公开(公告)号：EP3384931A1

公开(公告)日：2018-10-10

申请号：EP18173392.4

申请日：2003-02-26

申请人： Chiesi Farmaceutici S.p.A.

发明人： DAVIES, Rebecca Jaine ,  GANDERTON, David ,  LEWIS, David Andrew ,  MEAKIN, Brian John ,  CHURCH, Tanya Kathleen ,  BRAMBILLA, Gaetano ,  FERRARIS, Alessandra

IPC分类号： A61K47/10 ,  A61K31/485

CPC分类号： A61K9/008 ,  A61K31/4704 ,  A61K31/485 ,  A61K45/06 ,  A61K47/10 ,  A61K2300/00

摘要： A pharmaceutical aerosol formulation to be administered by a pressurized metered dose inhaler which comprises as active ingredient (R,R)-(±)-formoterol fumarate in a concentration comprised between 0.003 and 0.192 % w/v, in a solution of liquefied HFA 134a propellant and anhydrous ethanol as co-solvent, wherein the pH is comprised between 3.5 and 4.0 and is adjusted by adding hydrochloric acid, characterised in that the amount of residual water is less than 1500 ppm on the total weight of the formulation and that the fraction of particles equal or less than 1.1 µm delivered on actuation of the inhaler is higher or equal than 30% as defined by the content of the stages S6-AF of an Andersen Cascade Impactor, relatively to the content of the stages S3-AF, according to the method referred to in European Pharmacopoeia, second edition, 1995, part v.5.9.1, pages 15-17.

公开(公告)号：EP3494995A3

公开(公告)日：2019-07-24

申请号：EP19166324.4

申请日：2003-02-26

申请人： Chiesi Farmaceutici S.p.A.

发明人： DAVIES, Rebecca Jaine ,  GANDERTON, David ,  LEWIS, David Andrew ,  MEAKIN, Brian John ,  CHURCH, Tanya Kathleen ,  BRAMBILLA, Gaetano ,  FERRARIS, Alessandra

IPC分类号： A61K47/10 ,  A61K31/485

摘要： A propellant/co-solvent system comprising fully dissolved formoterol, or a stereoisomer, physiologically acceptable salt or solvate thereof, and capable of providing on actuation of a pressurized metered dose inhaler a fraction of at least 30% of emitted particles with an aerodynamic diameter equal or less than 1.1 µm for use in the treatment of a respiratory disorder selected from asthma and chronic obstructive pulmonary disease.

公开(公告)号：EP3536344B1

公开(公告)日：2020-02-19

申请号：EP19171326.2

申请日：2003-02-26

申请人： Chiesi Farmaceutici S.p.A.

发明人： DAVIES, Rebecca Jaine ,  GANDERTON, David ,  LEWIS, David Andrew ,  MEAKIN, Brian John ,  CHURCH, Tanya Kathleen ,  BRAMBILLA, Gaetano ,  FERRARIS, Alessandra

IPC分类号： A61K47/10 ,  A61K31/485

公开(公告)号：EP3384931B1

公开(公告)日：2019-07-24

申请号：EP18173392.4

申请日：2003-02-26

申请人： Chiesi Farmaceutici S.p.A.

发明人： DAVIES, Rebecca Jaine ,  GANDERTON, David ,  LEWIS, David Andrew ,  MEAKIN, Brian John ,  CHURCH, Tanya Kathleen ,  BRAMBILLA, Gaetano ,  FERRARIS, Alessandra

IPC分类号： A61K47/10 ,  A61K31/485

公开(公告)号：EP3494995B1

公开(公告)日：2020-02-19

申请号：EP19166324.4

申请日：2003-02-26

申请人： Chiesi Farmaceutici S.p.A.

发明人： DAVIES, Rebecca Jaine ,  GANDERTON, David ,  LEWIS, David Andrew ,  MEAKIN, Brian John ,  CHURCH, Tanya Kathleen ,  BRAMBILLA, Gaetano ,  FERRARIS, Alessandra

IPC分类号： A61K47/10 ,  A61K31/485

公开(公告)号：EP3494995A2

公开(公告)日：2019-06-12

申请号：EP19166324.4

申请日：2003-02-26

申请人： Chiesi Farmaceutici S.p.A.

发明人： DAVIES, Rebecca Jaine ,  GANDERTON, David ,  LEWIS, David Andrew ,  MEAKIN, Brian John ,  CHURCH, Tanya Kathleen ,  BRAMBILLA, Gaetano ,  FERRARIS, Alessandra

IPC分类号： A61K47/10 ,  A61K31/485

摘要： A propellant/co-solvent system comprising fully dissolved formoterol, or a stereoisomer, physiologically acceptable salt or solvate thereof, and capable of providing on actuation of a pressurized metered dose inhaler a fraction of at least 30% of emitted particles with an aerodynamic diameter equal or less than 1.1 µm for use in the treatment of a respiratory disorder selected from asthma and chronic obstructive pulmonary disease.