3D Printing of Baclofen Gastro-Floating Drug Delivery Systems: A Comparison Study with In vitro and In vivo Evaluation

Abstract

This study aims to formulate baclofen gastro-floating drug delivery dosage forms in two different approaches using hot melt extrusion and FDM 3D printing and then compare the effectiveness and select the best formula from the two approaches for further characterization. The first approach involved the preparation of baclofen-loaded filament by HME and then FDM 3D printing of floating tablets with low infill percentages. The second approach involved the formulation of sustained-release tablets by HME and 3D printing of a gastro-floating device (GFD) that holds the tablet inside it. Prepared tablets were tested for drug content, in vitro floating behavior, and in vitro dissolution test, and the optimized formula was tested for DSC, FT-IR, and in vivo radiographic study. Filaments prepared by HME with a diameter of less than 1.3 mm were not printed. Variations in filament diameter affect the printing quality of the 3D printed tablets resulting in tablets' weight variation and failure to float sometimes otherwise tablets were successfully printed and remained floating for 12 hr. Formulas prepared by both approaches with the same composition were found to have significant different dissolution profiles due to the rigid structure formed by 3D printing compared to a compressed tablet. Formulation of the HME tablet and 3D printing of GFD were more reliable and were able to float for more than 12 hr. Optimized formula containing Eudragit RS-100 and ethyl cellulose as release modifier polymers, released the drug and remained floating over 12 hr and this was confirmed by x-ray imaging of Albino rabbit. Formulation of sustained-release tablets by HME and inserting them into 3D printed GFD were found to be superior in terms of producing floating dosage forms compared to 3D printed tablets with low infill percentage.