杀菌对in situ凝形成聚合物稳定性的作用
Elena O Bakhrushina1, Alina M Afonina1, Iosif B Mikhel1
1A.P. Nelyubin Institute of Pharmacy, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow 119048, Russia.
Polymers
|October 26, 2024
概括
消毒刺激敏感药物输送系统是具有挑战性的,因为目前的方法可以降低药物特性. 本综述提供了有效的风险管理策略,用于开发无菌的现场药物输送系统.
科学领域:
- 制药科学 制药科学
- 生物材料工程 生物材料工程
- 药物输送系统 药物输送系统
背景情况:
- 敏感于刺激的药物输送系统,特别是使用智能聚合物的现场存储系统,正在获得亲肠道输送的吸引力.
- 无菌性是所有门和眼部剂型的关键要求,包括这些先进的系统.
- 现有的灭菌方法带来了改变聚合物构成和活性药物成分 (API) 的重大风险,损害了药物的疗效和系统性能.
研究的目的:
- 解决关于风险评估和降低风险的不足文献,以消毒敏感的刺激系统.
- 为管理绝育相关风险提供基于证据的建议和方法.
- 引导开发稳定和无菌的现场药物输送配方.
主要方法:
- 对已发表的关于杀菌技术及其对智能聚合物和API的影响的实验数据的审查和综合.
- 分析与各种灭菌方法 (如热,辐射,过) 相关的风险因素.
- 在杀菌过程中制定稳定刺激敏感成分的策略.
主要成果:
- 目前的灭菌方法可能会对智能聚合物和API的物理化学和药理性质产生负面影响.
- 关于在现场药物输送系统灭菌的具体挑战和解决方案,存在重大知识差距.
- 有效的风险管理需要仔细选择和优化适合特定系统组件的灭菌技术.
结论:
- 开发无菌的现场药物输送系统需要采取积极的方法来管理灭菌风险.
- 提供了建议,以稳定刺激敏感系统,并保持其完整性和功能消毒后.
- 需要进一步的研究和标准化的协议,以确保这些先进的药物输送技术的安全和有效的临床转化.
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