Abstract:
OBJECTIVE To develop a flow-through cell method for the dissolution test of omeprazole enteric capsules and compare the dissolution behaviors of omeprazole enteric capsules from different manufacturers.
METHODS An open-loop mode of flow-through cell apparatus was employed, with pH 1.2 hydrochloric acid solution, pH 6.0 phosphate buffer solution and pH 6.2 phosphate buffer solution as the dissolution medium, and the flow rate was 4 mL·min
-1, the samples were collected at the specified time point and determined by HPLC. The dissolution profiles of omeprazole enteric capsules from different pharmaceutical manufacturers were determined, and the dissolution curves of consistency were evaluated by calculating the similarity factor(
f2).
RESULTS The dissolution profiles of the products from 7 domestic pharmaceutical manufacturers were similar to those of the reference listed drug(RLD). The dissolution curves of the rest of the manufacturers' products were different with the RLD.
CONCLUSION The method which can be used to determine the dissolution of omeprazole enteric capsules is instructive to the quality control of the products. There is difference of
in vitro dissolution behavior between the generic preparations and the RLD, which provides assistance for further optimizing manufacturing process and evaluating the consistency of generic drugs.