在PCCA基的阿扎西奥普林悬浮剂的生理化学和微生物学稳定性,悬浮剂It
Yahoda V Pramar1, Tarun K Mandal2, Levon A Bostanian2
1College of Pharmacy, Xavier University of Louisiana, New Orleans, Louisiana. yvpramar@xula.edu.
International journal of pharmaceutical compounding
|August 18, 2023
概括
这项研究发现,在PCCA SuspendIt中临时复合的阿扎西奥普林悬浮液在182天内保持稳定. 这为风湿性关节炎和移植患者提供了灵活的液体剂量形式.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 复合药房 复合药房 复合药房
背景情况:
- 阿扎西奥普林用于类风湿性关节炎和移植排斥.
- 需要Azathioprine的液体剂量形式以灵活剂量.
- 目前,没有商用液体阿扎西奥普林配方存在.
研究的目的:
- 为了确定随时复合的阿扎西奥普林悬浮液的物理化学和微生物稳定性.
- 为了评估PCCA SuspendIt的稳定性,PCCA SuspendIt是一种无糖,无的载体.
- 为制药药师提供稳定性数据.
主要方法:
- 在PCCA SuspendIt.It中以10 mg/mL和50 mg/mL的剂量准备的阿扎西奥普林悬浮剂.
- 在珀色塑料瓶中以5°C和25°C的温度储存样品.
- 在182天内测定药物度,pH值,粘度和外观.
- 进行了微生物稳定性测试.
主要成果:
- 在整个研究中,阿扎西奥普林度保持在标签声明的96.8%以上.
- 在任何样本中都没有观察到微生物生长.
- pH 和粘度保持不变,促进重新分散.
- 这些悬浮物表现出物理,化学和微生物学的稳定性.
结论:
- 在PCCA SuspendIt中随时复合的阿扎西奥普林悬浮液在冷藏和室温下稳定182天.
- 这种配方为平板电脑提供了一个可行的,可定制的液体替代品.
- 提供延长后使用的约会,以满足不同患者的剂量要求.
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