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

This study explored the development of an amorphous solid dispersion (ASD) of ibuprofen (IBU) with hydroxypropyl methylcellulose acetate succinate (HPMC-AS) using single screw hot-melt extrusion (HME), for obtaining solid-oral dosage forms (SODFs) with the aid of fused deposition modelling (FDM) 3D printing and conventional tabletting by direct compression, providing a head-to-head platform comparison. Pre-formulation studies identified a suitable IBU to HPMC-AS ratio for obtaining stable ASDs and allowed for the selection of HME conditions. HME was used to produce ASD filaments which were subsequently processed into solid dosage forms through 3D printing by FDM or conventional tableting by direct compression. Filaments containing HPMC-AS, IBU and additives: plasticisers (triethyl citrate (TEC) and polyethylene glycol (PEG)), superdisintegrants (Kollidon® CL), pore formers (sorbitol), or combinations of them were successfully extruded at 120–140 °C. Physicochemical characterisation confirmed IBU content and amorphisation. 3DP SODFs initially showed a slow, controlled dissolution compared to conventionally manufactured tablets; however, modifying the 3DP design to minimize print overlap and print thickness to 0.25 mm while maximizing exposed surface area, as well as adjusting the formulation, significantly improved 3D printing performance and allowed for tuning of drug release. from 5% at 60 min to 85% at 60 min. Reduced print thickness (from 0.8 to 0.25 mm) and limited print infill overlap, by using a “parallel” infill pattern rather than the commonly used “grid” infill had a greater influence on drug release than composition, for the 3DP samples, while the conventionally manufactured tablets showcased a consistent, rapid drug release. Overall, single screw HME effectively produced stable IBU:HPMCAS filaments suitable for FDM 3DP, that allowed for a tuneable drug release, offering a versatile alternative to conventional tabletting.