临时制备的酸溶液的稳定性
M Todd Hovey1, Umesh S Patel2, Mark A Servos1
1Small Molecule API, AbbVie, Inc., North Chicago, IL, USA.
概括
随时准备的基尿素溶液 (50毫克/毫升) 在室温和冷藏下稳定78天. 这种方便的配方为氧尿素化合物提供了可靠的选择.
科学领域:
- 制药科学 制药科学
- 药物的稳定性 药物的稳定性
- 随机的复杂化 随机的复杂化
背景情况:
- 氧尿素是治疗各种疾病的关键药物.
- 液体基尿素的随时制备提供了方便,但需要进行稳定性评估.
- 传统的准备方法可能会耗费大量时间.
研究的目的:
- 为了评估一种新型的稳定性,快速制备的基尿素溶液.
- 为了确定随时复合的基尿素 (50毫克/毫升) 的保质期.
主要方法:
- 一种经过验证的高性能液态染色学 (HPLC) 方法与HILIC列被用于氧尿素量化.
- 用无菌水和ORASweet载体溶解并稀释到50mg/ml.
- 溶液在4°C,26°C和40°C保存78天.
主要成果:
- 水氧尿素溶液在4°C和26°C下维持了78天的强度 (<2%的损失).
- 在40°C保存的溶液在28天内显示出>10%的功效损失.
- 珀聚烯塑料瓶被用于储存.
结论:
- 在室温 (26°C) 和冷藏 (4°C) 下存储时,随时复合的基尿素50mg/ml溶液至少稳定78天.
- 水和ORASweet载体的1:1混合物适用于制备稳定的氧尿素溶液.
- 高温 (40°C) 显著降低化合物酸溶液的稳定性.
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