A new process for obtaining meglumine antimoniate aiming at the production of generic drug

Abstract

The meglumine antimoniate (Glucantime®) is the drug of choice used for the treatment of leishmaniasis. Despite used for over half a century, its composition and its toxic inorganic contaminants are not yet fully elucidated. These problems affect directly the quality of formulated generic drugs, resulting in serious side effects. In this article, we report a new improved process for obtaining the active pharmaceutical ingredient (IFA) of meglumine antimoniate, aiming at the production of generic drugs. Getting meglumine antimoniate bench scale, its optimization and subsequent process of "scale-up" was performed using the methodology "one-pot" where no organic solvents derived from petroleum were used. Meglumine antimoniate was obtained in good yield and exhibited low levels of toxic contaminants. In a further study, evaluation of the reaction calorimeter and analysis of heavy metals were made in order to achieve security, reliability and economy of the process. Another group who has reported its effectiveness compared to the reference drug Glucantime ® assessed antileishmanial activity of this API. Parallel to the development of the synthetic process, a method has been proposed for the treatment and recycling of wastewater to improve the performance process and reduce the cost of waste treatment.