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

This study investigates the feasibility of fabrication of poly(1-vinyl-2-pyrrolidone) (Kollidon (R) 25)-mediated (R) 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 (R) 25, (R) 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 (R) 25. (R) 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 f 7.44 mg and 270.87 f 9.33 mg, hardness of 155.01 f 11.79 N and 265.3 f 7.62 N, and friability of 0.1583 f 0.0011 % and 0.2254 f 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 (R) 25 (R) 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.