Fast dissolving oral films (FDFs) provide an alternative approach to increase consumer acceptance by advantage of rapid dissolution and administration without water. Usually FDFs require
taste-masking agents. However, inclusion of these excipients could make developing the formulation a challenging task. Hence, this work employed fused-deposition modelling three-dimensional (FDM 3D)
printing to produce single-layered (SLFDFs), or multilayered (MLFDFs) films, with taste-masking layers being separated from drug layer. Filaments were prepared containing polyethylene oxide (PEO)
with ibuprofen or paracetamol as model drugs at 60°C. Also filaments were produced containing polyvinyl alcohol (PVA) and paracetamol at 130°C. Furthermore, a filament was prepared containing PEO and
strawberry powder for taste-masking layer. FDFs were printed at temperatures of 165°C (PEO) or 190ºC (PVA) with plain or mesh designs. HPLC and mass-spectroscopy analysis indicated active ingredient
stability during film preparation process. SLFDFs had thicknesses as small as 197±21μm, and MLFDFs had thicknesses starting from 298±15μm. Depending on the formulation and design, mesh SLFDFs
presented disintegration time as short as 42±7s, and this was 48±5s for mesh MLFDFs. SLFDFs showed drug content uniformity in the range of 106.0%-112.4%. In conclusion, this study provides
proof-of-concept for the manufacturing of FDFs by using 3D printing.
