Abstract
Three-dimensional (3D)-printed tablets prepared using powder-based printing techniques like selective laser sintering (SLS) typically disintegrate/dissolve and release the drug within a few minutes because of their inherent porous nature and loose structure. The goal of this study was to demonstrate the suitability of SLS 3DP technology for fabricating sustained-release dosages utilizing Kollidon® SR (KSR), a matrix-forming excipient composed of polyvinyl acetate and polyvinylpyrrolidone (8:2). A physical mixture (PM), comprising 10:85:5 (% w/w) of acetaminophen (ACH), KSR, and Candurin®, was sintered using a benchtop SLS 3D printer equipped with a 2.3-W 455-nm blue visible laser. After optimization of the process parameters and formulation composition, robust 3D-printed tablets were obtained as per the computer-aided design (CAD) model. Advanced solid-state characterizations by powder X-ray diffraction (PXRD) and wide-angle X-ray scattering (WAXS) confirmed that ACH remained in its native crystalline state after sintering. In addition, X-ray micro-computed tomography (micro-CT) studies revealed that the tablets contain a total porosity of 57.7% with an average pore diameter of 24.8 μm. Moreover, SEM images exhibited a morphological representation of the ACH sintered tablets’ exterior surface. Furthermore, the KSR matrix 3D-printed tablets showed a sustained-release profile, releasing roughly 90% of the ACH over 12 h as opposed to a burst release from the free drug and PM. Overall, our work shows for the first time that KSR can be used as a suitable polymer matrix to create sustained-release dosage forms utilizing the digitally controllable SLS 3DP technology, showcasing an alternative technique and pharmaceutical excipient.
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Acknowledgements
The authors would also like to thank Dr. Jessica A. Maisano and Mark Costello for their assistance with X-ray Micro-CT analysis, as well as the University of Texas High-Resolution X-ray CT Facility, which is supported by the NSF EAR-2223808.
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Bhupendra Raj Giri: conceptualization, methodology, formal analysis, investigation, data curation, writing–original draft, writing (review and editing); Mohammed Maniruzzaman: conceptualization, resources, supervision, project administration, funding acquisition.
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The authors declare the following conflict of interest. All authors are co-inventors of related intellectual property (IP). M.M., an author of this manuscript, holds stock in, serves on a scientific advisory board for, or is a consultant for CoM3D Ltd., (Surrey, UK) and Septum Solutions LLC. (Texas, USA). The terms of this arrangement have been reviewed and approved by the University of Texas at Austin in accordance with its policy on objectivity in research.
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Giri, B.R., Maniruzzaman, M. Fabrication of Sustained-Release Dosages Using Powder-Based Three-Dimensional (3D) Printing Technology. AAPS PharmSciTech 24, 4 (2023). https://doi.org/10.1208/s12249-022-02461-z
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DOI: https://doi.org/10.1208/s12249-022-02461-z