Fabrication and Evaluation of Differential Release Bilayer Tablets of Clarithromycin and Levofloxacin by 3D Printing

Purpose Formulation of customized drug delivery systems is considered as an effective approach to fulfill the individualized needs of the patients. Methods In this study, differential release bilayer tablets containing clarithromycin (CAM) as sustained release (SR) and levofloxacin (LVX) as immediate release (IR) were fabricated by bridging the techniques of hot melt extrusion (HME) and fused deposition modeling (FDM). Both processes were optimized to minimize the drug degradation and to achieve the safe deposition of drugs in their respective layers. This design may offer better clinical efficacy, better patient compliance and may overcome side effects caused by the generalized dosing. Results In vitro drug release studies confirmed that almost 100% of LVX was released within 1 h, while CAM showed sustained drug release for up to 24 h. The thermal stability of drugs and polymers was evident from the differential scanning calorimetry (DSC) result. Powder X-ray diffraction (PXRD) and DSC results showed a decrease in the crystalline behavior of drugs after FDM. The Fourier rransform infrared spectroscopy (FT-IR) data showed no significant interactions between drugs and polymers after incorporation in the final formulation. Conclusion This work illustrated the potential applications of HME and FDM in formulation of customized drug delivery systems to fulfil the individualized needs of the patients.