ABSTRACT
OBJECTIVE: To investigate and compare the dissolution behaviors of diclofenac sodium enteric-coated tablets from Beijing Novartis, Turkey Novartis and German Novartis respectively. METHODS: According to the dissolution test METHODS: in Chinese Pharmacopoeia, the dissolution curves of the preparations in various media were investigated. Whether the dissolution stage in acidic medium has influence on the dissolution behavior as well as the influence of the ionic strength of buffer medium were investigated. RESULTS: The dissolution curves of diclofenac sodium enteric-coated tablets in media of pH 1.0, 5.5, 6.0 and 6.8 could be used as the characteristic dissolution curves of the preparation. The dissolution behaviors of the three preparations after being dissolved in acidic medium for 2 h were similar; the dissolution behaviors were quite different without the dissoulution stage in acid medium; the larger the ionic strength of the buffer medium was, the faster the dissolution rate of the enteric coated tablets was. CONCLUSION: The dissolution behavior of diclofenac sodium enteric-coated tablets depends on the dissolution rates of the enteric coating and the tablet core. The RSD of the dissolution rate just after the formulation starts to dissolute is large; the dissolution phase in acidic medium and the ionic strength of the buffer medium has influence on the dissolution behavior. There is difference in the in vitro dissolution behaviors of diclofenac sodium enteric-coated tablets from manufacturers in different areas of the same group. This study may provide data support for the selection of multi-source reference preparations in the evaluation of generic drug conformance, and plays an important role in guiding the prescription screening and bioequivalence risk assessment.