FORMULATIONS OF ISOSORBIDE MONONITRATE (ISMN) TABLET AND COMPARATIVE STUDY WITH AVAILABLE BRANDS

Abstract

In the present study new formulations of Isosorbide mononitrate were manufactured by dry granulation method using Talc instead of magnesium stearate and compared with different brands of isosorbide mononitrate tablets available in the market. The present study is divided into two phases. For the first phase new formulation of Isosorbide mononitrate was prepared by dry granulation method and during manufacturing magnesium stearate was replaced by Talc as it is cheaper, less process dependant and requires less blending time as compared to magnesium stearate. Mixing time differences of as little as two minutes can significantly alter the dissolution pattern of finished tablets. In the 2^nd phase of present study three different brands of isosorbide dinitrate tablets were randomly selected from the local market using probability sampling tools and evaluated for weight variation test, friability test and hardness test. Disintegration was also conducted according to the methods and guidelines given in BP/USP. The results showed that all parameters like weight-variation, disintegration, hardness, thickness and friability of new formulations are in accordance with the BP/USP limits and the new formulation containing talc showed better potency as compared to other market brands. The most obvious advantage of replacement of magnesium stearate by talc is its better economy, resulting to reduce processing time, less equipment and space required less process validation and lower energy utilization with equal potency and safety