Fabricating Oral Disintegrating Tablets Without Disintegrant Using Powder-Based 3D Printing
Jiu Wang,
Shunfang Liu,
Minmei Lin,
Peihong Chen,
Huagui Yi,
Zhufen Lv,
Yuanfen Liu
Affiliations
Jiu Wang
Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China
Shunfang Liu
Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China
Minmei Lin
Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China
Peihong Chen
Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China
Huagui Yi
Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China
Zhufen Lv
Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China
Yuanfen Liu
Guangdong Provincial Key Laboratory for Research and Evaluation of Pharmaceutical Preparations, Center for New Drug Research and Development, Guangdong Pharmaceutical University, Guangzhou 510006, China
Background: Powder-based 3D printing, an advanced additive manufacturing technique, can produce oral disintegrating tablets (ODTs) without disintegrants, creating larger-pored tablets via layer-by-layer powder stacking for better water absorption than traditional tablets. Methods: This study focused on using powder-based 3D printing to fabricate clozapine-based ODTs. Through central composite design (CCD), the formulation of ODTs was optimized for rapid disintegration. Analytical techniques such as X-ray Powder Diffraction (XRD), Fourier Transform Infrared Spectroscopy (FTIR), and Differential Scanning Calorimetry (DSC) were employed to investigate the compatibility between clozapine and excipients. Results: The optimized 3D-printed ODTs exhibited a remarkably short disintegration time of (9.9 ± 0.7) s compared to (40) s for compressed tablets. The contact angle of the 3D-printed ODTs was measured as 60.48 ± 0.36°, indicating favorable wettability for disintegration. Scanning Electron Microscopy (SEM) analysis revealed a porous structure in 3D-printed tablets, with a porosity of 48.97% (over two times higher than that of compressed tablets as determined by mercury injection meter). Conclusions: Collectively, this finding demonstrates the feasibility of fabricating highly hydrophilic and non-distensible ODTs without disintegrants using powder-based 3D printing.