基于挤出的半固体复合系统解决方案的评估,用于与拉曼光谱分析相结合的个性化Ondansetron剂型
Mahsa Bahman1,2, Jacopo Zini3, Julius Lahtinen2
1Pharmaceutical Sciences Laboratory, Åbo Akademi University, Artillerigatan 6A, 02520, Turku, Finland.
Pharmaceutical research
|August 20, 2025
概括
半固体挤压 (SSE) 技术有效地制造了个性化的小儿用Ondansetron片. 拉曼光谱 (RS) 为这些定制药物提供了可靠的,非破坏性的质量控制方法.
科学领域:
- 制药技术
- 药物输送系统
- 分析化学
背景情况:
- 个性化儿科需要适应性的药物配方.
- 半固体挤压 (SSE) 为定制药物提供了一个有前途的3D打印方法.
- 昂丹塞特朗是治疗儿童恶心和吐的重要药物.
研究的目的:
- 评估基于SSE的自动化复合系统解决方案 (CSS),用于制造定制的Ondansetron片.
- 开发和验证使用拉曼光谱 (RS) 和部分最小方形 (PLS) 分析的非破坏性质量控制方法.
主要方法:
- 使用CSS技术制造不同剂量 (2-10 mg) 和大小 (200-500 mg) 的400毫克Ondansetron片.
- 根据欧洲和美国药典标准测试药片,包括HPLC分析.
- 开发和验证基于拉曼光谱 (RS) 的部分最小方形 (PLS) 模型,用于预测活性药物成分 (API) 含量.
主要成果:
- 通过CSS技术制造出具有高质量均性的药片 (99.2%用于不同药物含量,98.8%用于不同尺寸).
- 药片在六个月内表现出极好的稳定性,并且符合体外溶解标准 (在30分钟内释放超过85%的药物).
- 基于RS的PLS模型准确地预测了API含量与HPLC的高相关性 (R2Pred = 0.96).
结论:
- 基于SSE的自动化CSS技术对于生产高质量,个性化的Ondansetron平板电脑非常有效.
- 药典测试,HPLC和基于RS的PLS模型验证了这种方法的质量和可行性.
- 这项研究强调了SSE和RS在个性化儿科药物配方和质量控制方面的潜力.
相关概念视频
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