COMPARATIVE IN-VITRO QUALITY EVALUATION OF COMMERCIALLY AVAILABLE DICLOFENAC SODIUM TABLETS.

BACKGROUND

Diclofenac Sodium is a widely used non-steroidal anti-inflammatory drug (NSAID) indicated for the management of various inflammatory and painful conditions. Multiple generic brands are available in the Saudi Arabian market, highlighting the importance of evaluating their pharmaceutical quality characteristics.

OBJECTIVE

This study aimed to compare four commercially available brands of Diclofenac Sodium 50 mg enteric-coated tablets using standard in-vitro quality control tests.

METHODS

Four brands of Diclofenac Sodium enteric-coated tablets were evaluated for weight variation, hardness, friability, disintegration, and dissolution characteristics using established pharmaceutical quality-control procedures. The obtained results were compared with relevant pharmacopeial specifications and commonly accepted quality criteria.

RESULTS

All tested brands met the specified acceptance criteria for weight variation and friability. Hardness values varied among brands, with one product exhibiting higher crushing strength than the others. Disintegration testing demonstrated resistance in acidic medium followed by disintegration in phosphate buffer medium. Dissolution testing showed progressive drug release in phosphate buffer, with cumulative drug release exceeding 90% after 60 minutes for all brands.

CONCLUSION

The evaluated Diclofenac Sodium tablet brands demonstrated acceptable in-vitro quality characteristics across the tested parameters. While variations were observed among products, all brands exhibited satisfactory physical performance and drug-release behavior under the study conditions. Further investigations, including content uniformity testing, similarity factor analysis, and in-vivo bioequivalence studies, are recommended to provide a more comprehensive assessment of product equivalence and therapeutic interchangeability.