Physicochemical Stability of 5 mg/mL Pediatric Prednisone Oral Suspension in Syrspend® SF PH4

Abstract

Prednisone is a corticosteroid used in several inflammatory diseases and cancers. In France, no available prednisone drinkable formulation exists. Instead, an oral syrup of prednisone with ethanol, sodium benzoate and simple syrup is produced. However, sodium benzoate can induce neonatal icterus and alcohol is not authorized for children below 3 years of age. The aim of this study was to determine the stability of 5 mg/mL prednisone oral suspension in a commercial compounding excipient: Syrspend® SF PH4.

Keywords

• suspension
• formulation
• excipient
• stability
• hplc (hight perfomance/pressure liquid chromatography)
• pediatric