A continuous manufacturing process for pharmaceutical indomethacin saccharine cocrystals was achieved by extrusion processing with high throughput. Down-stream milling and blending of the extrudates was followed by feeding the formulated cocrystals in a capsule-filling machine. By applying a quality by design approach, the process was optimized and scaled up to produce 3000 capsules/h of pharmaceutical cocrystals. Process analytical tools such as near infrared reflectance and spatial filter velocimetry probes were coupled at various process stages for in-line monitoring and quality control. Further physicochemical characterization of extruded batches confirmed the manufacturing of high quality cocrystals. A fully integrated continuous process starting from raw materials to produce a finished product was assembled with only six unit operations and a small footprint. The study is a paradigm of continuous manufacturing of pharmaceutical cocrystals.

• University of Greenwich
• Thermo Fisher Scientific

• PAT
• API

1. API
2. Extrusion processing
3. In-line process control
4. Near infra-red reflectances
5. pat
6. Physico-chemical characterization
7. Process analytical tool
8. quality by design
9. Research Article