Abstract:
OBJECTIVE To compare the dissolution profiles of brand name drug and generics of clopidogrel bisulfate tablets in four different medium.
METHODS The dissolution profiles of brand name drug and generics in four different medium (pH 2.0 hydrochloric acid-potassium chloride buffer solution, pH 4.5 phosphate buffer, pH 6.8 phosphate buffer and water) was determined and the similarity was investigated according to the
f2 factor method.
RESULTS The
f2 factors between two tablets in four different medium were 56, 80, 78 and 75, respectively.
CONCLUSION The dissolution profiles of brand name drug and generics in four different medium have significant similarity.