Department of Chemical Engineering and Biotechnology, University of Cambridge, Philippa Fawcett Drive, CB3 0AS, Cambridge, UK.
GSK Ware Research and Development, Park Road, SG12 0DP, Ware, UK.
Int J Pharm. 2023 Mar 25;635:122726. doi: 10.1016/j.ijpharm.2023.122726. Epub 2023 Feb 21.
The disintegration process of pharmaceutical solid dosage forms commences on contact with the dissolution medium and continues with subsequent spontaneous imbibition of the medium in the tablet matrix. Identifying the location of the liquid front in situ during imbibition, therefore, plays a significant role in understanding and modelling the disintegration process. Terahertz pulsed imaging (TPI) technology can be used to investigate this process by its ability to penetrate and identify the liquid front in pharmaceutical tablets. However, previous studies were limited to samples suitable for a flow cell environment, i.e. flat cylindrical disk shapes; thus, most commercial tablets could only be measured with prior destructive sample preparation. This study presents a new experimental setup named open immersion to measure a wide range of pharmaceutical tablets in their intact form. Besides, a series of data processing techniques to extract subtle features of the advancing liquid front are designed and utilised, effectively increasing the maximum thickness of tablets that can be analysed. We used the new method and successfully measured the liquid ingress profiles for a set of oval convex tablets prepared from a complex eroding immediate-release formulation.
药物固体制剂的崩解过程始于与溶媒接触,并随着随后片剂基质中介质的自发吸收而持续进行。因此,在吸收过程中原位识别液体前沿的位置对于理解和模拟崩解过程起着重要作用。太赫兹脉冲成像(TPI)技术可以通过其穿透和识别药物片剂中液体前沿的能力来研究这一过程。然而,以前的研究仅限于适用于流动池环境的样品,即扁平圆柱形圆盘形状;因此,大多数商业片剂只能通过预先的破坏性样品制备进行测量。本研究提出了一种名为开放式浸泡的新实验装置,用于测量各种完整形式的药物片剂。此外,还设计并利用了一系列用于提取前进液体前沿细微特征的数据处理技术,有效地增加了可以分析的片剂的最大厚度。我们使用新方法成功地测量了一组由复杂侵蚀型即释制剂制备的椭圆形凸面片剂的液体渗透曲线。