Continuous manufacture of hydroxychloroquine sulfate drug products via hot melt extrusion technology to meet increased demand during a global pandemic: From bench to pilot scale

During pandemics and global crises, drug shortages become critical as a result of increased demand, in personnel lockdown restrictions that disrupt the supply chain. The pharmaceutical industry is therefore moving towards continuous manufacturing instead conventional batch involving numerous steps, normally occur at different sites. In order to validate use large-scale industrial processes, feasibility studies need be performed using small-scale laboratory equipment. To end, scale-up process its effect on quality attributes (CQAs) end product were investigated this work. Hydroxychloroquine Sulphate (HCQS) was used model drug, Soluplus® polymeric carrier both horizontal vertical twin screw extruders undertake hot melt extrusion (HME) study. Seven formulations processed extruder pilot-scale various loadings, temperature profiles speeds. When utilising extruder, with highest load lowest speed had crystallinity higher release rates. Upon HCQS significantly reduced, less variation profile across extrudates. This study demonstrates improved robustness compared lab-scale extruder. reduced will allow for short increases production rate, minimum impact CQAs final enabling high-performance waste raw materials. Finally, research provides valuable information accessing technologies manufacture products, allowing efficient utilisation resources upon mass during shortages.