Innovation Strategies & External Liaison, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.
Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg, Sweden.
Int J Pharm. 2021 Jan 5;592:120056. doi: 10.1016/j.ijpharm.2020.120056. Epub 2020 Nov 5.
Currently, there is a need for new technology for in-line or fast at-line assessment of solid material porosity. One specific gap is a fast technology to be used in connection to roller compaction (RC) manufacturing, where the porosity of the RC ribbons is critical to the manufacturing of tablets of the right tensile strength and disintegration properties. In this paper, the development of an at-line technology for fast, non-destructive assessment of porosity of RC ribbons is reported. The technology is based on a diode laser spectroscopic technique called Gas in scattering media absorption spectroscopy (GASMAS). GASMAS measures the sample voids by laser light, giving the distance through air. The total distance the light travels is measured using time-of-flight spectroscopy (TOFS). The ratio of these measures gives an "optical porosity", which through theory relates to the porosity of the sample. We present a description of the technology, evaluations of measurement robustness and results from an experimental design where roller compactor, roll force, roll gap and formulation were varied. It is concluded that the data from two different pharmaceutical formulations is supported by the same calibration curve, which indicates that optical porosimetry is a general technique for pharmaceutical materials that does not require frequent calibrations.
目前,需要开发新的技术来在线或快速在线评估固体材料的孔隙率。一个具体的空白是一种用于与辊压(RC)制造相关的快速技术,其中 RC 带的孔隙率对于制造具有适当拉伸强度和崩解性能的片剂至关重要。本文报告了一种用于快速、非破坏性评估 RC 带孔隙率的在线技术的开发。该技术基于一种称为气体在散射介质中的吸收光谱(GASMAS)的二极管激光光谱技术。GASMAS 通过激光测量样品中的空隙,给出空气的距离。使用飞行时间光谱(TOFS)测量光传播的总距离。这些测量的比值给出了一个“光学孔隙率”,通过理论与样品的孔隙率相关。我们介绍了该技术的描述、测量稳健性的评估以及在不同的轧辊压力、轧辊间隙和配方变化的实验设计中的结果。结果表明,来自两种不同药物制剂的数据由相同的校准曲线支持,这表明光学孔隙率测量法是一种适用于药物材料的通用技术,不需要频繁校准。