实现个性化的3D打印延长释放口服药物产品:传输拉曼光谱作为快速质量控制工具
Anna Kirstine Jørgensen1, Julia Griffen2, Robert Wills2
1Department of Pharmaceutics, UCL School of Pharmacy, University College London, 29-39 Brunswick Square, London WC1N 1AX, United Kingdom.
概括
对3D打印药物的质量控制具有挑战性. 传输拉曼光谱 (TRS) 提供了一种快速,非破坏性的方法,用于在个性化的延长释放打印件中准确量化药物,支持分散制造.
科学领域:
- 制药技术 制药技术 制药技术
- 分析化学 分析化学
- 工艺工程的过程工程.
背景情况:
- 使用3D打印 (3DP) 进行个性化药物的分散制造 (DM) 正在出现,这是英国新立法所推动的.
- 确保小批量延长释放 (ER) 3DP片 (printlets) 的质量控制 (QC) 和剂量准确性存在重大挑战.
- 现有的质量控制方法可能不适合在DM环境中进行高通量,个性化的生产.
研究的目的:
- 开发和验证一种非破坏性,高通量方法,用于3D打印延长释放打印件的药物定量化,用于分散制药制造.
- 评估传输拉曼光谱法 (TRS) 与部分最小平方回归 (PLSR) 结合用于个性化药物的质量控制的适用性.
- 为了证明开发的方法在不同印刷尺寸的准确性和可靠性.
主要方法:
- 开发一种基于神叶素的药用墨水,用于直接粉末挤出 (DPE) 3DP的三种尺寸的ER印刷品.
- 打印小册子发行配置文件的表征,并确认跨尺寸的同等延长释放性能.
- 对PLSR模型的校准和验证,使用不同尺寸的印刷品中的TRS光谱来预测药物含量.
主要成果:
- 证实了所有印刷品尺寸的同等体外溶解概况,符合药库标准.
- 一个PLSR模型,从最小和最大的打印单元中使用TRS光谱校准,准确地预测了所有大小的药物含量 (R2 = 0.9948,RMSEP = 0.5611% w/w).
- 与药物量化的参考方法相比,TRS-PLSR方法没有显示出统计差异.
结论:
- 传输拉曼光谱 (TRS) 提供了一种快速,非破坏性和准确的方法,用于在3D打印的延长释放打印件中量化药物含量.
- 这种方法适用于个人化药物的分散制药制造中的高通量质量控制.
- 这些发现支持将TRS-PLSR作为剂量灵活3DP制药品的质量控制工具的实施.
相关概念视频
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