在长效释放剂型的体外释放过程中,对Levonorgestrel和Etonogestrel对聚烯的吸附的管理
Tao Zheng1, Avantika Dalvi1, Jie Tang1
1Department of Pharmaceutical Sciences and the Biointerfaces Institute, University of Michigan, Ann Arbor, Michigan 48109, United States.
ACS applied materials & interfaces
|April 9, 2025
概括
激活药物成分 (API),如levonorgestrel和etonogestrel可以吸附到聚烯实验室用品,导致不准确的药物释放数据. 使用玻璃瓶和酸可以减轻这种吸附,并提高检测准确度.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 材料科学 材料科学 材料科学
背景情况:
- 活性药物成分 (API) 可以吸附到实验室设备中,影响药物开发数据.
- 疏水性避孕类固醇,勒沃诺格斯特勒 (LNG) 和乙格斯特勒 (ENG),在体外释放研究中显示出显著的损失.
- 聚烯 (PP) 实验室用品被确定为API吸附的来源.
研究的目的:
- 研究液化天然气和电子天然气对聚烯的吸附.
- 为了确定影响API吸附和质量损失的因素.
- 在分析试验中制定减轻API吸附的策略.
主要方法:
- 在实验室释放研究中,使用聚乳-同-甘油酸 (PLGA) 微球和微针.
- 超高性能液态色谱 (UPLC) - 紫外线 (UV) 和LC-MS/MS测定.
- 原子力显微镜 (AFM) 用于描述材料接口.
- 对塑化剂对吸附作用的分析.
主要成果:
- 由于吸附在聚烯实验室用品,包括管管尖和瓶子上的液化天然气和电子天然气的大量损失.
- 在UPLC-UV测定中获得不准确的结果,在使用玻璃而不是PP瓶时,LC-MS/MS等离子体测定的准确性提高.
- 在采集后添加乙尼特里尔减轻了质量损失.
- 塑化剂,如二二酸,降低了LNG/ENG对PP的吸附.
- AFM 发现 PP 与 LNG 分子的表面积和粘附力更高.
结论:
- 对聚烯实验室用品的API吸附是影响药物开发试验的关键问题.
- 选择合适的实验室用品材料 (如玻璃) 和方法调整 (如乙二) 对于准确的结果至关重要.
- 了解浸出物和API材料相互作用对于开发长效避孕药的可靠分析方法至关重要.
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