Zhang Jianyi, Pei Chunlei, Schiano Serena, Heaps David, Wu Chuan-Yu
Department of Chemical and Process Engineering, University of Surrey, Guildford GU27XH, UK.
Advantest Inc., Princeton, NJ, USA.
Eur J Pharm Biopharm. 2016 Sep;106:20-5. doi: 10.1016/j.ejpb.2016.01.012. Epub 2016 Jan 27.
Roll compaction is a commonly used dry granulation process in pharmaceutical, fine chemical and agrochemical industries for materials sensitive to heat or moisture. The ribbon density distribution plays an important role in controlling properties of granules (e.g. granule size distribution, porosity and strength). Accurate characterisation of ribbon density distribution is critical in process control and quality assurance. The terahertz imaging system has a great application potential in achieving this as the terahertz radiation has the ability to penetrate most of the pharmaceutical excipients and the refractive index reflects variations in density and chemical compositions. The aim of this study is to explore whether terahertz pulse imaging is a feasible technique for quantifying ribbon density distribution. Ribbons were made of two grades of microcrystalline cellulose (MCC), Avicel PH102 and DG, using a roll compactor at various process conditions and the ribbon density variation was investigated using terahertz imaging and section methods. The density variations obtained from both methods were compared to explore the reliability and accuracy of the terahertz imaging system. An average refractive index is calculated from the refractive index values in the frequency range between 0.5 and 1.5THz. It is shown that the refractive index gradually decreases from the middle of the ribbon towards to the edges. Variations of density distribution across the width of the ribbons are also obtained using both the section method and the terahertz imaging system. It is found that the terahertz imaging results are in excellent agreement with that obtained using the section method, demonstrating that terahertz imaging is a feasible and rapid tool to characterise ribbon density distributions.
滚压是制药、精细化工和农用化工行业中常用的一种干法制粒工艺,适用于对热或湿气敏感的物料。带状物密度分布在控制颗粒特性(如颗粒尺寸分布、孔隙率和强度)方面起着重要作用。准确表征带状物密度分布对于过程控制和质量保证至关重要。太赫兹成像系统在实现这一点上具有巨大的应用潜力,因为太赫兹辐射能够穿透大多数药用辅料,且折射率反映了密度和化学成分的变化。本研究的目的是探讨太赫兹脉冲成像是否是一种量化带状物密度分布的可行技术。使用滚压机在不同工艺条件下由两种微晶纤维素(MCC)等级,即微晶纤维素PH102和DG制成带状物,并使用太赫兹成像和切片方法研究带状物密度变化。比较从这两种方法获得的密度变化,以探索太赫兹成像系统的可靠性和准确性。从0.5至1.5太赫兹频率范围内的折射率值计算出平均折射率。结果表明,折射率从带状物中间向边缘逐渐降低。还使用切片方法和太赫兹成像系统获得了带状物宽度上密度分布的变化。发现太赫兹成像结果与使用切片方法获得的结果非常一致,表明太赫兹成像是表征带状物密度分布的一种可行且快速的工具。