[Stability of prostaglandin E1 when fractioned into polypropylene syringes]

Prostaglandin E1 is indicated for the temporary maintenance of patent ductus arteriosus in newborns with ductus-dependent congenital heart defects. Since the standard daily dose is smaller (0.2-0.4 ml) than one ampoule (1 ml), we performed a chemical stability study of prostaglandin E1 when it is fractioned into polypropylene syringes. Three concentrations were studied: 500 mg/ml (original), and 1:2 and 1:4 dilutions in sodium chloride 0.9%. Syringes were kept at 4 degrees C for 30 days. Prostaglandin E1 levels were determined by using high-pressure chromatography. In all three formulations, the concentrations underwent no statistically significant changes over time (p>0.05).

PGE1 is chemically stable at 4 degrees C for 30 days when fractioned into polypropylene syringes, both in the original and the 1:2 and 1:4 diluted formulations.