Great paper in International Journal of Pharmaceutics about solutions for the pharmaceutical industry in accessing continuous manufacturing technologies and allowing for efficient utilization of resources upon scale-up and mass production during global pandemics and drug shortages.
This reflects a superb common common work between RONDOL, Queens University Belfast, Birmingham School of Pharma and Institut Jean Lamour since the beginning of the COVID crisis.
Hydroxychloroquine Sulphate (HCQS) was used as the model drug, Soluplus® as a model polymeric carrier and both horizontal and vertical twin screw extruders used to undertake this hot melt extrusion (HME) study.
7 formulations were processed using a small-scale horizontal extruder and a pilot-scale vertical extruder at various drug loadings, temperature profiles and screw speeds. When utilising a horizontal extruder, formulations with the highest drug load and processed at the lowest screw speed and temperature had the highest crystallinity with higher drug release rates.
Upon scale-up to a vertical extruder, the crystallinity of the HCQS was significantly reduced, with less variation in both crystallinity and release profile across the different extrudates.
The study therefore demonstrates improved robustness with the pilot-scale vertical extruder compared to lab-scale horizontal extruder. The reduced variation with the vertical extruder will allow for short increases in production rate, with minimum impact on the CQAs of the final product enabling high-performance continuous manufacturing with minimum waste of raw materials.
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