Stability of extemporaneously prepared voriconazole ophthalmic solution.
OBJECTIVE
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.


CONCLUSIONS
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.
Al-Badriyeh
Daoud
D
Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Victoria, Australia.
Li
Jian
J
Stewart
Kay
K
Kong
David C M
DC
Leung
Lok
L
Davies
Geoffrey E
GE
Fullinfaw
Robert
R
D000935:Antifungal Agents / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D004339:Drug Compounding; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D006801:Humans; D009883:Ophthalmic Solutions; D011743:Pyrimidines / Q000737:chemistry*; D013696:Temperature; D014230:Triazoles / Q000737:chemistry*; D065819:Voriconazole
D000935:Antifungal Agents; D009883:Ophthalmic Solutions; D011743:Pyrimidines; D014230:Triazoles; D065819:Voriconazole