Perfiles de disolución de prednisona 50 mg, tabletas, medicamentos referente y multifuente comercializados en la ciudad de Trujillo, año 2023
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Date
2024
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Universidad Nacional de Trujillo
Abstract
Es importante determinar la intercambiabilidad entre medicamentos con el mismo principio activo, esto para asegurar que cumplan la función deseada. Debido a esto se planteó el siguiente problema: ¿Serán similares los perfiles de disolución de prednisona 50mg, tabletas, medicamento referente y multifuente comercializados en la ciudad de Trujillo, año 2023?. Por este motivo se evaluaron los perfiles de disolución de prednisona 50 mg, para tabletas de un medicamento referente, multifuente 1 y 2; para lo cual se hizo uso de la USP del año 2023, que nos indica que se tienen que trabajar 12 tabletas, además de usar 3 distintos medios de disolución: ácido clorhídrico 0,1 N (pH 1,2), buffer acetato (pH 4,5) y buffer fosfato (pH 6,8), ya que estos medios simulan las condiciones del fluido gástrico, fluido duodenal y fluido intestinal; también se usaron los tiempos de muestreo: 5; 10; 15; 30; 45 y 60 minutos. Se determinó cuál es el mejor modelo matemático (orden cero, orden uno, raíz cúbica, Higuchi y Weibull) que explique la cinética de disolución del medicamento referente, multifuente 1 y 2; para realizar esto se tuvo que aplicar el Criterio de Información de Akaike (AIC). También se hizo uso del modelo independiente llamado factor de similitud (f2), que como nos indica la FDA (Food and Drug Administration) se debe encontrar en un rango de 50-100. Para el medicamento multifuente 1 se obtuvo los valores: 80,25 (pH 1,2); 87,47 (pH 4,5) y 76,53 (pH 6,8) y para el medicamento multifuente 2 se obtuvo los valores: 86,74 (pH 1,2); 91,46 (pH 4,5) y 90,56 (pH 6,8). Conclusión: Se determinó la similitud entre los perfiles de disolución, la intercambiabilidad entre el medicamento referente y multifuente 1 y 2; y que la mejor cinética de disolución es raíz cúbica
ABSTRACT It is important to determine the interchangeability between medications with the same active ingredient, this to ensure that they fulfill the desired function. Due to this, the following problem was raised: Will the dissolution profiles of prednisone 50mg, tablets, reference medication and multisource marketed in the city of Trujillo, year 2023, be similar? For this reason, the dissolution profiles of prednisone 50 mg were evaluated for tablets of a reference medication, multisource 1 and 2; for which the USP of the year 2023 was used, which tells us that 12 tablets have to be processed, in addition to using three different dissolution media: 0,1 N hydrochloric acid (pH 1,2), acetate buffer (pH 4,5) and phosphate buffer (pH 6,8), since these media simulate the conditions of gastric fluid, duodenal fluid and intestinal fluid; Sampling times were also used: 5; 10; 15; 30; 45 and 60 minutes. It was determined which is the best mathematical model (zero order, first order, cubic root, Higuchi and Weibull) that explains the dissolution kinetics of the reference drug, multisource 1 and 2; To do this, the Akaike Information Criterion (AIC) had to be applied. The independent model called similarity factor (f2) was also used, which as the FDA (Food and Drug Administration) tells us should be in a range of 50-100. For multisource medication 1, the values were obtained: 80,25 (pH 1,2); 87,47 (pH 4,5) and 76,53 (pH 6,8) and for multisource medication 2 the values were obtained: 86,74 (pH 1,2); 91,46 (pH 4,5) and 90,56 (pH 6,8). Conclusion: The similarity between the dissolution profiles was determined, the interchangeability between the reference drug and multisource 1 and 2; and that the best dissolution kinetics is cube root.
ABSTRACT It is important to determine the interchangeability between medications with the same active ingredient, this to ensure that they fulfill the desired function. Due to this, the following problem was raised: Will the dissolution profiles of prednisone 50mg, tablets, reference medication and multisource marketed in the city of Trujillo, year 2023, be similar? For this reason, the dissolution profiles of prednisone 50 mg were evaluated for tablets of a reference medication, multisource 1 and 2; for which the USP of the year 2023 was used, which tells us that 12 tablets have to be processed, in addition to using three different dissolution media: 0,1 N hydrochloric acid (pH 1,2), acetate buffer (pH 4,5) and phosphate buffer (pH 6,8), since these media simulate the conditions of gastric fluid, duodenal fluid and intestinal fluid; Sampling times were also used: 5; 10; 15; 30; 45 and 60 minutes. It was determined which is the best mathematical model (zero order, first order, cubic root, Higuchi and Weibull) that explains the dissolution kinetics of the reference drug, multisource 1 and 2; To do this, the Akaike Information Criterion (AIC) had to be applied. The independent model called similarity factor (f2) was also used, which as the FDA (Food and Drug Administration) tells us should be in a range of 50-100. For multisource medication 1, the values were obtained: 80,25 (pH 1,2); 87,47 (pH 4,5) and 76,53 (pH 6,8) and for multisource medication 2 the values were obtained: 86,74 (pH 1,2); 91,46 (pH 4,5) and 90,56 (pH 6,8). Conclusion: The similarity between the dissolution profiles was determined, the interchangeability between the reference drug and multisource 1 and 2; and that the best dissolution kinetics is cube root.
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Keywords
Perfil, disolución, cinética, prednisona, modelo