Ropero-Vega, Jorge M.

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    Development of near infrared spectroscopy methodologies to provide physical information for pharmaceutical processes
    (2013) Ropero-Vega, Jorge M.; Romañach, Rodolfo J.; College of Arts and Sciences - Sciences; Mina, Nairmen; Román, Félix; Perales, Oscar; Department of Chemistry; Bollman, Dorothy
    This research focused on increasing the number of applications and establishing methods to monitor physical properties from pharmaceutical materials using Near Infrared Spectroscopy (NIRS). NIRS in combination with chemometric data analysis was used increasing the number of applications and understanding the physical information of pharmaceutical materials, this work opens interesting perspectives for pharmaceutical analyses in solid form without sample preparation. The development of new NIR analytical methods contributes to the process analytical technology (PAT) initiative and pharmaceutical manufacturing. NIR spectroscopy was used to create a new method for in-line characterization of powder flow behavior. The spectra of flowing powders were used to measure the flow, continuity, and interruption of powder flow and evaluate the chemical heterogeneity of pharmaceutical powders. The main purpose of this work was used in-line NIRS to detect the flow uniformity, which in general depends on the flowability of the powder and their blends. The new NIRS method was used for the evaluation of active pharmaceutical ingredients (APIs) that have surface modified to improve their extremely poor flow properties. Near-infrared (NIR) spectroscopy was utilized as a novel approach to characterize the improved flow behavior of APIs and their blends. This NIRS application also involves a second study evaluating the performance of excipients and cohesive powders in a K-tron twin-screw gravimetric feeder. The evaluation used NIR spectroscopy and multivariate data analysis as an effective alternative for the real-time measure of flow behavior. The second objective of this study was the real-time determination of tablet compaction pressure in pharmaceutical tablets. This study determined the concentration and compaction pressure in moving tablets with NIR spectra. The third section of this dissertation describes the use of Near-infrared chemical imaging (NIRCI) to study pharmaceutical tablets that decrease in compaction of particles (tablet relaxation). NIR-CI spectra of lactose monohydrate tablets were acquired and the spectral slope from each pixel and the data hypercube was used to assess tablet compaction and relaxation over the time.