Formulation, development and in vitro characterization of modified release tablets of capecitabine

Objective: The main aim of this research work was to develop and evaluate cost effective modified release tablets of Capecitabine (CAP) without utilizing coating techniques. Methods: The tablets were prepared by non-aqueous wet granulation method. Hydroxypropyl cellulose (HPC) was used as an extended release matrix former and sodium alginate (SA) was used as sustained release agent due to its gel forming ability. 3(2) full factorial design was used to study the effect of the independent variables i.e. HPC and SA on dependent variables, in vitro drug release and swelling index. The physiochemical properties of the drug were analyzed by ultraviolet (UV), fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and powder X-ray diffraction (P-XRD). The formulated tablets were evaluated for hardness, thickness, weight variation, content uniformity, swelling index, and in vitro drug release study. Results: The FTIR and DSC studies confirmed that there was no any interaction between drug, polymers and excipients. Also from DSC and P-XRD studies it was clear that the crystalline nature of CAP was remain unchanged in the optimized formulation tablet. Formulation F8 retarded the drug release up to 24 h with the optimum concentration of the both the polymers. Conclusion: We have successfully developed the modified release tablets of CAP with the combination of diffusion and erosion controlled type of drug release mechanism.