Pirfenidone (Esbriet) is an important antifibrotic drug that plays a key role in the treatment of idiopathic pulmonary fibrosis (IPF).
What Are the Indications for Pirfenidone (Esbriet)?
Main Therapeutic Area
Idiopathic Pulmonary Fibrosis (IPF) is the primary indication for pirfenidone.
This drug is specifically used to improve lung function and slow disease progression in patients with IPF.
Applicable Population
At present, the efficacy of the drug has not been established in pediatric patients, so it is mainly suitable for adult patient populations.
Clinical research data show that the drug has demonstrated good therapeutic effects in patients aged between 40 and 80 years old.
Specifications and Properties of Pirfenidone (Esbriet)
Capsule Specifications
Content: Each capsule contains 267mg of pirfenidone.
Appearance: White to off-white hard gelatin capsules.
Marking: The capsule cap is printed with "PFD267mg" in brown ink.
Film-Coated Tablet Specifications
267mg tablet: Yellow oval biconvex tablet, engraved with the "PFD" marking.
801mg tablet: Brown oval biconvex tablet, engraved with the "PFD" marking.
Active Pharmaceutical Ingredient (API) Characteristics
Appearance: White to pale yellow non-hygroscopic powder.
Solubility: More soluble in methanol, ethanol, acetone, and chloroform than in water and 1.0N HCl.
Melting point: Approximately 109°C.
Formulation State
Capsules: Contain white to off-white powder.
Tablets: Smooth surface with uniform color.
Active Ingredient
Pirfenidone.
Capsule Excipient Components.
Microcrystalline cellulose.
Croscarmellose sodium.
Povidone.
Magnesium stearate.
Capsule shell: Gelatin and titanium dioxide.
Brown printing ink: Shellac, black iron oxide, red iron oxide, yellow iron oxide, propylene glycol, ammonium hydroxide.
Tablet Excipient Components
Microcrystalline cellulose.
Colloidal anhydrous silica.
Povidone.
Croscarmellose sodium.
Magnesium stearate.
Coating materials: Polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and iron oxide.
Storage Conditions for Pirfenidone (Esbriet)
Temperature Control
Storage temperature: 25°C (77°F).
Permissible temperature range: 15-30°C (59-86°F).
Packaging Requirements
Must be stored in a tightly closed container.
Protected from light and moisture.
Bottle seals must remain intact.
Expiry Date Management
Regularly check the drug's expiry date.
Expired drugs should be disposed of safely immediately.
Drugs with damaged seals should not be used.
Operating Specifications
Close the bottle cap tightly immediately after taking the drug.
Avoid storing with other medications.
Keep properly out of reach of children.
