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Procedure for the manufacture of a Pharmaceutical composition in the form of extended release Tablets containing Pirfenidone and its application in regression of renal insufficiency cronicA, Breast capsular contracture and Human hepatic fibrosis
专利权人:
CELL THERAPY AND TECHNOLOGY S.A. DE C.V.
发明人:
申请号:
ARP120102578
公开号:
AR087205A1
申请日:
2012.07.16
申请国别(地区):
AR
年份:
2014
代理人:
摘要:
A procedure for the manufacture of a Pharmaceutical composition in the form of extended release tablets, ranging from 600 to 2400 milligrams milligram of Pirfenidone (PFD),So the drug that contains it is bioavailable during an extended period of 12 hours after its administration.This optimizes the Action Anti fibrotic and anti inflammatory of Pirfenidone.In addition,Advantages and better therapeutic efficacy of Pirfenidone on other pharmaceutical dosage forms for oral administration and their Therapeutic application in regression of renal failure Cr u00f3nICA secondary to primary glomerulosclerosis; presents a better activity and / or regression in the reduction of the adverse effects observed in the breast capsular contracture after implantationSurgical implants and exerts a significant action in human anti TNF - and anti TGF - B1 for the treatment of hepatic fibrosis.Claim 1: a procedure for the manufacture of a Pharmaceutical composition in the form of extended release Tablets comprising 600 mg of PirfenidoneWhere said method includes the following steps: STEP 1) Pirfenidone and SILICON DIOXIDE are sieved by Mesh no. 30 in the oscillating Granulator and placed in the mixer -N and mixed for 5 minutes; STEP 2) microcrystalline CelluloseThe hydroxypropyl Methyl Cellulose (HPMC) of Low Viscosity hydroxypropyl Methyl Cellulose (HPMC) and High viscosity are sieved by 30 mesh in the oscillating Granulator and placed in the Mixer of liSt u00f3n of Step 1 and Step are mixed for 15 minutes; 3) sodium Stearyl fumarate is sieved by 30 mesh in the oscillating Granulator and placed in the Mixer of Ribbon from step 1 and mixed duStep 4) for 3 minutes; The Granules obtained in the tabletea tableteadora Stokes with punches oblonda form with the following parameters: Compression: average Weight of 850 mg + 5%;Za: up to 10 kg (F; friability: less than 1%.Claim 2: a Pharmaceutical composition in the form of extended release Tablets comprising 600 mg of Pirfenidone obtained from the
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