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. It is an established process in the plastics industry with a proven track record for high-volume commercial production with product output rates as high as 3,000 kg/hr.

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


KinetiSol Fits In-Line with Existing Manufacturing Operations

KinetiSol is a new unit operation for pharmaceutical manufacturing; however, the operations upstream and downstream of the KinetiSol compounder are conventional. The amorphous powder intermediate resulting from the KinetiSol process train can be utilized as a powder for constitution, or can be further processed into any conventional oral dosage form.