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ESBRIET is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
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Each ESBRIET capsule contains 267 mg of pirfenidone, which belongs to the chemical class of pyridone. ESBRIET is available as a white hard gelatin capsule for oral administration.
The chemical name of pirfenidone is 5-methyl-1-phenyl-2-1(H)-pyridone. It has a molecular formula of C12H11NO and a molecular weight of 185.23. The structural formula of pirfenidone is:
Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C.
ESBRIET capsule contains pirfenidone and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, and magnesium stearate.
In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes shellac, iron oxide black, iron oxide red, iron oxide yellow, propylene glycol, ammonium hydroxide.