title: Stability study of carboplatin infusion solutions in 0.9% sodium chloride in polyvinyl chloride bags.
abstract: OBJECTIVE
  Carboplatin is a platinum-containing compound with efficacy against various malignancies. The physico-chemical stability of carboplatin in dextrose 5% water (D5W) has been thoroughly studied; however, there is a paucity of stability data in clinically relevant 0.9% sodium chloride infusion solutions. The manufacturer's limited stability data in sodium chloride solutions hampers the flexibility of carboplatin usage in oncology patients. Hence, the purpose of this study is to determine the physical and chemical stability of carboplatin-sodium chloride intravenous solutions under different storage conditions.
  
  
  METHODS
  The physico-chemical stability of 0.5 mg/mL, 2.0 mg/mL, and 4.0 mg/mL carboplatin-sodium chloride solutions prepared in polyvinyl chloride bags was determined following storage at room temperature under ambient fluorescent light and under refrigeration in the dark. Concentrations of carboplatin were measured at predetermined time points up to seven days using a stability-indicating high-performance liquid chromatography method.
  
  
  RESULTS
  All tested solutions were found physically stable for at least seven days. The greatest chemical stability was observed under refrigerated storage conditions. At 4℃, all tested solutions were found chemically stable for at least seven days, with nominal losses of ≤6%. Following storage at room temperature exposed to normal fluorescent light, the chemical stability of 0.5 mg/mL, 2.0 mg/mL, and 4.0 mg/mL solutions was three days, five days, and seven days, respectively.
  
  
  CONCLUSIONS
  The extended physico-chemical stability of carboplatin prepared in sodium chloride reported herein permits advance preparation of these admixtures, facilitating pharmacy utility and operations. Since no antibacterial preservative is contained within these carboplatin solutions, we recommend storage, when prepared under specified aseptic conditions, no greater than 24 h at room temperature or three days under refrigeration.
authors.affiliation: Department of Pharmacy Research, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA almyers@mdanderson.org.
authors.forename: Alan L
authors.initials: AL
authors.lastname: Myers
authors.affiliation: Department of Pharmacy Research, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Yang-Ping
authors.initials: YP
authors.lastname: Zhang
authors.affiliation: Department of Pharmacy Research, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Jitesh D
authors.initials: JD
authors.lastname: Kawedia
authors.affiliation: Department of Pharmacy Clinical Programs, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Van A
authors.initials: VA
authors.lastname: Trinh
authors.affiliation: Department of Pharmacy Clinical Programs, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Huyentran
authors.initials: H
authors.lastname: Tran
authors.affiliation: Departments of Gynecologic Oncology and Reproductive Medicine and Pharmacy Research, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA Department of Obstetrics, Gynecology and Reproductive Sciences, The University of Texas Medical School at Houston, TX, USA.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Smith
authors.affiliation: Department of Pharmacy Research, The University of Texas M.D. Anderson Cancer Center, Houston, TX, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Kramer
mesh_terms: D016190:Carboplatin / Q000737:chemistry*; D004349:Drug Packaging / Q000379:methods; D004355:Drug Stability; D004356:Drug Storage / Q000379:methods; D007262:Infusions, Intravenous / Q000379:methods; D019999:Pharmaceutical Solutions / Q000737:chemistry*; D011143:Polyvinyl Chloride / Q000737:chemistry*; D012034:Refrigeration / Q000379:methods; D012965:Sodium Chloride / Q000737:chemistry*; D013696:Temperature
chemical_list: D019999:Pharmaceutical Solutions; D012965:Sodium Chloride; D011143:Polyvinyl Chloride; D016190:Carboplatin
keywords: Carboplatin; chemical stability; normal saline; physical stability; platinum compound; polyvinyl chloride bags