Extemporaneous sildenafil citrate oral suspensions for the treatment of pulmonary hypertension in children

Am J Health Syst Pharm. 2006 Feb 1;63(3):254-7. doi: 10.2146/ajhp050208.

Abstract

Purpose: 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.

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 degrees C.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Child
  • Drug Stability
  • Drug Storage / methods*
  • Humans
  • Hypertension, Pulmonary / drug therapy*
  • Piperazines / administration & dosage
  • Piperazines / chemistry*
  • Purines
  • Sildenafil Citrate
  • Sulfones
  • Suspensions
  • Temperature
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / chemistry*

Substances

  • Piperazines
  • Purines
  • Sulfones
  • Suspensions
  • Vasodilator Agents
  • Sildenafil Citrate