Stability of Pantoprazole Sodium in Glass Vials, Polyvinyl Chloride Minibags, and Polypropylene Syringes

摘要

Background: Pantoprazole sodium, a proton-pump inhibitor, is approved for the short-term treatment of several types of ulcer, Zollinger-Ellison syndrome, and gastroesophageal reflux disease.Objective: To determine the physical compatibility and chemical stability of ethylenediaminetetra-acetic acid (EDTA)-free pantoprazole in glass vials, polypropylene syringes, and polyvinylchloride (PVC) minibags, after storage at 2癈 to 8癈 with protection from light or at 20癈 to 25癈 with exposure to light.Methods: Solutions of pantoprazole 4 mg/mL reconstituted in 0.9% sodium chloride (normal saline [NS]) were stored in glass vials at 20癈 to 25癈. Similar solutions were transferred to polypropylene syringes and stored at 2癈 to 8癈. Stock solution was further diluted, in 5% dextrose in water (D5W) or NS, to 0.4 or 0.8 mg/mL, and samples were then packaged in PVC minibags for storage at 2癈 to 8癈 or at 20癈 to 25癈. Samples collected on days 0, 2, 3, 7, 14, 21, and 28 were analyzed in duplicate with a stability-indicating high-performance liquid chro-matography assay.Results: Pantoprazole 4 mg/mL was stable (i.e., retained at least 90% of initial concentration) for 3 days when stored in glass vials at 20癈 to 25癈 or for 28 days when stored in polypropylene syringes at 2癈 to 8癈. Pantoprazole 0.4 mg/mL diluted in D5W and stored in PVC minibags was stable for 2 days at 20癈 to 25癈 or for 14 days at 2癈 to 8癈. At 0.8 mg/mL, pantoprazole in D5W was stable for 3 days at 20癈 to 25癈 or 28 days at 2癈 to 8癈. Pantoprazole diluted to either 0.4 or 0.8 mg/mL in NS and stored in PVC minibags was stable for 3 days at 20癈 to 25癈 or 28 days at 2癈 to 8癈.Conclusions: The present study confirmed or extended previously reported expiry dates for pantoprazole sodium packaged in glass vials, polypropylene syringes, and PVC minibags.