Purpose <p>This study aimed to evaluate the feasibility of fabricating cetirizine-loaded orodispersible films (ODFs) using fused deposition modeling (FDM) 3D printing, and further comparing their physicochemical and performance attributes against film produced by the conventional solvent casting (SC) method. The impact of different hydrophilic polymers on printability, mechanical integrity, and drug release was also investigated.</p> Methods <p>Three drug-loaded filaments were prepared via hot-melt extrusion using polyvinyl alcohol (PVA), hydroxypropyl methylcellulose (HPMC), and their 1:1 blend. The filaments were subsequently printed into rectangular ODFs (2 × 3&#xa0;cm, 0.25&#xa0;mm thick) with 15% infill density. SC films with matching composition were produced for comparison. Fabricated films were assessed for morphology, mechanical properties, thermal behavior, drug content, disintegration, and <i>in vitro</i> release kinetics.</p> Results <p>FDM-printed films demonstrated superior dissolution profiles compared to SC films; for instance, the F2 printed films released 91% of the drug within 5&#xa0;min, whereas S2 cast films released only 66% (<i>p</i> &lt; 0.0001). Among the printed formulations, the HPMC E6 polymer demonstrated an outstanding release profile, confirming it as a suitable polymer for ODFs. Furthermore, FDM films maintained a more uniform thickness and ensured the drug remained in a fully amorphous state. Disintegration times of all formulations complied with pharmacopeial limits, although further optimization of design parameters may result in improved performance.</p> Conclusion <p>FDM 3D printing enabled production of cetirizine ODFs at a much faster time with higher reproducibility and enhanced dissolution performance. These findings underscore the potential of FDM for flexible, patient-centric drug delivery. Future work will focus on optimizing printing parameters to further accelerate disintegration and release profiles.</p> Graphical Abstract <p></p>

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Fabrication of Cetirizine Orodispersible Films using Hydrophilic Polymer Blends: A Comparative Study of Fused Deposition Modeling vs. Solvent Casting Method

  • Behnam Imani,
  • Hooman Hatami,
  • Farideh Rezaei,
  • Marzieh Mohammadi,
  • Hadi Afrasiabi Garekani,
  • Abbas Akhgari

摘要

Purpose

This study aimed to evaluate the feasibility of fabricating cetirizine-loaded orodispersible films (ODFs) using fused deposition modeling (FDM) 3D printing, and further comparing their physicochemical and performance attributes against film produced by the conventional solvent casting (SC) method. The impact of different hydrophilic polymers on printability, mechanical integrity, and drug release was also investigated.

Methods

Three drug-loaded filaments were prepared via hot-melt extrusion using polyvinyl alcohol (PVA), hydroxypropyl methylcellulose (HPMC), and their 1:1 blend. The filaments were subsequently printed into rectangular ODFs (2 × 3 cm, 0.25 mm thick) with 15% infill density. SC films with matching composition were produced for comparison. Fabricated films were assessed for morphology, mechanical properties, thermal behavior, drug content, disintegration, and in vitro release kinetics.

Results

FDM-printed films demonstrated superior dissolution profiles compared to SC films; for instance, the F2 printed films released 91% of the drug within 5 min, whereas S2 cast films released only 66% (p < 0.0001). Among the printed formulations, the HPMC E6 polymer demonstrated an outstanding release profile, confirming it as a suitable polymer for ODFs. Furthermore, FDM films maintained a more uniform thickness and ensured the drug remained in a fully amorphous state. Disintegration times of all formulations complied with pharmacopeial limits, although further optimization of design parameters may result in improved performance.

Conclusion

FDM 3D printing enabled production of cetirizine ODFs at a much faster time with higher reproducibility and enhanced dissolution performance. These findings underscore the potential of FDM for flexible, patient-centric drug delivery. Future work will focus on optimizing printing parameters to further accelerate disintegration and release profiles.

Graphical Abstract