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DAOUD AL-BADRIYEH, B.PHARM., PHARM.SCI., is Ph.D. candidate; JIAN LI, B.SC., PH.D., is Senior Scientist; KAY STEWART, B.PHARM., PH.D., is Associate Professor; and DAVID C. M. KONG, M.PHARM., PH.D., GCHE, is Lecturer, Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Victoria, Australia. LOK LEUNG, B.PHARM., is Senior Pharmacist; and GEOFFREY E. DAVIES, B.PHARM., FSHP, is Director of Pharmacy, Pharmacy Department, Royal Victorian Eye and Ear Hospital, Victoria. ROBERT FULLINFAW, B.SC., M.SC., is Senior Scientist, Pathology Department, Royal Melbourne Hospital, Victoria.

Address correspondence to Dr. Kong at the Facility for Anti-infective Drug Development and Innovation, Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville 3052, Victoria, Australia (david.kong{at}pharm.monash.edu.au).

Purpose. The stability of extemporaneously prepared voriconazole ophthalmic solution was studied. Methods. Voriconazole solutions (2% and 1%) were reconstituted from the i.v. formulation. After thorough mixing, 3-mL samples of each of the resulting 2% and 1% solutions were filtered into eyedroppers. Three samples for both solutions were analyzed in triplicate at each time point. The 2% voriconazole ophthalmic solutions were stored at 2–8 °C, 25 °C, and 40 °C. The 1% voriconazole eye drops were stored at 2–8 °C. The 2% voriconazole solution samples were analyzed at time 0 and at weeks 1, 2, 4, 8, 16, and 32. The 1% solution samples were analyzed at time 0 and at weeks 6 and 14. Stability was measured using high-performance liquid chromatographic analysis. Results. The 2% voriconazole ophthalmic solution demonstrated excellent stability at 2–8 °C and 25 °C for up to 16 weeks. The voriconazole solution displayed no significant change in pH at all time intervals. No change in visual appearance or clarity was observed in the 2% voriconazole eye drops at any point of the study for all study temperatures. Voriconazole 1% solution was stable at 2–8 °C for up to 14 weeks. Conclusion. Voriconazole 2% (20 mg/mL) solution preserved with 0.01% benzalkonium chloride prepared as alternative antifungal eye drops was stable for 16 weeks when stored at 2–8 °C and 25 °C and for 8 weeks when stored at 40 °C, while voriconazole 1% solution was stable at 2–8 °C for up to 14 weeks. Index terms: Antifungals; Chromatography, liquid; Compounding; Control, quality; Hydrogen ion concentration; Solutions, ophthalmic; Stability; Storage; Temperature; Voriconazole

 

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				D. Al-Badriyeh, L. Leung, G. E Davies, K. Stewart, and D. Kong Successful Use of Topical Voriconazole 1% Alone as First-Line Antifungal Therapy Against Candida albicans Keratitis Ann. Pharmacother., December 1, 2009; 43(12): 2103 - 2107. [Abstract] [Full Text] [PDF]