3D Printing in the Formulation of Multilayered Fast Dissolving Oral Films

Fast dissolving oral films (FDFs) provide an alternative approach to increase consumer acceptance by advantage of rapid dissolution and administration without water. Usually FDFs requiretaste-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 andstrawberry 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 ingredientstability 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 SLFDFspresented 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 providesproof-of-concept for the manufacturing of FDFs by using 3D printing.

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