Preparation and in Vitro Dissolution Evaluation of Imidapril Hydrochloride Tablets

OBJECTIVE To explore the preparation method of imidapril hydrochloride tablets, in order to obtain Tanatril^® similar in vitro dissolution curves. METHODS The prescription proportion of imidapril hydrochloride tablets was investigated by reverse study of reference preparation and single factor test. Imidapril hydrochloride tablets were prepared by wet granulation process. Using the original formulation as a reference, investigate the dissolution of the self-made formulation in four dissolution media to evaluate its in vitro dissolution similarity. RESULTS Compared with the reference preparation, the similarity factor(f₂) of the four dissolution curves of self-made preparation was more than 50, which indicated that the dissolution was similar in vitro. CONCLUSION The study of self-made preparation prescription and process provides a basis for the feasibility of bioequivalence test of imidapril hydrochloride tablets, and has guiding significance for the industrial production.