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Description
Reproducibility during scale-up remains a major challenge in nanoparticle synthesis due to variations in mixing efficiency, local concentration gradients, and crosslinking kinetics. This study evaluated the upscaling of chitosan nanoparticles (CNPs) prepared via the ionic gelation of chitosan with sodium tripolyphosphate (TPP) anions at a critical ratio of 2.4:1. The preparation was successfully scaled up to a final volume of 48,450 mL using two distinct mixing dynamics: manual dropwise addition and a 15-minute roller mixing method. Physicochemical characterization showed that the upscaled CNPs synthesized via the manual dropwise method preserved the original properties of the non-upscaled control, exhibiting no significant differences in mean effective diameter (62.60 ± 1.99 nm vs. 64.42 ± 0.82 nm, respectively). Conversely, the roller mixer method introduced a significant variation in particle size (57.89 ± 0.36 nm), though it successfully remained well within the stable nanoscale range. Both upscaling approaches maintained low polydispersity index (PDI) values (~0.20), indicating excellent homogeneity, a narrow size distribution, and robust formulation stability. Overall, while the manual dropwise addition method is ideal for strictly preserving original physicochemical traits, both upscaling strategies offer viable, stable, and reproducible delivery platforms for large-volume agricultural applications.
