Continuous Manufacture and Scale-Up of Theophylline-Nicotinamide Cocrystals

Autor:	Steven A. Ross, Andrew P. Hurt, Milan Antonijevic, Nicolaos Bouropoulos, Adam Ward, Pat Basford, Mark McAllister, Dennis Douroumis
Jazyk:	angličtina
Rok vydání:	2021
Předmět:	cocrystals hot-melt extrusion scale-up continuous manufacturing X-ray Rietveld refinement Pharmacy and materia medica RS1-441
Zdroj:	Pharmaceutics, Vol 13, Iss 3, p 419 (2021)
Druh dokumentu:	article
ISSN:	1999-4923
DOI:	10.3390/pharmaceutics13030419
Popis:	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.
Databáze:	Directory of Open Access Journals
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