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Continuous Manufacture and Scale-Up of Theophylline-Nicotinamide Cocrystals

The aim of the study was the manufacturing and scale-up of theophylline-nicotinamide (THL-NIC) pharmaceutical cocrystals processed by hot-melt extrusion (HME). The barrel temperature profile, feed rate and screw speed were found to be the critical processing parameters with a residence time of appro...

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Bibliographic Details
Main Authors: Steven A. Ross (Author), Andrew P. Hurt (Author), Milan Antonijevic (Author), Nicolaos Bouropoulos (Author), Adam Ward (Author), Pat Basford (Author), Mark McAllister (Author), Dennis Douroumis (Author)
Format: Book
Published: MDPI AG, 2021-03-01T00:00:00Z.
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Summary:The aim of the study was the manufacturing and scale-up of theophylline-nicotinamide (THL-NIC) pharmaceutical cocrystals processed by hot-melt extrusion (HME). The barrel temperature profile, feed rate and screw speed were found to be the critical processing parameters with a residence time of approximately 47 s for the scaled-up batches. Physicochemical characterization using scanning electron microscopy (SEM), differential scanning calorimetry (DSC), and X-ray diffraction of bulk and extruded materials revealed the formation of high purity cocrystals (98.6%). The quality of THL-NIC remained unchanged under accelerated stability conditions.
Item Description:10.3390/pharmaceutics13030419
1999-4923

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