Methods and Compositions for Treating Idiopathic Pulmonary Fibrosis

a technology of pulmonary fibrosis and compositions, applied in the direction of drug compositions, dispersed delivery, respiratory disorders, etc., can solve the problems of increasing the effort associated with breathing, slow decline of lung function, respiratory failure and death, etc., and achieve the effect of effective and safe manner

Inactive Publication Date: 2019-09-19
LIANG GUI BAI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007]The present inventors have surprisingly discovered that with a suitable dosing regimen or a novel

Problems solved by technology

Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive lung disease that results in respiratory failure and death.
As interstitial fibrosis advances with accompanying distortion of lung architecture, the lung becomes less compliant, increasing the effort associated with breathing, leading to dyspnea.
Typically, lung function declines slowly over time, but some patients experience rapid declines that can lead to hospitalization or death, particularly in later stages of the disease.
Development of agents for treatment of IPF has been slow in progress.
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Method used

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  • Methods and Compositions for Treating Idiopathic Pulmonary Fibrosis
  • Methods and Compositions for Treating Idiopathic Pulmonary Fibrosis
  • Methods and Compositions for Treating Idiopathic Pulmonary Fibrosis

Examples

Experimental program
Comparison scheme
Effect test

example 1

Establishment of Positive and Negative Controls

[0166]Forty male C57BL / 6 mice (Nanjing Biomedical Research Institute of Nanjing University) were randomly divided into two groups on Day 1, 10 animals for one group (referred to as Control group or Group 1) and 30 for the other. The animals in the Control group were administered intratracheally with PBS at a dose of 2 mL / kg while the others were administered intratracheally with bleomycin (Cat#HY-17565, MCE) at a dose of 0.66 mg / kg.

[0167]On Day 5, the mice with bleomycin treatment were divided into three groups at random (referred to as Group 2-4, n=10), and orally administered with vehicle (0.5% Methyl cellulose), nintedanib (Kangmanlin Co. Ltd., prepared in 0.5% Methyl cellulose with a final concentration of 6.0 mg / mL) and fluconazole (Kangmanlin Co. Ltd., prepared in 0.5% Methyl cellulose with a final concentration of 7.0 mg / mL) at daily doses of 10 mL / kg, 60 mg / kg and 70 mg / kg, respectively. The mice in the Control group was adminis...

example 2

Oral and Combination Treatment of Itraconazole Inhibited Fibrosis

[0179]Fifty male C57BL / 6 mice (Gempharmatech Co., Ltd.) were randomly divided into two groups on Day 1, 10 animals for one group (referred to as Control group or Group 1) and 40 for the other. The animals in the Control group were administered intratracheally with PBS at a dose of 2 mL / kg while the others were administered intratracheally with bleomycin (Cat#HY-17565, MCE) at a dose of 0.66 mg / kg.

[0180]On Day 5, the mice with bleomycin treatment were divided into four groups at random (referred to as Group 2-5, n=10), and orally administered with vehicle (DMSO: PEG400=1:9, V / V), itraconazole (Kangmanlin Co. Ltd. prepared in DMSO / PEG400 with a final concentration of 1.5 mg / mL), nintedanib (Kangmanlin Co. Ltd., prepared in DMSO / PEG400 with a final concentration of 6.0 mg / mL), and itraconazole +nintedanib (prepared in DMSO / PEG400 with final concentrations of 1.5 mg / mL and 6.0 mg / mL) at daily doses of 10 mL / kg, 15 mg / kg, 6...

example 3

Inhalation Treatment of Itraconazole Inhibited Fibrosis

[0186]Sixty male ICR mice (SHANGHAI SLAC LABORATORY ANIMAL CO., LTD) were randomly divided into two groups on Day 1, 10 animals for one group (referred to as Control group or Group 1) and 50 for the other. The mice were anesthetized by intraperitoneal injection of 1.5% pentobarbital sodium solution at a dose of 0.1 mL / 20 g, and then supinely positioned and immobilized. Iodine was used to disinfect the neck hair and skin. Later, the neck skin was cut to expose the trachea. 50 μL of PBS or bleomycin hydrochloride (Hisun Pfizer pharmaceutical Co., LTD, 17001711) in 0.9% sodium chloride solution (0.35 USP / ml, i.e., 350 bleomycin units / mL) was quickly sprayed as mist into the trachea of mice from the Control Group or the other group with a high pressure syringe connected to a spraying nozzle. At the end, the skin was sutured and disinfected, and the mice were returned to the cages for recovery.

[0187]On Day 5, the mice treated with bl...

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Abstract

Provided is a pharmaceutical composition comprising an effective amount of itraconazole, and a pharmaceutically acceptable excipient. The use of the pharmaceutical composition for treatment of idiopathic pulmonary fibrosis is also provided.

Description

BACKGROUND OF THE INVENTION[0001]Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive lung disease that results in respiratory failure and death. IPF is the most common cause of death from progressive lung disease, and affects about 5 million people worldwide. An estimated median survival after diagnosis is only 2-3 years (Chakraborty et al., (2014) Expert Opin Investig Drugs, 23:893-910; Spagnolo et al., (2015) Pharmacology &Therapeutics 152:18-27; Tzouvelekis et al., (2015) Therapeutics and Clinical Risk Management 11:359-370). In the United States, as many as 89,000 people are afflicted with IPF, with about 34,000 newly diagnosed annually (Raghu G et al., (2006) Am J Respir Crit Care Med 174: (7):810-816). Prevalence of IPF ranges from 14.0 to 42.7 cases per 100,000 persons and the annual incidence ranges from 6.8 to 16.3 cases per 100,000 persons, depending on the strictness of the diagnostic criteria employed (Raghu G et al., supra.). The prevalence of IPF increases...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K31/4418A61K9/00A61P11/00
CPCA61K31/496A61P11/00A61K31/4418A61K9/0078A61K2300/00
Inventor LIANG, GUI-BAI
Owner LIANG GUI BAI
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