Exploring stabilizing agents to prevent crystal growth or aggregation in PTX-NCs generated via diverse nanocrystallization technologies.

This study aimed to prepare paclitaxel nanocrystals (PTX-NCs) for developing a delivery platform for this poorly water-soluble drug. Using biocompatible polymers as stabilizers, paclitaxel (PTX) was formulated as a nanosuspension using two techniques: (I) ultrasonication followed by freeze-drying and (II) melt-based precipitation (MBP) approach. The effectiveness of stabilizers in inhibiting crystal growth and agglomeration of PTX-NCs was discussed. Nanosuspensions developed using the MBP method by employing polyethylene glycol (PEG) derivatives offered superior results compared to the ultrasonication method. Among the various stabilizers, Pluronic F-68 and myrj 52 were more efficient against particle size enlargement. The optimized formulation containing PTX/PEG/Pluronic F-68/myrj 52 produced re-dispersible particles of about 74 nm with a smooth spherical morphology, which were stable for ∼8 h in water, indicating good physical stability following reconstitution. The particles obtained after redispersion of MBP-PTX-NCs enhanced the dissolution of PTX compared to plain crystals and had superior chemical stability. A 6-month stability test showed no significant changes in drug content or X-ray powder diffraction (XRPD) pattern. These findings highlighted the potential of forming fine particles from MBP method using biocompatible polymers as a promising method for producing drug nanocrystals (NCs) for poorly soluble drugs without expensive, time-consuming freeze-drying steps.