Estudio comparativo de las propiedades fisicoquímicas entre azitromicina de marca frente a su genérico usada en infecciones respiratorias.
Fecha
2021
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
El consumo de medicamentos genéricos se ha incrementado con el transcurso del tiempo ya que son más accesibles por su bajo costo, aunque hay personas que prefieren el medicamento de marca porque suponen que tienen más efectividad, sin embargo, el medicamento genérico para poder ser comercializado deberá demostrar que es bioequivalente al medicamento innovador mediante los controles en el proceso de manufactura. En este trabajo investigativo se describen los resultados del estudio comparativo de los parámetros de calidad de la Azitromicina de 500 mg de diferentes fabricantes siendo uno el innovador y dos genéricos, la metodología empleada fue (HPLC) Cromatografía Líquida de Alta Resolución se evidenció el cumplimiento de las especificaciones estipuladas en la USP 40, los resultados obtenidos en las cinco partes experimentales demostraron semejanzas en los tres medicamentos de estudio, aunque en ciertos parámetros hubo diferencias, pero esto se deberá a las especificaciones internas de cada industria farmacéutica.
The consumption of generic drugs has increased over time as they are more accessible due to their low cost, although there are people who prefer the brand name drug because they assume that they are more effective, however, the generic drug to be marketed must demonstrate that it is bioequivalent to the innovative drug through controls in the manufacturing process. In this research work we describe the results of the comparative study of the quality parameters of Azithromycin 500 mg from different manufacturers being one the innovator and two generic, the methodology used was (HPLC) High Resolution Liquid Chromatography was evidenced compliance with the specifications stipulated in USP 40, the results obtained in the five experimental parts showed similarities in the three study drugs, although in certain parameters there were differences, but this will be due to the internal specifications of each pharmaceutical industry.
The consumption of generic drugs has increased over time as they are more accessible due to their low cost, although there are people who prefer the brand name drug because they assume that they are more effective, however, the generic drug to be marketed must demonstrate that it is bioequivalent to the innovative drug through controls in the manufacturing process. In this research work we describe the results of the comparative study of the quality parameters of Azithromycin 500 mg from different manufacturers being one the innovator and two generic, the methodology used was (HPLC) High Resolution Liquid Chromatography was evidenced compliance with the specifications stipulated in USP 40, the results obtained in the five experimental parts showed similarities in the three study drugs, although in certain parameters there were differences, but this will be due to the internal specifications of each pharmaceutical industry.
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AZITROMICINA, HPLC, INFECCIONES RESPIRATORIAS