Advancing Personalized Medicine Through FDM 3D Printing: Ketoprofen Tablets with Customizable Drug Release Profiles...

Background/Objectives: Fused deposition modeling (FDM) three-dimensional (3D) printing represents an emerging manufacturing platform for personalized oral dosage forms. Its success relies on developing robust drug-loaded filaments with consistent mechanical, thermal, and dissolution properties. This work aims to (i) develop and characterize ketoprofen-loaded filaments using hot-melt extrusion (HME) and (ii) utilize them to fabricate both immediate-release (IR) and sustained-release (SR) tablets via FDM 3D printing. Methods: Filaments were prepared using Kollicoat^® IR and hydroxypropyl methylcellulose (HPMC, 2600-5600 cP) as functional polymers. Sorbitol and sodium lauryl sulfate (SLS) were incorporated as plasticizer and surfactant, respectively. Filaments were evaluated for quality attributes, drug content, tensile strength, and physicochemical and surface characteristics using Scanning Electron Microscopy (SEM), Attenuated Total Reflection Fourier-transform infrared (ATR-FTIR), X-ray Diffraction (XRD), Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA). Optimized filaments were fed into an FDM 3D printer to fabricate ketoprofen tablets with varied geometries, shell numbers, and infill densities. Tablets were subjected to USP tests (weight variation, friability, hardness, disintegration, assay, content uniformity), dissolution profiling, and release kinetics modeling. Comparative dissolution studies with market Profenid^® and Bi-Profenid^® tablets were conducted. GastroPlus^® simulations were used for in vitro-in silico correlation. Results: Among the tested formulations, Kollicoat^® IR-based filaments with sorbitol and SLS (F6) demonstrated superior printability, characterized by consistent feeding, stable extrusion, and reliable formation of uniform structures for immediate-release applications. In contrast, HPMC-based filaments with sorbitol (F13) offered the most robust performance for SR formulations. Both exhibited uniform diameter, drug loading, and mechanical strength. IR tablets achieved >80% release within 30 min, while SR tablets prolonged release up to 12 h, following Higuchi and Korsmeyer-Peppas kinetics. All quality attributes complied with USP limits. Market products showed comparable dissolution, validating the approach. GastroPlus^® simulations predicted pharmacokinetic profiles consistent with reported data, supporting IVIVC. Conclusions: This integrated workflow establishes a robust strategy for producing IR and SR ketoprofen tablets from a single FDM platform. The results highlight the feasibility of point-of-care, personalized medicine using 3D printing technologies.