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Combination therapy for COPD

A technology for inhalation therapy and use, applied in the field of prevention and treatment of respiratory disorders), which can solve problems such as short storage period and instability of aerosol solution

Pending Publication Date: 2019-04-02
CHIESI FARM SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has long been known that aerosol solutions of formoterol fumarate are relatively unstable and have a short shelf life when stored under suboptimal conditions

Method used

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  • Combination therapy for COPD
  • Combination therapy for COPD
  • Combination therapy for COPD

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0160] Embodiment 1. Preparation of fixed ternary combination aerosol solution preparation

[0161] Compositions of formoterol fumarate dihydrate (FF), beclomethasone dipropionate (BDP) and glycopyrronium bromide (GB) were prepared as shown in Table 2 and packaged on FEP-coated In aluminum cans equipped with EPDM valves with a 63 μl metering chamber.

[0162] Table 2. Composition of an aerosol solution composition of a fixed ternary combination of formoterol fumarate (FF) dihydrate, glycopyrronium bromide (GB) and beclomethasone dipropionate (BDP). Content % w / w refers to the content percentage of the weight of each component relative to the total weight of the composition.

[0163]

Embodiment 2

[0164] Example 2. Comparison of the administration of the product (1) according to the invention with respect to the comparative therapy (2) and the comparative therapy (3)

[0165] Product therapy (1): It is the fixed-dose pMDI solution formulation of Example 1, consisting of beclomethasone dipropionate (BDP) 100 μg / actuation, formoterol fumarate (FF) dihydrate 6 μg / actuation Composed of a ternary combination with glycopyrronium bromide (GB) 12.5 μg / actuation, administered in 2 actuations twice daily (b.i.d.).

[0166] Comparator therapy (2): It is a DPI formulation of Tiotropium bromide (Tio) 18 μg / actuation (Spiriva Handihaler), administered in 1 actuation once a day.

[0167] Comparator therapy (3): It is a fixed-dose pMDI solution formulation of a binary combination of BDP 100 μg / actuation and FF 6 μg / actuation (administered in 2 actuations b.i.d.) + tiotropium Immediate triple combination of DPI formulation (administered in 1 actuation once daily) at 18 μg / actuation.

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PUM

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Abstract

Aerosol formulations comprising glycopyrronium bromide, formoterol or a salt thereof, and beclometasone dipropionate are useful for the prevention or treatment of moderate / severe chronic obstructive pulmonary disease.

Description

technical field [0001] The present invention relates to methods for the prevention and treatment of respiratory disorders, including moderate / severe chronic obstructive pulmonary disease (COPD), and to pharmaceutical aerosol formulations for the treatment of COPD. Background technique [0002] Glycopyrronium bromide (also known as glycopyrrolate) is a long-acting anti-muscarinic agent (LAMA), which is particularly active as an antagonist on M3 subtype cholinergic receptors. It is used to reduce salivation associated with the administration of certain anesthetics and as an adjunctive therapy for peptic ulcers. It has also been reported to be effective in treating asthma symptoms (Hansel et al., Chest, 2005; 128:1974-1979, which is hereby incorporated by reference in its entirety). [0003] WO 2005 / 107873, which is hereby incorporated by reference in its entirety, discloses the use of glycopyrronium bromide for the treatment of asthma in children. [0004] WO 01 / 76575, which...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K47/02A61K47/10A61K31/167A61K31/40A61K31/573A61P11/00
CPCA61M15/0021A61M15/0068A61K9/0075A61K9/008A61K31/167A61K31/40A61K31/56A61K31/573A61K47/02A61K47/10A61K9/00A61M16/20A61M15/00A61P11/00A61P43/00A61K2300/00A61K31/4015A61K31/575A61K31/4704A61K31/58A61K31/136A61K9/0078
Inventor M·斯库里P·克里G·德尔曼特
Owner CHIESI FARM SPA
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