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Aerosol formulation for COPD

a technology of aerosol solution and copd, which is applied in the directions of aerosol delivery, packaging goods type, drug composition, etc., can solve the problems of reduced dose delivery, incomplete powder deaggregation, and unsatisfactory device performance, and achieve the effect of prevention and therapy

Inactive Publication Date: 2011-06-23
CHIESI FARM SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012]These and other objects, which will become apparent during the following detailed description, have been achieved by the inventors' discovery that pharmaceutical compositions comprising glycopyrronium bro...

Problems solved by technology

One of the drawbacks of DPIs is that insufficient patient inhalation flow rates may lead to reduced dose delivery and incomplete deaggregation of the powder, leading to unsatisfactory device performance.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Glycopyrronium Bromide Stability During Storage with or without Acid Addition

[0080]Solution formulations were prepared with the compositions shown in Table 1.

TABLE 1Composition of the tested Gly pMDI solution formulations.Theoretical Unit Formula(μg / actuation for a 63 μl valve)GlycopyrroniumAnhydrousbromide (GLY)ethanol1M HClHFA 134aTotalWithout258856—6491973800AcidWith258856146490573800Acid

[0081]The samples containing acid were formulated by the addition of 1M HCl in an amount corresponding to 0.222 μg / μl of the solution. The solution was filled into canisters which were stored inverted under different conditions: 5°; 25° C. / 60% RH; 30° C. / 75% RH; 40° C. / 75% RH. The samples were analyzed chromatographically for glycopyrronium bromide content after 1 to 3 months of storage and after 6 months storage only for 5°; 25° C. / 60% RH. The results are reported in the following Table 2.

TABLE 2GLY pMDI can content (mean % residue ± standard deviation).Temperature / Glycopyrronium BromideGlycopyr...

example 2

Glycopyrronium Bromide Stability During Storage with Different Amount of HCl

[0083]Solution formulations were prepared with a composition corresponding to that of Example 1, Table 1, added with the following different amounts of 1 M HCl.

1M HClμg / actuation(for a 63 μl valve)μg / μl of the formulation0.3120.00503.130.04976.250.099211.80.18715.60.24820.60.32725.00.39728.10.44646.80.74365.61.041

[0084]The solutions were filled into conventional aluminium canisters provided with EPDM valves which were stored inverted for 1 month at 40° C. / 75% RH. The samples were analyzed chromatographically for glycopyrronium bromide content, and the values are the mean values from three cans.

[0085]No stability issues were found for the whole range of acid concentrations.

[0086]The residual glycopyrronium bromide content ranged from 95.9±0.5% to 101.9±2.4% with respect to the content at time 0, and the total degradation product ranged from 0.8±0.1% to 3.7±1.0% of the total composition. Moreover when the conc...

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PUM

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Abstract

Stable aerosol solution formulations comprising glycopyrronium bromide are useful for administration to patients with COPD and other respiratory conditions.

Description

CROSS REFERENCES TO RELATED APPLICATIONS[0001]This application claims priority to European Patent Application No. 09015980.7 filed on Dec. 23, 2009, 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 pharmaceutical aerosol solution formulations comprising glycopyrronium bromide, intended for use in pressurized metered dose inhalers. The present invention further relates to use of such formulations in the prevention and therapy of respiratory disorders, including chronic obstructive pulmonary disease (COPD).[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 for peptic ulcers. It has also been reported to be effective in the treatment of asthmatic symptoms (Hansel et al., Chest, 2005; 128:19...

Claims

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Application Information

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IPC IPC(8): A61K9/12A61P11/00B65B3/04
CPCA61K9/008A61K31/40A61K45/06A61K2300/00A61K31/167A61K31/573A61P11/00A61P11/06A61P11/08A61P43/00A61K9/12A61K47/06A61K47/10B65B31/06B65B31/10
Inventor BONELLI, SAUROUSBERTI, FRANCESCAZAMBELLI, ENRICO
Owner CHIESI FARM SPA
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