Physicochemical and Microbiological Stability of the Extemporaneous Sildenafil Citrate Oral Suspension

• Published in: Scientia pharmaceutica Vol. 83; no. 4; pp. 659 - 670
• Main Authors: Sae Yoon, Attawadee, Sawatdee, Somchai, Woradechakul, Chuthamas, Sae Chee, Kridsada, Atipairin, Apichart
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 01.10.2015; The Austrian Journal of Pharmaceutical Sciences
• Subjects: Extemporaneous preparation; Suspension; Sildenafil; ASEAN guideline; Stability study
• ISSN: 0036-8709; 2218-0532
• DOI: 10.3797/scipharm.1505-08

Sildenafil is a potent and selective phosphodiesterase-5 inhibitor that is effectively used in the treatment of pulmonary arterial hypertension. In several countries, hospital pharmacists prepare the drug in an extemporaneous liquid preparation as there are no liquid formulations available for pediatric and adult uses. The purpose of this study was to evaluate the stability of an extemporaneous sildenafil citrate oral suspension for 90 days, according to the ASEAN guideline on stability studies of drug products. The results showed that the preparation was a white suspension with a sweet taste. It was a viscous and weakly acidic mixture with pseudoplastic behavior. The drug content was in the range between 99.23% and 102.23%, and the microbial examination met the general requirements throughout the study period. Therefore, the extemporaneously compounded sildenafil suspensions were physically, chemically, and microbiologically stable for at least 90 days when stored at 30° and 40°C. Furthermore, the in-use stability study showed that the preparations had acceptable attributes at least 14 days after the first-time use. This might provide an alternative option when the commercial suspension is unavailable.