Near infrared and Raman spectroscopy for the in-process monitoring of pharmaceutical production processes.

Within the Process Analytical Technology (PAT) framework, it is of utmost importance to obtain critical process and formulation information during pharmaceutical processing. Process analyzers are the essential PAT tools for real-time process monitoring and control as they supply the data from which relevant process and product information and conclusions are to be extracted. Since the last decade, near infrared (NIR) and Raman spectroscopy have been increasingly used for real-time measurements of critical process and product attributes, as these techniques allow rapid and nondestructive measurements without sample preparations. Furthermore, both techniques provide chemical and physical information leading to increased process understanding. Probes coupled to the spectrometers by fiber optic cables can be implemented directly into the process streams allowing continuous in-process measurements. This paper aims at reviewing the use of Raman and NIR spectroscopy in the PAT setting, i.e., during processing, with special emphasis in pharmaceutics and dosage forms.