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MILAP C. NAHATA, M.S., PHARM.D., is Professor and Division Chair, College of Pharmacy, and Professor of Internal Medicine and Pediatrics, College of Medicine; RICHARD S. MOROSCO is Research Associate; and MICHAEL T. BRADY, M.D., is Professor of Pediatrics, College of Medicine, The Ohio State University, Columbus.

Address correspondence to Dr. Nahata at the College of Pharmacy, The Ohio State University, 500 West 12th Avenue, Columbus, OH 43210 (nahata.1{at}osu.edu).

Purpose. The stability of sildenafil citrate 2.5 mg/mL in two extemporaneously prepared oral suspensions stored at 4 and 25 °C was studied. Methods. Thirty 25-mg tablets of sildenafil citrate were ground to powder, and the powder was combined with a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of methylcellulose 1% and Simple Syrup, NF, to produce two 2.5-mg/mL suspensions. Five plastic bottles of each suspension were stored in amber plastic prescription bottles at 4 or 25 °C. Samples were collected on days 0, 7, 14, 28, 42, 56, 70, and 91 for analysis of sildenafil content by high-performance liquid chromatography; pH was also measured. Samples were visually observed against black and white backgrounds. Results. The mean concentration of sildenafil citrate exceeded 98% of the initial concentration in all samples at both temperatures throughout the 91-day study period. No changes in pH, odor, or physical appearance were observed. Conclusion. Sildenafil citrate 2.5 mg/mL in two extemporaneously compounded oral suspensions was stable for 91 days in plastic prescription bottles at 4 and 25 °C. Index terms: Compounding; Concentration; Hydrogen ion concentration; Hypertension; Methylcellulose; Odors; Ora-Plus; Ora-Sweet; Pediatrics; Sildenafil citrate; Stability; Storage; Sucrose; Suspending agents; Suspensions; Temperature; Vasodilating agents; Vehicles