Abstract

FORMULATION AND EVALUATION STUDIES OF ENTERIC COATED TABLET CONTAINING NON-STEROIDAL ANTIINFLAMMATORY DICLOFENAC SODIUM

Dr. S. Chandra*, B. Nandhini, D. Ezhilarasi, S. Kavi bharathi, S. Sangeetha, A. Sheikalish

ABSTRACT

In the present study, an attempt has been made to formulate and evaluate enteric coated tablets of Diclofenac sodium using two different enteric polymers that will only dissolve in the small intestine, such as cellulose acetate phthalate and methacrylic acid ethyl acrylate copolymer to reduce the gastrointestinal tract side effects. Preformulation studies were performed to analyze the characteristics of Diclofenac sodium. Drug and excipients were confirmed to be standard without any incompatibility by Drug Excipients Compatibility study. Four formulations of core tablets were prepared by wet granulation method and good flow properties were observed. All the physical parameters like appearance, weight variation, thickness, hardness, friability and disintegration time were found to be within the limits for F4 formulation and selected for further enteric coating. Enteric coating was optimized using two different enteric polymers in different concentrations to achieve various percentage weight gains. In vitro analysis, Assay and Related Substances test were carried out. The in vitro release results showed that the enteric coated tablets were capable of restricting release in acidic media. The optimized formulation was capable of releasing the drug in pH 6.8 in a same manner as marketed formulation of Diclofenac sodium.

Keywords: Diclofenac sodium, Enteric coating, Delayed release, cellulose acetate phthalate, methacrylic acid ethyl acrylate copolymer.