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Real Customers - Their Applications, Raman Solutions
Raman Spectroscopy for At-Line KinetiSol® Process Monitoring
KinetiSol® is a high-energy, fusion-based solubility enhancement technology that is used to generate pharmaceutical amorphous solid dispersions (ASDs) without the assistance of solvent and often below the melting point of the active pharmaceutical ingredient (API). Kaiser Raman spectroscopy is being used as an at-line process analytical technology (PAT) for polymorphic content analysis of KinetiSol®-generated ASDs. Crystalline content is analyzed using a Kaiser Raman 785nm analyzer with a PhAT probe immediately upon ejection of the shots from KinetiSol® compounders, eliminating the time constraints of off-line powder X-ray diffraction (XRD) analysis. Spectral features reflecting the polymorphic content of the shots have been analyzed using multivariate techniques such as partial least squares regression (PLSR) analysis and support vector machines (SVM) classification. These methods are being implemented with the objective of monitoring, controlling, and improving the Kinetisol® process by continuous evaluation of product quality during manufacturing.
Keywords: Raman, process analytical technology, PAT, polymorph, API, amorphous solid dispersions, XRD, partial least squares regression, support vector machine, product quality measurements DisperSol, Kaiser
AIR DATE: March 24, 2020
Name: Angela Spangenberg
Title: Senior Research Scientist
Company: DisperSol Technologies
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