FARMACIA, vol.70, no.5, pp.816-830, 2022 (SCI-Expanded)
Pharmaceutical preparations containing erdosteine, ibuprofen, and pseudoephedrine HCl are among the most prescribed drugs in the treatment of upper respiratory infections. Physicians are obliged to write separately or in combinations of dual since there is no single combined dosage form containing these three active substances at the same time. In this study, for the first time, erdosteine, ibuprofen, and pseudoephedrine HCl were combined, and a different dosage form was prepared apart from the dosage forms available in the pharmaceutical market. First of all, an analytical method that can analyse erdosteine, ibuprofen, and pseudoephedrine HCl at the same time was developed by high-performance liquid chromatography (HPLC) and validation of this method was performed. Afterward, pellet formulations were developed with these three active substances and characterized by using various techniques (encapsulation efficiency, drug loading capacity, yields, particle size and distributions, swelling degrees, in vitro release properties, release kinetics, morphologies, DSC thermograms, FT-IR spectra, XRD diffractograms, and stabilities). XRD study of erdosteine was performed for the first time in the literature. Pellets have been successfully developed without any change or incompatibility in the structure of the active substances.