Preparation and Physical Characterization of a Diclofenac-Ranitidine

CALVO, NATALIA L; MAGGIO, R. M.; KAUFMAN, T. S.; BRUSAU, ELENA; NARDA, GRISELDA; GAITANO, ROBERTINO

JOURNAL OF PHARMACEUTICAL SCIENCES

JOHN WILEY & SONS INC

Lugar: New York; Año: 2016 vol. 105 p. 1258 - 1268

0022-3549

Mixingaqueous solutions of sodium diclofenac (DIC-Na) and ranitidine hydrochloride(RAN$HCl) afforded an off-white solid (DIC-RAN)that was investigated from the microscopic, thermal, diffractometric, spectroscopic,and functional (chemometrics-assisted dissolution) points of view. The solidhas a 2:1 (DIC:RAN) molar ratio according to 1H nuclear magnetic resonance spectroscopy. It is thermallystable, displaying a broad endothermic signal centered at 105_C in the thermogram, and its characteristic reflections in the powder X-ray diffractogramremained unchanged after a 3-month aging period. Scanning electron microscopymicrographs uncovered its morphology, whereas the spectral data suggested an interactionbetween the carboxylic acid of DIC and the alkyldimethylamino moiety of RAN.The dissolution of DIC-RAN was monitored at different pH values by anultraviolet/chemometrics procedure, being complete within 5 min at pH 6.8. Thiscompares favorably with the dissolution of a DIC-Na sample of the same particle size.