Evaluating FDM 3D printing and conventional tableting for producing ibuprofen amorphous solid dispersions.

Established methods for amorphous solid dispersion production include hot-melt extrusion and direct compression. These techniques are widely used to improve drug solubility and dissolution rates. However, the potential of fused deposition modeling (FDM) 3D printing in this context remains underexplored. Prior research has shown that amorphous dispersions can enhance drug bioavailability. Yet, the comparative performance of 3D printing versus conventional methods for ASDs is unclear. This gap motivated a direct comparison of FDM 3D printing and direct compression for ASD manufacturing. No prior work had resolved how 3D printing parameters influence drug release from ASDs. The need to evaluate tunable drug release through design and formulation adjustments is critical. This paper addresses these uncertainties through a head-to-head study.

The aim of this work was to compare FDM 3D printing with conventional tabletting for ASD production. Specifically, the study focused on ibuprofen and HPMC-AS dispersions. The goal was to assess the feasibility of using HME to create ASD filaments suitable for 3D printing. The study also sought to evaluate how print design and formulation affect drug release. A head-to-head comparison was necessary to determine the relative advantages of each method. The researchers aimed to identify optimal printing parameters for controlled drug release. They also wanted to confirm the stability of ASDs produced via HME. The study's design allowed for a direct evaluation of both methods under identical conditions.

The study used single screw hot-melt extrusion to produce ASD filaments containing ibuprofen and HPMC-AS. Filaments were extruded at 120-140°C with additives like TEC, PEG, Kollidon CL, and sorbitol. These filaments were then processed into solid dosage forms using FDM 3D printing or direct compression. Pre-formulation studies guided the selection of IBU to HPMC-AS ratios and HME parameters. Physicochemical analysis confirmed the amorphous state and drug content of the ASDs. Two printing methods were compared: FDM with varying infill patterns and tabletting via direct compression. Drug release was measured in dissolution tests to assess performance differences. The study also evaluated how print thickness and infill design affected release rates.

Physicochemical analysis confirmed successful amorphisation of ibuprofen in HPMC-AS dispersions. Initial 3D printed tablets showed slower drug release compared to conventional tablets. However, modifying print design improved performance, achieving up to 85% drug release within 60 minutes. Reducing print thickness from 0.8 to 0.25 mm increased surface area and accelerated drug release. Using a parallel infill pattern instead of a grid pattern reduced print overlap and improved dissolution rates. The effect of print design was more significant than formulation changes in 3D printed samples. Conventional tablets showed consistent and rapid drug release across all tests. The study demonstrated that FDM 3D printing can produce ASDs with tunable release profiles.

The findings suggest that FDM 3D printing can produce stable ibuprofen ASDs with tunable drug release. Single screw HME effectively produced filaments suitable for 3D printing. Print design adjustments, such as reduced thickness and parallel infill patterns, significantly improved dissolution rates. The study supports the use of FDM as a viable alternative to conventional tabletting for ASDs. The results indicate that 3D printing allows for greater control over drug release profiles. The researchers propose that optimizing print parameters can enhance ASD performance. These findings may inform future work on personalized drug delivery systems. The study highlights the potential of 3D printing in pharmaceutical manufacturing.