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Stability of extemporaneously prepared voriconazole ophthalmic solution
AL-BADRIYEH, DAOUD; LI, JIAN; STEWART, KAY; KONG, DAVID C. M.; LEUNG, LOK; DAVIES, GEOFFREY E.; FULLINFAW, ROBERT
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.
Reference: American Journal of Health-System Pharmacy
Issue: Volume 66(16), 15 August 2009, p 1478–1483
