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 less than 20 seconds
Elevated temperatures for typically less than 5 seconds
Processing of high viscosity materials
cGMP compliant
Scale-up established

Fusion-Based Process

KinetiSol® is a fusion-based process that utilizes frictional and shear energies (no externally applied heat) to rapidly transition drug-polymer blends into a molten state with simultaneous high-intensity mixing. Real-time temperature is monitored by a computer-control module and product is immediately discharged upon reaching the temperature setpoint.

Processing Scale

The KinetiSol® process is capable of operating in batch mode on lab-scale equipment using less than 10 grams of drug-polymer blend per batch. For commercial processing,larger-scale manufacturing machines are operated continuously to achieve product throughput up to 40 kg/hr/unit.

WHY USE KINETISOL ?

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.