Características fisicoquímicas de Sulfametoxazol asociadas a la disolución y variación de peso en Tabletas
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Date
2024
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Universidad Nacional de Trujillo
Abstract
El presente informe de tesis tuvo como objetivo determinar la asociación entre las características fisicoquímicas de Sulfametoxazol con la disolución y variación de peso en tabletas. Se trabajó con el ingrediente farmacéutico activo (IFA) Sulfametoxazol y 3 productos multifuentes. Se analizó el IFA mediante descripción, solubilidad, valoración, impurezas, Análisis Termogravimétrico (TG), Calorimetría Diferencial de Barrido (DSC), Difracción de rayos X, índice de Hausner (IH), índice de Carr (IC) y ángulo de reposo. El producto terminado se analizó mediante ensayos de disolución y variación de peso. Los ensayos farmacopeicos realizados al IFA cumplen con los criterios de aceptación establecidos en su monografía, asimismo, se identificó el polimorfo I (SMXI). También, se evidenció que existe incompatibilidad entre el IFA sulfametoxazol y lactosa monohidrato. Los resultados del IC, IH y ángulo de reposo demostraron que el flujo del polvo es pobre. El porcentaje disuelto de los productos multifuentes fue mayor al 70% (Q) + 5% de la cantidad de Sulfametoxazol en 60 minutos. Los pesos individuales de las tabletas se encontraron dentro del +/- 5% de variación con relación al peso promedio. Por lo tanto, se concluye que existe asociación entre las pruebas fisicoquímicas evaluadas con la disolución, además, se determinó la asociación positiva entre las pruebas físicas evaluadas y la variación de peso de las tabletas.
ABSTRACT The objective of this thesis report was to determine the association between the physicochemical characteristics of sulfamethoxazole with the dissolution and weight variation in tablets. We worked with the active pharmaceutical ingredient (API) Sulfamethoxazole and 3 multisource products. The API was analyzed by description, solubility, titration, impurities, Thermogravimetric Analysis (TG), Differential Scanning Calorimetry (DSC), X-ray diffraction, Hausner index (HI), Carr index (CI) and angle of repose. The finished product was analyzed by dissolution and weight variation tests. The pharmacopoeial trials carried out at the API meet the acceptance criteria established in its monograph; polymorph I (SMXI) was also identified. Also, it was evident that there is incompatibility between the IFA sulfamethoxazole and lactose monohydrate. The results of IC, IH and angle of repose showed that the powder flow is poor. The dissolved percentage of the multisource products was greater than 70% (Q) + 5% of the amount of Sulfamethoxazole in 60 minutes. Individual tablet weights were within +/- 5% variation from the average weight. Therefore, it is concluded that there is an association between the physicochemical tests evaluated with the dissolution, in addition, the positive association between the physical tests evaluated and the variation in weight of the tablets was determined.
ABSTRACT The objective of this thesis report was to determine the association between the physicochemical characteristics of sulfamethoxazole with the dissolution and weight variation in tablets. We worked with the active pharmaceutical ingredient (API) Sulfamethoxazole and 3 multisource products. The API was analyzed by description, solubility, titration, impurities, Thermogravimetric Analysis (TG), Differential Scanning Calorimetry (DSC), X-ray diffraction, Hausner index (HI), Carr index (CI) and angle of repose. The finished product was analyzed by dissolution and weight variation tests. The pharmacopoeial trials carried out at the API meet the acceptance criteria established in its monograph; polymorph I (SMXI) was also identified. Also, it was evident that there is incompatibility between the IFA sulfamethoxazole and lactose monohydrate. The results of IC, IH and angle of repose showed that the powder flow is poor. The dissolved percentage of the multisource products was greater than 70% (Q) + 5% of the amount of Sulfamethoxazole in 60 minutes. Individual tablet weights were within +/- 5% variation from the average weight. Therefore, it is concluded that there is an association between the physicochemical tests evaluated with the dissolution, in addition, the positive association between the physical tests evaluated and the variation in weight of the tablets was determined.
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Keywords
Polimorfo. Incompatibilidad. Análisis termogravimétrico. Calorimetría diferencial de barrido. Fluidez