Inhalable compositions for use in the treatment of pulmonary diseases

A pharmaceutical composition comprising cyclosporine A in liposomally solubilized form (L-CsA) 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 μm 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);
• wherein the mouthpiece (40) comprises:
• a body (46) defining a fluid path (47) from an inlet port (41) connectable to the nebulizer (100) to an inhalation opening (42) to be received in the mouth of the user;
• and
• an exhalation filter (30) having a filter base (31) in fluid communication with the fluid path (47), a filter top (33) detachably connected to the filter base (31) and a filter material (32) provided between the filter base (31) and the filter top (33), wherein the filter top (33) has an exhalation opening (36) cooperating with a one-way valve (39) allowing exhaustion of fluid from the fluid path (47) through the filter material (32) to the outside of the mouthpiece (40) upon exhalation of a patient through the inhalation opening;
• wherein the body (46) and the filter base (31) are an integrated one-piece unit.

A kit comprising

• a pharmaceutical composition comprising cyclosporine A in liposomally solubilized form for use in the prevention or treatment of a pulmonary disease or condition in a subject;
• and
• 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 μm 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)
• wherein the mouthpiece (40) comprises:
• a body (46) defining a fluid path (47) from an inlet port (41) connectable to the nebulizer (100) to an inhalation opening (42) to be received in the mouth of the user;
• and
• an exhalation filter (30) having a filter base (31) in fluid communication with the fluid path (47), a filter top (33) detachably connected to the filter base (31) and a filter material (32) provided between the filter base (31) and the filter top (33), wherein the filter top (33) has an exhalation opening (36) cooperating with a one-way valve (39) allowing exhaustion of fluid from the fluid path (47) through the filter material (32) to the outside of the mouthpiece (40) upon exhalation of a patient through the inhalation opening;
• wherein the body (46) and the filter base (31) are an integrated one-piece unit.