Abstract

DEVELOPMENT, FORMULATION AND EVALUATION OF ETHAMBUTOL HYDROCHLORIDE AND ISONIAZID COMBINATION TABLETS

Kiran B. Aphale*, Sushant Mukherjee, Pankaj Thakur, Dr. Ashok Bhosale and Sujit Kakade

ABSTRACT

Tuberculosis is a chronic disease and a major health problem in developing countries. About 1/3rd of the world’s population is infected with Mycobacterium tuberculosis. Ethambutol and isoniazid drugs are used as anti-tuberculosis agent in the initial treatment of pulmonary tuberculosis. Combination preparation plays an important role in tuberculocidal clinical treatment because of its better and wider curative synergism and weaker side effects. In the present study combination tablet containing ethambutol and isoniazid were prepared by the wet granulation method using a different binder such as starch paste, PVP-IPA, gelatine, HPMC and HPC. In the study common tablet properties like thickness, hardness, weight variation, friability, percent release and assay were done. Among these different formulations with different binders, batches F1 to F5 with wet granulation, the formulation batch F5 shows the satisfactory in vitro drug release and other evaluation parameter as compared to innovator formulation. The cumulative percentage drug release of optimized formulation ethambutol and isoniazid was found to be 99.23% and 99.28% respectively. The result of stability study of optimized formulation batch F5 shows that it is stable at 400C±20C. /75% RH. ± 5% RH as there was no significant changes in assay, physicochemical parameters and release pattern observed after two month.

Keywords: Anti tuberculosis Agent, Effect of different binders, % drug release, Assay.