Comparison of dissolution profile of ibuprofen sustained-release capsules between 15 manufacturers'generics and reference formulations
Objective To compare the in vitro dissolution profiles of ibuprofen sustained-release capsules between 15 manufacturers'generic and reference formulations,in order to provide reference for the evaluation of quality consistency.Methods The dissolution medium used in this study were pH 1.0 hydrochloric acid solution,pH 4.0 acetate buffer,pH 6.0 phosphate buffer and pH 7.2 phosphate buffer,respectively,with the volume of 900 ml.The basket method was applied at the rotation speed of 30 r/min.The content of ibuprofen was determined by HPLC.The cumulative dissolution was calculated and the dissolution curves were obtained.The difference factor(f1)and similarity factor(f2)method were used to evaluate the similarity of dissolution profiles.Results Among the domestic generic preparations,products from manufacturer A in pH 1.0 hydrochloric acid solution or pH 4.0 acetate buffer,the f1 were more than 15,which were not similar to the reference formulations,there were differences in the dissolution curves.Products from the other 14 manufacturers,in the four dissolution media,all f1 were less than 15 and all f2 were more than 50,the dissolution profiles were similar and the dissolution behaviors were consistent to the reference formulations.Conclusion In the dissolution medium not specified in the pharmacopoeia of ibuprofen sustained-release capsules,generic preparations from manufacturer A have dissimilar dissolution profiles and inconsistent dissolution behaviors,which may be related to its prescription and production technology.In order to make a comprehensive assessment of the consistency of ibuprofen sustained-release capsules,the specific bioequivalence experiments and other indicators of pharmacy still needs to be integrated for the reference and domestic generic preparations from different sources.
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