title: Stability of granisetron hydrochloride in a disposable elastomeric infusion device.
abstract: The stability and sterility of granisetron hydrochloride in 5% dextrose injection or 0.9% sodium chloride injection when stored in a disposable elastomeric infusion device were studied. Granisetron was diluted to 0.02 mg/mL (as the hydrochloride salt) in 5% dextrose chloride injection. The solution was placed in the drug reservoir of a disposable elastomeric infusion device and refrigerated at 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 containing granisetron 0.02 mg/mL in 0.9% sodium chloride injection. The solutions were assayed for granisetron concentration by stability-indicating high-performance 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. Throughout the study, the mean concentration of granisetron remaining was more than 92% of the initial concentration both in 5% dextrose injection and in 0.9% sodium chloride injection. Individual solutions in 0.9% sodium chloride injection consistently maintained more than 90% of the initial drug concentration for only seven days. No microbial growth was detected. No precipitation, color change, or haziness was seen. Granisetron 0.02 mg/mL (as the hydrochloride salt) was stable and free of microbial 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 to 14 days when stored at 4 degrees C in a disposable elastomeric infusion device.
authors.affiliation: Department of Clinical Pharmacy, School of Pharmacy, University of Southern California (USC), Los Angeles 90033, USA.
authors.forename: K C
authors.initials: KC
authors.lastname: Chung
authors.forename: A
authors.initials: A
authors.lastname: Chin
authors.forename: M A
authors.initials: MA
authors.lastname: Gill
mesh_terms: D000932:Antiemetics / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004209:Disposable Equipment; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D017829:Granisetron / Q000737:chemistry*; D006801:Humans; D007263:Infusions, Parenteral / Q000295:instrumentation; D012408:Rubber; D012702:Serotonin Antagonists / Q000737:chemistry*
chemical_list: D000932:Antiemetics; D017829:Granisetron; D012408:Rubber; D012702:Serotonin Antagonists