PROCESS FOR MANUFACTURING A PHARMACEUTICAL COMPOSITION IN A SUSTAINED-RELEASE TABLET FORM CONTAINING PIRFENIDONE AND THE APPLICATION THEREOF IN THE REGRESSION OF CHRONIC RENAL FAILURE, BREAST CAPSULAR CONTRACTURE AND LIVER FIBROSIS IN HUMANS.

摘要

The present invention is related to a process for the manufacture of a pharmaceutical composition in a sustained-release tablet form containing from 600 milligrams to 2400 milligrams of pirfenidone (PFD), in such a manner that the drug containing the same is bio-available during a long period of time of 12 hours from the administration. In this manner, the anti-fibrotic and anti-inflammatory action of the pirfenidone is optimised. In addition, the present invention offers advantages and an improved therapeutic efficiency over further pharmaceutical forms of pirfenidone for the oral administration and therapeutic administration thereof in the regression of secondary chronic renal failure to primary glomerulosclerosis; this invention presents an improved activity in the reduction and/or regression of the harming effects in the breast capsular contracture observed after the surgical implant of breast implants in humans and exerts an important anti-TNF-a and anti-TGF-ß1 for the treatment of liver fibrosis.