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Monitoring and modeling of film coating in a side vented pan coater using near-infrared reflectance spectroscopy, digital video imaging and computational methods.

机译:使用近红外反射光谱仪,数字视频成像和计算方法,在侧面通风的锅式涂布机中监控薄膜涂层并进行建模。

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摘要

The impact of process understanding, continuous improvement and designing quality into products has been a major focus issue within the pharmaceutical industry and regulatory agencies. This thesis explores new tools and methods that can be used for process monitoring and control as well as obtaining enhanced predictive capabilities.;One of the main objectives of this study was to monitor a pan coating process in real-time and develop methods for calibration of NIR spectra for the tracking of coating thickness on pharmaceutical tablets and enable end-point determination.;A series of methods based on digital video analysis of moving tablet beds were also developed to elucidate tablet bed behavior and dynamics as well as inter-tablet and intra-tablet coating variability in a side-vented perforated coating pan. Results are compared to those obtained using discrete element method (DEM) simulations that model a similar system of tablets inside a coating pan. The study focuses on the effect of coating process variables like pan loading size, and pan speed on the movement of tablets within the coating pan. It was found that information on overall tablet movement and bed dynamics can be obtained by using a combination of experimental and computational tools and can be used for pharmaceutical pan coating process optimization and design.
机译:过程理解,持续改进和产品质量设计的影响一直是制药行业和监管机构关注的主要问题。本论文探索了可用于过程监测和控制以及获得增强的预测能力的新工具和方法。;本研究的主要目的之一是实时监测锅包衣过程并开发用于校准涂料的方法。 NIR光谱,用于跟踪药物片剂的涂层厚度并能够确定终点;还开发了一系列基于数字视频分析的移动片剂床的方法,以阐明片剂床的行为和动力学以及片剂间和片剂内侧面通风的涂层锅中片剂的涂层变化。将结果与使用离散元素方法(DEM)模拟获得的结果进行比较,该模型对包衣锅内部类似的药片系统进行建模。这项研究集中在包衣过程变量(如锅的装料大小和锅速度)对片剂在包衣锅内运动的影响。已经发现,可以通过结合使用实验工具和计算工具来获得有关总体片剂运动和床动力学的信息,这些信息可以用于药物包衣过程的优化和设计。

著录项

  • 作者

    Perez-Ramos, Jose D.;

  • 作者单位

    Purdue University.;

  • 授予单位 Purdue University.;
  • 学科 Health Sciences Pharmacy.
  • 学位 Ph.D.
  • 年度 2007
  • 页码 168 p.
  • 总页数 168
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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