Design and In Vitro Characterization of Orally Disintegrating Modified Release Tablets of Naproxen Sodium

Objectives: The aim of this study was to prepare orally disintegrating, slow release tablets of naproxen sodium for prompt onset and sustained action required in many types of acute pain. Materials and Methods: Tablet formulations containing varying concentrations of croscarmellose sodium (a superdisintegrant) and Soluplus (R) (as release modifier) were prepared by wet granulation method using a single punch tablet machine. The prepared granules were evaluated for their bulk properties and the tablets were evaluated for hardness, disintegration time, and drug release profiles. Results: The results showed that the granules so prepared have good flow and compressional properties. A disintegration time of tablets <30 s was achieved by selecting an optimum concentration of croscarmellose sodium. The drug release from the tablets was sustained for 2 h by incorporating a suitable amount of Soluplus (R). Conclusion: This study examined the use of Soluplus (R) (a novel solubilizer) for the first time as a release modifier of API from tablets.