(707e) Characterization of in-Situ near-Infrared Imaging to Aid Pharmaceutical Powder Blend Formulation Development

Pharmaceutical powder blending is a complex process widely studied in recent years. The characterization of blends as a bulk (macro-mixing characterization) has been the main focus of past studies. The present study introduces a new in-situ near-infrared imaging technique (imMix^™) designed to characterize micro-mixing (particle to particle interaction and arrangement) in pharmaceutical powder blends. This technique uses in-line / non-contact monitoring of the blending process eliminating the bias introduced by any powder sampling technique commonly used. A Science-Based Calibration (SBC) method, which uses pure component spectral data to create a calibration model, was used to create concentration maps of the blends studied here. The advantage of SBC over PLS or PCA calibration methods is that it does not require a large amount of samples to create a calibration curve. The imMix system showed to be useful in monitoring the distribution and aggregate sizes of the model API and excipients used for this study. It was also able to measure changes in the constituents in a 1-liter test blender as a function of blending time and other experimental parameters. The use of this technique can help in the development of pharmaceutical powder blend formulations.