Comparative Study of Alcohol Dose Dumping Studies for Ibuprofen Sustained-release Capsules Generic Drugs and Reference Standard Preparations
OBJECTIVE To establish the dissolution method of alcohol dose dumping studies for ibuprofen sustained-release capsules,and evaluate the consistency of alcohol dose dumping between generic drugs and reference standard preparations.METHODS Use pH 1.2 hydrochloride acid as the dissolution medium,and the concentration of ethanol in the medium was 0％,5％,20％and 40％.The dissolution curves of ibuprofen sustained-release capsules generic drugs and reference standard preparations were determined respectively by using the valided method,and the similarity was compared.RESULTS When the concentration of ethanol was 5％and 20％,there was no significant change in the cumulative dissolution of ibuprofen sustained-release capsules and reference standard preparations at each sampling time point compared with that without ethanol.The dissolution curves of generic drugs and reference standard preparations were considered similar.when the concentration of ethanol was 40％,the dissolution curves of generic drugs were similar to those of reference standard preparations,and both of them showed alcohol dose dumping.CONCLUSION The combination of ethanol and ibuprofen sustained-release capsules may cause interaction,and the risk of ethanol dose dumping of generic drugs is not higher than that of reference standard preparations.
ibuprofen sustained-release capsulesalcohol dose dumping studiesgeneric drugsreference standard preparationsdissolution curves
万方数据
维普
