Applications of Near Infrared Spectroscopy in the Full-Scale Manufacturing of Pharmaceutical Solid Dosage Forms Lene Maurer1,2, Hans Leuenberger2,3,4 F. Hoffmann-La Roche Ltd., Basel (Switzerland)1, Institute of Pharmaceutical Technology, University of Basel, Basel (Switzerland)2, Institute for innovation in industrial pharmacy Ifiip llc, Basel (Switzerland)3, Department of Pharmaceutics and Biopharmaceutics, School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva (Switzerland)4 Corresponding author: Dr. Lene Maurer, F. Hoffmann-La Roche Ltd., Grenzacherstrasse, 4070 Basel (Switzerland), e-mail: lene.maurer@roche.com The following article gives an overview over the application of near infrared (NIR) spectroscopy during the full-scale manufacturing of oral solid dosage forms in solids manufacturing plants of several pharmaceutical companies in Switzerland and Germany. At-line, on-line and in-line NIR spectroscopy is in use for nearly all process steps such as raw-material identification, blending, drying and tabletting. Most common are at-line applications. For the identification of incoming materials, NIR spectroscopy is already widely applied. The blending of powders or granules is monitored by in-line NIR spectroscopy by several companies, and the water content determination by NIR spectroscopy during drying is also applied in some manufacturing plants. In tablet pressing, at-line and online methods for fast in-process controls are more common than 100 % in-line tablet control, which is very challenging due to the speed of the press. Concerning the instrumentation, mainly diode array and acousto-optic tunable filter spectrometers are in use for fast applications such as in-line tabletting, blending or drying monitoring. FT-NIR and grating devices are often used for at-line applications. Fiber optics play an important role in the manufacturing environment. |
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pharmind 2009, Nr. 4, Seite 672
