - Técnicas, procedimientos, aparatos, equipos, materiales610 - Medicina y salud::615 - Farmacología y terapéuticaCarbamazepina/síntesis químicaDisoluciónTécnicas In Vitro/métodosCarbamazepine/chemical synthesisDissolutionIn Vitro Techniques/methodsCorrelación in vivo in vitroCarbamazepinaMétodo de disoluciónLiberación modificadaAparato de disolución USP 4Celda de flujoIn vivo in vitro correlationCarbamazepineDissolution methodModified releaseDissolution apparatus USP 4Flow-through cellContribución al diseño de un método de disolución predictivo para evaluar una forma farmacéutica de liberación modificada de carbamazepinaTwo-Step In Vitro-In Vivo Correlation for the Development a Predictive Flow Through Cell Dissolution Method for Carbamazepine Modified Release TabletTrabajo de grado - Maestríainfo:eu-repo/semantics/masterThesisinfo:eu-repo/semantics/acceptedVersionTexthttp://purl.org/redcol/resource_type/TMBiremeAguilar Ros, A., Caamaño Somoza, Manuel., Martín Martín, F. 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Drug Development and Industrial Pharmacy, 20(13), 2063–2078. https://doi.org/10.3109/03639049409050222Pharmetique LabsInvestigadoresLICENSElicense.txtlicense.txttext/plain; charset=utf-85879https://repositorio.unal.edu.co/bitstream/unal/86344/1/license.txteb34b1cf90b7e1103fc9dfd26be24b4aMD51ORIGINAL1151961385.2024.pdf1151961385.2024.pdfTesis de Maestría en Ciencias Farmacéuticasapplication/pdf1501114https://repositorio.unal.edu.co/bitstream/unal/86344/2/1151961385.2024.pdfc7ff631500fa2ed6fed8156865fd067fMD52THUMBNAIL1151961385.2024.pdf.jpg1151961385.2024.pdf.jpgGenerated Thumbnailimage/jpeg5257https://repositorio.unal.edu.co/bitstream/unal/86344/3/1151961385.2024.pdf.jpg174d261008ea81bd9e196f603b833768MD53unal/86344oai:repositorio.unal.edu.co:unal/863442024-08-26 23:10:16.078Repositorio Institucional Universidad Nacional de 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