Manufacturing of new formulations of Isosorbide dinitrate by direct compression method and their comparative evaluation with different brands available in the market

Author(s)

Huma Dilshad , Safila Naveed ,

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Volume 2 - August 2013 (08)

Abstract

The aim of this study was to develop new formulations of Isosorbide dinitrate by direct compression method using Talc instead of magnesium stearate. The present study is divided into two phases. In the first phase new formulation of Isosorbide dinitrate was prepared by direct compression 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. Blending time differences of as little as two minutes can significantly alter the dissolution pattern of finished tablets. In the 2nd phase three different brands of isosorbide dinitrate tablets were randomly selected from the local market using probability sampling tools and evaluated for weight variation, hardness, friability, disintegration, dissolution (by using HPLC). Pharmaceutical assays (by using spectrophotometer and HPLCr) were also conducted according to the methods and guidelines given in BP/USP. The results showed that all parameters (weight-variation, thickness, hardness, friability, disintegration, dissolution and Pharmaceutical assays 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, owing to reduce processing time, less equipment and space required less process validation and lower energy utilization with equal potency and safety.

Keywords

ISDN (Isosorbide dinitrate), Talc, Mg-Stearate, Friability, Disintegration, Dissolution, Pharmaceutical Assay.

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