Manufacturing of amorphous pharmaceutical formulations can be complex and costly. KinetiSol is an elegantly simple manufacturing technology capable of high-throughput production of amorphous systems.
KinetiSol is based on a commercial plastics compounding process and was developed by DisperSol into a cGMP-compliant pharmaceutical technology. The KinetiSol pharmaceutical manufacturing process can be run from kiloton-commercial scale down to sub-10 gram batch sizes to accommodate the material-sparing needs of early drug development.
Process Attributes
– Non-solvent process
– No external heat applied
– Processing times typically <20 s
– Elevated temperatures for typically <5 s
– Processing of high viscosity materials
– cGMP compliant
– Scale-up established
Fusion-Based Process
– Utilizes frictional and shear energies
– Rapid transition to molten state
– Simultaneous high-intensity mixing
– Real-time temperature monitoring
– Discharge at temperature set-point
Processing Scale
– Lab-scale with <10 g per batch
– Commercial-scale 40 kg/hr/unit
WHY USE KINETISOL ?
KinetiSol Fits In-Line with Existing Manufacturing Operations
- Solve formulating challenges no other technology can
- Create patent-protected compositions no other technology can
- Make higher-performing products