Application of Micronization As Dissolution Enhancement Technique For Formulation Development of Bcs Class 2 Drug

Abstract

In order to achieve rapid action for hypertension and dihydropyridine group, which inhibits the transmembrane influx of calcium into cardiac and smooth muscle, the research's goal was to design and develop an immediate-release compressed tablet for an anti-hypertensive drug using a selection of super-disintegrant, binder, and diluent concentrations. This anti-hypertensive medication, which is used to treat adults with newly diagnosed high blood pressure, is a calcium antagonist medication. To obtain the desired pure API particle size and alter the API's shape from crystalline to amorphous, we use an air jet mill. In order to screen the super-disintegrants, binder, and diluents that would be utilized in the final formulation, preliminary batches were prepared utilizing the direct compression technique and a quick mixer granulator. To investigate the impact of various doses on drug release, further batches were created utilizing sodium starch glycolate as the super-disintegrant and polyvinylpyrrolidone K30 as the Binder. One element at a time was used to optimize the Rapid Mixer Granulator approach for the crucial process variables, i.e. Based on pharmaceutical characteristics and an in-vitro release profile compared to the reference-listed product, the optimized formulation was chosen. The drug release increased gradient Aly with the concentration of the super-disintegrants, according to the dissolving data. The study showed that the required release may be accomplished by varying the concentrations of binder and diluent while also raising the concentration of super-disintegrant.