Formulation Development and Optimization of Fenoprofen Floating Tablet Using QbD Approach

Aim: The study’s goal was to develop and characterize a new type of Fenoprofen tablet that can float. Materials and Methods: Research on the drug’s performulation was carried out to evaluate its organoleptic qualities, solubility, melting point, and partition coefficient. Bulk and pharmaceutical formulations of the medication were evaluated using UV spectroscopy to identify Fenoprofen in accordance with ICH Guidelines. Fenoprofen floating tablets were made utilizing the direct compression method with different concentrations of HPMC K100 M, Xanthan gum, and guar gum. Furthermore, a QbD method was used to manufacture the Fenoprofen tablets. To find the optimal formulation of the solid dispersed drug material in Fenoprofen tablets, a 23-full factorial Design of Experiment (DoE) was carried out using Design-Expert 22.0.2.0 software. Results: The produced tablets were subjected to a micromeritics research, which included both a pre- and post-compression phase. Using a USP Dissolution test device type II (Paddle), an in vitro dissolution research was conducted. There were three months of stability testing done at high temperatures. The research confirmed that Fenoprofen had a distinct odor and a white color look. Its melting point (MP) was 171°C, and it was soluble in DMSO without any difficulty. We measured 0.31gm/cm3 for the optimized formulation’s bulk density, 0.46gm/cm3 for the tapped density, 14.78 for the Carr index, 1.42 for the hausner ratio, and 30.17 degrees for the angle of repose. The optimized batch (F4) including polymers and excipients floated for a long duration and had a short lag time for buoyancy. There was a 99.12 percent drug release rate after 12 hours in in vitro dissolution tests. Conclusion: The stability showing that formulation was stable for months of storage and minimal change was found in color, shape, appearance, drug content, in vitro dissolution studies and floating lag time value.