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DK2501363T3 - Inhalationsopløsninger - Google Patents

Inhalationsopløsninger Download PDF

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Publication number
DK2501363T3
DK2501363T3 DK10795437T DK10795437T DK2501363T3 DK 2501363 T3 DK2501363 T3 DK 2501363T3 DK 10795437 T DK10795437 T DK 10795437T DK 10795437 T DK10795437 T DK 10795437T DK 2501363 T3 DK2501363 T3 DK 2501363T3
Authority
DK
Denmark
Prior art keywords
inhaler
pharmaceutically acceptable
pharmaceutical composition
tiotropium
micrograms
Prior art date
Application number
DK10795437T
Other languages
English (en)
Inventor
Amar Lulla
Geena Malhotra
Original Assignee
Cipla Ltd
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=54196583&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2501363(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Cipla Ltd filed Critical Cipla Ltd
Application granted granted Critical
Publication of DK2501363T3 publication Critical patent/DK2501363T3/da

Links

Classifications

    • 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
    • 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
    • A61K31/33—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
    • A61K31/439—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 the ring forming part of a bridged ring system, e.g. quinuclidine
    • 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
    • A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
    • 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
    • A61K31/4748—Quinolines; Isoquinolines forming part of bridged ring systems
    • 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
    • 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
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/04—Sprayers or atomisers specially adapted for therapeutic purposes operated by the vapour pressure of the liquid to be sprayed or atomised
    • 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
    • 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
    • A61P11/06—Antiasthmatics
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Claims (13)

1. Inhalator til inhalationspræparat omfattende en dåse, der indeholder en farmaceutisk sammensætning under tryk; en måleventil til afmåling af en afmålt dosis af sammensætningen fra dåsen til indgivelse til en patient med behov derfor; og en udløser til at udløse udtømning af den afmålte dosis til patienten; hvor udløseren indeholder en udtømningsåbning med en diameter i området 0,2 til 0,4 mm; og hvori den farmaceutiske sammensætning omfatter et anticholinergisk middel og et farmaceutisk acceptabelt drivmiddel, kendetegnet ved, at måleventilen er udformet til at udlevere den afmålte dosis af den farmaceutiske sammensætning, som indeholder 2,5 til 8 mikrogram af det eller hvert af de anticholinergiske midler.
2. Inhalator ifølge krav 1, hvori det anticholinergiske middel er valgt blandt tiotropium, ipratropium, oxitropium, aclidinium, deres farmaceutisk acceptable salte eller solvater og blandinger deraf.
3. Inhalator ifølge krav 1 eller 2, hvori det anticholinergiske middel er tiotropiumbromid.
4. Inhalator ifølge et vilkårligt foregående krav, hvori drivmidlet omfatter ét eller flere farmaceutisk acceptable HFC-drivmidler og/eller ét eller flere farmaceutisk acceptable carbonhydriddrivmidler.
5. Inhalator ifølge et vilkårligt foregående krav, hvori sammensætningen endvidere indeholder et hjælpeopløsningsmiddel, som fortrinsvis er et polært hjælpeopløsningsmiddel.
6. Inhalator ifølge krav 5, hvori hjælpeopløsningsmidlet omfatter én eller flere alifatiske C2-C6-alkoholer og/eller polyoler.
7. Inhalator ifølge et vilkårligt foregående krav, hvori den farmaceutiske sammensætning endvidere omfatter ét eller flere β-adrenergiske midler.
8. Inhalator ifølge et vilkårligt foregående krav, hvori den farmaceutiske sammensætning endvidere omfatter ét eller flere corticosteroider.
9. Inhalator ifølge krav 1, hvori den farmaceutiske sammensætning omfatter et tiotropium eller et salt deraf, ét eller flere farmaceutisk acceptable HFC-drivmidler og/eller ét eller flere farmaceutisk acceptable carbonhydriddrivmidler og ét eller flere farmaceutisk acceptable excipienser.
10. Inhalator ifølge krav 9, hvori den farmaceutiske sammensætning endvidere omfatter ét eller flere β-adrenergiske midler.
11. Inhalator ifølge krav 9 eller 10, hvori den farmaceutiske sammensætning endvidere omfatter ét eller flere corticosteroider.
12. Inhalator ifølge et vilkårligt foregående krav, som er egnet til anvendelse ved behandling af en respirationslidelse.
13. Inhalator ifølge et hvilket som helst af kravene 1 til 11, som er egnet til anvendelse ved behandling af atsma og/eller kronisk obstruktiv lungesygdom.
DK10795437T 2009-11-17 2010-11-17 Inhalationsopløsninger DK2501363T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2657MU2009 2009-11-17
PCT/GB2010/002126 WO2011061498A2 (en) 2009-11-17 2010-11-17 Inhalation solutions

Publications (1)

Publication Number Publication Date
DK2501363T3 true DK2501363T3 (da) 2015-03-23

Family

ID=54196583

Family Applications (1)

Application Number Title Priority Date Filing Date
DK10795437T DK2501363T3 (da) 2009-11-17 2010-11-17 Inhalationsopløsninger

Country Status (15)

