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. RezumatPreparatele farmaceutice care conțin erdosteină, ibuprofen și clorhidrat de pseudoefedrină sunt printre cele mai prescrise medicamente în tratamentul infecțiilor căilor respiratorii superioare. Medicii sunt obligați să prescrie separat sau în combinații duale, deoarece nu există un singur preparat combinat care să conțină aceste trei substanțe active. În acest studiu, pentru prima dată, erdosteina, ibuprofenul și pseudoefedrina HCl au fost combinate și a fost preparată o formă farmaceutică diferită de cele disponibile pe piața farmaceutică. A fost dezvoltată și validată o metodă HPLC care poate analiza erdosteina, ibuprofenul și pseudoefedrina HCl simultan. Ulterior, au fost dezvoltate formulări de pelete cu aceste trei substanțe active și caracterizate prin diferite tehnici: eficiența încapsulării, capacitatea de încărcare a medicamentului, dimensiunea și distribuția particulelor, gradul de gonflare, proprietățile de cedare in vitro, cinetica de eliberare, termogramele DSC, FT-IR, difractogramele XRD și studii de stabilitate.
Nanosuspensions (NS) are one of the new generation drug carrier forms developed to overcome the deficiencies of drugs with poor water solubility or insolubility and are considered to be one of the most successful approaches to formulate compounds in recent years. Boron nitride (BN) is insoluble in water and chemically more stable than carbon, it offers better biological superiority although the application of carbon structures in the biomedical field has increased in recent years. Chitosan is a polymer with excellent processability and biocompatibility thanks to its high dielectric constant. In addition, chitosan has a high affinity for metal ions. This study aims to combine BN and chitosan, which have unique properties, using six different surfactants, and to investigate their long-term stability for the use of both in medicine. In this direction, 24 different BN NS formulations were prepared. The 6th and 12th months’ stability of these formulations were studied at +25 °C, 60% relative humidity, and +4 °C. Also, the prepared formulations were evaluated by cell viability test and examined in terms of toxicity. FTIR spectra of the formulations were taken and their morphologies were characterized by SEM. Prepared NSs with Poloxamer 407 + Tween (N1 − N6) were found to be the most stable formulations for 6 and 12 months both at +4 °C and +25 °C. The fact that BN has a negative zeta potential and chitosan has a high positive zeta potential in formulations is very important in terms of their potential antimicrobial activities. The low cellular toxicity of BN NSs, especially chitosan-coated BN NSs, at higher concentrations shows that they have enormous potential in the diagnosis and treatment of diseases with boron-based compounds in the future.
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