MX368835B - Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol. - Google Patents

Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol.

Info

Publication number
MX368835B
MX368835B MX2016008594A MX2016008594A MX368835B MX 368835 B MX368835 B MX 368835B MX 2016008594 A MX2016008594 A MX 2016008594A MX 2016008594 A MX2016008594 A MX 2016008594A MX 368835 B MX368835 B MX 368835B
Authority
MX
Mexico
Prior art keywords
solution composition
glycopyrronium bromide
aerosol solution
hydroxy
salt
Prior art date
Application number
MX2016008594A
Other languages
English (en)
Other versions
MX2016008594A (es
Inventor
Bonelli Sauro
Copelli Diego
Dagli Alberi Massimiliano
Usberti Francesca
Zambelli Enrico
Original Assignee
Chiesi Farm Spa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49886777&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=MX368835(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Chiesi Farm Spa filed Critical Chiesi Farm Spa
Publication of MX2016008594A publication Critical patent/MX2016008594A/es
Publication of MX368835B publication Critical patent/MX368835B/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/007—Pulmonary tract; Aromatherapy
    • A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy comprising drug dissolved or suspended in liquid propellant for inhalation via a pressurized metered dose inhaler [MDI]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/16—Amides, e.g. hydroxamic acids
    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/124—Aerosols; Foams characterised by the propellant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0065—Inhalators with dosage or measuring devices
    • A61M15/0068—Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/007—Mechanical counters
    • A61M15/0071—Mechanical counters having a display or indicator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0086—Inhalation chambers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/08—Bronchodilators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M2039/226—Spindles or actuating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer

Abstract

Se describe una composición en solución para aerosol para utilizarse con un inhalador presurizado de dosis medida, que comprende bromuro de glicopirronio y formoterol, o una sal del mismo o un solvato de la sal, opcionalmente en combinación con uno o más ingredientes activos adicionales, estabilizado con una cantidad seleccionada de un ácido mineral y donde la cantidad del producto de degradación N- (3-bromo) - [2-hidroxi -5- [1-hidroxi-2- [1- (4-metoxifenil) propan-2-ilamino]etil]fenil]form amida es menor que el límite de cuantificación, cuando se almacena en condiciones de envejecimiento acelerado a 25°C y 60% de humedad relativa (RH) durante 6 meses en una lata recubierta internamente por una resina que comprende un copolímero de etileno-propileno fluorado (FEP). Los uno o más ingredientes activos opcionales pueden ser corticosteroides para inhalación que se pueden seleccionar entre: dipropionato de beclometasona, budesonida o su 22R-epímero, ciclesonida, flunisolida, propionato de fluticasona, furoato de fluticasona, furoato de mometasona, etc.
MX2016008594A 2013-12-30 2014-12-23 Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol. MX368835B (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13199784 2013-12-30
PCT/EP2014/079259 WO2015101576A1 (en) 2013-12-30 2014-12-23 Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination

Publications (2)

Publication Number Publication Date
MX2016008594A MX2016008594A (es) 2016-09-26
MX368835B true MX368835B (es) 2019-10-18

Family

ID=49886777

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016008594A MX368835B (es) 2013-12-30 2014-12-23 Composición combinada de bromuro de glicopirronio y formoterol en solución estable presurizada para aerosol.

Country Status (34)

Country Link
US (2) US10596113B2 (es)
EP (3) EP3566694A1 (es)
JP (2) JP6563950B2 (es)
KR (2) KR101861119B1 (es)
CN (2) CN111150728B (es)
AR (1) AR098982A1 (es)
AU (1) AU2014375301B2 (es)
BR (1) BR112016014583B1 (es)
CA (1) CA2935305C (es)
CL (1) CL2016001653A1 (es)
CY (1) CY1120668T1 (es)
DK (1) DK3089735T3 (es)
EA (1) EA033227B1 (es)
ES (1) ES2687345T3 (es)
HK (1) HK1225313A1 (es)
HR (1) HRP20181551T1 (es)
HU (1) HUE039513T2 (es)
IL (1) IL246498B (es)
LT (1) LT3089735T (es)
MA (1) MA39155A1 (es)
MX (1) MX368835B (es)
MY (1) MY182861A (es)
PE (1) PE20160997A1 (es)
PH (1) PH12016501268B1 (es)
PL (1) PL3089735T3 (es)
PT (1) PT3089735T (es)
RS (1) RS57687B1 (es)
SA (1) SA516371427B1 (es)
SG (1) SG11201605311UA (es)
SI (1) SI3089735T1 (es)
TN (1) TN2016000261A1 (es)
TW (1) TWI660747B (es)
UA (1) UA117845C2 (es)
WO (1) WO2015101576A1 (es)

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Also Published As

Publication number Publication date
BR112016014583B1 (pt) 2022-12-20
EP3384898A1 (en) 2018-10-10
CA2935305C (en) 2022-07-12
CN105848641A (zh) 2016-08-10
AU2014375301B2 (en) 2020-03-26
PH12016501268A1 (en) 2016-08-15
NZ721642A (en) 2021-02-26
HRP20181551T1 (hr) 2018-11-30
DK3089735T3 (en) 2018-09-17
CN105848641B (zh) 2021-07-09
TW201609185A (zh) 2016-03-16
EA201691126A1 (ru) 2016-12-30
AR098982A1 (es) 2016-06-22
PE20160997A1 (es) 2016-10-14
SG11201605311UA (en) 2016-07-28
PT3089735T (pt) 2018-10-19
JP2019206557A (ja) 2019-12-05
JP6563950B2 (ja) 2019-08-21
EP3089735B1 (en) 2018-07-11
CN111150728A (zh) 2020-05-15
KR20180032660A (ko) 2018-03-30
IL246498A0 (en) 2016-08-31
JP2017507169A (ja) 2017-03-16
PH12016501268B1 (en) 2016-08-15
MA39155A1 (fr) 2017-04-28
JP6823118B2 (ja) 2021-01-27
BR112016014583A2 (es) 2017-08-08
ES2687345T3 (es) 2018-10-24
KR20160104041A (ko) 2016-09-02
SA516371427B1 (ar) 2018-12-24
KR101861119B1 (ko) 2018-05-28
CY1120668T1 (el) 2019-12-11
US10617638B2 (en) 2020-04-14
EA033227B1 (ru) 2019-09-30
MY182861A (en) 2021-02-05
LT3089735T (lt) 2018-09-10
AU2014375301A1 (en) 2016-07-14
CN111150728B (zh) 2024-02-06
TN2016000261A1 (en) 2017-10-06
MX2016008594A (es) 2016-09-26
RS57687B1 (sr) 2018-11-30
US20160303045A1 (en) 2016-10-20
CL2016001653A1 (es) 2017-08-25
SI3089735T1 (sl) 2018-10-30
TWI660747B (zh) 2019-06-01
KR101861117B1 (ko) 2018-05-28
US20150182450A1 (en) 2015-07-02
UA117845C2 (uk) 2018-10-10
HUE039513T2 (hu) 2019-01-28
EP3566694A1 (en) 2019-11-13
WO2015101576A1 (en) 2015-07-09
EP3089735A1 (en) 2016-11-09
IL246498B (en) 2020-05-31
PL3089735T3 (pl) 2018-12-31
HK1225313A1 (zh) 2017-09-08
US10596113B2 (en) 2020-03-24
CA2935305A1 (en) 2015-07-09

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