Formulation and Evaluation of Dendrimer-Loaded Naproxen Sodium Tablets for Enhanced Controlled Release

Naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID), is widely used for treating pain and inflammation but is associated with gastrointestinal (GI) side effects such as ulcers and bleeding, especially with prolonged use. This study aimed to develop dendrimer-loaded naproxen sodium tablets to enhance solubility and provide controlled release, thereby reducing GI irritation. Poly(amidoamine) (PAMAM) dendrimers were used as carriers to encapsulate naproxen sodium via the solvent evaporation technique. The dendrimer-drug complex was formulated into tablets using both direct compression and wet granulation methods. The formulations were evaluated for pre- and post-compression properties, including bulk density, hardness, friability, and in vitro dissolution profiles. Results indicated that the dendrimer-loaded formulations achieved sustained release over 12 hours, with the F2 and F3 formulations showing significant improvements in drug release profiles compared to conventional naproxen sodium tablets. These findings suggest that dendrimer-based delivery systems can reduce peak plasma concentrations, improve therapeutic efficacy, and potentially minimize GI side effects. Further clinical studies are needed to validate these in vitro results and confirm the safety and effectiveness of this novel drug delivery system.