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MA39155A1 - Composition de solution d'aérosol stable, mise sous pression, de combinaison de bromure de glycopyrronium et de formotérol - Google Patents

Composition de solution d'aérosol stable, mise sous pression, de combinaison de bromure de glycopyrronium et de formotérol

Info

Publication number
MA39155A1
MA39155A1 MA39155A MA39155A MA39155A1 MA 39155 A1 MA39155 A1 MA 39155A1 MA 39155 A MA39155 A MA 39155A MA 39155 A MA39155 A MA 39155A MA 39155 A1 MA39155 A1 MA 39155A1
Authority
MA
Morocco
Prior art keywords
formoterol
combination
glycopyrronium bromide
aerosol solution
hydroxy
Prior art date
Application number
MA39155A
Other languages
English (en)
Inventor
Sauro Bonelli
Diego Copelli
Alberi Massimiliano Dagli
Francesca Usberti
Enrico Zambelli
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=MA39155(A1) "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 MA39155A1 publication Critical patent/MA39155A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • A61K9/124Aerosols; Foams characterised by the propellant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/008Sprays 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]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/12Aerosols; Foams
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57Compounds 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
    • A61K31/573Compounds 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/56Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/007Mechanical counters
    • A61M15/0071Mechanical counters having a display or indicator
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0086Inhalation chambers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/06Antiasthmatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • A61P11/08Bronchodilators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M2039/226Spindles or actuating means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/02General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pulmonology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Pain & Pain Management (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention concerne une composition de solution d'aérosol, conçue pour être utilisée avec un aérosol-doseur mis sous pression, comportant du bromure de glycopyrronium et du formotérol, ou un sel de ceux-ci ou un solvate dudit sel, facultativement en combinaison avec un ou plusieurs principes actifs supplémentaires, stabilisée par une quantité choisie d'un acide minéral, la quantité de produit de dégradation n-(3-bromo)-[2-hydroxy-5-[l-hydroxy-2-[l-(4- méthoxyphényl) propan-2-ylamino]éthyl] phényl] formamide étant inférieure à la limite de quantification, lorsqu'elle est stockée dans des conditions accélérées à 25 °c et à une humidité relative (rh) de 60 % pendant 6 mois dans une boîte recouverte intérieurement par une résine comportant un polymère d'éthylène-propylène fluoré (fep). Le ou les principes actifs facultatifs peuvent être un corticostéroïde d'inhalation choisi parmi le dipropionate de béclométasone, le budésonide ou son épimère 22r, le ciclésonide, le flunisolide, le propionate de fluticasone, le furoate de fluticasone, le furoate de mométasone, etc.
MA39155A 2013-12-30 2016-06-28 Composition de solution d'aérosol stable, mise sous pression, de combinaison de bromure de glycopyrronium et de formotérol MA39155A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13199784 2013-12-30
PCT/EP2014/079259 WO2015101576A1 (fr) 2013-12-30 2014-12-23 Composition de solution d'aérosol stable, mise sous pression, de combinaison de bromure de glycopyrronium et de formotérol

Publications (1)

Publication Number Publication Date
MA39155A1 true MA39155A1 (fr) 2017-04-28

Family

ID=49886777

Family Applications (1)

Application Number Title Priority Date Filing Date
MA39155A MA39155A1 (fr) 2013-12-30 2016-06-28 Composition de solution d'aérosol stable, mise sous pression, de combinaison de bromure de glycopyrronium et de formotérol

Country Status (34)

Country Link
US (2) US10596113B2 (fr)
EP (3) EP3089735B1 (fr)
JP (2) JP6563950B2 (fr)
KR (2) KR101861119B1 (fr)
CN (2) CN105848641B (fr)
AR (1) AR098982A1 (fr)
AU (1) AU2014375301B2 (fr)
BR (1) BR112016014583B1 (fr)
CA (1) CA2935305C (fr)
CL (1) CL2016001653A1 (fr)
CY (1) CY1120668T1 (fr)
DK (1) DK3089735T3 (fr)
EA (1) EA033227B1 (fr)
ES (1) ES2687345T3 (fr)
HK (1) HK1225313A1 (fr)
HR (1) HRP20181551T1 (fr)
HU (1) HUE039513T2 (fr)
IL (1) IL246498B (fr)
LT (1) LT3089735T (fr)
MA (1) MA39155A1 (fr)
MX (1) MX368835B (fr)
MY (1) MY182861A (fr)
PE (1) PE20160997A1 (fr)
PH (1) PH12016501268B1 (fr)
PL (1) PL3089735T3 (fr)
PT (1) PT3089735T (fr)
RS (1) RS57687B1 (fr)
SA (1) SA516371427B1 (fr)
SG (1) SG11201605311UA (fr)
SI (1) SI3089735T1 (fr)
TN (1) TN2016000261A1 (fr)
TW (1) TWI660747B (fr)
UA (1) UA117845C2 (fr)
WO (1) WO2015101576A1 (fr)

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ES2464520T3 (es) * 2009-12-23 2014-06-03 Chiesi Farmaceutici S.P.A. Formulación en aerosol para EPOC
JP5914354B2 (ja) * 2009-12-23 2016-05-11 シエシー ファルマセウティチィ ソシエタ ペル アチオニ Copd用併用療法
ES2467928T3 (es) 2009-12-23 2014-06-13 Chiesi Farmaceutici S.P.A. Formulación en aerosol para EPOC
EP2613828B1 (fr) 2010-09-06 2019-11-27 CHIESI FARMACEUTICI S.p.A. Actionneur d'inhalateur de dose mesurée, inhalateur de dose mesurée
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BR112015002757A2 (pt) 2012-08-29 2017-07-04 Chiesi Farm Spa acionador para dispositivo inalador de aerossol, objeto em forma cilíndrica oca, inalador, acionador de inalador dosimétrico, kit e uso de um acionador
LT3089735T (lt) * 2013-12-30 2018-09-10 Chiesi Farmaceutici S.P.A. Glikopironio bromido ir formoterolio derinio stabili suslėgta aerozolinė tirpalo kompozicija
MY176191A (en) * 2013-12-30 2020-07-24 Chiesi Farm Spa Stable pressurised aerosol solution composition of glycopyrronium bromide and formoterol combination

Also Published As

Publication number Publication date
JP2017507169A (ja) 2017-03-16
JP6823118B2 (ja) 2021-01-27
JP2019206557A (ja) 2019-12-05
UA117845C2 (uk) 2018-10-10
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US20150182450A1 (en) 2015-07-02
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US10617638B2 (en) 2020-04-14
US10596113B2 (en) 2020-03-24
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IL246498B (en) 2020-05-31
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