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Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination

a technology of glycopyrronium bromide and aerosol solution, which is applied in the direction of aerosol delivery, drug compositions, inorganic non-active ingredients, etc., can solve the problems of relatively unstable aerosol solution of formoterol fumarate and short shelf li

Inactive Publication Date: 2015-07-02
CHIESI FARM SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides novel aerosol solutions containing glycopyrronium bromide and formoterol, or a salt or solvate of this substance, in combination with an inhalation corticosteroid (ICS) stabilized by a mineral acid. These solutions are contained in an aerosol can. The technical effect of this invention is the provision of an effective treatment for respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) that can be conveniently and safely used as a nasal spray.

Problems solved by technology

In this respect, it is 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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Examples

Experimental program
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Effect test

example 1

Stability of a Triple Combination Aerosol Solution Composition Stored at 25° C. and 60% Relative Humidity (RH)

[0154]A study was performed to investigate the stability of a triple combination of formoterol fumarate (FF), glycopyrronium bromide (GLY), and beclometasone dipropionate (BDP) in an aerosol solution formulation whose composition is shown in Table 1 and which was stored for 6 months at 25° C. and 60% relative humidity (RH), in different kinds of can, crimped with different kinds of valve.

TABLE 1Composition of the aerosol solution composition of the triplecombination of formoterol fumarate (FF) dihydrate, glycopyrroniumbromide (GLY) and beclometasone dipropionate (BDP). Content% w / w means the percent content by weight of each componentwith respect to the total weight of the composition.Mass in μg perMass inContent %Componentactuation (63 μL)μg / μL(w / w)BDP1001.590.135FF dihydrate60.0950.0081GLY12.50.200.0169Ethanol (anhydrous)8856140.5712.0001M HCl140.220.0019HFA 134a64811.5102...

example 2

Stability of a Further Triple Combination Aerosol Solution Composition Stored for 6 Months at 25° C. and 60% Relative Humidity (RH)

[0162]A study was performed to investigate the stability of a triple combination of formoterol fumarate (FF), glycopyrronium bromide (GLY), and budesonide in an aerosol solution formulation whose composition is shown in Table 3 and which was stored for 6 months at 25° C. and 60% relative humidity (RH), in different kinds of can, crimped with different kinds of valves.

TABLE 3Composition of the aerosol solution composition of the triplecombination of formoterol fumarate (FF) dihydrate, glycopyrroniumbromide (GLY), and budesonide. Content % w / w means the percentcontent by weight of each component with respect to thetotal weight of the composition.Mass in μg perMass inContent %Componentactuation (63 μL)μg / μL(w / w)Budesonide1001.590.135FF dihydrate60.0950.0081GLY12.50.200.0169Ethanol (anhydrous)8856140.5712.0001M HCl140.220.0019HFA 134a64811.51028.7587.820

[016...

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Abstract

Aerosol solution compositions intended for use with a pressurized metered dose inhaler, comprising glycopyrronium bromide and formoterol, or a salt thereof, optionally in combination with one or more additional active ingredients, and stabilized by a selected amount of a mineral acid, exhibit improved stability when contained in an aerosol can provided with a metering valve having at least a butyl rubber gasket.

Description

CROSS REFERENCES TO RELATED APPLICATIONS[0001]This application claims priority to European Patent Application No. 13199783.5, filed on Dec. 30, 2013, which is incorporated herein by reference in its entirety.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[0003]The present invention relates to stable aerosol solution compositions, comprising glycopyrronium bromide and formoterol, or a salt thereof or a solvate of said salt, optionally in combination with an inhalation corticosteroid (ICS), stabilized by a mineral acid, which are contained in an aerosol can. The present invention also relates to methods of treating and / or preventing certain diseases and conditions by administering such a composition contained in such an aerosol can.[0004]2. Discussion of the Background[0005]Glycopyrronium bromide (also known as glycopyrrolate) is a muscarinic M3 anticholinergic agent used to reduce salivation associated with administration of certain anaesthetics, and as adjunctive therapy ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/12A61M15/00A61K31/573A61K47/06A61K31/40A61K31/167
CPCA61K9/124A61K31/40A61K31/167A61K31/573A61M15/009A61M15/0021A61M15/0071A61M15/0086A61K47/06A61K9/008B65D83/54A61K47/02A61K47/10B65D83/752A61P11/00A61P11/06A61P11/08A61P43/00A61K2300/00A61K31/58A61K45/06A61M39/22A61M2039/226A61K47/08
Inventor BONELLI, SAUROCOPELLI, DIEGOALBERI, MASSIMILIANO DAGLIUSBERTI, FRANCESCAZAMBELLI, ENRICO
Owner CHIESI FARM SPA
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