Administration of aerosolised iloprost
Inventors
Gessler, Tobias • Schmehl, Thomas • Seeger, Werner • Voswinckel, Robert
Assignees
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Publication Number
US-9486427-B2
Publication Date
2016-11-08
Expiration Date
Abstract
The present invention relates to novel methods, compositions and kits useful for the treatment of pulmonary diseases such as pulmonary arterial hypertension. In particular, aerosolisable compositions of iloprost are provided which are for use in inhalation therapy. The administration is by inhalation over a short period of time, which is patient-friendly, effective, and well tolerated. Inhalation may, for example, be achieved using an efficient nebulizer based on the vibrating mesh technology.
Core Innovation
The invention relates to a method of treatment of pulmonary arterial hypertension by administering an inhalable aerosolised composition comprising an active ingredient selected from iloprost and salts thereof. The method provides an effective single dose of about 1.5 μg to about 5.0 μg using an inhaler adapted or configured to provide said dose in aerosolised form for inhalation within a period of less than 2 minutes.
The aerosol is administered in more than 12 breathing manoeuvres, and rapid inhalation is described as technically and clinically feasible and well tolerated compared with conventional longer nebulisation. The described outcomes include comparable pulmonary hemodynamic effects and similar systemic side-effect profiles when compared with conventional longer nebulisation.
The document further describes inhaler and aerosol delivery constraints and kit embodiments. These embodiments include the use of inhalers and device technologies, including vibrating mesh nebulisers, and include kit arrangements with an inhaler configured for the effective single dose delivered as an aerosol in more than 12 breathing manoeuvres within less than 2 minutes, including kit embodiments that optionally include electronic data storage means for controlling inhaler operation.
Claims Coverage
The provided independent claims cover three inventive features: a treatment method for pulmonary arterial hypertension using a single aerosol dose delivered within less than 2 minutes over more than 12 breathing manoeuvres, a pharmaceutical kit containing an iloprost composition and an inhaler configured for the same dosing, timing, and breathing-manoeuvre conditions, and a pharmaceutical kit further including electronic data storage means capable of controlling an inhaler to provide the same conditions.
Aerosolised iloprost single-dose pulmonary arterial hypertension inhalation within less than 2 minutes
A method of treatment of pulmonary arterial hypertension comprising administering to a patient a composition with an active ingredient selected from iloprost and salts thereof, wherein an effective single dose from about 1.5 μg to about 5.0 μg is provided in aerosolised form for inhalation within a period of less than 2 minutes.
Aerosol administered in more than 12 breathing manoeuvres
The method wherein the aerosol is administered in more than 12 breathing manoeuvres.
Pharmaceutical kit with iloprost composition and inhaler for single-dose aerosol inhalation within less than 2 minutes
A pharmaceutical kit comprising a composition with an active ingredient selected from iloprost or a salt thereof, and an inhaler adapted for providing an amount of the composition comprising an effective single dose from about 1.5 μg to about 5.0 μg in aerosolised form for inhalation in more than 12 breathing manoeuvres within less than 2 minutes.
Pharmaceutical kit with electronic data storage means controlling an inhaler to deliver the single-dose aerosol within less than 2 minutes
A pharmaceutical kit comprising a composition with an active ingredient selected from iloprost or a salt thereof, and an electronic data storage means capable of controlling the operation of an inhaler so as to provide an amount comprising an effective single dose from about 1.5 μg to about 5.0 μg in aerosolised form for inhalation in more than 12 breathing manoeuvres within a period of less than 2 minutes.
The claim coverage is directed to delivering a single aerosolised dose of iloprost or salts for pulmonary arterial hypertension within less than 2 minutes, with the aerosol administered over more than 12 breathing manoeuvres, and to corresponding pharmaceutical kit embodiments including an inhaler and optionally electronic data storage means for controlling inhaler operation.
Stated Advantages
Rapid inhalation is technically and clinically feasible.
Rapid inhalation is well tolerated versus conventional longer nebulisation.
Comparable pulmonary hemodynamic effects (PAP, PVR) versus conventional longer nebulisation.
Similar systemic side-effect profiles (SAP, SVR) versus conventional longer nebulisation.
Documented Applications
Treatment of pulmonary arterial hypertension by administering an aerosolised composition comprising iloprost or salts as an effective single dose in less than 2 minutes using an inhaler, with aerosol administered in more than 12 breathing manoeuvres.
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