使用非破坏性和快速的紫外线成像方法确定含有药物的无形固体分散剂的药物含量
Anna Péter-Haraszti1, Liliána Györgyi Bakucz1, Lilla Alexandra Mészáros1
1Department of Organic Chemistry and Technology, Faculty of Chemical Technology and Biotechnology, Budapest University of Technology and Economics, Műegyetem rkp. 3., H-1111 Budapest, Hungary.
International journal of pharmaceutics
|May 16, 2025
概括
紫外线成像提供了一种快速,具有成本效益的方法来量化无形固体分散 (ASD) 片中的药物含量. 这个过程分析技术 (PAT) 工具准确地测量了活性药物成分 (API) 的水平,有助于制药质量控制.
科学领域:
- 制药技术 制药技术 制药技术
- 分析化学 分析化学
- 过程分析技术 过程分析技术
背景情况:
- 无形固体分散 (ASD) 对于提高药物的溶解性和生物可用性至关重要.
- 需要有效的质量控制方法用于ASD制药,特别是那些通过连续工艺制造的药物.
研究的目的:
- 评估紫外线成像作为一种快速,非破坏性的过程分析技术 (PAT) 工具,用于量化ASD片中的药物含量.
- 评估紫外线成像的能力,以区分分批量和连续制造过程的ASD平板电脑.
主要方法:
- ASD纤维是由电制成的,并使用批量和连续方法与辅助剂混合.
- 药片被压缩,并使用紫外线成像来捕捉药物的光.
- 部分最小平方回归模型是使用图像数据开发的,用于活性药物成分 (API) 的量化.
主要成果:
- 紫外线成像成功量化了ASD片中的API含量,准确度很高 (RMSEP 0.381 w/w%,4.59%的相对误差).
- 紫外线图像的主要组件分析区分了批量和连续混合过程中的片.
- 开发的模型通过外部验证证明了可靠性.
结论:
- 紫外线成像是一种可行的,具有成本效益的PAT工具,用于实时监测和质量控制ASD药片制造中的药品制造.
- 该方法支持批量制造和连续制造模式,为流程理解和控制提供了显著的优势.
- 紫外线成像检测工艺变化的能力突出了其在确保产品的一致性和防止假冒药物的潜力.
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