Study on Consistency Evaluation of the Dissolution of Generic and Original Preparations of Fenofibrate Tablet

OBJECTIVE To establish a new method for the dissolution curve determination of fenofibrate tablet, and evaluate the comparability of dissolution curve of 10 domestic generic tablets and the original tablet. METHODS Four dissolution media including pH 1.0 hydrochloric acid solution, pH 4.0 buffer solution, pH 6.8 buffer solution and water solution containing 0.025 mol·L^-1 SDS were used, the dissolution behaviors of generic and original preparations of fenofibrate tablet were detected, and the dissolution curves of consistency were evaluated by calculating the similarity factor(f₂). RESULTS The dissolution curve of only one enterprise product in China was similar with the original tablet in the four dissolution media. The dissolution of the rest of the company's products were inconsistent with the original tablet. CONCLUSION The new dissolution behavior method is suitable for dissolution curve determination of fenofibrate tablet, can make reference for further quality consistency evaluation.