Estudio de estabilidad de tres formulaciones magistrales hospitalarios de sildenafil en suspensión oral pediátrica elaboradas con diferentes vehículos.

Abstract

The objective of the study was to determine the stability of the master formulation in oral suspension of 2% sildenafil used in pulmonary hyertension of neonates in hospital centers. The preparation was to obtain sildenafil citrate 50 mg sildenafil chewable tablets and using as vehicles: sterile water (Formulation 1) and water conservans (Formulation 2). The analyzed parameters were physical (color, odor, pH and volume of sedimentation), chemical (sildenafil content) and microbiological, evaluated on 72 samples packed in amber glass bottle of 30 mL and stored at temperatures of 2–8 º C and less than 30º C, with test times of 0, 2, 5, 8, 11 and 15 days. The results showed that the color and odor characteristics were significantly modifies in each of the formulations depending on the storage condition and time, being more stable at a temperature of 2-8ºC and with water conservans as a vehicle. The chemical stability represented by the sildenafil content was unchanged for both formulations in the different storage conditions and until day 8 of the study, determining that to the formulation 2 the sildenafil concentration was maintained until day 11, no matter the storage condition. Regarding microbiological stability, both formulations were found to comply with the limits established for non-sterile pharmaceutical products detailed in the American Pharmacopoeia 30.