PROCESS FOR THE PREPARATION OF A PHARMACEUTICAL COMPOSITION CONTAINING PIRFENIDONE IN SUSTAINED-RELEASE TABLET FORM AND ITS APPLICATION IN THE REGRESSION OF HUMAN CHRONIC RENAL FAILURE, BREAST CAPSULAR CONTRACTURE AND HEPATIC FIBROSIS
Juan Socorro Armendáriz Borunda,José Agustin Rogelio Magaña Castro,Jorge Cervantes Guadarrama
申请号：
US16544643
公开号：
US20200038386A1
申请日:
2019.08.19
申请国别(地区):
US
年份:
2020
代理人:
摘要：
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-α and anti-TGF-β1 action for the treatment of hepatic fibrosis.
