Resumen

ANDRADE, Beatriz et al. Comparative study stability of the three master formulation of Sildenafil solution obtained from differents trademarks. INHRR [online]. 2011, vol.42, n.1, pp.43-51. ISSN 0798-0477.

Sildenafil is a drug with proven therapeutic activity in erectile dysfunction is available under the pharmaceutical form of tablets for oral administration. It is currently being de veloped skillfully in an oral solution at a concentration of 1mg/ml, for pulmonary hypertension (pH), as has been planned to perform a study of stability in three conditions: environmental (25 ± 2 ºC), refrigeration (5 ± 3 ºC) and exaggerated storage (40 °C ± 2 ºC). The parameters evaluated were appearance, clarity, density, pH and content of sildenafil. The analytical method used was high performance liquid chromatography (HPLC) reverse phase. The appearance, pH and density of the solutions were no significant changes in the different samples and study conditions. As for the results of the initial content of sildenafil was obtained about 75% by weight in for mulating the solution, based on the tablet. It should be noted that there was discrepancy in the values of concentration of sildenafil obtained at different times and conditions, results they expected because it is a masterly formulation of tablets of different business houses, so this study suggest that the wording allowed masterful be reformulated to the pharmaceutical form of suspension, to ensure the contents of the entire active.

Palabras clave : Sildenafil oral solution; compounding; pulmonary hypertension; stability; pediatric patient.