Procedure for the manufacture of a pharmaceutical composition in the form of long-acting pirfenidone-containing tablets and their application in the regression of chronic renal failure, human breast capsular contracture and hepatic fibrosis
abstract the instant invention relates to a process for the preparation of a pharmaceutical composition in sustained-release tablet form comprising from 600 milligrams to 2400 milligrams of pirfenidone (pfd), in such a way that the drug is bioavailable during an extended period of time of 12 hours from its administration. In this way, the anti-fibrotic and anti-inflammatory action of the drug pirfenidone is optimized. moreover, the instant invention offers advantages and a higher therapeutic efficacy compared to other pharmaceutical forms of pirfenidone for oral administration and its therapeutic application in the regression of chronic renal failure secondary to primary glomerulosclerosis; it shows a better activity with regard to the reduction and / or regression of deleterious effects in breast capsular contracture observed after the surgical implantation of breast implants in humans and has an important anti-tnf-a and anti-tgf-ß1 action for the treatment of hepatic fibrosis. ************************************************** ************* Abstract: "Procedure for the manufacture of a pharmaceutical composition in the form of prolonged-release tablets containing pirfenidone and its application in the regression of chronic renal failure, human breast capsular contracture and liver fibrosis ". The present invention relates to a procedure for the manufacture of a sustained release tablet pharmaceutical composition comprising from 600 milligrams to 2,400 milligrams of pirfenidone (pfd) such that the drug containing it is bioavailable during an extended period of time of 12 hours from its administration. Thus, the antifibrotic and anti-inflammatory action of the drug pirfenidone is optimized. furthermore, the present invention offers advantages and improved therapeutic efficacy over other pharmaceutical forms of pirfenidone for its oral administration and its therapeutic application in the regression of chronic renal failure secondary to primary glomerulosclerosis; ex