Breath Therapeutics Gmbh

Other

Oliver Denk

Gerhard Boerner

Martin Knoch

Aldo T Iacono

Aldo Iacono

Gerhard Börner

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 (), the nebulizer comprising: a) an aerosol generator () comprising: —a fluid reservoir () for holding the pharmaceutical composition or an interface configured to connect a fluid reservoir, and—a vibratable membrane () 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 15 4.0 μm as measured with a 0.9% (w/v) aqueous solution of sodium chloride; b) a chamber () for temporarily accommodating the aerosol generated by the aerosol generator (), the chamber having an inner lumen with a volume in the range of from about 50 to about 150 ml; and c) a mouthpiece () for delivering the aerosol supplied by the nebulizer () to the subject, the mouthpiece having an exhalation filter ().

Inhalable compositions comprising macrocyclic immunosuppressants

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 (), the nebulizer comprising: a) an aerosol generator () comprising: —a fluid reservoir () for holding the pharmaceutical composition or an interface configured to connect a fluid reservoir, and a vibratable membrane () 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 () for temporarily accommodating the aerosol generated by the aerosol generator (), the chamber having an inner lumen with a volume in the range of from about 50 to about 150 ml; and c) a mouthpiece () for delivering the aerosol supplied by the nebulizer () to the subject, the mouthpiece having an exhalation filter ().

Inhalable compositions for use in the treatment of pulmonary diseases

The present invention relates to a composition comprising cyclosporine A (CsA) for use in the prevention of bronchiolitis obliterans syndrome (BOS) in a double lung transplanted patient, or for the treatment of BOS or for the prevention or delay of the progression of BOS in a double lung transplanted patient being diagnosed with BOS, wherein the composition is administered to said patient by inhalation of said composition in aerosolized form comprising a therapeutically effective dose of cyclo-sporine A.

Cyclosporine formulations for use in the treatment of bronchiolitis obliterans syndrome (BOS)

The invention relates to cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection. In particular, the invention provides a cyclosporine liquid formulation for use as an aerosol for inhalation in a method of preventing or treating pulmonary chronic graft rejection in single lung transplanted patients. The formulation is preferably administered once or twice daily. The formulation may be aerosolized with a nebulizer that comprises features for monitoring the time, date and duration of inhalation by the patient, in order to monitor patient adherence. The formulation according to the invention may be combined with standard immunosuppressants and corticosteroids.

Cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection

The present invention relates to a composition comprising cyclosporine A (CsA) for use in the prevention of bronchiolitis obliterans syndrome (BOS) in a double lung transplanted patient, or for the treatment of BOS or for the prevention or delay of the progression of BOS in a double lung transplanted patient being diagnosed with BOS, wherein the composition is administered to said patient by inhalation of said composition in aerosolized form comprising a therapeutically effective dose of cyclosporine A.

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 (), the nebulizer comprising: a) an aerosol generator () comprising: &#x2014;a fluid reservoir () for holding the pharmaceutical composition or an interface configured to connect a fluid reservoir, and a vibratable membrane () 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 () for temporarily accommodating the aerosol generated by the aerosol generator (), the chamber having an inner lumen with a volume in the range of from about 50 to about 150 ml; and c) a mouthpiece () for delivering the aerosol supplied by the nebulizer () to the subject, the mouthpiece having an exhalation filter ().

The invention relates to cyclosporine formulations for use in the prevention or treatment of pulmonary chronic graft rejection. In particular, the invention provides a cyclosporine liquid formulation for use as an aerosol for inhalation in a method of preventing or treating pulmonarychronic graft rejection in single lung transplanted patients. The formulation is preferably administered once or twice daily. The formulation may be aerosolized with a nebulizer that comprises features for monitoring the time, date and duration of inhalation by the patient, in order to monitor patient adherence. The formulation according to the invention may be combined with standard immunosuppressants and corticosteroids.

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Muensing, Germany

Oliver Denk