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

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.

• Authors: Frédéric Feutry, Nicolas Simon, Stéphanie Genay, Damien Lannoy, Christine Barthélémy, Bertrand Décaudin, Pierre Labalette, Pascal Odou
• Journal: Drug development and industrial pharmacy (Drug Dev Ind Pharm) Vol. 42 Issue 1 Pg. 166-174 (Jan 2016) ISSN: 1520-5762 [Electronic] England
• PMID: 26006333 (Publication Type: Comparative Study, Journal Article)

Chemical References

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

Topics

• Anti-Bacterial Agents (administration & dosage, chemistry, therapeutic use)
• Cefuroxime (administration & dosage, chemistry, 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, chemistry, therapeutic use)
• Polypropylenes (chemistry)
• Postoperative Complications (prevention & control)
• Syringes
• Temperature