DESIGN AND EVALUATION OF FAST DISSOLVING TABLETS OF ROFLUMILAST SOLID DISPERSIONS

The main objective of the present investigation was to formulate and evaluate fast dissolving tablets of Roflumilast solid dispersions using a direct compression method. Roflumilast solid dispersions were prepared by solvent evaporation as well as melting method. Roflumilast is a selective, long-acting inhibitor of the enzyme PDE-4 and has anti-inflammatory effects. It is used orally in the treatment of chronic obstructive pulmonary disease (COPD). The roflumilast drug belongs to BCS class II drugs that have low solubility and high permeability. The current research work was focused on improving the aqueous solubility of Roflumilast using solid dispersion technique and enhancing the dissolution rate. Based on the results of solubility analysis, phosphate buffer pH 6.8 was chosen as the dissolution medium. The powder blend of Roflumilast solid dispersions was evaluated for flow characteristics. The fast dissolving tablets of Roflumilast solid dispersions were subjected to post-compression parameters such as weight variation, hardness, thickness, friability, drug content, wetting time, water absorption ratio, in-vitro dispersion time and in-vitro disintegration time and the results were found to be within the acceptable limits. Based on FT-IR spectra obtained, it was evident that there was no significant interaction of Roflumilast with carriers and other excipients. From the results of dissolution study, SD1 and SD18 formulations were considered as best formulations.