艾米奥达龙化口服悬浮剂的物理化学和微生物学稳定性为40 mg/mL
Marine Cavelier1, Henri Gondé2, Damien Costa3
1Department of Pharmacy, CHU Rouen, Normandie University, UNIROUEN, EA7510 ESCAPE, Rouen, France.
概括
一种新的40 mg/mL口服阿米奥达龙化悬浮剂是为儿科使用而开发的. 这种稳定的配方满足儿科用剂量需求,并保持60天的冷藏质量.
科学领域:
- 制药科学 制药科学
- 儿科药理学 儿科药理学
- 药物的配方 药物的配方
背景情况:
- 阿米奥达龙化是一种关键的抗心律失常药物,用于超心室性心跳动.
- 由于缺乏商业上可用的儿科配方,需要专门的复合剂.
- 现有的口服配方的度低于临床处方的儿科剂量.
研究的目的:
- 开发一种稳定的阿米奥达龙化口服液体配方,其度适合儿科患者.
- 评估开发的儿科阿米奥达龙化配方的物理化学和微生物学稳定性.
主要方法:
- 一种40mg/ml的阿米奥达龙化口服悬浮剂使用选定的辅助剂 (基甲基纤维素,酸盐,酸/酸缓冲剂,糖,草调味剂) 进行复合.
- 稳定性通过视觉/显微镜检查,抗微生物保护测试,度和pH值测量以及通过稳定性指示液体色谱测量amiodarone化物来评估.
- 在整个研究期间进行了微生物学计数.
主要成果:
- 艾米奥达龙化口服悬浮剂在冷藏 (5°C) 后60天内保持至少95%的初始度.
- 物理化学参数 (pH,度) 保持稳定.
- 抗微生物保护测试表明,在第14天,微生物的目标日志减少,在第28天没有增长.
结论:
- 开发的40毫克/毫升阿米奥达龙化口服悬浮剂在开放前60天内在冷藏下稳定.
- 在打开瓶子后,配方在1个月内保持稳定.
- 这种配方满足了儿科患者需要稳定,适当度的口服阿米奥达龙化选项的需求.
相关概念视频
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