Stainless steel can for pressurised metered dose inhalers
Inventors
Zambelli, Enrico • BONELLI, Sauro • COPELLI, Diego • DAGLI ALBERI, MASSIMILIANO • Usberti, Francesca
Assignees
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Publication Number
US-12616654-B2
Publication Date
2026-05-05
Expiration Date
Abstract
The invention generally refers to a stainless steel can for use in a metered dose inhaler device, containing an aerosol formulation, comprising glycopyrronium bromide and formoterol, or a salt or a solvate thereof, optionally in combination with one or more additional active ingredient, endowed with a high stability.
Core Innovation
The invention relates to a pharmaceutical aerosol solution formulation contained in an aerosol can made of stainless steel. The formulation comprises glycopyrronium bromide and formoterol, or a salt or solvate thereof, together with a HFA propellant, a co-solvent, and a mineral acid, with the option to include an inhalation corticosteroid. The stainless steel is selected from specified grades including 904L, 316, 316L, 305, 304, 304L, 6Mo, or 2205.
The invention addresses the formation and level of a specific degradation product, identified as DP3. The formulation is characterized so that, after accelerated storage, DP3 is controlled to be below 0.10% w/w, relative to the theoretical amount of formoterol fumarate. In addition, total formoterol degradation products are controlled to be below 10% w/w and residual formoterol fumarate is maintained above 90% w/w.
The described work includes comparative stability assessment of can materials, including stainless steel versus various aluminum or coated aluminum can materials, under simulated worst-case storage. The outcomes are reported in terms of DP3 and other formoterol degradation and residual content, with the stainless-steel aerosol can configuration supporting suppression of DP3 and maintenance of formoterol fumarate levels.
Claims Coverage
The document contains one independent claim covering a stainless-steel aerosol can formulation for a pressurized metered dose inhaler with glycopyrronium bromide, formoterol, an HFA propellant, a co-solvent, and a mineral acid, with optional inclusion of an inhalation corticosteroid. The claim incorporates inventive features including limiting the stainless-steel can grades and defining the formulation components, with dependent claims further constraining mineral acid identity, formoterol salt identity, corticosteroid selection, and stability/quality thresholds tied to DP3 after accelerated storage.
Stainless-steel aerosol can formulation with glycopyrronium bromide and formoterol stabilized by mineral acid
A pharmaceutical aerosol solution formulation in an aerosol can made of stainless steel, wherein the solution comprises glycopyrronium bromide, formoterol or a salt or a solvate thereof, an HFA propellant, a co-solvent, and a mineral acid, with optional inclusion of an inhalation corticosteroid.
Stainless-steel can grades are limited to specified alloys
The stainless steel is selected from grade 904L, 316, 316L, 305, 304, 304L, 6Mo, or 2205.
Stability threshold for DP3 under accelerated storage
The formulation is characterized so that the degradation product DP3 is below 0.10% w/w after accelerated storage.
Control of total degradation products and residual formoterol fumarate
The formulation maintains total formoterol degradation products below 10% w/w and residual formoterol fumarate above 90% w/w.
Use of specified mineral acid
The mineral acid is hydrochloric acid in a defined concentration range as specified in the dependent claim.
Formoterol is specified as formoterol fumarate
The formoterol salt is formoterol fumarate.
Optional inhalation corticosteroid is selected from a specified group
The inhalation corticosteroid is selected from a defined group of corticosteroids including beclometasone dipropionate and budesonide.
Reduced DP3 during shelf-life by using stainless-steel aerosol can
A method to lower the amount of degradation product DP3 during shelf-life by containing the formulation in an aerosol can made of stainless steel.
Overall claim coverage centers on a stainless-steel aerosol-can pharmaceutical solution combining glycopyrronium bromide and formoterol with an HFA propellant, co-solvent, and mineral acid, optionally with an inhalation corticosteroid, with stainless steel restricted to specified grades. Dependent features further narrow mineral acid identity and concentration, specify formoterol fumarate and corticosteroid selection, and impose stability and quality constraints using DP3 and related degradation and residual formoterol fumarate thresholds after accelerated storage.
Stated Advantages
DP3 is suppressed to below the 0.10% w/w limit of quantification after accelerated storage.
Total formoterol degradation products are controlled to below 10% w/w after storage.
Residual formoterol fumarate is maintained above 90% w/w.
Environmental and sustainability advantages are stated from avoiding internal polymer coatings.
Documented Applications
Pressurized metered dose inhaler use of a pharmaceutical aerosol solution formulation containing glycopyrronium bromide and formoterol in a stainless-steel aerosol can, with optional inhalation corticosteroid.
Stability assessment comparing stainless-steel aerosol cans versus various aluminum or coated can materials, reporting DP3 and formoterol degradation and residual content after simulated worst-case storage.
Shelf-life use case aiming to lower the amount of degradation product DP3 by containing the formulation in an aerosol can made of stainless steel.
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