临时制备氟康唑口服混悬液(50mg /mL)的理化稳定性

K. Ip, A. Shan, M. Carvalho, S. Baker, D. Banov
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引用次数: 2

摘要

背景缺乏适合年龄的氟康唑配方。临时制备一种口服混悬液,延长了使用日期,可能是儿科人群的一种良好的治疗选择。方法制备氟康唑50 mg/mL口服混悬液,均匀分布于20个琥珀色塑料瓶中,10瓶室温保存(25℃),其余10瓶室温保存(5℃)。在182天的时间内,在9个预先确定的时间点测试了口服混悬液的物理特性(颜色/外观、气味、pH值和密度)和化学特性(使用超高高效液相色谱法测定氟康唑浓度)。结果口腔悬浮液的浓度、pH和平均浓度无明显变化。氟康唑的回收率为92.67% ~ 98.79%(5℃)和94.31% ~ 100.02%(25℃),均在标准范围内。结论:本研究为氟康唑50mg /mL口服悬浮载体suspenpendit™开发了一种可口的无糖配方,可在医院环境下方便、快速地进行临时制备。采用有效的稳定性分析方法确定配方的过期时间,并得出临时制备的口服混悬液在冷藏和室温控制下稳定6个月的结论。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Physicochemical Stability of Extemporaneously Prepared Oral Suspension of Fluconazole 50 mg/mL in SuspendIt™
Abstract Background There is a lack of an age-appropriate formulation of fluconazole. The extemporaneous preparation of an oral suspension with an extended beyond-use-date may represent a good therapeutic alternative for the paediatric population. Methods A fluconazole 50 mg/mL oral suspension was prepared and evenly distributed into twenty amber plastic bottles: ten bottles were stored in controlled room temperature (25 °C) whereas the remainder ten bottles were stored in refrigerated temperature (5 °C). The physical characteristics (colour/appearance, odor, pH and density) and chemical characteristics [fluconazole concentration using Ultra High Performance Liquid Chromatography (UPLC)] of the oral suspension were tested at nine pre-determined time-points over a period of 182 days. Results The density, pH and mean concentration of the oral suspension did not change significantly. The recovery of fluconazole ranged from 92.67 % to 98.79 % (5 °C) and from 94.31 % to 100.02 % (25 °C), both within the specification limits. Conclusions A palatable, sugar-free formula was developed for fluconazole 50 mg/mL in the oral suspending vehicle SuspendIt™ to allow an easy and rapid extemporaneous preparation in the hospital setting. The beyond-use-date of the formula was determined using a valid, stability-indicating analytical method and it was concluded that the extemporaneously prepared oral suspension is stable for 6 months at refrigerated and controlled room temperature.
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