Dose Dumping Study of Gliclazide Sustained-release Tablets
By adding different volume fractions of ethanol into 0.1 mol/L hydrochloric acid and increasing the rotational speed,the risk of dose dumping of gliclazide(1)sustained-release tablets(self-made and reference preparations)was evaluated by HPLC,and the detection method was validated.The results showed that the release behavior of the reference preparation and the self-made tablets was basically the same after adding different volume fractions of ethanol in hydrochloric acid and increasing the rotational speed.The similarity factor(f2)values were all greater than 50,and there was no dose dumping phenomenon.This study also found that 1 degraded very rapidly in the hydrochloric acid containing ethanol,with the degradation rate of about 40％in one hour,resulting in impurity A and impurity C.The impurity contents had far exceeded the acceptable limits specified by the quality standard.It was suggested that when taking the 1 sustained-release tablets,alcohol consumption should be prohibited in order to avoid increasing unknown safety risks due to excessive impurities.
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