Application of in-Line near Infrared Spectroscopy to Pharmaceutical Blends

NIR spectroscopy was used for real time monitoring of a blending process Near Infrared Spectroscopy involved tracking changes in the chemical distribution of the active pharmaceutical ingredient. The feasibility of using near infrared (NIR) spectroscopy for monitoring pharmaceutical processes was demonstrated about ten years ago by scientists from Pfizer pharmaceuticals. However, this technology has not been implemented in the pharmaceutical industry and pharmaceutical blend uniformity is currently assessed by off-line methods that cannot control that this technology generates huge amount of data, and one of the most important aspects is how to interpret and evaluate the data. A NIR spectrometer has been interfaced to a 16 quart V-blender. Data acquired in real time, during blending will be presented. The use of moving block standard deviation approach, and principal components analysis (PCA) will be shown. The experience gained will be valuable for facilitating the transfer of this technology to the pharmaceutical industry.