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. The pharmaceutical process is cGMP compliant and meets all pharmaceutical manufacturing requirements.
KINETISOL PROCESS
Manufacturing with KinetiSol:
- Manufacturing at all scales
- Batch and continuous processing modes
- Rapid product output up to 50 kg/hr/unit
- Elegantly strightforward process
- Direct mapping of operating space
- Scale-up principles well established
- Less costly to install and operate, particularly at large scales, than solvent-based processes
- Real-time, continuous process monitoring for enhanced process control and understanding
KINETISOL FORMULATOR AND COMPOUNDERS
Development to Production
KinetiSol Research Formulator
Generation (1) Lab Scale
- Beta Testing in September 2015
- Unit size: 5 – 8 g
- Unit processing times: 5 – 20 sec
- Feed/quenching operations are manual
- Early formulations development
- Real-time computer monitoring system
- Dimensions – 33” x 38” x 54”.
- Weight 500 lb
KinetiSol KC254B Compounder (Batch)
Generation (1) Lab/Commercial Scale
- First Generation – 2012
- Unit size: 50 – 350 g
- Unit processing times: 5 – 20 sec
- Feed/quenching operations are manual
- Formulations and process development
- GMP manufacturing of up to 10 kg of AI
- Real-time computer monitoring system
- Dimensions – 25” x 65” x 57”
- Weight 2,000 lb
KinetiSol KC254C Compounder (Continuous)
Generation (2) Commercial Scale
- Developed in 2014
- Identical dimensions to batch compounder
- Product output up to 40 kg/hr
- Feed and quenching operations are automated
- GMP manufacturing Phase I through commercial
- Integrated Process Analytical Technologies
- Dimensions – 34” x 75” x 60” (w/o feeding system)
- Weight 2,500 lb