Estudio de la bioequivalencia in vitro de las tabletas de ciprofloxacino de 500 mg, elaboradas por dos laboratorios farmacéuticos del Ecuador, mediante el empleo de los perfiles de disolución
Fecha
2016
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
Introducción: La investigación y aplicación de los ensayos de Bioequivalencia ha permitido indicar la posibilidad de que un principio activo cumple con la misma actividad farmacológica en un medicamento genérico respecto al innovador. Ciprofloxacino es un antibiótico de amplio espectro aprobado para el tratamiento de infecciones bacterianas.
Materiales y Métodos: Se emplearon tabletas de ciprofloxacino de 500 mg de dos laboratorios farmacéuticos y el medicamento innovador; un equipo disolutor (aparato
2) y como medio de disolución HCl 0.01N. Los cálculos se realizaron en base al
modelo independiente determinando el factor de similitud y diferencia.
Resultados: En el genérico A el valor de F1 fue 9,49 y F2 49,81 y en el caso del Genérico B el valor de F1 fue de 7,06 y el de F2 48,76 incumpliendo con el valor de F2 lo que demuestra que el producto no cumplió con el factor de similitud, ya que el rango de aceptación para F1: 0 – 15; y F2: 50 -100.
Discusión: Los perfiles de disolución determinados para los diferentes lotes de los medicamentos genéricos estudiados, presentaron diferencias en el tiempo de 5 minutos, existiendo diferencias entre lotes para ambos laboratorios y con respecto al medicamento innovador.
Conclusión: Se determinó que los dos medicamentos genéricos no son
intercambiables en relación con el de referencia, esto puede ser debido a variaciones con los excipientes o durante el proceso manufactura que pudieron afectar en la disolución.
Introduction: The research and application of the Bioequivalence tests has allowed to indicate the possibility that an active principle fulfills the same pharmacological activity in a generic drug with respect to the innovator. Ciprofloxacin is a broad spectrum antibiotic approved for the treatment of bacterial infections. Materials and Methods: Ciprofloxacin tablets 500 mg two pharmaceutical laboratories and innovative drug were used; one disolutor equipment (apparatus 2) and as 0.01N HCl dissolution medium. The calculations were made based on the independent model determining the factor of similarity and difference. Results: A generic value F1 and F2 were 9.49 and 49.81 in the case of Generic B value was 7.06 F1 and F2 48.76 breach with the value F2 which It shows that the product did not meet the similarity factor, since the acceptance range for F1: 0-15; and F2: 50 -100. Discussion: The dissolution profiles determined for different batches of generic drugs studied, showed differences in the time of 5 minutes, with differences between batches for both laboratories and regarding innovative drug. Conclusion: It was determined that the two are not interchangeable generic regarding the reference, this may be due to variations with excipients or during manufacturing process that could affect the dissolution.
Introduction: The research and application of the Bioequivalence tests has allowed to indicate the possibility that an active principle fulfills the same pharmacological activity in a generic drug with respect to the innovator. Ciprofloxacin is a broad spectrum antibiotic approved for the treatment of bacterial infections. Materials and Methods: Ciprofloxacin tablets 500 mg two pharmaceutical laboratories and innovative drug were used; one disolutor equipment (apparatus 2) and as 0.01N HCl dissolution medium. The calculations were made based on the independent model determining the factor of similarity and difference. Results: A generic value F1 and F2 were 9.49 and 49.81 in the case of Generic B value was 7.06 F1 and F2 48.76 breach with the value F2 which It shows that the product did not meet the similarity factor, since the acceptance range for F1: 0-15; and F2: 50 -100. Discussion: The dissolution profiles determined for different batches of generic drugs studied, showed differences in the time of 5 minutes, with differences between batches for both laboratories and regarding innovative drug. Conclusion: It was determined that the two are not interchangeable generic regarding the reference, this may be due to variations with excipients or during manufacturing process that could affect the dissolution.
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CIPROFLOXACINA, BIOEQUIVALENCIA, PERFILES DE DISOLUCIÓN