Formula Development of Diclofenac Sodium Extended Release Tablets Prepared from Eudragit® NE 40 D

Abstract

The objective of this research was to study the concentration of Eudragit® NE 40 D as matrix former on dissolution of diclofenac sodium extended release tablets. Tablets were prepared by wet granulation method using concentrations of Eudragit® NE 40 D at 15% and 16% as dry content. Dibasic calcium phosphate dihydrate was used as filler. The dissolution of tablets prepared with Eudragit® NE 40 D 15% was complied with USP 36. The mechanism of drug release through the matrix was found to be diffusion control. The dissolution profiles of the developed formulation and the commercial tablet formulation were compared by using the similarity factor (ƒ₂ ) and difference factor (ƒ₁). The release profile of tablets with Eudragit® NE 40 D 15% dry content was similar to that of the innovator providing values of the similarity factor (ƒ₂) and difference factor (ƒ₁) of 83 and 3, respectively. Developing diclofenac sodium extended release tablets by using Eudragit® NE 40 D 15% dry content as matrix former and dibasic calcium phosphate dihydrate as filler would be benefit from the results of this study.