Abstract
Spherical drug particles prepared by the spherical crystallization technique can simultaneously improve the mobility of particles, mechanical properties, drug solubility and bioavailability, etc. However, high-efficient mixing of a solution and the formation of uniform bridging liquid droplets were crucial for accurate control of spherical crystallization processes. Herein, a novel membrane-assisted spherical crystallization (MASC) technology was proposed to produce monodisperse spherical agglomerates of ceftriaxone sodium. The poor solvent permeation rate of MASC was stabilized by adjusting the liquid flow velocity in the shell side and tube side. Uniform bridging liquid droplets constructed by a polytetrafluoroethylene hollow fiber membrane were observed in real time. A stable flow field and crystallization microenvironment were provided on the hollow fiber membrane surface. The crystal size distribution and the coefficient of variation of ceftriaxone sodium products were improved compared with those of conventional spherical crystallization (CSC) under the same stirring rate. The impurities of CSC products did not meet the requirements due to the degradation after 14 days’ acceleration experiment, while the one of MASC products still met the pharmacopoeia requirements after 30 days. This study provides a potential membrane-based technology for the enhancement of spherical crystallization of related drugs.
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