Optimisation of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation and its application for process characterisation.

In a previous publication, the development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation was presented. An in-line method was developed successfully and the developed method showed an acceptable prediction error. A disadvantage of the developed method was that a measurement was only possible in the dark since light influenced the Raman spectra and made a data interpretation impossible.

Impact of Different Dry and Wet Granulation Techniques on Granule and Tablet Properties: A Comparative Study.

Four granulation techniques were compared evaluating their impact on granule properties and the tablet tensile strength. A common formulation was chosen to be processed with both wet and dry granulation techniques: roll compaction/dry granulation, high-shear granulation, twin-screw granulation, and fluidized-bed granulation. The produced granules were characterized in terms of granule size distribution, X-ray powder diffraction, scanning electron microscopy, porosity, and strength.

Development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation.

Raman spectroscopy was evaluated as a process analytical technology (PAT) tool for continuous API quantification during twin-screw wet granulation. Therefore, a Raman probe was implemented in front of the granulator barrel. This setup enabled the collection of Raman spectra upon a constant granule flow.