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Universitas (León)
Article . 2021 . Peer-reviewed
License: CC BY NC SA
Data sources: Crossref
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Bioequivalencia Farmacéutica in vitro de Amoxicilinas cápsulas de 500 mg

Authors: Keyla J. Medrano López; Fania V. Valladares Silva; Cesar Antonio Peralta; Saura L. Mendoza Marín; Yader B. Salgado Mercado; Tania M. Díaz Pérez; Kimberly Morán Jarquín; +2 Authors

Bioequivalencia Farmacéutica in vitro de Amoxicilinas cápsulas de 500 mg

Abstract

Para establecer la intercambiabilidad de los medicamentos, principalmente de los genéricos, es necesario demostrar la equivalencia de estos con respecto al medicamento de referencia (Talevi, Quiroga, & Ruiz, 2016). Entre las principales pruebas que se realizan, están las de biodisponibilidad, bioequivalencia y la comparación de perfiles de disolución. Estas pruebas permiten garantizar la seguridad del intercambio entre medicamentos durante la práctica clínica.La Amoxicilina, antibiótico de amplio espectro muy utilizado en nuestro país para el tratamiento de diversas patologías infecciosas se encuentra en la Clase I dentro del Sistema de Clasificación Biofarmacéutica (SCB) (OPS, 2011), por lo cual, su equivalencia se puede demostrar a través de estudios in vitro. En este estudio se realizó la comparación de los perfiles de disolución de tres medicamentos de Amoxicilina cápsulas 500 mg comercializados en Nicaragua, con el objetivo de demostrar si son intercambiables. La metodología utilizada en el estudio es la descrita en la Guía de la FDA para comparación de perfiles de disolución; se utilizaron tres medios de disolución a pH 1.2, 4.5 y 6.8 y se calculó f2 para determinar la intercambiabilidad. A pH 1.2, todos los productos alcanzaron en el primer tiempo de muestreo, un porcentaje disuelto mayor al 85%, en el medio de disolución pH 4.5, tanto el medicamento C como el de referencia, no lo alcanzaron.En cambio, a pH 6.8, solamente el medicamento B logró más del 85% del principio activo disuelto en los primeros diez minutos de la prueba. 

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
gold