Development and stability assessment of liquid paediatric formulations containing sildenafil citrate
DOI:
https://doi.org/10.1590/S1984-82502013000200021Keywords:
Chemical stability, Microbiological stability, Sildenafil citrate, Paediatric formulationsAbstract
The purpose of this study is to develop and improve oral liquids formulations of sildenafil citrate for paediatric use. Four different formulations were developed, which are as follows: two aqueous solutions of sildenafil citrate (2.5 mg/mL), with or without preservatives, and two other solutions of sildenafil in simple syrup (1.25 mg/mL), with or without preservatives. All of the formulations were physically, chemically and microbiologically stable for three months. The results of the stability studies allowed for the optimisation of formulations without preservatives due to their simplicity and their similar stable conditions when compared to the formulations containing antimicrobials. The shelf life of both formulations was three months; however, upon opening, aqueous solutions should be used within 10 days and kept refrigerated, and syrup solutions should be used within 14 days in a hospital setting.Downloads
Downloads
Published
2013-06-01
Issue
Section
Articles
License
All content of the journal, except where identified, is licensed under a Creative Commons attribution-type BY.
The on-line journal has open and free access.
How to Cite
Development and stability assessment of liquid paediatric formulations containing sildenafil citrate . (2013). Brazilian Journal of Pharmaceutical Sciences, 49(2), 381-388. https://doi.org/10.1590/S1984-82502013000200021