基于结构的释放动力学分析多克萨佐甲酸持续释放片使用微型计算机断层扫描
Qian Liu1, Mengqing Zan1,2, Hanhan Huang1,2
1NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs, National Institutes for Food and Drug Control, Beijing 100050, China.
Asian journal of pharmaceutical sciences
|December 6, 2024
概括
微型计算机断层扫描 (micro-CT) 显示了多克萨佐辛甲酸片的结构差异. 这些结构变异解释了不同的药物释放行为,特别是在酒精诱导的条件下,有助于药物开发.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
- 药物运输 药物运输 药物运输
背景情况:
- 固体剂型结构极大地影响药物释放动力学和性能.
- 了解内部结构是评估修饰释放配方的关键.
- 多克萨佐甲酸持续释放片需要进行详细的结构分析以进行质量控制.
研究的目的:
- 通过微型计算机断层扫描 (micro-CT) 来评估多克萨佐辛甲酸持续释放片的3D结构.
- 研究内部结构和药物释放行为之间的相关性,特别是在酒精诱导的条件下.
- 为了比较参考列表药物 (RLD) 和通用配方的结构参数和释放特征.
主要方法:
- 使用微型计算机断层扫描 (micro-CT) 进行3D平板结构的并行评估.
- 传统的溶解测试.
- 在含有乙醇的介质中进行酒精诱导的剂量倾销试验.
- 分析结构参数,包括体积和表面积.
主要成果:
- 在常规溶解中,RLD和通用配方之间的释放概况没有显著差异.
- 在剂量倾销试验中,通用配方在乙醇介质中释放的速度略快.
- 乙醇加速溶解并改变了药片的内部结构,RLD和40%乙醇中的通用药之间存在明显的结构参数 (体积,面积) 差异.
结论:
- 来自微CT的3D结构数据为修改释放配方的独特释放行为提供了宝贵的见解.
- 内部细结构显著影响药物释放动力学,特别是在乙醇的存在下.
- 在压力条件下,RLD和仿制药的结构差异变得明显,这对药物开发和质量控制至关重要.
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