Influence of Raw Materials Nature on the Biological Activity of Generic Products of Drug Using Atorvastatin and Isosorbide Dinitrate Tablets as a Model Drugs

Abstract

In this work, two tablet formulas of amorphous and crystalline atorvastatin calcium beside two formulas of crystalline and amorphous isosorbide dinitrate from different raw materials manufacturing companies were prepared by direct compression method. The process variables were identical in order to concentrate on the effect of the crystalline form of the drugs on the release behavior of the prepared tablets. Compared with crystalline atorvastatin calcium, amorphous form tablets were of better performance in solubility and dissolution, resulting in higher solubility and faster dissolution rate. In addition, the dissolution rates of crystalline isosorbide dinitrate tablets were highly increased in comparison with tablet prepared with amorphous ones.The results imply that the absorption of atorvastatin calcium and isosorbide dinitrate after oral administration was remarkably higher when using the crystalline forms compared to the amorphous ones .these results recommends the attention towards analysis of raw materials of drugs when different brands of same drug shows dissimilar release disposal .