dc.contributorBaena Ariztizábal, Yolima
dc.contributorSistema para Liberación Controlada de Moléculas Biológicamente Activas (SILICOMOBA)
dc.creatorSanchez Martinez, Angie Carolina
dc.date.accessioned2023-01-25T20:24:23Z
dc.date.accessioned2023-06-06T23:20:04Z
dc.date.available2023-01-25T20:24:23Z
dc.date.available2023-06-06T23:20:04Z
dc.date.created2023-01-25T20:24:23Z
dc.date.issued2023-01-23
dc.identifierhttps://repositorio.unal.edu.co/handle/unal/83120
dc.identifierUniversidad Nacional de Colombia
dc.identifierRepositorio Institucional Universidad Nacional de Colombia
dc.identifierhttps://repositorio.unal.edu.co/
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/6651230
dc.description.abstractEl presente estudio se realizó con el fin de determinar la posible equivalencia in vitro de dos medicamentos que contienen aciclovir en forma farmacéutica de tabletas de liberación inmediata frente al producto líder en el mercado en Colombia, de acuerdo con las directrices establecidas en la Resolución 1124 de 2016 del Ministerio de Salud y Protección Social. Para ello, se realizó la validación de la metodología analítica para la cuantificación del principio activo aciclovir, en cada uno de los niveles de pH evaluados, así como el control de calidad de los diferentes lotes de los tres productos que hacen parte del estudio, verificando el cumplimiento de las especificaciones establecidas en la monografía de aciclovir tabletas USP 41. Los perfiles de disolución en los tres niveles de pH (1,2; 4,5 y 6,8) se analizaron estadísticamente, comparando la eficiencia y el tiempo medio de disolución. Los resultados mostraron que, tanto el producto comparador como los dos productos de prueba se disolvieron muy rápidamente, por lo cual estos dos productos se consideraron equivalentes frente al líder del mercado y no fue necesaria la comparación de perfiles mediante el cálculo de los factores f1 y f2. De acuerdo con estos resultados, teniendo en cuenta que el aciclovir está clasificado como clase III en el sistema de clasificación biofarmacéutica, los productos evaluados se podrían considerar intercambiables desde la óptica de disolución, sin embargo, no se podría afirmar nada respecto a su equivalencia terapéutica debido a que el producto de referencia no se comercializa en el país. (Texto tomado de la fuente)
dc.description.abstractThe present study was carried out to determine the possible in vitro equivalence of two drugs products that contain acyclovir in tablets of immediate release against the lead market product in Colombia, according to the guidelines established in Resolution 1124 of 2016 from the Ministry of Health and Social Protection. For that reason, the validation of the quantification analytical methodology for the active pharmaceutical ingredient acyclovir was carried out in each one of the pH levels evaluated, so as the quality control of the different batches of the three products that conformed the study; the specifications were verified in accordance with the USP 41 monograph for acyclovir tablets. The three pH level dissolution profiles (1.2, 4,5 and 6,8) were statistically analyzed using the independent model method, comparing the efficiency and mean dissolution time. The results showed that both, the comparator product and the two tested products, dissolved very rapidly, therefore these two products were considered equivalent against the market leader and a profile comparison by calculating the f1 and f2 factor was not necessary. According to these results, considering that acyclovir is classified as class III in the biopharmaceutical classification system, the tested products could be considered interchangeable from the dissolution point of view, however, no affirmation could be done regarding its therapeutic equivalence because the reference product is not marketed in the country.
dc.languagespa
dc.publisherUniversidad Nacional de Colombia
dc.publisherBogotá - Ciencias - Maestría en Ciencias Farmacéuticas
dc.publisherFacultad de Ciencias
dc.publisherBogotá - Colombia
dc.publisherUniversidad Nacional de Colombia - Sede Bogotá
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dc.rightsAtribución-NoComercial-SinDerivadas 4.0 Internacional
dc.rightshttp://creativecommons.org/licenses/by-nd/4.0/
dc.rightsinfo:eu-repo/semantics/openAccess
dc.titleEstudio de equivalencia in vitro de algunos medicamentos de aciclovir, presentados como tabletas de liberación inmediata, comercializados en Colombia
dc.typeTrabajo de grado - Maestría


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