title: Stability of 10 mg/mL cefuroxime solution for intracameral injection in commonly used polypropylene syringes and new ready-to-use cyclic olefin copolymer sterile vials using the LC-UV stability-indicating method.
abstract: BACKGROUND
  Injecting intracameral cefuroxime has been found beneficial in reducing the risk of postoperative endophthalmitis but its use has been limited through a lack of approved marketing and of ready-to-use single-units as well as the problem of aseptic compounding.
  
  
  OBJECTIVE
  Our aim was to assess a new automated primary packaging system which should ensure a higher level of sterility, thanks to its closed, sterile, ready-to-use polymer vial called "Crystal® vial". The chemical stability of a 10 mg/mL cefuroxime solution was compared in 1 mL Crystal® vials and 1 mL Luer-lock polypropylene syringes (actual reference) to eliminate any potential and specific interactions with its cyclic olefin copolymer (COC) body and elastomer stopper.
  
  
  METHODS
  Cefuroxime solution was introduced into vials and syringes and stored at -20 °C, +5 °C and +25°C/60% Relative Humidity. Cefuroxime concentration and the relative amount of the main degradation product (descarbamoyl-cefuroxime) were both determined by an HPLC/UV method indicating stability. Solutions were considered steady if the concentration remained at over 90% of the initial value. In the adapted storage conditions, the evolution of osmolality, pH and sterility was assessed.
  
  
  RESULTS
  Stability profiles were identical between vials and syringes in all storage and temperature conditions. The solution was stable (cefuroxime concentration, pH and osmolality) and still sterile for 365 days at -20°C. The concentration fell below 90% after 21 days at +5 °C and after 16 h at +25°C/60%s relative humidity.
  
  
  CONCLUSIONS
  The COC and thermoplastic elastomer of the vials had no impact on the degradation process confirming its possible use for a ready-to-use cefuroxime solution single-unit dose.
authors.affiliation: a Pharmacy Institute, University Hospital Center , Lille , France.|b Department of Biopharmacy , Galenic and Hospital Pharmacy, EA GRITA, UFR Pharmacie , Lille , France , and.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Feutry
authors.affiliation: a Pharmacy Institute, University Hospital Center , Lille , France.|b Department of Biopharmacy , Galenic and Hospital Pharmacy, EA GRITA, UFR Pharmacie , Lille , France , and.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Simon
authors.affiliation: a Pharmacy Institute, University Hospital Center , Lille , France.|b Department of Biopharmacy , Galenic and Hospital Pharmacy, EA GRITA, UFR Pharmacie , Lille , France , and.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Genay
authors.affiliation: a Pharmacy Institute, University Hospital Center , Lille , France.|b Department of Biopharmacy , Galenic and Hospital Pharmacy, EA GRITA, UFR Pharmacie , Lille , France , and.
authors.forename: Damien
authors.initials: D
authors.lastname: Lannoy
authors.affiliation: b Department of Biopharmacy , Galenic and Hospital Pharmacy, EA GRITA, UFR Pharmacie , Lille , France , and.
authors.forename: Christine
authors.initials: C
authors.lastname: Barthélémy
authors.affiliation: a Pharmacy Institute, University Hospital Center , Lille , France.|b Department of Biopharmacy , Galenic and Hospital Pharmacy, EA GRITA, UFR Pharmacie , Lille , France , and.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Décaudin
authors.affiliation: c Department of Ophthalmology , University Hospital Center , Lille , France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Labalette
authors.affiliation: a Pharmacy Institute, University Hospital Center , Lille , France.|b Department of Biopharmacy , Galenic and Hospital Pharmacy, EA GRITA, UFR Pharmacie , Lille , France , and.
authors.forename: Pascal
authors.initials: P
authors.lastname: Odou
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use; D002444:Cefuroxime / Q000008:administration & dosage / Q000737:chemistry* / Q000627:therapeutic use; D003516:Cycloparaffins / Q000737:chemistry*; D004339:Drug Compounding / Q000592:standards; D004349:Drug Packaging / Q000379:methods*; D004355:Drug Stability; D004356:Drug Storage; D009877:Endophthalmitis / Q000517:prevention & control; D005240:Feasibility Studies; D005898:Glass; D056965:Injections, Intraocular; D009994:Osmolar Concentration; D019999:Pharmaceutical Solutions / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use; D011126:Polypropylenes / Q000737:chemistry*; D011183:Postoperative Complications / Q000517:prevention & control; D013594:Syringes; D013696:Temperature
chemical_list: D000900:Anti-Bacterial Agents; D003516:Cycloparaffins; D019999:Pharmaceutical Solutions; D011126:Polypropylenes; D002444:Cefuroxime
keywords: Antibiotic; aseptic filling process; container-content interaction; endophthalmitis; injectable drug; plastic container; stability study