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

Chédru-Legros, Valérie PharmD; Fines-Guyon, Marguerite PharmD; Chérel, Aurélie PharmD; Perdriel, Agathe PharmD; Albessard, Françoise PharmD; Debruyne, Danièle MD; Mouriaux, Frédéric PhD, MD

doi: 10.1097/ICO.0b013e3181c32573
Basic Investigation

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.

From the Departments of *Pharmacy; †Microbiology; ‡Pharmacology; and §Ophthalmology; University Hospital of Caen, Caen, France.

Received for publication February 26, 2009; revision received September 16, 2009; accepted September 23, 2009.

Presented partially at the Association for Research in Vision and Ophthalmology Annual Meeting, May 3-7, 2009, Fort Lauderdale, FL.

Competing interests: none.

Reprints: Frédéric Mouriaux, Ophthalmology Department, University Hospital of Caen, 14032 Caen Cedex, Caen, France (e-mail: mouriaux-f@chu-caen.fr).

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