Preliminary Prediction of Bioequivalence of Glipizide Tablets Based on Parallel Artificial Membrane Permeability Assay
To preliminarily predict the bioequivalence of glipizide tablets,the in vitro dissolution and permeation rates were studied with the parallel artificial membrane permeability assay(PAMPA).The Macro Flux system for drug bioequivalence prediction was used to investigate the dissolution and permeability processes of three test preparations and the reference preparation in the fasting and fed states.To predict whether the test preparations were bioequivalent to the reference preparation,two key quality parameters,namely the permeation rate and the total permeation amount,were compared.The 90％confidence interval of the geometric mean ratio of the quality parameters that passed the consistency evaluation was in the range of 80.00％-125.00％.For the others that did not fall into this interval,one batch of the test preparation had a similar dissolution curve to the reference preparation.The PAMPA may provide support for the prescription screening and bioequivalence risk assessment of preparations.
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