Stability for 6 months and accuracy of a specific enteral caffeine base preparation for a multi-site clinical trial.

The "Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF)" study (NCT03321734) uses an extemporaneously compounded enteral caffeine base solution for its study drug. The primary aim of this report is to determine the stability of this specific enteral caffeine base preparation stored for up to six months and assess optimal storage temperature. To analyze stability, caffeine solutions were prepared and stored at 4°C and 25°C (room temperature). The caffeine concentrations were analyzed over time using high-performance liquid chromatography (HPLC). To confirm the accuracy of compounded caffeine concentrations, study drug samples from three research pharmacies were analyzed. Stability results showed that caffeine concentrations are within 5% of the expected concentration when stored for up to 6 months at room temperature. Our results also show that accurate caffeine concentrations were achieved by multiple research pharmacies.