Procedure for preparing a pharmaceutical composition in the form of prolonged-release tablets containing pirfenidone and its use in the regression of chronic renal failure, breast capsular contracture, and liver fibrosis in humans

摘要

Process for preparing a pharmaceutical composition in the form of an extended-release tablet comprising 600 mg of pirfenidone, wherein said process comprises the following steps: Step 1. Pirfenidone and silicon dioxide are screened through a 30 mesh screen. in the oscillating granulator and arranged in the tape mixer and mixed for 5 minutes; Stage 2. Microcrystalline cellulose, low viscosity hydroxypropylmethylcellulose (HPMC) and high viscosity hydroxypropylmethylcellulose (HPMC) are screened through a 30 mesh sieve in the oscillating granulator and arranged in the belt mixer of stage 1 and mixed for 15 minutes; Stage 3. The sodium stearyl fumarate is screened through a 30 mesh sieve in the oscillating granulator and arranged in the belt mixer of stage 1 and mixed for 3 minutes; and Step 4. The granulate obtained is formed into a tablet in the Stokes tablet machine provided with oblong punches having the following compression parameters: average weight: 850 mg + 5%; hardness: maximum 10 kgF; fragility: less than 1%.