POSTUPAK PROIZVODNJE FARMACEUTSKE KOMPOZICIJE U OBLIKU TABLETA SA PRODUŽENIM-OSLOBAĐANJEM KOJE SADRŽE PIRFENIDON I NJIHOVA UPOTREBA U REGRESIJI HRONIČNE RENALNE INSUFICIJENCIJE, KAPSULARNE KONTRAKTURE GRUDI I HEPATIČKE FIBROZE KOD LJUDI
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-± and anti-TGF-²1 action for the treatment of hepatic fibrosis.
