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

Drug Dev Ind Pharm. 2016 Jan;42(1):166-174. doi: 10.3109/03639045.2015.1038273. Epub 2015 May 26.

Abstract

Context: 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.

Keywords: Antibiotic; aseptic filling process; container-content interaction; endophthalmitis; injectable drug; plastic container; stability study.

Publication types

  • Comparative Study

MeSH terms

  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / chemistry
  • Anti-Bacterial Agents / therapeutic use
  • Cefuroxime / administration & dosage
  • Cefuroxime / chemistry*
  • Cefuroxime / therapeutic use
  • Cycloparaffins / chemistry*
  • Drug Compounding / standards
  • Drug Packaging / methods*
  • Drug Stability
  • Drug Storage
  • Endophthalmitis / prevention & control
  • Feasibility Studies
  • Glass
  • Injections, Intraocular
  • Osmolar Concentration
  • Pharmaceutical Solutions / administration & dosage
  • Pharmaceutical Solutions / chemistry
  • Pharmaceutical Solutions / therapeutic use
  • Polypropylenes / chemistry*
  • Postoperative Complications / prevention & control
  • Syringes
  • Temperature

Substances

  • Anti-Bacterial Agents
  • Cycloparaffins
  • Pharmaceutical Solutions
  • Polypropylenes
  • Cefuroxime