title: Physical and chemical stability of esomeprazole sodium solutions.
abstract: BACKGROUND
  Esomeprazole sodium (Nexium IV, AstraZeneca) is the S-isomer of omeprazole and acts as a proton pump inhibitor gastric antisecretory agent indicated for the short-term treatment of gastroesophageal reflux disease in patients with a history of erosive esophagitis. Currently, there is no information on the long-term stability of esomeprazole sodium in infusion solutions beyond 12 hours.
  
  
  OBJECTIVE
  To evaluate the stability of esomeprazole sodium in 5% dextrose, 0.9% sodium chloride, and lactated Ringer's injection, at 2 concentrations, at room temperature and when refrigerated.
  
  
  METHODS
  Triplicate samples of esomeprazole 0.4 and 0.8 mg/mL as the sodium salt were prepared in the solutions required. Stability evaluations were performed initially, over 2 days stored at 23 degrees C, and over 5 days stored at 4 degrees C. Physical stability was assessed using turbidimetric and particulate measurement, as well as visual observation. Chemical stability was evaluated by stability-indicating high-performance liquid chromatography.
  
  
  RESULTS
  The samples in all 3 infusion solutions were physically stable throughout the study. None of the samples had evidence of visible haze or particulates. Most samples developed a slight yellow discoloration within 24 hours, but this discoloration was not accompanied by an excessive loss of drug content. The esomeprazole sodium samples in all 3 infusion solutions exhibited less than 7% loss over 2 days at 23 degrees C and over 5 days at 4 degrees C.
  
  
  CONCLUSIONS
  Esomeprazole 0.4 and 0.8 mg/mL as the sodium salt in the infusion solutions tested is chemically and physically stable for at least 2 days at room temperature and 5 days under refrigeration.
authors.affiliation: Analytical Research Laboratories, Oklahoma City, OK, USA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Kupiec
authors.forename: Vasileios
authors.initials: V
authors.lastname: Aloumanis
authors.forename: Michel
authors.initials: M
authors.lastname: Ben
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Trissel
authors.forename: Pak
authors.initials: P
authors.lastname: Chan
authors.forename: Joe
authors.initials: J
authors.lastname: Patterson
mesh_terms: D000897:Anti-Ulcer Agents / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage; D064098:Esomeprazole / Q000737:chemistry*; D005947:Glucose / Q000737:chemistry; D006801:Humans; D007552:Isotonic Solutions / Q000737:chemistry; D009853:Omeprazole / Q000737:chemistry; D011143:Polyvinyl Chloride / Q000737:chemistry; D000077325:Ringer's Lactate; D012965:Sodium Chloride / Q000737:chemistry; D012996:Solutions / Q000737:chemistry; D013997:Time Factors
chemical_list: D000897:Anti-Ulcer Agents; D007552:Isotonic Solutions; D000077325:Ringer's Lactate; D012996:Solutions; D012965:Sodium Chloride; D011143:Polyvinyl Chloride; D005947:Glucose; D009853:Omeprazole; D064098:Esomeprazole