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Chemical Stability of Voriconazole 1% Eye Drops
Author(s) -
Lau David,
Leung Lok,
Fullinfaw Robert,
Davies Geoffrey E
Publication year - 2008
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/j.2055-2335.2008.tb00833.x
Subject(s) - voriconazole , benzalkonium chloride , medicine , potency , fungal keratitis , shelf life , chromatography , eye drop , anesthesia , keratitis , ophthalmology , dermatology , food science , chemistry , antifungal , biochemistry , pathology , in vitro
Background Case reports suggest that voriconazole 1% eye drops are effective in treating refractory fungal keratitis. There are no data available on the stability and shelf‐life of extemporaneously prepared voriconazole 1% eye drops. Aim To determine the stability and shelf‐life of extemporaneous voriconazole 1% eye drops when stored at 2 to 8 °C. Method Voriconazole 1% solution was manufactured using voriconazole injection and preserved with 0.01% benzalkonium chloride. Aliquots (2.5 mL) were dispensed into pre‐sterilised plastic eye dropper bottles. Samples from 3 different batches were stored at 2 to 8 °C and analysed using high performance liquid chromatography to measure voriconazole concentrations on Days 0, 15, 30, 45, 60 and 75 after manufacture. Results After 75 days at 2 to 8 °C there was minimal reduction in the potency of the voriconazole 1% solution. Extrapolating the stability data beyond 75 days using linear regression suggest that it may take up to 4 months for voriconazole concentrations to drop below 90% of the nominal content. Conclusion Voriconazole 1% eye drops stored at 2 to 8 °C display negligible chemical degradation after 75 days.