Country Link
US (1) US20130295023A1 (da)
EP (1) EP2501363B1 (da)
JP (1) JP2013510898A (da)
KR (1) KR20120109504A (da)
CN (1) CN102905694B (da)
AU (1) AU2010320728A1 (da)
BR (1) BR112012011770A2 (da)
CA (1) CA2781012A1 (da)
DK (1) DK2501363T3 (da)
ES (1) ES2533535T3 (da)
MX (1) MX2012005711A (da)
NZ (1) NZ600208A (da)
RU (1) RU2012125043A (da)
WO (1) WO2011061498A2 (da)
ZA (1) ZA201203833B (da)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201200504D0 (en) * 2011-12-19 2012-02-22 Teva Branded Pharmaceutical Prod R & D Inc An inhaler
GB201200525D0 (en) * 2011-12-19 2012-02-29 Teva Branded Pharmaceutical Prod R & D Inc An inhalable medicament
EP2819669B1 (de) 2012-02-28 2021-04-21 Boehringer Ingelheim International GmbH Neue treibgashaltige tiotropium-formulierung
EP3368083A1 (en) * 2015-10-29 2018-09-05 3M Innovative Properties Company Formulation and aerosol canisters, inhalers, and the like containing the formulation
CN110251787A (zh) * 2019-05-29 2019-09-20 广东工业大学 一种便携式哮喘吸入器
KR20250108394A (ko) 2024-01-08 2025-07-15 한국기계연구원 흡입기 사용 모니터링 장치 및 이를 이용한 모니터링 방법
WO2025170986A1 (en) * 2024-02-06 2025-08-14 Kindeva Drug Delivery L.P. Drug delivery device

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NL7708731A (nl) 1976-08-13 1978-02-15 Montedison Spa Werkwijze voor de bereiding van nieuwe drijf- middelsamenstellingen voor aerosolen.
ES2129117T3 (es) 1992-12-09 1999-06-01 Boehringer Ingelheim Pharma Formulaciones en disolucion en forma de aerosol medicinales estabilizadas.
US5899201A (en) * 1993-05-26 1999-05-04 Minnesota Mining And Manufacturing Company Aerosol actuator
EA000889B1 (ru) 1995-04-14 2000-06-26 Глаксо Веллкам Инк. Дозирующий ингалятор дипропионата беклометазона
TR199701168T1 (xx) 1995-04-14 1998-05-21 Glaxo Wellcome Inc. Flutikazon Propionat i�in �l��lm�� doz inhaleri.
BR9604977A (pt) 1995-04-14 1998-06-09 Glaxo Wellcome Inc Inalador de dose medida sistema inalador de dose medida e uso do mesmo
EE03997B1 (et) 1995-04-14 2003-04-15 Glaxo Wellcome Inc. Albuterooli doseeriv inhalaator
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IT1317846B1 (it) * 2000-02-22 2003-07-15 Chiesi Farma Spa Formulazioni contenenti un farmaco anticolinergico per il trattamentodella broncopneumopatia cronica ostruttiva.
EP1531866A1 (en) * 2002-08-29 2005-05-25 Cipla Ltd. Pharmaceutical products and compositions comprising specific anticholinergic agents, beta-2 agonists and corticosteroids
US20050058606A1 (en) * 2002-12-16 2005-03-17 Boehringer Ingelheim Pharma Gmbh & Co. Kg Tiotropium containing HFC solution formulations
EP1595531A1 (en) * 2004-05-13 2005-11-16 CHIESI FARMACEUTICI S.p.A. Stable pharmaceutical solution formulations for pressurized metered dose inhalers
CA2579096C (en) * 2004-09-08 2012-11-13 Chelsea Therapeutics, Inc. Quinazoline derivatives as metabolically inert antifolate compounds
DE602005009012D1 (de) * 2004-10-12 2008-09-25 Generics Uk Ltd Rmulierungen, worin die partikel durch präzipition in einem aerosolbehälter gebildet werden
JP2009504604A (ja) * 2005-08-06 2009-02-05 ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング 重症持続型喘息の治療におけるチオトロピウム塩の使用
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EP2011534A1 (en) * 2007-07-03 2009-01-07 CHIESI FARMACEUTICI S.p.A. Metered dose inhaler actuator
EP2080507A1 (en) 2008-01-15 2009-07-22 CHIESI FARMACEUTICI S.p.A. Pharmaceutical formulations comprising an anticholinergic drug
GB0801876D0 (en) 2008-02-01 2008-03-12 Vectura Group Plc Suspension formulations

Also Published As

Publication number Publication date
ZA201203833B (en) 2012-12-27
AU2010320728A1 (en) 2012-06-14
EP2501363A2 (en) 2012-09-26
WO2011061498A2 (en) 2011-05-26
MX2012005711A (es) 2012-10-05
JP2013510898A (ja) 2013-03-28
CN102905694A (zh) 2013-01-30
ES2533535T3 (es) 2015-04-10
RU2012125043A (ru) 2013-12-27
CN102905694B (zh) 2015-10-14
BR112012011770A2 (pt) 2017-10-10
WO2011061498A3 (en) 2011-09-29
NZ600208A (en) 2014-06-27
CA2781012A1 (en) 2011-05-26
KR20120109504A (ko) 2012-10-08
EP2501363B1 (en) 2015-01-14
US20130295023A1 (en) 2013-11-07
HK1176290A1 (en) 2013-07-26

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