Formulation development, in vitro and in vivo assessment of Diclofenac diethylamine nanosponge loaded topical formulation

Abstract

The present work was performed with the objective of novel topical formulation development of poorly water-soluble drug Diclofenac diethylamine by loading the drug-containing nanosponge into the topical formulation. The nanosponges are polymeric nanoparticles that entrap the drug. The drug-loaded nanosponge has different absorption characteristics in comparison to the pure drug in the topical drug delivery system. Methods: The drug was first loaded in the ethylcellulose nanosponge using the emulsion solvent diffusion method. Then Diclofenac diethylamine nanosponge-loaded topical gel formulations were developed by using Carbopol 940 as a gel-forming polymer. Result: The Diclofenac diethylamine-loaded nanosponges were evaluated for various evaluation parameters such as particle size distribution, surface morphology, drug entrapment efficiency, polydispersity index, etc. The topical gel formulations were evaluated for pH, in vitro drug release, viscosity, in vivo performance and compared with the marketed formulation. The average size of prepared nanosponge formulations was found in the range of 102.8 nm to 475.5 nm. Scanning electron microscopy photographs of developed formulations reveal the spongy and porous nature of particles along with spherical shape. The polydispersity index (PI) was found in the range of 0.756 to 0.954.