Study On Industrial Production Of Nisoldipine Sustained-release Tablets

Objective:Development of Nisoldipine sustained-release tablets, study on the formulation, manufacturing process, product qualification, stability research and bio-equivalence trial.Methods:Select hydroxypropyl methylcellulose as polymer, Eudragit(?) as the pH sensitive polymer to adjust the dissolution at different pH buffer; process effect on tablets dissolution were studied with the wet granulation process and direct compression process; dissolution profile comparison between the sustained-release tablets with the brand tablets was studied; product manufacture parameters was studied; the analytical method was validated; bioequivalence were studied through clinical study; accelerate stability were studied.Results:The dissolution similarity factors (f2) between sustained-release tablets with the brand tablets in different buffer of pH1.2、pH6.8 were more than 50%; the key parameters from scale-up batches were finalized; the assay test method was validated; bioequivalence study passed the FDA requirement; product stability study proved that the storage is stable at the accelerate condition within the study time.Conclusion:Nisoldipine sustained-release tablets showed desired dissolution profile, the manufacture process is simple and robust.