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.
[Full Text Article]