STABILITY OF GRANISETRON HYDROCHLORIDE IN A DISPOSABLE ELASTOMERIC INFUSION DEVICE

The stability and sterility of granisetron hydrochloride in 5% dextros e injection or 0.9% sodium chloride injection when stored in a disposa ble elastomeric infusion device were studied. Granisetron was diluted to 0.02 mg/mL (as the hydrochloride salt) in 5% dextrose injection or 0.9% sodium chloride injection. The solution was placed in the drug re servoir of a disposable elastomeric infusion device and refrigerated a t 4 degrees C for 14 days. A total of eight pumps were prepared, four containing granisetron 0.02 mg/mL in 5% dextrose injection and four co ntaining granisetron 0.02 mg/mL in 0.9% sodium chloride injection. The solutions were assayed for granisetron concentration by stability-ind icating highperformance liquid chromatography at 0 hours, 24 hours, 48 hours, 7 days, and 14 days. Each solution was inspected for clarity, color, and precipitation, and sterility testing was performed. Through out the study, the mean concentration of granisetron remaining was mor e than 92% of the initial concentration both in 5% dextrose injection and in 0.9% sodium chloride injection. Individual solutions in 0.9% so dium chloride injection consistently maintained more than 90% of the i nitial drug concentration for only seven days. No microbial growth was detected. No precipitation, color change, or haziness was seen. Grani setron 0.02 mg/mL (as the hydrochloride salt) was stable and free of m icrobial growth in 0.9% sodium chloride injection for up to 7 days and stable and free of microbial growth in 5% dextrose injection for up t o 14 days when stored at 4 degrees C in a disposable elastomeric infus ion device.