Chakraborty Mousumi, Ridgway Cathy, Bawuah Prince, Markl Daniel, Gane Patrick A C, Ketolainen Jarkko, Zeitler J Axel, Peiponen Kai-Erik
Institute of Photonics, University of Eastern Finland, P.O. Box 111, FI-80101 Joensuu, Finland.
Omya International AG, CH-4665 Oftringen, Switzerland.
Int J Pharm. 2017 Jun 15;525(1):85-91. doi: 10.1016/j.ijpharm.2017.03.093. Epub 2017 Apr 2.
The objective of this study is to propose a novel optical compressibility parameter for porous pharmaceutical tablets. This parameter is defined with the aid of the effective refractive index of a tablet that is obtained from non-destructive and contactless terahertz (THz) time-delay transmission measurement. The optical compressibility parameter of two training sets of pharmaceutical tablets with a priori known porosity and mass fraction of a drug was investigated. Both pharmaceutical sets were compressed with one of the most commonly used excipients, namely microcrystalline cellulose (MCC) and drug Indomethacin. The optical compressibility clearly correlates with the skeletal bulk modulus determined by mercury porosimetry and the recently proposed terahertz lumped structural parameter calculated from terahertz measurements. This lumped structural parameter can be used to analyse the pattern of arrangement of excipient and drug particles in porous pharmaceutical tablets. Therefore, we propose that the optical compressibility can serve as a quality parameter of a pharmaceutical tablet corresponding with the skeletal bulk modulus of the porous tablet, which is related to structural arrangement of the powder particles in the tablet.
本研究的目的是为多孔药物片剂提出一种新型的光学压缩性参数。该参数借助片剂的有效折射率来定义，而片剂的有效折射率是通过无损且非接触式的太赫兹（THz）时延传输测量获得的。对两组孔隙率和药物质量分数已知的药物片剂训练集的光学压缩性参数进行了研究。这两组药物片剂均使用最常用的辅料之一微晶纤维素（MCC）和药物吲哚美辛进行压制。光学压缩性与通过压汞法测定的骨架体积模量以及根据太赫兹测量计算出的最近提出的太赫兹集总结构参数明显相关。这个集总结构参数可用于分析多孔药物片剂中辅料和药物颗粒的排列模式。因此，我们提出光学压缩性可作为药物片剂的一个质量参数，它与多孔片剂的骨架体积模量相对应，而骨架体积模量与片剂中粉末颗粒的结构排列有关。
