A robust quantitative near infrared modeling approach for blend monitoring

作者：Mohan Shikhar; Momose Wataru; Katz Jeffrey M; Hussain Md Nayeem; Velez Natasha; Drennen James K III; Anderson Carl A^*

来源：Journal of Pharmaceutical and Biomedical Analysis, 2018, 148: 51-57.

DOI：10.1016/j.jpba.2017.09.011

• Near infrared spectroscopy
• Pharmaceutical blend homogeneity
• Calibration design
• Partial least squares

This study demonstrates a material sparing Near-Infrared modeling approach for powder blend monitoring. In this new approach, gram scale powder mixtures are subjected to compression loads to simulate the effect of scale using an Instron universal testing system. Models prepared by the new method development approach (small-scale method) and by a traditional method development (blender-scale method) were compared by simultaneously monitoring a 1 kg batch size blend run. Both models demonstrated similar model performance. The small-scale method strategy significantly reduces the total resources expended to develop Near-Infrared calibration models for on-line blend monitoring. Further, this development approach does not require the actual equipment (i.e., blender) to which the method will be applied, only a similar optical interface. Thus, a robust on-line blend monitoring method can be fully developed before any large-scale blending experiment is viable, allowing the blend method to be used during scale-up and blend development trials.

• 出版日期2018-1-30