在半固体局部配方的情况下,用于开发体外释放试验方法和设备选择的分析目标配置文件
Réka Szoleczky1,2, Anita Kovács2, Szilvia Berkó2
1Egis Pharmaceuticals Plc., Laboratory of Finished Product Analytical Development 3, Bökényföldi Str. 116-120, 1165 Budapest, Hungary.
Pharmaceutics
|March 28, 2024
概括
本研究定义了分析目标配置文件 (ATP),以选择最佳的Diclofenac局部产品体外释放试验 (IVRT) 方法. 具有浸泡细胞的USP Apparatus II在质量控制测试中被证明是最有效的.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 分析化学 分析化学
背景情况:
- 建立强大的体外释放试验 (IVRT) 方法对于局部药物产品的开发至关重要.
- 目前的指导方针,包括国际协调委员会 (ICH Q14) 和美国药典 (USP) 第1220章,强调需要明确的分析目标配置文件 (ATP).
研究的目的:
- 为了实际应用,定义一个分析目标配置文件 (ATP).
- 为了方便选择适合的IVRT技术用于二二的局部水凝和奶油配方.
- 根据定义的ATP,比较不同IVRT装置的性能.
主要方法:
- 开发一个ATP,结合ICH Q14和USP第1220章指导方针.
- 对四种IVRT装置的比较评估:USP装置II (浸泡电池),USP装置IV (半固体适配器),静态垂直扩散电池,以及一种新的流通扩散电池.
- 评估性能特征,包括准确性,精度,累积释放和稳定性.
主要成果:
- 具有浸泡电池的USP Apparatus II被确定为开发IVRT质量控制 (QC) 测试的最佳设备,适用于水凝和奶油配方.
- 与ATP和文献数据相比,所有四个评估的IVRT装置都表现出不同的性能特征.
结论:
- ATP 作为一个有效的工具来指导选择 IVRT 技术用于局部产品.
- 具有浸泡细胞的USP Apparatus II为二二局部配方的IVRT QC提供了卓越的性能.
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