Perfil de disolución en tabletas de clorhidrato de propranolol 40 miligramos de 1 marca genérica que se comercializa en Ecuador, comparado con la marca innovadora
Fecha
2018
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Universidad de Guayaquil. Facultad de Ciencias Químicas
Resumen
El presente trabajo de investigación tiene como objetivo determinar la bioequivalencia in-vitro de tabletas de Clorhidrato de Propranolol de 40 mg, comparando el medicamento genérico del innovador. Los perfiles de disolución del medicamento genérico e innovador se midieron, en tres medios: pH 1.2, pH
4.5 y pH 6.8. Se cuantificó el contenido de Clorhidrato de Propranolol en ambos medicamentos y se evidenció que los valores del medicamento genérico se encuentran dentro del rango establecido por la Farmacopea de los Estados Unidos (USP 38 NF), es decir 90% - 100%. Se demostró mediante el factor de diferencia (f1) y factor de similitud (f2) que tanto el medicamento genérico como medicamento innovador poseen una curva de disolución similar, por lo que se asegura su intercambiabilidad terapéutica.
The aim of this research is to determine the in-vitro bioequivalence of propranolol hydrochloride with pharmaceutical form of 40 mg tablets, generic and innovative. The content of Propranolol Hydrochloride was quantified in both drugs and it was determined that the generic drug values are within the range established by the United States Pharmacopoeia, that is, 90% - 100%. The dissolution profiles of the generic and innovative drug were measured, in three media: pH 1.2, pH 4.5 and pH 6.8. It was demonstrated by means of the difference factor (f1) and similarity factor (f2) that both drugs, the generic and the innovative drug have a similar dissolution curve, thus ensuring its therapeutic interchangeability.
The aim of this research is to determine the in-vitro bioequivalence of propranolol hydrochloride with pharmaceutical form of 40 mg tablets, generic and innovative. The content of Propranolol Hydrochloride was quantified in both drugs and it was determined that the generic drug values are within the range established by the United States Pharmacopoeia, that is, 90% - 100%. The dissolution profiles of the generic and innovative drug were measured, in three media: pH 1.2, pH 4.5 and pH 6.8. It was demonstrated by means of the difference factor (f1) and similarity factor (f2) that both drugs, the generic and the innovative drug have a similar dissolution curve, thus ensuring its therapeutic interchangeability.
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BIOEQUIVALENCIA, DISOLUCIÓN, PROPRANOLOL