Scale-Up and Pilot Projects for Hot Melt Extrusion
Identify the right drug candidates
Thermo Scientific™ twin-screw extruders are built with similar geometries. This enables experimentation and feasibility projects with a lab-scale (11 mm screw) extruder that minimizes the use of expensive APIs and enables easy clean-up between experiments.
Finding the right API/excipients formulation and testing if this formulation is the right candidate for hot melt extrusion can be difficult. A micro twin-screw compounder requires as little as 3 grams of total material to identify the right drug candidates for hot melt extrusion. The compounder with conical co- or counter-rotating screws is designed to minimize waste and reduce downtime necessary for cleaning.
With a minimum throughput of 20 g/h, a benchtop extruder is ideal for Phase 1 research applications, especially when developing and testing recipes with expensive API and associated compounds. As a GMP-compliant unit, the Thermo Scientific™ Pharma 11 is also suitable for clinical trials and small-scale production for throughputs up to 2.5 kg/h. The screw and barrel designs are geometrically scalable across the whole Thermo Scientific portfolio of extruders from lab and pilot through to production scale.
Designed to fit between the development lab and production line, a modular 16 mm twin screw extruder is capable of managing several drug formulation projects, including controlled release formulations, solubility enhancement, co-extrusion and implants, abuse deterrent formulations, and wet and melt granulation projects. A modular design enables formulation scientists to switch from hot melt extrusion and continuous granulation projects without engineering the extruder system.
Reduce scale-up risks by running production on same equipment as development. A 24 mm twin-screw granulator will match the performance of 300 to 600 litre batch processors. Reduce in-process inventory to minimize risks to expensive ingredients and from ATEX hazards. Maximum volume of ingredients in the process is approximately 100 ml for 16 mm and 360 ml for 24 mm twin screw granulators.
For consistent, controllable processing of hot melt drug formulations that are suitable for PAT, the 24mm twin screw extruder promises reduced product changeover time, minimized scale-up risk and easy cleaning.
This platform includes a number of integrated ancillary equipment for both project development and small-scale production including pre-mixers, feeders, chill rolls, air-cooled conveyors, pelletizers, and cast sheet or blown film lines. GMP standard pharmaceutical versions of the ancillaries are available with stainless steel construction and dust-tight touch-screen operator interface.
|Pharma Twin-Screw Extruders||Micro-Compound||11mm TSE||16mm TSE
|Recommended for||Feasibility||Research Phase 1||Pilot Phase 2||Manufacturing Phase 3|
|Typical Throughput Hot Melt Extrusion||3 g batch or 100 g/h||20 g/h – 2.5 kg/h||500 g/h – 5 kg/h||500 g/h – 20 kg/h|
|Typical Throughput Continuous Granulation||N/A||up to 3 kg/h||up to 15 kg/h||up to 60 kg/h|
(L × W × H)
|650 × 470 × 590mm||820 × 480 × 410mm||1750 × 610 × 1220mm||1900 × 800 × 1300mm|
|Downstream Options||Take Off Belt||Conveyor Belt Pelletizer||Conveyor Belt Pelletizer Chill Roll||Conveyor Belt Pelletizer Chill Roll|
|Suitable for||Co-Extrusion Implant Production||Co-Extrusion Sheet Extrusion Implant Production||Co-Extrusion Sheet Extrusion Implant Production||Sheet Extrusion High-Volume HME Production|
|Parallel, Co-Rotating||Parallel, Co-Rotating||Parallel, Co-Rotating|
|Max. Torque||5 Nm/shaft||6 Nm/shaft||18 Nm/shaft||52.5 Nm/shaft|