A High Throughput Microfluidic Approach for the Continuous Manufacture of Ibuprofen Nanocrystals

Abstract

Nanocrystals offer a promising avenue for enhancing drug dissolution and bioavailability; however, considerable challenges in reliable and scalable manufacture remain, particularly with respect to size control, batch-to-batch variation, and physical stability. This study describes a novel continuous manufacturing platform for nanocrystal production, utilizing a microfluidic reactor for the generation of ibuprofen nanosuspension. Through systematic optimization of critical process parameters, nanocrystals with an average size of 108 nm and a narrow particle size distribution (polydispersity index: 0.236) are produced. This optimized process demonstrates significant industrial potential, achieving a high productivity of 80 mL min−1, a key achievement that moves beyond the production limitations of using microfluidics in producing nanosuspensions. Characterization confirmed the crystalline nature of the nanoparticles. Critically, the nanocrystals exhibited a transformative 6-fold improvement in dissolution rate compared to a marketed ibuprofen formulation, completely dissolving within the first five minutes. This study demonstrates a robust and scalable pathway for overcoming key pharmaceutical manufacturing challenges, providing a promising avenue for the continuous industrial-scale production of drug nanocrystals.