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
- 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
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| 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 |
| dc.relation.references.spa.fl_str_mv |
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R., Palomino-Jhong, J. J., García, J. A., Alvarado, C. A., Alvarado, E. A., Ochoa-Pachas, G., Pineda-Pérez, M., & Bolarte, M. (2021). In Vitro Biopharmaceutical Equivalence of Carbamazepine Sodium Tablets Available in Lima, Peru. Dissolution Technologies, 28(2). https://doi.org/10.14227/DT280221PGC2 Ambrósio, A. F., Soares-da-Silva, P., Carvalho, C. M., & Carvalho, A. P. (2002). Mechanisms of action of carbamazepine and its derivatives, oxcarbazepine, BIA 2-093, and BIA 2-024. Neurochemical Research, 27(1–2), 121–130. https://doi.org/10.1023/A:1014814924965 Amidon, G. L., Lennernäs, H., Shah, V. P., & Crison, J. R. (1995). A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharmaceutical Research, 12(3), 413–420. https://doi.org/10.1023/A:1016212804288 Baena, Y., & Ponce D’León, L. F. (2008). 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A., Abdallah, O. Y., Galal, S., & Daabis, N. A. (2006). Towards a Universal Dissolution Medium for Carbamazepine. Drug Development and Industrial Pharmacy, 32(7), 893–905. https://doi.org/10.1080/03639040600762677 European Medicines Agency (EMEA). (2010). Guideline On The Investigation of Bioequivalence Discussion in the Joint Efficacy and Quality Working Group. http://www.ema.europa.eu Figueroa, A. I., Gonzalez, M., Merino, V., & Bermejo, M. del V. (2019). Desarrollo de métodos de disolución con capacidad predictiva del rendimiento in vivo de formulaciones farmacéuticas [Tesis doctoral, Universitat de València]. https://hdl.handle.net/10550/70578 Food and Drug Administration (FDA). (1997). Guía para la Industria: Pruebas de disolución de formas de dosificación oral sólidas de liberación inmediata. 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Justification of Biowaiver for Carbamazepine, a Low Soluble High Permeable Compound, in Solid Dosage Forms Based on IVIVC and Gastrointestinal Simulation. Molecular Pharmaceutics, 6(1), 40–47. https://doi.org/10.1021/mp800128y Kuo, C. C., Chen, R. S., Lu, L., & Chen, R. C. (1997). Carbamazepine inhibition of neuronal Na+ currents: quantitative distinction from phenytoin and possible therapeutic implications. Molecular Pharmacology, 51(6), 1077–1083. https://doi.org/10.1124/MOL.51.6.1077 Lake, O. A., Olling, M., & Barends, D. M. (1999). In vitro/in vivo correlations of dissolution data of carbamazepine immediate release tablets with pharmacokinetic data obtained in healthy volunteers. European Journal of Pharmaceutics and Biopharmaceutics, 48(1), 13–19. https://doi.org/10.1016/S0939-6411(99)00016-8 Langenbucher, F. (2011). Letters to the Editor: Linearization of dissolution rate curves by the Weibull distribution. 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International Journal of Pharmaceutics, 418(1), 142–148. https://doi.org/10.1016/j.ijpharm.2011.01.010 Mateu López, L., & Herrera LLópiz, A. (2007). Fracturar tabletas de liberación modificada: ¿una práctica adecuada? Revista Cubana de Farmacia, 41(1). http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152007000100013 McLean, M. J., & Macdonald, R. L. (1983). Multiple actions of phenytoin on mouse spinal cord neurons in cell culture. Journal of Pharmacology and Experimental Therapeutics, 227(3). Medina, J. R., Salazar, D. K., Hurtado, M., Cortés, A. R., & Domínguez-Ramírez, A. M. (2014). Comparative in vitro dissolution study of carbamazepine immediate-release products using the USP paddles method and the flow-through cell system. Saudi Pharmaceutical Journal, 22(2), 141–147. https://doi.org/10.1016/J.JSPS.2013.02.001 Medina Lopez, J. R., & Hurtado Y de la Peña, M. (2009). 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Research Journal of Pharmacy and Technology, 13(3), 1339. https://doi.org/10.5958/0974-360X.2020.00247.4 Moreno, J., Belmont, A., Jaimes, O., Santos, J. A., López, G., Campos, M. G., Amancio, O., Pérez, P., & Heinze, G. (2004). Pharmacokinetic study of carbamazepine and its carbamazepine 10,11-epoxide metabolite in a group of female epileptic patients under chronic treatment. Archives of Medical Research, 35(2), 168–171. https://doi.org/10.1016/j.arcmed.2003.09.016 Okumu, A., DiMaso, M., & Löbenberg, R. (2008). Dynamic dissolution testing to establish in vitro/in vivo correlations for montelukast sodium, a poorly soluble drug. Pharmaceutical Research, 25(12), 2778–2785. https://doi.org/10.1007/S11095-008-9642-Z Olling, M., Mensinga, T. T., Barends, D. M., Groen, C., Lake, O. A., & Meulenbelt, J. (1999). Bioavailability of carbamazepine from four different products and the occurrence of side effects. 