Previously, we have reported on a zwitterionic cocrystal of diclofenac acid and L-proline. However, the soly. of this multicomponent crystal was still lower than that of diclofenac sodium salt. Therefore, this study aimed to observe whether a multicomponent crystal could be produced from diclofenac sodium hydrate with the same coformer, L-proline, which was expected to improve the pharmaceutics performance. Methods involved screening, solid phase characterization, structure detn., stability, and in vitro pharmaceutical performance tests. First, a phase diagram screen was carried out to identify the molar ratio of the multicomponent crystal formation. Next, the single crystals were prepd. by slow evapn. under two conditions, which yielded two forms: one was a rod-shape and the second was a flat-square form. The characterization by IR spectroscopy, thermal anal., and diffractometry confirmed the formation of the new phases. Finally, structural detn. using single crystal X-ray diffraction anal. solved the new salt cocrystals as a stable diclofenac-sodium-proline-water (1:1:1:4) named NDPT (natrium diclofenac proline tetrahydrate), and unstable diclofenac-sodium-proline-water (1:1:1:1), named NDPM (natrium diclofenac proline monohydrate). The soly. and dissoln. rate of these multicomponent crystals were superior to those of diclofenac sodium alone. The exptl. results that this salt cocrystal is suitable for further development. [on SciFinder(R)]
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