Perfil reológico y caracterización fisicoquímica de atorvastatina cálcica como materia prima
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Date
2020
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Universidad Nacional de Trujillo
Abstract
El estudio tiene como objetivo caracterizar fisicoquímicamente la atorvastatina cálcica (ATC) y evaluar su perfil reológico utilizando el Reómetro Mixer Torque Rheometer (MTR). La materia prima fue caracterizada mediante la difracción de rayos X (XRD), calorimetría diferencial de barrido (DSC), análisis termogravimétrico (TGA), tamaño de partículas y propiedades de flujo. Del mismo modo, para evaluar el perfil reológico se realizaron dos ensayos a partir de una formulación (30% de Celulosa microcristalina, 30% de polivinilpirrolidona y 69% de ATC), para el ensayo 1 se utilizó como medio agua y para el ensayo 2 se utilizó agua con 0,1% de polisorbato 80. Los resultados evidenciaron que la muestra presentaba forma polimórfica VIII, punto de fusión en 162,4 ºC, degradación a partir de 200 ºC, diámetro de partículas de 26,33 ± 0.31 µm, índice de Hausner >1,35 lo que lo clasifica como un polvo con flujo deficiente. En el perfil reológico de la ATC, el torque máximo obtenido en el ensayo 1 y 2 fue 0,823 Nm y 0,750 Nm respectivamente, la razón más adecuada para la adición del medio a la muestra fue 0.667 mL/g para ambos ensayos. Se concluye sobre la importancia de la caracterización fisicoquímica de la ATC, ya que existen diferentes formas polimórficas y cada una presenta sus propias propiedades, las cuales pueden influir en el rendimiento y la estabilidad del producto final; además que utilizar el MRT para determinar la relación ideal de líquido/sólido (L/S) para la granulación húmeda, es un método confiable para la granulación de la ATC.
ABSTRACT The objective of the study is to physically characterize atorvastatin calcium (ATC) and evaluate its rheological profile using the Mixer Torque Rheometer (MTR). The raw material was characterized by X-ray diffraction (XRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), particle size and flow properties. Similarly, to evaluate the rheological profile, two tests were carried out from a formulation (30% microcrystalline cellulose, 30% polyvinylpyrrolidone and 69% ATC), for test 1 water was used as medium and for test 2 water with 0.1% polysorbate 80 was used. The results showed that the sample had polymorphic form VIII, melting point at 162.4 ºC, degradation from 200 ºC, particle diameter of 26.33 ± 0.31 µm, Hausner index> 1.35 which classifies it as a poor flow powder. In the rheological profile of the ATC, the maximum torque obtained in tests 1 and 2 was 0.823 Nm and 0.750 Nm respectively, the most appropriate ratio for adding the medium to the sample was 0.667 mL / g for both tests. It is concluded the importance of the physicochemical characterization of the ATC, since there are different polymorphic forms and each one has its own properties, which can influence the performance and stability of the final product; In addition, using the MRT to determine the ideal liquid / solid (L / S) ratio for wet granulation is a reliable method for ATC granulation.
ABSTRACT The objective of the study is to physically characterize atorvastatin calcium (ATC) and evaluate its rheological profile using the Mixer Torque Rheometer (MTR). The raw material was characterized by X-ray diffraction (XRD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), particle size and flow properties. Similarly, to evaluate the rheological profile, two tests were carried out from a formulation (30% microcrystalline cellulose, 30% polyvinylpyrrolidone and 69% ATC), for test 1 water was used as medium and for test 2 water with 0.1% polysorbate 80 was used. The results showed that the sample had polymorphic form VIII, melting point at 162.4 ºC, degradation from 200 ºC, particle diameter of 26.33 ± 0.31 µm, Hausner index> 1.35 which classifies it as a poor flow powder. In the rheological profile of the ATC, the maximum torque obtained in tests 1 and 2 was 0.823 Nm and 0.750 Nm respectively, the most appropriate ratio for adding the medium to the sample was 0.667 mL / g for both tests. It is concluded the importance of the physicochemical characterization of the ATC, since there are different polymorphic forms and each one has its own properties, which can influence the performance and stability of the final product; In addition, using the MRT to determine the ideal liquid / solid (L / S) ratio for wet granulation is a reliable method for ATC granulation.
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Keywords
Atorvastatina cálcica, perfil reológico, granulación húmeda