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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Detalles Bibliográficos
Autores principales: Ross, Steven A., Hurt, Andrew P., Antonijevic, Milan, Bouropoulos, Nicolaos, Ward, Adam, Basford, Pat, McAllister, Mark, Douroumis, Dennis
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8004052/
https://www.ncbi.nlm.nih.gov/pubmed/33804705
http://dx.doi.org/10.3390/pharmaceutics13030419
Descripción
Sumario: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.

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