WO2003074025A3 - Pressurised metered dose inhalers containing solutions of beta-2 agonists - Google Patents

Pressurised metered dose inhalers containing solutions of beta-2 agonists Download PDF

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Publication number
WO2003074025A3
WO2003074025A3 PCT/EP2003/002004 EP0302004W WO03074025A3 WO 2003074025 A3 WO2003074025 A3 WO 2003074025A3 EP 0302004 W EP0302004 W EP 0302004W WO 03074025 A3 WO03074025 A3 WO 03074025A3
Authority
WO
WIPO (PCT)
Prior art keywords
agonists
metered dose
dose inhalers
beta
pressurised metered
Prior art date
Application number
PCT/EP2003/002004
Other languages
French (fr)
Other versions
WO2003074025A2 (en
Inventor
Rebecca Jaine Davies
David Ganderton
David Andrew Lewis
Brian John Meakin
Tanya Kathleen Church
Gaetano Brambilla
Alessandra Ferraris
Original Assignee
Chiesi Farma Spa
Rebecca Jaine Davies
David Ganderton
David Andrew Lewis
Brian John Meakin
Tanya Kathleen Church
Gaetano Brambilla
Alessandra Ferraris
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=27790093&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2003074025(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from EP02004786A external-priority patent/EP1340492A1/en
Priority claimed from EP02023589A external-priority patent/EP1415647A1/en
Priority to YU76604A priority Critical patent/RS76604A/en
Priority to IL16384403A priority patent/IL163844A0/en
Priority to EP03743343A priority patent/EP1480617A2/en
Priority to US10/505,861 priority patent/US20050154013A1/en
Priority to AU2003210370A priority patent/AU2003210370C1/en
Priority to BR0308275-0A priority patent/BR0308275A/en
Priority to JP2003572545A priority patent/JP2005524664A/en
Priority to MXPA04008369A priority patent/MXPA04008369A/en
Priority to NZ535017A priority patent/NZ535017A/en
Application filed by Chiesi Farma Spa, Rebecca Jaine Davies, David Ganderton, David Andrew Lewis, Brian John Meakin, Tanya Kathleen Church, Gaetano Brambilla, Alessandra Ferraris filed Critical Chiesi Farma Spa
Priority to MEP-302/08A priority patent/MEP30208A/en
Priority to KR1020047013502A priority patent/KR100961603B1/en
Priority to CA2477885A priority patent/CA2477885C/en
Priority to EA200401005A priority patent/EA008592B1/en
Priority to UA20040806968A priority patent/UA80695C2/en
Publication of WO2003074025A2 publication Critical patent/WO2003074025A2/en
Publication of WO2003074025A3 publication Critical patent/WO2003074025A3/en
Priority to TNP2004000149A priority patent/TNSN04149A1/en
Priority to HRP20040753 priority patent/HRP20040753A2/en
Priority to NO20043625A priority patent/NO20043625L/en
Priority to US12/487,988 priority patent/US20090263488A1/en

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
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • 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
    • 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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/4704—2-Quinolinones, e.g. carbostyril
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • 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
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/16—Central respiratory analeptics
    • 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
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Dispersion Chemistry (AREA)
  • Otolaryngology (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Quinoline Compounds (AREA)

Abstract

The present invention relates to a pharmaceutical formulation for use in the administration of 2(1H)-quinolinone derivatives long-acting β2-agonists by inhalation. In particular this invention relates to a chemically stable highly efficient TA 2005 HFA solution formulation to be administered by pressurised metered dose inhalers (pMDIs) characterized by a deep lung penetration. The invention also relates to methods for the preparation of said formulation and to its use in respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD).
PCT/EP2003/002004 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists WO2003074025A2 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
CA2477885A CA2477885C (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists
EA200401005A EA008592B1 (en) 2002-03-01 2003-02-27 Pressurised metered dose inhailers containing solutions of beta-2-agonists
UA20040806968A UA80695C2 (en) 2002-03-01 2003-02-27 Pharmaceutical formulation containing 2(1h)-quinolinone derivative long-acting -agonists administered by pressurised metered dose inhalers and method for the preparation thereof
KR1020047013502A KR100961603B1 (en) 2002-03-01 2003-02-27 Pressurized metered dose inhalers containing solutions of ?-2 agonists
EP03743343A EP1480617A2 (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists
US10/505,861 US20050154013A1 (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists
AU2003210370A AU2003210370C1 (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists
BR0308275-0A BR0308275A (en) 2002-03-01 2003-02-27 Pressurized metered dose inhalers containing beta-2 agonist solutions
JP2003572545A JP2005524664A (en) 2002-03-01 2003-02-27 Pressurized metered dose inhaler containing β2-agonist solution
MXPA04008369A MXPA04008369A (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists.
NZ535017A NZ535017A (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers for asthma and chronic obstructive pulmonary disease (COPD) containing 2(1H)-quinolinone derivatives
YU76604A RS76604A (en) 2002-03-01 2003-02-27 Pressuriesed metered dose inhalers containing solutions of beta-2 agonists
MEP-302/08A MEP30208A (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists
IL16384403A IL163844A0 (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists
TNP2004000149A TNSN04149A1 (en) 2002-03-01 2004-08-06 Pressurised metered dose inhalers containing solutions of beta-2 agonists
HRP20040753 HRP20040753A2 (en) 2002-03-01 2004-08-20 Pressurised metered dose inhalers containing solutions of beta-2 agonists
NO20043625A NO20043625L (en) 2002-03-01 2004-08-31 Pressurized ground dose inhalers containing beta-2 agonist solutions
US12/487,988 US20090263488A1 (en) 2002-03-01 2009-06-19 Pressurised metered dose inhalers containing solutions of beta-2 agonists

