DEVELOPMENT AND EVALUATION OF ACECLOFENAC-LOADED NANOSPONGE HYDROGEL FOR ENHANCED TOPICAL ANTI-INFLAMMATORY DELIVERY

Objective: Aceclofenac (ACE) is a derivative of phenylacetic acid and a non-steroidal anti-inflammatory drug (NSAID) known for its anti-inflammatory, analgesic, and antipyretic properties. This study aims to enhance ACE's solubility and therapeutic efficacy by developing NanoSponges (NS) loaded into a hydrogel for topical drug delivery, addressing the limitations of current ACE formulations, such as rapid metabolism and short half-life. Methods: NS were synthesized using the emulsion solvent diffusion technique with varying concentrations of Ethyl Cellulose (EC) and Poly Vinyl Alcohol (PVA). Ten NS formulations were evaluated for particle size (PS), Particle Dispersion Index (PDI), Production Yield percentage (PY%), and Entrapment Efficiency percentage (EE%). Fourier Transform Infrared Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC) analyses confirmed the compatibility between ACE and the excipients. The surface morphology of the NS was examined using Field Emission Scanning Electron Microscopy (FESEM). The optimal Formulation (F2) was integrated into seven hydrogel formulations based on Hydroxy Propyl Methyl Cellulose (HPMC). Results: The F2 had a PY% of 77.92±2.2%, an EE% of 90.05±1.1%, a PS of 127.3±3.2 nm, and a PDI of 0.1±0.02. The optimal hydrogel formulation (G1) showed a pH of 6.2±0.15, a Drug Content (DC%) of 95.19±0.23%, a spreadability of 9.5±0.2 cm, and a permeation rate of 55.94±1.4% over 8 h. Additionally, G1 demonstrated in vivo anti-inflammatory activity of 65.38±1.1% over 24 h and a cumulative drug release of 84.5±3.8% over the same period. Conclusion: The NS-loaded hydrogel presents a promising strategy for enhancing ACE's therapeutic potential by providing extended drug release and improved stability, effectively addressing the limitations of existing formulations.