乌尔索迪醇口服复合物悬浮剂的物理化学和微生物学稳定性
Kendice Ip1, Courtaney Davis2, Zainab Iqbal3
1Research and Development (KI, MC), PCCA, Houston, TX.
概括
这项研究发现,复合ursodiol口服悬浮剂在室温下稳定长达六个月. 这为无法吞固体剂型的儿科患者提供了安全有效的替代方案.
科学领域:
- 制药科学 制药科学
- 儿科配方 儿科配方 儿科配方
- 药物的稳定性 药物的稳定性
背景情况:
- 乌尔索迪醇主要以固体剂量形式提供,这对不能吞囊或片剂的儿科患者构成挑战.
- 需要适合儿童年龄的稳定口服配方,用于儿科的ursodiol.
- 随时制备口服悬浮剂提供了一个潜在的治疗替代方案.
研究的目的:
- 评估复合ursodiol口服悬浮剂的物理,化学和微生物稳定性.
- 为了确定超出使用日期 (BUD) 的临时准备的ursodiol悬浮液.
- 为药剂师提供针对儿科配方的验证稳定性数据.
主要方法:
- 使用商业囊和专有悬浮载体的ursodiol (20-60 mg/mL) 复合口服悬浮剂.
- 用稳定性指标分析方法来确定BUD.
- 物理特征包括外观,颜色和pH测试.
- 根据USP第51章评估了微生物学稳定性.
主要成果:
- 复合的ursodiol悬浮剂保持着均的白色外观,没有显著的pH值变化.
- 在整个研究过程中,功效保持在规格的±10%.
- 没有观察到挑战微生物的生长,这表明微生物的稳定性.
结论:
- 乌尔索迪醇复合口服悬浮剂在室温下在物理,化学和微生物学上保持长达6个月的稳定.
- 这种配方为儿科患者提供了可行的和稳定的选择.
- 经过验证的稳定性数据支持临时制备ursodiol口服悬浮剂.
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