JPWO2021113334A5

JPWO2021113334A5 -

Info

Publication number: JPWO2021113334A5
Application number: JP2022533398A
Authority: JP
Publication date: 2023-12-20

Claims

A pharmaceutical composition comprising anakinra for the treatment of an inflammatory disorder of the lower respiratory tract or upper respiratory tract in a human subject in need of said treatment, said treatment comprising administering an effective amount of said pharmaceutical composition comprising anakinra to said human subject. Direct administration to the lower or upper respiratory tract in a subject;
The effective amount of anakinra is about 0.1 mg to about 200 mg/day;
The inflammatory disorders of the lower or upper respiratory tract include toxic inhalation lung injury, pulmonary Langerhans cell histiocytosis, non-cystic fibrosis bronchiectasis, diffuse panbronchiolitis, acute respiratory distress syndrome (ARDS), and reactive Selected from the group consisting of airway dysfunction syndrome (RADS), bronchiolitis obliterans organizing pneumonia (BOOP), idiopathic pulmonary fibrosis (IPF), pneumonia, primary graft dysfunction (PGD), and reperfusion injury. be done,
The pharmaceutical composition.

whether said poison inhalation lung injury is caused by inhalation of one or more poisons selected from the group consisting of one or more chemical warfare agents, environmental toxicants, and industrial toxicants;
the poison inhalation lung injury is chlorine-induced bronchiolitis obliterans syndrome (BOS) or sulfur mustard-induced bronchiolitis obliterans syndrome (BOS); or
the ARDS is associated with complications resulting from a viral infection caused by a virus selected from the group consisting of SARS-CoV-2, SARS-CoV, MERS-CoV, 229E, NL63, OC43, and HKU1;
The pharmaceutical composition according to claim 1.

the chemical warfare agent is selected from the group consisting of chlorine gas and sulfur mustard; or
The industrially toxic substances include isocyanates, nitrogen oxides, morpholine, sulfuric acid, ammonia, phosgene, diacetyl, 2,3-pentanedione, 2,3-hexanedione, fly ash, fiber glass, silica, coal dust, asbestos, and hydrogen cyanide. , cadmium, acrolein, acetaldehyde, formaldehyde, aluminum, beryllium, iron, cotton, tin oxide, bauxite, mercury, sulfur dioxide, zinc chloride, polymer fume, and metal fume,
The pharmaceutical composition according to claim 2.

the toxic inhalation lung injury is pneumoconiosis, bronchiolitis obliterans (BOS), or vaping-related lung injury; or
The poison inhalation lung injury is pneumoconiosis, bronchiolitis obliterans (BOS), or vaping-related lung injury, and the vaping-related lung injury includes diacetyl, α-tocopheryl acetate, 2,3-pentanedione, nicotine, caused by inhalation of one or more agents selected from the group consisting of carbonyls, benzene, toluene, metals, bacterial endotoxins, and fungal glucans;
The pharmaceutical composition according to claim 1.

The pharmaceutical composition according to claim 1, wherein the inflammatory disorder is an inflammatory disorder of the lower respiratory tract.

2. The pharmaceutical composition of claim 1, further comprising a pharmaceutically acceptable carrier.

the pharmaceutically acceptable carrier comprises saline, Ringer's solution, dextrose solution, or a combination thereof;
whether the pharmaceutically acceptable carrier includes a buffer, a stabilizer, an osmotic tonicity modifier, or a combination thereof;
the sustained exposure of the pharmaceutical composition in the lung epithelial lining fluid is from about 15 hours to about 100 hours;
the sustained exposure of the pharmaceutical composition in the lung epithelial lining fluid is from about 15 hours to about 100 hours, and the sustained exposure of the pharmaceutical composition in the lung epithelial lining fluid is at least 24 hours;
the pharmaceutical composition is administered from about once a week to about 3 times per day;
the pharmaceutical composition is administered about once or twice a day;
the pharmaceutical composition is administered via inhalation for about 3 minutes to about 20 minutes;
anakinra in said pharmaceutical composition is administered at a dose of about 0.5 mg/kg to about 2 mg/kg; or
anakinra in the pharmaceutical composition binds to the endogenous IL-1 type I receptor with an affinity similar to that of the endogenous IL-1β ligand;
The pharmaceutical composition according to claim 6.

Claim 1, wherein the effective amount of anakinra is about 0.1 mg/day to about 100 mg/day, about 0.1 mg/day to about 50 mg/day, or about 0.1 mg/day to about 10 mg/day. The pharmaceutical composition described in .

9. The pharmaceutical composition of claim 8, wherein the effective amount of anakinra is about 0.125 mg/day to about 5.0 mg/day.

2. The pharmaceutical composition of claim 1, wherein said treatment comprises administering said pharmaceutical composition via inhalation or via direct instillation.

2. The pharmaceutical composition of claim 1, wherein said treatment comprises administering said pharmaceutical composition by a delivery device selected from the group consisting of a nebulizer, an inhaler, and a microaerolyzer.

the delivery device is a nebulizer; or
the delivery device is a mesh nebulizer;
The pharmaceutical composition according to claim 11.

13. The pharmaceutical composition is a liquid composition, and the nebulizer is configured to produce droplets of the liquid composition having a droplet size of about 0.5 μm to 30 μm in diameter. Pharmaceutical composition.

14. The pharmaceutical composition is a liquid composition, and the nebulizer is configured to produce droplets of the liquid composition having a droplet size of about 0.5 μm to 10 μm in diameter. Pharmaceutical composition.

the pharmaceutical composition is a liquid composition, and the nebulizer is configured to produce droplets of the liquid composition having a droplet size of less than about 5 μm in diameter; or
the pharmaceutical composition is a liquid composition, and the nebulizer is configured to produce droplets of the liquid composition having a droplet size of less than about 3.5 μm in diameter;
The pharmaceutical composition according to claim 14.