Investigation on dissolution characteristics of diclofenac sodium extended release tablets using flow-through cell method / 中国药学杂志

ABSTRACT

OBJECTIVE: To develop a unified and discriminative method for the characterization of different diclofenac sodium extended release tablets. METHODS The flow-through cell method was employed to investigate the dissolution characteristics of all the samples at different flow rates and in different dissolution media. The dissolution data under the finally selected dissolution condition was also used to analyze the similarity of dissolution curves and statistical significance of Weibull parameters. RESULTS: The dissolution behaviors of the samples were not significantly influenced by flow rates in the selected range. The dissolution at a flow rate of 4 mL · min-1 and in hydrochloric acid (0.1 mol · L-1) for one hour followed by water for another seven hours was satisfactory to discriminate the samples, which was demonstrated by f2 and Weibull parameters analysis. CONCLUSION: This method can be used for dissolution tests of diclofenac sodium extended release tablet samples from the manufacturers in this study with meanings in guiding both comprehensive investigation on the dissolution of diclofenac sodium extended release tablets and quality improvement of generic drugs.