Stable pharmaceutical solution formulations for pressurized metered dose inhalers
AssigneeChiesi Farmaceutici S.p.A.
InventorsDavid Lewis, David Ganderton, Brian Meakin, Gaetano Brambilla, Alessandra Ferraris
Life of this patent
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Abstract
An aerosol solution composition for use in an aerosol inhaler comprises an active material, a propellant containing a hydrofluoroalkane, a cosolvent and optionally a low volatility component to increase the mass median aerodynamic diameter (MMAD) of the aerosol particles on actuation of the inhaler. The composition is stabilized by using a small amount of mineral acid and a suitable can having part or all of its internal metallic surfaces made of stainless steel, anodized aluminium or lined with an inert organic coating.
Claims25
A composition, comprising:
- formoterol, a stereoisomer of formoterol, or a salt of formoterol, in a solution of a:
- liquefied HFA propellant,
- a co-solvent selected from pharmaceutically acceptable alcohols, and
- a mineral acid,
- wherein said solution has a pH between about 2.5 and about 5.0.
A method for preparing an aerosol composition which comprises formoterol, a stereoisomer of formoterol, or a salt of formoterol, in a solution of a liquefied HPA propellant, a co-solvent and a mineral acid, said method comprising:
- (a) preparing a solution of one or more of formoterol, a stereoisomer of formoterol, or a salt of formoterol, in one or more cosolvent(s) optionally containing an appropriate amount of a low volatility component;
- (a) filling a device with said solution;
- (c) adding a mineral acid to said solution in such an amount to obtain a pH between about 2.5 and about 5.0;
- (d) adding a propellant containing a hydrofluoro-alkane (HFA) to said solution;
- and
- (e) crimping said device with a valve and gassing.
Dependencies are inferred from the claim text.