Biosimilitud in vitro de tabletas de clorfenamina maleato 4 mg producto multifuente e innovador dispensadas en ESSALUD, Trujillo
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Date
2021
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Universidad Nacional de Trujillo
Abstract
En el presente trabajo se compararon los perfiles de disolución de clorfenamina maleato 4 mg, que se dispensan en el Hospital Alta Complejidad Virgen de la Puerta – ESSALUD e innovador, utilizando el método de disolución farmacopeico USP 42. Se utilizaron tabletas de clorfenamina maleato 4 mg de ESSALUD y producto innovador CLORO- TRIMETON®, se usó el aparato de disolución tipo II, 37°C, en medios de disolución HCl 0,1N pH 1,2; buffer acetato pH 4,5 y buffer fosfato pH 6,8; según el protocolo de estudio de bioequivalencia in vitro establecido por la OMS. Se analizaron los perfiles de disolución según el criterio de aceptación de Akaike (AIC), el mejor modelo elegido fue Weibull, se determinaron los tiempos medio de disolución (TMD), la eficiencia de disolución (ED%) y el factor de similitud f2 entre el producto multifuente e innovador, fueron estadísticamente significativas. El factor de similitud f2 fue 54.99 para el pH 1,2; 51.47 para el pH 4,5 y 55.2 para el pH 6,8. Se concluye que los perfiles de disolución de clorfenamina maleato en tabletas 4 mg EsSalud multifuente e innovador expendidas en Perú, utilizando el método de disolución farmacopeico USP 42 son similares, y por tanto intercambiables.
ABSTRACT In the present work, the dissolution profiles of chlorphenamine maleate 4 mg, which are dispensed at the Hospital Alta Complexidad Virgen de la Puerta - ESSALUD and innovative, were compared using the pharmacopoeial dissolution method USP 42. chlorphenamine maleate tablets of 4 mg of ESSALUD and innovative product CLORO- TRIMETON®, the type II dissolution apparatus was used, 37 ° C, in dissolution media HCl 0.1N pH 1.2; acetate buffer pH 4.5 and phosphate buffer pH 6.8; according to the in vitro bioequivalence study protocol established by the WHO. The dissolution profiles were analyzed according to the Akaike acceptance criteria (AIC), the best model chosen was of Weibull, the mean dissolution times (TMD), the dissolution efficiency (ED%) and the similarity factor f2 were determined. between the multi-source and innovative product, they were statistically significant. The similarity factor f2 was 54.99 for pH 1.2; 51.47 for pH 4.5 and 55.2 for pH 6.8. It is concluded that the dissolution profiles of chlorphenamine maleate in 4 mg EsSalud multi-source and innovative tablets sold in Peru, using the USP 42 pharmacopoeial dissolution method are similar, and therefore interchangeable.
ABSTRACT In the present work, the dissolution profiles of chlorphenamine maleate 4 mg, which are dispensed at the Hospital Alta Complexidad Virgen de la Puerta - ESSALUD and innovative, were compared using the pharmacopoeial dissolution method USP 42. chlorphenamine maleate tablets of 4 mg of ESSALUD and innovative product CLORO- TRIMETON®, the type II dissolution apparatus was used, 37 ° C, in dissolution media HCl 0.1N pH 1.2; acetate buffer pH 4.5 and phosphate buffer pH 6.8; according to the in vitro bioequivalence study protocol established by the WHO. The dissolution profiles were analyzed according to the Akaike acceptance criteria (AIC), the best model chosen was of Weibull, the mean dissolution times (TMD), the dissolution efficiency (ED%) and the similarity factor f2 were determined. between the multi-source and innovative product, they were statistically significant. The similarity factor f2 was 54.99 for pH 1.2; 51.47 for pH 4.5 and 55.2 for pH 6.8. It is concluded that the dissolution profiles of chlorphenamine maleate in 4 mg EsSalud multi-source and innovative tablets sold in Peru, using the USP 42 pharmacopoeial dissolution method are similar, and therefore interchangeable.
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Keywords
Biosimilitud. Disolución. Clorfenamina