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Methods to Compare Dissolution Profiles and a Rationale for Wide Dissolution Specifications for Metoprolol Tartrate tablets†. Journal of Pharmaceutical Sciences, 86(6), 690–700. https://doi.org/10.1021/js960473x Punyawudho, B., Ramsay, E. R., Brundage, R. C., Macias, F. M., Collins, J. F., & Birnbaum, A. K. (2012). Population Pharmacokinetics of Carbamazepine in Elderly Patients. Therapeutic Drug Monitoring, 34(2), 176–181. https://doi.org/10.1097/FTD.0b013e31824d6a4e Rabti, H., Mohammed Salmani, J. M., Elamin, E. S., Lammari, N., Zhang, J., & Ping, Q. (2014). Carbamazepine solubility enhancement in tandem with swellable polymer osmotic pump tablet: A promising approach for extended delivery of poorly water-soluble drugs. Asian Journal of Pharmaceutical Sciences, 9(3), 146–154. https://doi.org/10.1016/J.AJPS.2014.04.001 Rane, Y., Mashru, R., Sankalia, M., & Sankalia, J. (2007). Effect of hydrophilic swellable polymers on dissolution enhancement of carbamazepine solid dispersions studied using response surface methodology. AAPS PharmSciTech, 8(2), E1–E11. https://doi.org/10.1208/pt0802027 Rawlins, M. D., Collste, P., Bertilsson, L., & Palmér, L. (1975). Distribution and elimination kinetics of carbamazepine in man. European Journal of Clinical Pharmacology 1975 8:2, 8(2), 91–96. https://doi.org/10.1007/BF00561556 Riva, R., Albani, F., Ambrosetto, G., Contin, M., Cortelli, P., Perucca, E., & Baruzzi, A. (1984). Diurnal Fluctuations in Free and Total Steady-State Plasma Levels of Carbamazepine and Correlation with Intermittent Side Effects. Epilepsia, 25(4), 476–481. https://doi.org/10.1111/J.1528-1157.1984.TB03446.X Rodriguez, C., Guevara, B. H., & Lobo, G. (2010). Mecanismos de acción de fármacos antiepilépticos. Informe Médico, 12(6), 321–326. https://www.researchgate.net/publication/235769333_Mecanismos_de_accion_de_farmacos_antiepilepticos Roni, M., Kibria, G., & Jalil, R. (2009). Formulation and in vitro Evaluation of Alfuzosin Extended Release Tablets Using Directly Compressible Eudragit. Indian Journal of Pharmaceutical Sciences, 71(3), 252. https://doi.org/10.4103/0250-474X.56019 Ruiz, A. M., Restrepo, M. M., Cuesta, F., Giraldo, J., Archbold, R., & Holguín, G. (2001). Estudio de bioequivalencia de dos formulaciones de tabletas de carbamazepina de liberación retardada. Iatreia, 13(3), 131–139. Sakore, S., & Chakraborty, B. (2011). In Vitro - In Vivo Correlation (IVIVC): A Strategic Tool in Drug Development. Journal of Bioequivalence & Bioavailability, 8(4). https://doi.org/10.4172/JBB.S3-001 Sánchez-Dengra, B., González-García, I., González-Álvarez, M., González-Álvarez, I., & Bermejo, M. (2021). Two-step in vitro-in vivo correlations: Deconvolution and convolution methods, which one gives the best predictability? Comparison with one-step approach. European Journal of Pharmaceutics and Biopharmaceutics, 158, 185–197. https://doi.org/10.1016/j.ejpb.2020.11.009 Shargel, L., & Yu, A. B. C. (2016). Applied Biopharmaceutics & Pharmacokinetics (7th ed.). McGraw-Hill. https://accesspharmacy.mhmedical.com/book.aspx?bookID=1592 Springer Boston, M. (2004). Bioavailability and Bioequivalence. In Foundations of Pharmacokinetics (pp. 171–177). Kluwer Academic Publishers. https://doi.org/10.1007/0-306-47924-9_17 Tomson, T. (1984). Interdosage fluctuations in plasma carbamazepine concentration determine intermittent side effects. Archives of Neurology, 41(8), 830–834. https://doi.org/10.1001/ARCHNEUR.1984.04050190036011 Tunnicliff, G. (1996). Basis of the antiseizure action of phenytoin. 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A collaborative in vitro dissolution study: comparing the flow-through method with the USP paddle method using USP prednisone calibrator tablets. International Journal of Pharmaceutics, 53(1), 35–41. https://doi.org/10.1016/0378-5173(89)90358-X World Health Oranization Collaborating Centre for Drug Statistics Methodology. (2022). ATC/DDD Index: Carbamazepine. Norwegian Institute of Public Health. https://www.whocc.no/atc_ddd_index/?code=N03AF01 Zadbuke, N., Khan, A. R., Battase, A., & Shahi, S. (2017). Convolution and Deconvolution Based Approach For Prediction of in-vivo Performance. European Journal of Biomedical and Pharmaceutical Sciences, 4(11), 447–453. https://www.ejbps.com/ejbps/abstract_id/3377 Zhang, G. H., Vadino, W. A., Yang, T. T., Cho, W. P., & Chaudry, I. A. (1994). Evaluation of the Flow-Through Cell Dissolution Apparatus: Effects of Flow Rate, Glass Beads and Tablet Position on Drug Release from Different Type of Tablets. Drug Development and Industrial Pharmacy, 20(13), 2063–2078. https://doi.org/10.3109/03639049409050222 |
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Facultad de Ciencias |
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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.pdfc7ff631500fa2ed6fed8156865fd067fMD52unal/86344oai:repositorio.unal.edu.co:unal/863442024-07-02 13:56:02.478Repositorio Institucional Universidad Nacional de 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