Objective: To assess the stability and activity of voriconazole 3 microg/mL eyedrops as prepared for use against amphotericin B- and fluconazole-resistant fungal endophthalmitis.
Method: Stability (concentration using UV-spectrophotometry; pH, osmolarity, and particle formation) and sterility were analyzed under various preservation conditions--room temperature (22-24 degrees C) or refrigerated (2-8 degrees C). The preparation's in vitro efficacy was analyzed using the standard National Committee for Clinical Laboratory Standards method for 30 days.
Results: Voriconazole concentrations were found to be within limits allowed by the United Stated Pharmacopeia (90-115%). pH (room temperature: 6.96-7.60; refrigerated: 6.84-7.21) and osmolarity (room temperature: 265-284 mOsm/l; refrigerated: 270-285 mOsm/l) remained within eye physiological ranges throughout the study under the analyzed conditions. The preparation s antifungal activity remained stable during the first three weeks.
Conclusions: The voriconazole 3 microg/mL eyewash preparation remained stable, sterile and with full antifungal activity for 21 days when stored both at room temperature and under refrigeration conditions.