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Stability of Extemporaneously Prepared Voriconazole Ophthalmic Solution

Daoud Al-Badriyeh, Jian Li, Kay Stewart, David C M Kong, Lok Leung, Geoffrey E Davies, Robert Fullinfaw

Am J Health Syst Pharm. 2009 Aug 15;66(16):1478-83.

PMID: 19667005

Abstract:

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 degrees C, 25 degrees C, and 40 degrees C. The 1% voriconazole eye drops were stored at 2-8 degrees 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 degrees C and 25 degrees 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 degrees 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 degrees C and 25 degrees C and for 8 weeks when stored at 40 degrees C, while voriconazole 1% solution was stable at 2-8 degrees C for up to 14 weeks.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP137234629-A Voriconazole solution Voriconazole solution 137234-62-9 Price
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