An investigation of reconstituted terlipressin infusion stability for use in hepatorenal syndrome

Abstract

Hepatorenal syndrome (HRS) is a fatal complication of renal dysfunction associated with ascites, liver failure and advanced cirrhosis. Although the best option for long-term survival is liver transplantation, in the critical acute phase, vasoconstrictors are considered first-line supportive agents. Terlipressin is the most widely used vasoconstrictor globally but owing to its short elimination half-life, it is usually administered six hourly by slow intravenous bolus injection. This requires patients to remain in hospital, increasing hospital bed costs and affecting their quality of life. An alternative option for administration of terlipressin is as a continuous infusion using an elastomeric infusor device in the patient’s home. However, stability data on terlipressin in elastomeric infusor devices is lacking. This research aimed to evaluate the stability of terlipressin reconstituted in infusor devices for up to 7 days at 2–8 °C and subsequently at 22.5 °C for 24 h, to mimic home storage and administration temperatures. We report that terlipressin was physically and chemically stable under these conditions; all reconstituted infusor concentrations retained above 90% of the original concentration over the test conditions. No colour change or precipitation in the solutions were evident.