In Vitro Stability of Fortified Ophthalmic Antibiotics Stored at −20°C for 6 Months

Abstract

Purpose: This study evaluates the in vitro stability and sterility of fortified ophthalmic antibiotic preparations of 5% solutions (50 mg/mL) made from commercially available powders of amikacin, ceftazidime, and vancomycin stored at −20°C for 6 months. Methods: Antibiotic solutions were prepared with aseptic techniques by reconstitution and dilution of the commercially available powders (amikacin, ceftazidime, and vancomycin) and stored at −20°C. After various durations of storage, the stability of various physical and chemical properties was determined by a pH meter, an osmometer, and high-performance liquid chromatography. Microbiological activity was assayed according to the European Pharmacopoeia. Results: Solutions of 5% amikacin or ceftazidime in 0.9% sodium chloride and vancomycin in 5% dextrose were found to be physically, chemically, and microbiologically stable after storage at −20°C for 190 days. A time limitation of 6 months is proposed. Conclusion: Fortified ophthalmic antibiotic solutions prepared and supplied by a pharmacy can be stored in freezers at −20°C for later use.