IMPROVED PROCESS FOR PREPARATION OF ANTI-TUBERCULAR PHARMACEUTICAL COMPOSITION IN FIXED DOSE COMBINATION OF FOUR DRUGS

摘要

An improved process for the preparation of an antitubercular pharmaceutical composition in fixed dose combination containing four drugs rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride comprising : mixing rifampicin with excipients free of any surfactant followed by wet granulation, of resulting mixture with a binder material to obtain granules of said mixture and thereafter subjecting the said granules to drying ; b) mixing isoniazid with excipients free of any surfactant followed by wet granulation of resulting mixture with a bmder material to obtain granules of said mixture and thereafter subjecting the said granules to drying; cj mixing pyrazinamide with excipients free of any surfactant followed by wet granulation of resulting mixture with a binder material to obtain granules of said mixture and thereafter subjecting the said granules to drying; d) mixing ethambutol hydrochloride with excipients free of any surfactant_followed by wet granulation of resulting mixture with a binder material to obtain granules of said mixture and thereafter subjecting the said granules to drying; e) mixing the granules obtained in steps a), b), c) and d) with excipients free of any surfactant to obtain a lubricated blend; f) converting the resulting lubricated blend into a solid dosage form.