A quality by design study of the use of microfluidic nanoprecipitation for the generation of sub-100 nm drug nanocrystals
Year: 2026
Type: article
Abstract: Although drug nanocrystals have attracted considerable interest within the pharmaceutical industry, there remain issues with the production of nanocrystals with a size below 100 nm. The aim of the present study is to develop a stable, reproducible Canagliflozin (CFZ) sub-100 nm nanosuspension system using microfluidic nanoprecipitation and Quality by Design (QbD) techniques. By means of the circumscribed central composite design (CCCD), critical parameters of the microfluidic nanoprecipitation process and nanosuspension formulation components were optimised. Optimal CFZ nanosuspension with Z-average of 89.52 ± 3.30 nm, PDI of 0.12 ± 0.01 and drug content of 92.49 ± 0.03% was successfully fabricated using Soluplus as a stabiliser. An increase in saturation solubility corresponding to approximately 250 times the value of the pure CFZ in water was noted. The optimised CFZ nanosuspension was solidified by freeze-drying and electrospraying. Overall, the study has demonstrated that by using a combination of microfluidics and QbD it is promising to generate stable sub-100 nm nanocrystals with high yield, and narrow size distribution and favourable stability. • Nanosuspension sub-100 nm was produced using microfluidic nanoprecipitation and QbD • Circumscribed central composite design (CCCD) was used to optimise system • Optimal nanosuspension with Z-average of 89.5, PDI of 0.115 and drug content of 92.5% • Electrospraying can be used as a drying method for nanosuspension
Language: English
Subfield: Pharmaceutical Science
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,790
Award: G5505655214
OpenAlex ID: W7127586484