Currently FDA and other regulatory agencies encourage the pharmaceutical industry to use process analytical technologies (PAT) in order to support a paradigm shift in manufacturing. The chance will go away from validated pharmaceutical production towards science based, well characterised processes, which are deeply understood. One key enabler for better manufacturing is the use of innovative online analytics for process control.

An example for the capability of process analytical technologies (PAT) in drug productions is the online monitoring of potency and moisture by near infrared spectroscopy on an in-process control unit of a tablet press. We have realized this PAT application by combining the in process control (IPC) unit for tablet presses RQ 100 of IMA Kilian with a process spectrometer SpectroBAY of Bayer Technology Services.

The idea to add NIR spectroscopy to the in process control unit RQ 100 of tablet presses was born in discussion with IMA Kilian based on long term experience with on-line spectroscopy within the Bayer group.

A team of experts of Bayer Technology Services and IMA Kilian integrated the NIR spectrometer Spectro- BAY into the tablet test system RQ 100.

Series of tablets with varying content of magnesium stearate were produced, to demonstrate the capability of this joined test system for tablets. In a feasibility study NIR spectra of these tablets were recorded automatically. The NIR spectra shown below belong to a calibration set of tablets with different contents of magnesium stearate.

Applying the multivariate calibration method to unknown tablets, which will be analyzed in the RQ 100 system, the concentration of magnesium stearate can by measured quantitatively .

We are able to discriminate of tablets with 1% or 2% magnesium stearate content clearly with our NIR application, as demonstrated at the ACHEMA 2006 fair in Frankfurt.

With the combined expertise of Bayer Technology Services and IMA Kilian you have access to the concentrations API and excipients in your tablets. The RQ 100 with integrated NIR spectroscopy enables you to monitor tablets quantities online.