title: Stability of cyclosporine solutions stored in polypropylene-polyolefin bags and polypropylene syringes.
abstract: OBJECTIVE
  The stability of cyclosporine diluted to 0.2 or 2.5 mg/mL with 0.9% sodium chloride injection or 5% dextrose injection and stored in polypropylene-polyolefin containers or polypropylene syringes was evaluated.
  
  
  METHODS
  Intravenous cyclosporine solutions (0.2 and 2.5 mg/mL) were aseptically prepared and transferred to 250-mL polypropylene-polyolefin bags or 60-mL polypropylene syringes. Chemical stability was measured using a stability-indicating high-performance liquid chromatography (HPLC) assay. Physical stability was assessed by visual inspection and a dynamic light scattering (DLS) method.
  
  
  RESULTS
  After 14 days, HPLC assay showed that the samples of i.v. cyclosporine stored in polypropylene-polyolefin bags remained chemically stable (>98% of initial amount remaining); the physical stability of the samples was confirmed by DLS and visual inspection. The samples stored in polypropylene syringes were found to contain an impurity (attributed to leaching of a syringe component by the solution) that could be detected by HPLC after 1 day; on further investigation, no leaching was detected when the syringes were exposed to undiluted i.v. cyclosporine 50 mg/mL for 10 minutes.
  
  
  CONCLUSIONS
  Samples of i.v. cyclosporine solutions of 0.2 and 2.5 mg/mL diluted in 0.9% sodium chloride injection or 5% dextrose injection and stored at 25 °C in polypropylene-polyolefin bags were physically and chemically stable for at least 14 days. When stored in polypropylene syringes, the samples were contaminated by an impurity within 1 day; however, the short-term (i.e., ≤10 minutes) use of the syringes for the preparation and transfer of i.v. cyclosporine solution is considered safe.
authors.affiliation: Université de Montréal, Canada.
authors.forename: Mengqing
authors.initials: M
authors.lastname: Li
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Forest
authors.forename: Christian
authors.initials: C
authors.lastname: Coursol
authors.forename: Grégoire
authors.initials: G
authors.lastname: Leclair
mesh_terms: D002851:Chromatography, High Pressure Liquid; D016572:Cyclosporine / Q000737:chemistry*; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D005947:Glucose / Q000737:chemistry; D007166:Immunosuppressive Agents / Q000737:chemistry*; D008027:Light; D019999:Pharmaceutical Solutions; D011090:Polyenes / Q000737:chemistry*; D011126:Polypropylenes / Q000737:chemistry*; D012542:Scattering, Radiation; D012965:Sodium Chloride / Q000737:chemistry; D013594:Syringes; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D019999:Pharmaceutical Solutions; D011090:Polyenes; D011126:Polypropylenes; D012965:Sodium Chloride; C035051:PL 732; D016572:Cyclosporine; D005947:Glucose