Due to the possibility of designing various spatial structures, three-dimensional printing can be implemented in the production of customized medicines. Nevertheless, the use of these methods for the production of dosage forms requires further optimization, understanding, and development of printouts' quality verification mechanisms. Therefore, the goal of our work was the preparation and advanced characterization of 3D printed orodispersible tablets (ODTs) containing fluconazole, printed by the fused deposition modeling (FDM) method. We prepared and analyzed 7 printable filaments containing from 10% to 70% fluconazole, used as model API. Obtaining a FDM-printable filament with such a high API content makes our work unique. In addition, we confirmed the 12-month stability of the formulation, which, to our knowledge, is the first study of this type. Next, we printed 10 series of porous tablets containing 50 mg of API from both fresh and stored filaments containing 20 %, 40 %, or 70 % fluconazole. We confirmed the high quality and precision of the printouts using scanning electron microscopy. The detailed analysis of the tablets' disintegration process included the Pharmacopeial test, but also the surface dissolution imaging analysis (SDI) and the test simulating oral conditions performed in own-constructed apparatus. For each composition, we obtained tablets disintegrating in less than 3 min, i.e., meeting the criteria for ODTs required by the European Pharmacopeia. The filaments' storage at ambient conditions did not affect the quality of the tablets. All printed tablets released over 95% of the fluconazole within 30 min. Moreover, the printouts were stable for two weeks.

Biodegradable biliary stents are promising treatments for biliary benign stenoses. One of the materials considered for their production is polydioxanone (PPDX), which could exhibit a suitable degradation time for use in biodegradable stents. Proper material degradation characteristics, such as sufficient stiffness and disintegration resistance maintained for a clinically relevant period, are necessary to ensure stent safety and efficacy. The hydrolytic degradation of commercially available polydioxanone biliary stents (ELLA-CS, Hradec Králové, Czech Republic) in phosphate-buffered saline (PBS) was studied. During 9 weeks of degradation, structural, physical, and surface changes were monitored using Raman spectroscopy, differential scanning calorimetry, scanning electron microscopy, and tensile and torsion tests. It was found that the changes in mechanical properties are related to the increase in the ratio of amorphous to crystalline phase, the so-called amorphicity. Monitoring the amorphicity using Raman spectroscopy has proven to be an appropriate method to assess polydioxanone biliary stent degradation. At the 1732 cm⁻¹ Raman peak, the normalized shoulder area is less than 9 cm⁻¹ which indicates stent disintegration. The stent disintegration started after 9 weeks of degradation in PBS, which agrees with previous in vitro studies on polydioxanone materials as well as with in vivo studies on polydioxanone biliary stents.

Polydioxanone (PPDX), as an FDA approved polymer in tissue engineering, is an important component of some promising medical devices, e.g., biodegradable stents. The hydrolytic degradation of polydioxanone stents plays a key role in the safety and efficacy of treatment. A new fast and convenient method to quantitatively evaluate the hydrolytic degradation of PPDX stent material was developed. PPDX esophageal stents were degraded in phosphate-buffered saline for 24 weeks. For the first time, the changes in Raman spectra during PPDX biodegradation have been investigated here. The level of PPDX hydrolytic degradation was determined from the Raman spectra by calculating the area under the 1732 cm⁻¹ peak shoulder. Raman spectroscopy, unlike Fourier transform infrared (FT-IR) spectroscopy, is also sensitive enough to monitor the decrease in the dye content in the stents during the degradation. Observation by a scanning electron microscope showed gradually growing cracks, eventually leading to the stent disintegration. The material crystallinity was increasing during the first 16 weeks, suggesting preferential degradation of the amorphous phase. Our results show a new easy and reliable way to evaluate the progression of PPDX hydrolytic degradation. The proposed approach can be useful for further studies on the behavior of PPDX materials, and for clinical practice.