Estudio de estabilidad de fórmulas magistrales líquidas preparadas para uso pediátrico de Enalapril, Sildenafil e Irbesartán.

Abstract

At present the majority of pediatric treatments used for different pathologies don't have the concentrations of active ingredients and suitable pharmaceutical forms. There have been known that a lot of rare diseases occur in the pediatric age, this is pretty due to genetic or infectious origin, what has led to choosing of the development of a compounded formula to cover the treatment. Sildenafil is a drug with proven therapeutic activity in erectile dysfunction; available in the pharmaceutical form of tablets. In the current conditions it is pharmaceutically compounding, for pulmonary hypertension, Enalapril and Irbesartán are drugs of proven activity in arterial hypertension; available in tablets and currently they are pharmaceutically compounding for hypertensive crisis, what has arisen a study of the stability of these active ingredients in three environmental conditions (25 ± 2 °C), refrigeration (5 ± 2 °C) and exaggerated storage (40 ± 2 °C). The evaluated parameters were: appearance, odor, color, flavor, density, pH and content of the active ingredient. The used analytical method was High-performance liquid chromatography (HPLC). The organoleptic characteristics, pH values and density of the obtained solutions showed no significant changes in the different samples and study conditions. Regarding Sildenfil content results it was observed that the stored compounding at 25 °C maintains its stability for 4 days. In Enalapril the stored compounding at 25 °C remains stable for 5 days and in the case of Irbesartan stored compounding at 5 °C remains stable for 7 days.