200.Stability study of 5 mg/ml pediatric prednisone oral suspension in Syrspend®

Background

Prednisone is a corticosteroid used in several inflammatory pathology and cancers. Actually, in our hospital, we produce an oral syrup of prednisone with alcohol (ethanol), sodium benzoate, and simple syrup. However, sodium benzoate can induce neonatal icterus and alcohol is not authorized for children’s behind 3 years.

Purpose

The aim of this study was to determine the stability of 5 mg/ml prednisone oral suspension in commercial compounding excipient: Syrspend® SF PH4 (FAGRON).

Material and Method

Three batches of oral suspensions were prepared, using micronized prednisone and Syrspend® SF PH4, and were packaged in amber glass vials to protect from light and stored at room temperature. Several parameters were observed on day 0-1-4-10-30-60-90: physical stability (visual inspection and osmolality measurement) and chemical stability (pH measurement, residual concentrations of prednisone and degradation products identification). Prednisone concentration of each sample was measured using high performance liquid chromatography with UV detection at 254 nm.

Results

No variations of pH and osmolality were observed during the studied period. Prednisone concentrations remained stable within ± 5% of nominal values over 60 days. No degradation products were detected.

Conclusion

This study showed that 5 mg/mL prednisone oral suspension in Syrspend was stable for 60 days, at room temperature and protected from light. This new suspension would provide an interesting alternative to the syrup with alcohol and sodium benzoate, especially for pediatric use.