Intercambiabilidad de Tabletas Multifuentes de Isoniazida 100 mg adquiridas por el Estado peruano
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Date
2024
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Universidad Nacional de Trujillo
Abstract
Este estudio tuvo como finalidad determinar la intercambiabilidad de tabletas multifuente de isoniazida 100 mg adquiridas por el Estado peruano. Se evaluaron los perfiles de disolución de las tabletas de isoniazida de dos laboratorios siguiendo lo descrito en la guía de la Organización Mundial de la Salud. El ensayo de disolución se realizó utilizando un aparato tipo II (paleta) a 75 rpm, con 900 mL de medio buffer con pH 1,2; 4,5 y 6,8, a una temperatura de 37 ± 0,5 ºC. Se extrajeron muestras de 10 mL en los tiempos de 5, 10, 15, 20, 30 y 45 minutos, y la lectura espectrofotométrica se realizó a 263 nm. Se utilizó el Criterio de Información de Akaike para identificar el modelo dependiente que mejor describe la cinética de disolución en cada pH y se compararon las constantes de velocidad mediante la prueba T de Student (α = 0,05). También se evaluaron los porcentajes disueltos a los 15 minutos y el factor de similitud (f2). El modelo dependiente de mejor ajuste para las cinéticas de disolución fue Hixson y Crowell, cuyas constantes de velocidad fueron diferentes para los tres medios de disolución (p < 0,05). Los valores del factor de similitud (21,70 a pH 1,2; 20,53 a pH 4,5; y 22,39 a pH 6,8) no son concluyentes. Sin embargo, ya que ambas tabletas disolvieron más del 85% en menos de 15 minutos, se concluye que las tabletas multifuente de isoniazida 100 mg adquiridas por el Estado peruano son intercambiables.
ABSTRACT The purpose of this study was to determine the interchangeability of 100 mg isoniazid multisource tablets purchased by the Peruvian State. The dissolution profiles of isoniazid tablets from two laboratories were evaluated following the World Health Organization guidelines. The dissolution test was performed using a type II apparatus (paddle) at 75 rpm, with 900 mL of buffer medium with pH 1.2, 4.5 and 6.8, at a temperature of 37 ± 0.5 ºC. Samples of 10 mL were extracted at times of 5, 10, 15, 20, 30 and 45 minutes, and the spectrophotometric reading was performed at 263 nm. The Akaike Information Criterion was used to identify the dependent model that best describes the dissolution kinetics at each pH and the rate constants were compared using the Student T test (α = 0.05). The percentages dissolved at 15 minutes and the similarity factor (f2) were also evaluated. The best-fitting dependent model for dissolution kinetics was Hixson and Crowell, whose rate constants were different for the three dissolution media (p < 0.05). The similarity factor values (21.70 at pH 1.2; 20.53 at pH 4.5; and 22.39 at pH 6.8) are not conclusive. However, since both tablets dissolved more than 85% in less than 15 minutes, it is concluded that the 100 mg isoniazid multisource tablets purchased by the Peruvian State are interchangeable
ABSTRACT The purpose of this study was to determine the interchangeability of 100 mg isoniazid multisource tablets purchased by the Peruvian State. The dissolution profiles of isoniazid tablets from two laboratories were evaluated following the World Health Organization guidelines. The dissolution test was performed using a type II apparatus (paddle) at 75 rpm, with 900 mL of buffer medium with pH 1.2, 4.5 and 6.8, at a temperature of 37 ± 0.5 ºC. Samples of 10 mL were extracted at times of 5, 10, 15, 20, 30 and 45 minutes, and the spectrophotometric reading was performed at 263 nm. The Akaike Information Criterion was used to identify the dependent model that best describes the dissolution kinetics at each pH and the rate constants were compared using the Student T test (α = 0.05). The percentages dissolved at 15 minutes and the similarity factor (f2) were also evaluated. The best-fitting dependent model for dissolution kinetics was Hixson and Crowell, whose rate constants were different for the three dissolution media (p < 0.05). The similarity factor values (21.70 at pH 1.2; 20.53 at pH 4.5; and 22.39 at pH 6.8) are not conclusive. However, since both tablets dissolved more than 85% in less than 15 minutes, it is concluded that the 100 mg isoniazid multisource tablets purchased by the Peruvian State are interchangeable
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Antituberculosos. Bioexención. Cinética de disolución. Factor de similitud.