EVALUATION OF THE QUALITY OF DICLOFENAC SODIUM COATED TABLETS PROVIDED BY THE SÃO PAULO PUBLIC HEALTH SYSTEM, SP, BRAZIL

Abstract

Diclofenac is the most prescribed nonsteroidal anti-inflammatory (NSAI) drug in the world. Diclofenac sodium gastro- resistant tablets were developed for reducing the risk of gastrointestinal adverse effects, commonly associated to
NSAI. The Municipal Drug Quality Verification Program of São Paulo, SP, Brazil, evaluates the quality of diclofenac sodium coated tablets distributed by the municipal Public Health System. Therefore, the objective of this study was
to evaluate the quality of diclofenac sodium coated tablets distributed in municipal public health units in the year of 2013. The Pharmacopoeal physical-chemical tests performed included aspect, weight variation, diclofenac sodium
identification and potency, uniformity of dosage units and dissolution. The analyzed diclofenac sodium samples presented satisfactory results. Monitoring drugs distributed by the Public Health System is an important health surveillance action. The evaluation of diclofenac sodium coated tablets quality is relevant to guarantee the efficacy and safety of the pharmacological treatment, especially because it is a modified release pharmaceutical product.