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Titre du Document
Applications of Near Infrared Spectroscopy in the Full-Scale Manufacturing of Pharmaceutical Solid Dosage Forms
Auteur(s)
MAURER Lene ; LEUENBERGER Hans
Résumé
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 on-line 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.
Editeur
Cantor
Identifiant
ISSN : 0031-711X CODEN : PHINBO
Source
Pharmazeutische Industrie A. 2009, vol. 71, n° 4, [672-678 [6 p.]]
Langue
Anglais
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