通过光学相干断层扫描评估的酸阶段溶解的技术和监管观点 (第1部分:释放场景)
Jesús Alberto Afonso Urich1, Matthias Wolfgang2, Raymar Andreina Lara Garcia2
1Research Center Pharmaceutical Engineering GmbH, Inffeldgasse 13, 8010 Graz, Austria; Institute of Process and Particle Engineering, Graz University of Technology, Inffeldgasse 13, 8010 Graz, Austria.
光学一致性断层扫描 (OCT) 提供了一种非破坏性的方法来测量肠道涂层厚度,确保有针对性的药物释放. 这种技术与传统的溶解测试相关,增强了口服剂型的质量保证.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
- 医疗成像医学成像
背景情况:
- 肠道涂层对于向药物输送至关重要,防止在胃中过早溶解.
- 涂层厚度和完整性对于有效的酸性保护和药物释放配置文件至关重要.
- 传统的溶解测试可能具有破坏性和耗时性.
研究的目的:
- 评估光学一致性断层扫描 (OCT) 作为测量肠道涂层厚度的非破坏性方法.
- 为了将OCT测量与传统的酸阶段溶解试验相关联.
- 评估不同涂层材料在OCT测量中的操作员变异性.
主要方法:
- 采用光学一致性断层扫描 (OCT) 来测量三种肠道涂层材料的厚度:Acryl-Eze®,AquariusTM Control ENA和Nutrateric®.
- 涂层厚度测量与药物库酸阶段溶解测试相关.
- 用两个制造批量来评估操作员的变化.
主要成果:
- 确定了临界涂层厚度:阿克里尔-Eze®的68微米,AquariusTM Control ENA的69微米,Nutrateric®的65微米.
- 海外国家和地区的测量结果与传统溶解测试结果有很强的一致性.
- 该研究证明了将OCT纳入产品发布协议的可行性.
结论:
- 超标国土是肠道涂层传统溶解测试的可行,非破坏性的替代品.
- 海外国家和地区可以提高生产效率和质量保证,制造肠膜涂层口服剂型.
- 海洋和海上国家的测量可以整合到产品发布的监管框架中.
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