Estudio de la eficacia de los aglutinantes en la disolución del metronidazol tabletas 250 mg
Fecha
2001
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
Se realizó el estudio para determinar la concentración óptima de aglutinantes como: Almidón de maíz, Povidona, Carboximetilcelulosa sódica, Avicel® PH-101 y obtener el mejor porcentaje de disolución para tabletas de Metronidazol 250 mg, para lo cual se fabricaron lotes con diferentes concentraciones de cada uno, utilizando dos métodos diferentes de manufactura.
Los porcentajes de disolución fueron determinados según técnica descrita en la USP XXIV, cuya tolerancia es de no menos de 90 % de Metronidazol disuelto en 60 minutos. La naturaleza y concentración de los aglutinantes alteran los valores de disolución.
Establecidas las correlaciones entre disolución y dureza, se encontró que a mayor concentración del aglutinante aumenta la dureza y disminuye la disolución para fórmulas B y C, excepto para A.
Analizando la disolución y friabilidad para fórmulas B y C, cuando la concentración del aglutinante es mayor la disolución y la friabilidad disminuyen, pero no en A.
En cuanto a dureza y friabilidad para todas las fórmulas, cuando la concentración del aglutinante es mayor, la dureza también es mayor y menor la friabilidad.
El mejor aglutinante para Metronidazol es el Avicel® PH-101 al 20 %, ya que a más de presentar buena disolución reúne características físico-químicas que satisfacen todas las especificaciones.
A study has been made in order to stablish the best concentration of binding agents like: Maize starch, Povidone, Sodium carboximethilcellulose, Avicel ® PH-101, and the best percentage of dissolution of Metronidazole tablets containing 250 mg of active drug, for this purpose three batches with different concentrations of each binding agent were manufactured using two different methods of granulation. The porcentage of dissolution were stablished by USP XXIV technique, with tolerance nor less than 90 % of dissolved Metronidazole in 60 minutes. The nature and concentration of the binding agents modify the dissolution values. Correlations have been stablished between dissolutions and hardness, it was found that with high concentrations of binding agents the hardness increases and the dissolution decreases for the formulations B and C with exception of formulation A. Studying dissolution and friability for formulations B and C, when the concentrations of binding agent is high the dissolution and friability decrease, but not in formulation A. In reference of hardness and friability for all formulations, when the concentration of binding agents is high, the hardness is also high and the friability is small. The best binding agent for Metronidazole is Avicel ® PH-101 20 %, with this binding agent we can get the best dissolution and phisico-chemical characteristics that satisfy every specifications.
A study has been made in order to stablish the best concentration of binding agents like: Maize starch, Povidone, Sodium carboximethilcellulose, Avicel ® PH-101, and the best percentage of dissolution of Metronidazole tablets containing 250 mg of active drug, for this purpose three batches with different concentrations of each binding agent were manufactured using two different methods of granulation. The porcentage of dissolution were stablished by USP XXIV technique, with tolerance nor less than 90 % of dissolved Metronidazole in 60 minutes. The nature and concentration of the binding agents modify the dissolution values. Correlations have been stablished between dissolutions and hardness, it was found that with high concentrations of binding agents the hardness increases and the dissolution decreases for the formulations B and C with exception of formulation A. Studying dissolution and friability for formulations B and C, when the concentrations of binding agent is high the dissolution and friability decrease, but not in formulation A. In reference of hardness and friability for all formulations, when the concentration of binding agents is high, the hardness is also high and the friability is small. The best binding agent for Metronidazole is Avicel ® PH-101 20 %, with this binding agent we can get the best dissolution and phisico-chemical characteristics that satisfy every specifications.
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AGLUTINANTES, METRONIDAZOL, TABLETAS, FORMAS FARMACEUTICAS, INDUSTRIA FARMACEUTICA, FARMACOLOGÍA