Galenic development of a capsule containing rosuvastatin, repaglinide, and olmesartan mini-tablets for the treatment of metabolic syndrome

Abstract

This research project studies the possibility of improving adherence to treatment in patients with metabolic syndrome, by developing a capsule containing rosuvastatin, repaglinide and olmesartan mini-tablets. The formulations were characterized by scanning electron microscopy, differential scanning calorimetry, thermogravimetry, Fourier transform infrared spectroscopy and powder X-ray diffraction. At the same time, the SeDeM galenic methodology was used to establish the suitability of the mixture to produce tablets by the direct compression method. Concurrently, an analytical method for the identification of N-nitrosodimethylamine in olmesartan medoxomil was developed and validated using high-performance liquid chromatography-mass spectrometry. Finally, the pharmaceutical technological characteristics of the tablets were determined: content uniformity, tablet hardness, thickness, friability, in vitro disintegration time and dissolution profile. Keywords: Pharmacology; Therapeutic; Repositioning; Clinical research; Drug authorization; Drug evaluation