Fabrication And Characterization of 3D Printed Fast Dissolving Oral Films of Ivabradine Hydrochloride

Author(s): Preetesh P. Sawant, Rajashree Gude*, Akshata J. Naik, Saba Jamadar

Abstract: Three-dimensional (3D) printing technology is gaining significance due to its wide applications, rapid prototyping and customization. Fast-Dissolving Oral Films (FDOFs) provide an alternative approach to increase consumer acceptance by advantage of rapid disintegration and dissolution and administration without water. Combination of fused deposition modelling with preparation of the FDOFs seems to be extra advantageous in terms of pharmaceutical parameters. Ivabradine Hydrochloride was selected for formulating FDOF which is an Anti-Anginal drug. The aim of the present study is to fabricate filament extruder and 3D printed fast dissolving oral films by FDM technique and to check the influence of disintegrant on disintegration time and drug release kinetics. For FDM 3D printing technique the polymers were converted into filaments by using extrusion process. The drug loaded filaments were prepared by using hydrophilic polymers viz. PVA and HPC SL along with Sodium Starch Glycollate as Super-disintegrants and Polyethylene Glycol 400 as plasticizer and the drug. The drug loaded filaments were introduced into 3D printer and FDOF were printed at 185°C (HPC SL) and 195°C (PVA). Preformulation studies and compatibility studies (DSC, FT-IR) were done. The films were evaluated for physicochemical parameters and mechanical strength. All the formulations exhibited more than 90% of drug release within 15 minutes. The optimized formulation, P3 was selected as it showed lowest disintegration time of 42.33 ± 1.15 sec and faster dissolution rate of 99.22% with a release time of 8 minutes. The morphology of the films was studied by SEM analysis.

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