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP02004786A EP1340492A1 (en) 2002-03-01 2002-03-01 Aerosol formulations for pulmonary administration of medicaments having systemic effects
EP02004786.6 2002-03-01
EP02023589.1 2002-10-23
EP02023589A EP1415647A1 (en) 2002-10-23 2002-10-23 "Long-acting beta-2 agonists ultrafine formulations"

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/487,988 Continuation US20090263488A1 (en) 2002-03-01 2009-06-19 Pressurised metered dose inhalers containing solutions of beta-2 agonists

Publications (2)

Publication Number Publication Date
WO2003074025A2 WO2003074025A2 (en) 2003-09-12
WO2003074025A3 true WO2003074025A3 (en) 2003-12-24

Family

ID=27790093

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/EP2003/001964 WO2003074024A1 (en) 2002-03-01 2003-02-26 Formoterol superfine formulation
PCT/EP2003/002004 WO2003074025A2 (en) 2002-03-01 2003-02-27 Pressurised metered dose inhalers containing solutions of beta-2 agonists

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/EP2003/001964 WO2003074024A1 (en) 2002-03-01 2003-02-26 Formoterol superfine formulation

Country Status (36)

Country Link
US (4) US20050152846A1 (en)
EP (6) EP1480615B1 (en)
JP (3) JP2005523905A (en)
KR (2) KR100947409B1 (en)
CN (2) CN100398094C (en)
AR (2) AR038644A1 (en)
AT (1) ATE465712T1 (en)
AU (2) AU2003222753B2 (en)
BR (2) BRPI0308274B8 (en)
CA (2) CA2477881C (en)
CO (2) CO5611091A2 (en)
CY (4) CY1111133T1 (en)
DE (1) DE60332321D1 (en)
DK (4) DK3536344T3 (en)
EA (2) EA007735B1 (en)
ES (4) ES2779273T3 (en)
GE (2) GEP20063986B (en)
HK (1) HK1079425A1 (en)
HR (2) HRP20040753A2 (en)
HU (3) HUE044926T2 (en)
IL (3) IL163843A0 (en)
LT (3) LT3384931T (en)
MA (1) MA27175A1 (en)
ME (3) MEP30108A (en)
MX (2) MXPA04008372A (en)
MY (2) MY137603A (en)
NO (2) NO342575B1 (en)
NZ (2) NZ535018A (en)
PE (2) PE20030824A1 (en)
PL (2) PL209212B1 (en)
PT (4) PT3494995T (en)
RS (2) RS52387B (en)
SI (4) SI3384931T1 (en)
TN (2) TNSN04147A1 (en)
TW (2) TW200303752A (en)
WO (2) WO2003074024A1 (en)

Cited By (2)

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US9056100B2 (en) 1999-07-14 2015-06-16 Almirall, S.A. Quinuclidine derivatives and medicinal compositions containing the same
US9254262B2 (en) 2008-03-13 2016-02-09 Almirall, S.A. Dosage and formulation

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EP2100599A1 (en) 2008-03-13 2009-09-16 Laboratorios Almirall, S.A. Inhalation composition containing aclidinium for treatment of asthma and chronic obstructive pulmonary disease
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GB0918149D0 (en) 2009-10-16 2009-12-02 Jagotec Ag Improved medicinal aerosol formulation
EP2515854B1 (en) 2009-12-23 2014-03-19 Chiesi Farmaceutici S.p.A. Aerosol formualtion for COPD
EA021917B1 (en) 2009-12-23 2015-09-30 КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. Combination therapy for asthma and copd
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BR112013001119A2 (en) * 2010-07-16 2016-05-24 Cipla Ltd pharmaceutical composition, process for manufacturing a pharmaceutical composition, use of r (+) budesonide and a bronchodilator, and method of prophylaxis or treatment of a respiratory, inflammatory, or obstructive airway disease
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JP2023513969A (en) 2020-02-20 2023-04-04 キエシ・フアルマチエウテイチ・ソチエタ・ペル・アチオニ A pressurized metered dose inhaler containing a buffered pharmaceutical formulation
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