3D printed tinidazole tablets coupled with melt-extrusion techniques for formulating child friendly medicines

Abstract

This study investigates the feasibility of fabrication of poly(1-vinyl-2-pyrrolidone) (Kollidon®25)-mediated filaments for producing tinidazole (TNZ)-loaded, customizable, child-friendly tablets (with varying shapes and sizes) using hot melt extrusion (HME) coupled with fused deposition modeling (FDM) technology. Kollidon®25, chosen for its ability to enhance the dissolution of TNZ (a BCS Class II drug), was evaluated for polymer-drug compatibility through Hansen solubility, polarity, and interaction parameter analyses, confirming good miscibility and affinity between TNZ and Kollidon®25. Placebo- and TNZ-loaded filaments were prepared in different ratios using HME, followed by the development of 3D-printed tablets via FDM. The fabricated batches of placebo and TNZ-loaded 3D tablets were characterized, and it was found that they had an average weight variation of 270.41 ± 7.44 mg and 270.87 ± 9.33 mg, hardness of 155.01 ± 11.79 N and 265.3 ± 7.62 N, and friability of 0.1583 ± 0.0011 % and 0.2254 ± 0.0013 %. Amorphization was confirmed by differential scanning calorimetry (DSC) and powder X-ray diffraction (PXRD) analysis. Scanning electron microscopy (SEM) revealed a layer-by-layer pattern with tiny fractures on the tablet surfaces, which enhanced media penetration, resulting in improved dissolution profiles. The TNZ release profile showed complete 100 % release within 2.0 h in a gastric acidic medium. These findings support the potential of Kollidon®25 to create customizable, child-friendly, 3D-printed dosage forms with different shapes and sizes for TNZ delivery, offering a unique approach to paediatric medications.