Extemporaneous sildenafil citrate oral suspensions for the treatment of pulmonary hypertension in children.
OBJECTIVE
The stability of sildenafil citrate 2.5 mg/mL in two extemporaneously prepared oral suspensions stored at 4 and 25 degrees 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 degrees 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.


CONCLUSIONS
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 degrees C.
Nahata
Milap C
MC
The Ohio State University, Columbus, OH 43210, USA. nahata.1@osu.edu
Morosco
Richard S
RS
Brady
Michael T
MT
D002648:Child; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods*; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy*; D010879:Piperazines / Q000008:administration & dosage / Q000737:chemistry*; D011687:Purines; D000068677:Sildenafil Citrate; D013450:Sulfones; D013535:Suspensions; D013696:Temperature; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000737:chemistry*
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D013535:Suspensions; D014665:Vasodilator Agents; D000068677:Sildenafil Citrate