Researchers and scientists at the University of Illinois at Chicago and AbbVie Inc. developed a novel device to screen and test formation of drug substance-Active Pharmaceutical Ingredient (API).
The industries currently using microtiter plates and droplet-based microfluidic devices to screen different forms, but these devices run into problems due to depletion of supersaturation.
If the nucleation process occurs crystals, grow in the microtiter plate using the initial supply of the API, causing supersaturation to deplete the screening results.
The incomplete perception of the polymorphic landscape of API obtained from the microtiter plates causes a huge risk when companies move to scale up. Technology transfer to manufacturing APIs in larger vessels called crystallisers and subsequent process equipment uses filters and dryers.
To overcome this issue, the researchers and scientists created a microfluidic device called cyclone mixer, consists of small valves with multiple inlets that work together to create a vortex in the device to ensure the solution is well mixed and keeps supersaturation constant by a continuous supply of API solution.
The device automatically shuts down after enough API crystals captured in the cyclone mixer.
The scientists tested the device to screen anthranilic acid, whose derivates are anti-inflammatory drugs. Then found the device can also be used to screen agrochemicals, semiconductors, catalysts, and other speciality chemicals for other industries more consistently and stably than the currently available.
The new device can also help pharmaceutical companies to move from batch-based production to continuous manufacturing, which FDA hopes it drives progress in robust API manufacturing at lower costs.