Liquid pediatric formulation of sildenafil citrate: Preparation and stability evaluation - 14/08/19
, Nour El Yakine Ahmed Gaid, Cheyma Deghboudj, Nacéra Chaffai
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Resumen |
Sildenafil citrate, neonatal pulmonary antihypertensive, not being marketed as a pediatric drug, an extemporaneous liquid preparation of this drug could be proposed for a pediatric use.
The objective of this study is therefore to prepare a solution of Sildenafil citrate, in a simple syrup (1.25mg/ml), from Sildenafil Tablets (VIACTAL® 50mg), according to a common practice “dosage adjustment” allowing to adjust doses in pediatrics.
A physicochemical and microbiological stability study of this solution was carried out at 5°C. The results of this study have shown that Sildenafil citrate syrup solutions stored in the refrigerator are stable for a period of 04 weeks: unchanged color and odor, no crystallization observed, no pH variation, unchanged active substance concentration and no microbial contamination detected. However, after opening the vials, these preparations must be used within 07 days.
El texto completo de este artículo está disponible en PDF.Keywords : Liquid pediatric formulation, Stability, Sildenafil citrate
Esquema
Vol 11 - N° 4
P. e399 - septembre 2019 Regresar al número
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Bienvenido a EM-consulte, la referencia de los profesionales de la salud.