Résumé
OBJECTIVE: To evaluate the similarity of the mean drug dissolution or release curves by the experimental model of reformatory Weibull. METHODS: Three drugs were taken as the model drugs. With the fiber-optic in site dissolution testing equipment(FODT), the percentages of accumulated dissolution/release changing with time of the control and test preparations of every drug were respectively monitored. The mean percentages were calculated and the dissolution/release curves were drawn. The data were fitted by the reformatory Weibull model. The fitted parameters c, Ti, b, a, and the 95% confidence intervals of every parameters were extracted. The similarity of the mean drug dissolution curves between the control and test preparations was evaluated by the fitted parameters and observation of the dissolution curves. RESULTS: For the sustained-release preparations, there was no significant difference in the parameters c, Ti, b, and a of the test and control samples, and the mean drug release curves were similar. As for the non-modified preparations, whether the dosage forms of the test and control preparations were the same or not, there existed differences in the parameters fitted by the method of reformatory Weibull model. CONCLUSION: The modified method of reformatory Weibull model can be applied in the evaluation of similarity of drug dissolution behavior with satisfactory goodness-of-fit and quantitative result.