Inhalable compositions for use in the treatment of pulmonary diseases
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Publication Number
US-11890376-B2
Publication Date
2024-02-06
Expiration Date
Abstract
The present disclosure relates to a pharmaceutical composition comprising an inhalable immunosuppressive macrocyclic active ingredient for use in the prevention or treatment of a pulmonary disease or condition in a subject, wherein the pharmaceutical composition is administered to the subject by inhalation in form of an aerosol, and wherein the aerosol is generated by nebulization of the pharmaceutical composition using a nebulizer (100), the nebulizer comprising: a) an aerosol generator (101) comprising: —a fluid reservoir (103) for holding the pharmaceutical composition or an interface configured to connect a fluid reservoir, and a vibratable membrane (110) having a plurality of apertures, the apertures being adapted to produce an aerosol comprising droplets having a mass median aerodynamic diameter (MMAD) of up to about 4.0 gm as measured with a 0.9% (w/v) aqueous solution of sodium chloride; b) a chamber (105) for temporarily accommodating the aerosol generated by the aerosol generator (101), the chamber having an inner lumen with a volume in the range of from about 50 to about 150 ml; and c) a mouthpiece (40) for delivering the aerosol supplied by the nebulizer (100) to the subject, the mouthpiece having an exhalation filter (30).
Core Innovation
The invention relates to a method of delaying the onset of bronchiolitis obliterans in a subject by administering a pharmaceutical composition comprising cyclosporine A in a liposomally solubilized form after lung transplantation. The pharmaceutical composition is administered by inhalation as an aerosol generated by nebulization of the pharmaceutical composition. The approach links an inhaled liposomally solubilized cyclosporine A formulation with an aerosol generation and delivery nebulizer system.
The method specifies an aerosol generator including a fluid reservoir and a vibratable membrane having a plurality of apertures adapted to produce aerosol droplets having a mass median aerodynamic diameter of up to about 4.0 µm. The generated aerosol is temporarily accommodated in a chamber having an inner lumen volume in the range of about 50 to about 150 mL. Delivery to the subject is performed using a mouthpiece that includes an exhalation filter.
The mouthpiece includes a body defining a fluid path from an inlet port connectable to the nebulizer to an inhalation opening for receipt in the mouth of the subject. The exhalation filter includes a filter base in fluid communication with the fluid path and a filter top detachably connected to the filter base with a filter material provided between the filter base and the filter top. The filter top has an exhalation opening cooperating with a one-way valve allowing exhaustion of fluid from the fluid path through the filter material to the outside of the mouthpiece upon exhalation, and the body and the filter base are an integrated one-piece unit.
Claims Coverage
The relevant content includes one independent claim, which combines three inventive features: delayed bronchiolitis obliterans after lung transplantation using inhaled liposomally solubilized cyclosporine A, a nebulizer aerosol generation structure, and an exhalation-filter mouthpiece.
Delayed onset of bronchiolitis obliterans after lung transplantation by inhaled liposomally solubilized cyclosporine A
A method of delaying the onset of bronchiolitis obliterans in a subject by administering a pharmaceutical composition comprising cyclosporine A in liposomally solubilized form after lung transplantation, wherein the pharmaceutical composition is administered to the subject by inhalation in the form of an aerosol.
Vibratable membrane nebulizer producing droplets with MMAD up to about 4.0 µm and chamber volume 50 to 150 mL
An aerosol generated by nebulization using a nebulizer having an aerosol generator with a fluid reservoir and a vibratable membrane having a plurality of apertures adapted to produce droplets having a mass median aerodynamic diameter of up to about 4.0 µm, with a chamber for temporarily accommodating the aerosol generated by the aerosol generator having an inner lumen volume of about 50 to about 150 mL.
Mouthpiece with exhalation filter using one-way valve to route exhaled fluid through filter material, with integrated one-piece body and filter base
A mouthpiece for delivering the aerosol with an exhalation filter, wherein the mouthpiece comprises a body defining a fluid path to an inhalation opening and an exhalation filter having a filter base in fluid communication with the fluid path, a filter top detachably connected to the filter base with filter material between the filter base and the filter top, and a filter top exhalation opening cooperating with a one-way valve allowing exhaustion of fluid from the fluid path through the filter material to the outside of the mouthpiece upon exhalation, where the body and the filter base are an integrated one-piece unit.
The independent claim combines inhaled liposomally solubilized cyclosporine A for delaying bronchiolitis obliterans after lung transplantation with nebulizer aerosol generation producing droplets of up to about 4.0 µm and a mouthpiece with an exhalation filter, one-way valve, and integrated one-piece body/filter base structure.
Stated Advantages
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