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Revista Cubana de Farmacia

Print version ISSN 0034-7515


RODRIGUEZ CHANFRAU, Jorge E et al. Magnesium bile salts obtained from spray drying. Rev Cubana Farm [online]. 2014, vol.48, n.1, pp.108-117. ISSN 0034-7515.

Introduction: since the 60's, the Cuban pharmaceutical industry has as one basic production line the obtaining of the bile acids and its saline derivatives from bovine bile. This process consists of bile saponification and further precipitation of the cholic acid that changed into magnesium salt through a reaction process with magnesium hydroxide. The final active substance is used as active pharmaceutical ingredient to produce tablets for treatment of gastrointestinal disorders and of malfunctioning of the gallbladder. Objective: to change the drying process currently in use by a spray drying variant. Methods: a technological drying process was set. Bench scale studies were conducted. The results were then compared to those of the traditional process. Chemical, physical and technological evaluations were carried out, for example electronic microscopy and infrared spectroscopy. Results: the results showed that the product obtained by spray drying was similar to that of the traditional process but with better physical and chemical characteristics. This helped in the further process of production of the finished form. Conclusions: based on the results, one may state that the technological process of spray drying for production of magnesium bile salts assures the quality of the final product and improves the work and environmental conditions.

Keywords : magnesium bile salts; spray drying; electronic spectroscopy method; electronic spectroscopy.

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