Procedure for the manufacture of a Pharmaceutical composition in the form of extended release Tablets comprising Pirfenidone； and its use for the treatment of chronic renal failure or regression, Breast capsular contracture and hepatic fibrosis.
ARMENDARIZ BORUNDA JUAN,MAGAÑA CASTRO JOSE AGUSTIN ROGELIO,CERVANTES GUADARRAMA JORGE
申请号：
CL2014000131
公开号：
CL2014000131A1
申请日:
2014.01.17
申请国别(地区):
CL
年份:
2014
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-± and anti-TGF-²1 action for the treatment of hepatic fibrosis.<；p>；Composició；n farmacé；utica en forma de tableta de liberació；n prolongada que comprende 600 mg de pirfenidona； 70 mg de HPMC baja viscosidad y 46,5 mg de HPMC alta viscosidad； 118,8 mg de celulosa microcristalina； 8,5 mg de dió；xido de silicio y 6,2 mg de estearil fumarato de sodio. Procedimiento para la fabricació；n de dicha composició；n farmacé；utica en forma de tableta de liberació；n prolongada. Uso de dicha composició；n farmacé；utica en forma de tableta de liberació；n prolongada en el tratamiento de la insuficiencia renal cró；nica secundaria a glomeruloesclerosis primaria, la contractura capsular mamaria y la fibrosis hepá；tica.<；/p>；
