Fabrication of Sustained-Release Dosages Using Powder-Based Three-Dimensional (3D) Printing Technology

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.

Keywords: 3D printing (3DP); Kollidon® SR; Selective laser sintering (SLS); acetaminophen; sustained release; x-ray micro-computed tomography (micro-CT).