Chemical imaging of pharmaceutical granules by Raman global illumination and near-infrared mapping platforms.
Raman global illumination and near-infrared (NIR) mapping instruments were used to chemically image pharmaceutical granules obtained by the wet granulation process in order to determine whether the API was mixed with the major excipient or granulates on its own. The granules were randomly distributed onto a microscope slide and an average area of about 3.5mmx3.5mm, covering 50-100 granules, was analyzed by both instruments. Light microscopy images of the separated granules were collected before the spectroscopic data acquisition. Both Raman and NIR signals of API and major excipient (mannitol) were easily detected by both techniques which allowed the chemical structure of the granules to be characterised. Most of the granules were found to contain both API and mannitol but pure mannitol and a few pure API granules were also identified. Raman global illumination was found to provide a comprehensive insight into chemical structure of the granules being able to more clearly determine the API in comparison with NIR mapping. Owing to the differences in shapes of the particles and reflection characteristics, visual microscopy and methods based on reflection can be potentially useful for analyzing this particular formulation.
Sasić
Slobodan
S
Pfizer, Analytical Research and Development, Ramsgate Road, Sandwich CT13 9NJ, UK. slsasic@yahoo.com
D004364:Pharmaceutical Preparations / Q000737:chemistry*; D019265:Spectroscopy, Near-Infrared / Q000379:methods*; D013059:Spectrum Analysis, Raman / Q000379:methods*
D004364:Pharmaceutical Preparations