Avaliação polimórfica de amostras comerciais de cloridrato de buspirona: caracterização, triagem e impacto em formulações farmacêuticas

Abstract

The polymorphism of active pharmaceutical ingredients is a solid-state property that can directly affect the quality and effectiveness of a medicine, especially when verificated in medicines with low solubility, since to be absorved it must first be soluble. In this sense, the present work aismed to the polymorphic evaluation of commercial samples of buspirone hydrochloride (an active pharmaceutical ingredient used for the production of anxiolytic medication), through characterization using the techniques of mid-infrared spectroscopy, differential scanning calorimetry and diffraction. powder Xrays, seeking to verify which polymorph is produced by two different suppliers. According to the literature, buspirone hydrochloride can present two different polymorphs, called Form 1 and Form 2 and after characterizing the materials it was found that supplier B sells Form 2 and supplier A sells a mixture of Form 1 with Form 2. Furthermore, a polymorphic screening carried out through stress with elevated temperatures and humidity showed that Form 1 is the most stable polymorph. Finally, it was concluded that the different polymorphic forms do not present significant differences in solubility and are presented as highly soluble by the Biopharmaceutical Classification System, causing no risks to patients and pharmaceutical industries in relation to this solid-state property.