Development of 3D Printed Gastroretentive Floating Tablet Devices for Metronidazole

Abstract

Background: In this study, 3D printed floating tablet devices for Metronidazole (MTZ) were developed to prolong its exposure with Helicobacter pylori and eradicate it from causing peptic ulcer.

Objectives: To utilize Quality by Design (QbD) in the development of the tablet devices through Fused Deposition Modelling (FDM) 3D printing. This aimed to develop and construct optimized design dimensions of tablet devices subject for characterization.

Methodology: Tablet designs were established using QbD, Design Failure Mode Effect and Analysis (DFMEA) and 2² factorial design. Four floating tablets devices were developed through FDM 3D printing using Polyvinyl alcohol (PVA) filament. Characterization tests determined their dimensions, density, floating mechanism, in vitro dissolution rate, drug release kinetics, surface morphology, infill and thermal characteristics. Significance of the QbD model was also assessed.

Results: Density of all devices were less than 1.004 g/cm³ . The floating Lag time (FLT) showed instant floatation and Total Floating Time (TFT) lasted for an average of 1 hour. Drug release kinetics show Korsmeyer-Peppas kinetics. Thermal characteristics fall within 186.12⁰ C-187.27⁰ C. 3D CTX-ray results show accuracy of printing 3D renders. Tablet device 3 exhibited the best surface morphology, longest floating time and slowest drug release.

Conclusion: The study successfully developed 3D printed floating tablet devices for Metronidazole with sustained release mechanism. Thus, utilizing QbD in pre-formulation studies using novel technology is essential in optimizing drug dosage forms. Plots from Design Expert Software show the significant design models.