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

Abstract

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. 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°C to 8°C with protection from light or at 20°C to 25°C with exposure to light. Solutions of pantoprazole 4 mg/mL reconstituted in 0.9% sodium chloride (normal saline [NS]) were stored in glass vials at 20°C to 25°C. Similar solutions were transferred to polypropylene syringes and stored at 2°C to 8°C. 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°C to 8°C or at 20°C to 25°C. Samples collected on days 0, 2, 3, 7, 14, 21, and 28 were analyzed in duplicate with a stability-indicating high-performance liquid chromatography assay. 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°C to 25°C or for 28 days when stored in polypropylene syringes at 2°C to 8°C. Pantoprazole 0.4 mg/mL diluted in D5W and stored in PVC minibags was stable for 2 days at 20°C to 25°C or for 14 days at 2°C to 8°C. At 0.8 mg/mL, pantoprazole in D5W was stable for 3 days at 20°C to 25°C or 28 days at 2°C to 8°C. 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°C to 25°C or 28 days at 2°C to 8°C. The present study confirmed or extended previously reported expiry dates for pantoprazole sodium packaged in glass vials, polypropylene syringes, and PVC minibags.