Preparation and in vitro dissolution consistency of clopidogrel and aspirin tablets
Objective To prepare clopidogrel and aspirin tablets and optimize the formulation process to achieve consistency with the reference preparation on dissolution behavior in vitro.Methods Clopidogrel was prepared by hot melt granulation and aspirin was prepared by direct powder compression method and enteric coating.The key formulation factors of the preparation process were determined by single factor to obtain the optimal formulation conditions.The dissolution of clopidogrel and aspirin was determined by high performance liquid chromatography.The dissolution curves of self-made preparation and reference preparation were compared by similarity factor f2 method.Results The f2 of the optimized self-made preparation and the reference preparation in different media was greater than 50,with similar dissolution curves.Conclusion The dissolution behavior of self-made clopidogrel and aspirin tablets in vitro is consistent with that of reference preparation.
clopidogrelaspirindissolution in vitrohot melt granulationsimilarity factor
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