Al-Badriyeh Daoud, Li Jian, Stewart Kay, Kong David C M, Leung Lok, Davies Geoffrey E, Fullinfaw Robert
Department of Pharmacy Practice, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Victoria, Australia.
Am J Health Syst Pharm. 2009 Aug 15;66(16):1478-83. doi: 10.2146/ajhp080110.
The stability of extemporaneously prepared voriconazole ophthalmic solution was studied.
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.
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.
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.
研究伏立康唑临时配制的眼用溶液的稳定性。
伏立康唑溶液（2%和1%）由静脉制剂复溶而成。充分混合后，将所得2%和1%溶液各取3 mL样品过滤至滴管中。两种溶液的三个样品在每个时间点均进行三次重复分析。2%伏立康唑眼用溶液分别储存在2 - 8℃、25℃和40℃。1%伏立康唑滴眼液储存在2 - 8℃。2%伏立康唑溶液样品在0周、1周、2周、4周、8周、16周和32周时进行分析。1%溶液样品在0周、6周和14周时进行分析。使用高效液相色谱分析法测定稳定性。
2%伏立康唑眼用溶液在2 - 8℃和25℃下长达16周表现出优异的稳定性。伏立康唑溶液在所有时间间隔内pH值均无显著变化。在所有研究温度下，在研究的任何时间点，2%伏立康唑滴眼液的外观或清晰度均未观察到变化。1%伏立康唑溶液在2 - 8℃下长达14周稳定。
用0.01%苯扎氯铵保存的2%（20 mg/mL）伏立康唑溶液作为替代抗真菌滴眼液，在2 - 8℃和25℃下储存时稳定16周，在40℃下储存时稳定8周，而1%伏立康唑溶液在2 - 8℃下长达14周稳定。
