Preliminary prediction of bioequivalence of montelukast sodium chewable tablets based on permeability analysis / 中国药学杂志

ABSTRACT

OBJECTIVE: To study the in vitro dissolution and permeation process of montelukast sodium chewable tablets, and establish the in vivo-in vitro correlation models to predict the bioequivalence of the generic preparations. METHODS:The Macro Flux drug dissolution absorption test system was used, and the satiety intestinal simulated liquid ( pH 5. 0) was used as the medium to compare the penetration of the reference preparation and test preparation. The rate, release and absorption process of the drug were examined by the quality parameters, and the bioavailability of the test preparation was predicted, thereby predicting whether the preparation was bioequivalent. RESULTS: In the satiety small intestine simulating solution, the permeation rate, ρmax and AUC0-t of the test preparation and the reference preparation were basically the same. The bioavailability was approximately 97% of the reference formulation. CONCLUSION: It is preliminarily predicted that the test preparation of montelukast sodium chewable tablets is bioequivalent with the reference preparation.