AU2016209363B2 - Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat - Google Patents

Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat Download PDF

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Publication number
AU2016209363B2
AU2016209363B2 AU2016209363A AU2016209363A AU2016209363B2 AU 2016209363 B2 AU2016209363 B2 AU 2016209363B2 AU 2016209363 A AU2016209363 A AU 2016209363A AU 2016209363 A AU2016209363 A AU 2016209363A AU 2016209363 B2 AU2016209363 B2 AU 2016209363B2
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AU
Australia
Prior art keywords
inhaler
dose
port
dry powder
fluticasone propionate
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2016209363A
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English (en)
Other versions
AU2016209363A1 (en
Inventor
Mukul Dalvi
Seah Kee Tee
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Branded Pharmaceutical Products R&D Inc
Original Assignee
Teva Branded Pharmaceutical Products R&D Inc
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55443303&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2016209363(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Branded Pharmaceutical Products R&D Inc filed Critical Teva Branded Pharmaceutical Products R&D Inc
Publication of AU2016209363A1 publication Critical patent/AU2016209363A1/en
Application granted granted Critical
Publication of AU2016209363B2 publication Critical patent/AU2016209363B2/en
Priority to AU2021202784A priority Critical patent/AU2021202784A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61K9/0075Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic 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
    • A61M15/0005Details of inhalators; Constructional features thereof with means for agitating the medicament
    • 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
    • A61M15/0005Details of inhalators; Constructional features thereof with means for agitating the medicament
    • A61M15/0006Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating means
    • A61M15/0008Details of inhalators; Constructional features thereof with means for agitating the medicament using rotating means rotating by airflow
    • 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/10Preparation of respiratory gases or vapours
    • A61M16/14Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • 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
    • A61P11/02Nasal agents, e.g. decongestants
    • 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
    • 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
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/06Solids
    • A61M2202/064Powder

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2016209363A 2015-01-20 2016-01-20 Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat Active AU2016209363B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2021202784A AU2021202784A1 (en) 2015-01-20 2021-05-04 Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562105479P 2015-01-20 2015-01-20
US62/105,479 2015-01-20
PCT/US2016/014072 WO2016118589A1 (en) 2015-01-20 2016-01-20 Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2021202784A Division AU2021202784A1 (en) 2015-01-20 2021-05-04 Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat

Publications (2)

Publication Number Publication Date
AU2016209363A1 AU2016209363A1 (en) 2017-08-24
AU2016209363B2 true AU2016209363B2 (en) 2021-02-04

Family

ID=55443303

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016209363A Active AU2016209363B2 (en) 2015-01-20 2016-01-20 Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat
AU2021202784A Abandoned AU2021202784A1 (en) 2015-01-20 2021-05-04 Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2021202784A Abandoned AU2021202784A1 (en) 2015-01-20 2021-05-04 Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat

Country Status (19)

Country Link
US (2) US9415008B2 (https=)
EP (1) EP3247331A1 (https=)
JP (1) JP2018503687A (https=)
KR (1) KR20170103975A (https=)
CN (1) CN107530357A (https=)
AR (1) AR104771A1 (https=)
AU (2) AU2016209363B2 (https=)
BR (1) BR112017015353A2 (https=)
CA (1) CA2974125A1 (https=)
CL (1) CL2017001859A1 (https=)
CO (1) CO2017008395A2 (https=)
EA (1) EA201791632A1 (https=)
HK (1) HK1245125A1 (https=)
IL (1) IL253499A0 (https=)
MA (1) MA41378A (https=)
MX (2) MX383344B (https=)
PE (1) PE20171258A1 (https=)
TW (1) TW201628607A (https=)
WO (1) WO2016118589A1 (https=)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX374870B (es) * 2013-10-07 2025-03-06 Teva Branded Pharmaceutical Products R&D Inc Inhalador de polvo seco.
MA41378A (fr) * 2015-01-20 2017-11-28 Teva Branded Pharmaceutical Prod R & D Inc Inhalateur de poudre sèche comprenant du propionate de fluticasone et du xinafoate de salmétérol
US11344685B2 (en) 2016-11-18 2022-05-31 Norton (Waterford) Limited Drug delivery device with electronics
CN110201278B (zh) * 2018-02-28 2021-07-30 张江 用于吸入给药的药盒和吸入给药组合结构
CN110201280B (zh) * 2018-02-28 2021-07-30 张江 用于吸入给药装置的吸嘴和吸入给药装置
CN110201281B (zh) * 2018-02-28 2021-08-06 张江 吸入给药装置和吸入给药组合结构
CN110064110A (zh) * 2019-05-29 2019-07-30 上海理工大学 一种容积旋钮式干粉储存吸入装置
GB2585206B (en) 2019-07-01 2021-08-11 Merxin Ltd Portable inhaler

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020078950A1 (en) * 2000-06-23 2002-06-27 O'leary David Reservoir pressure system for medicament inhaler
US20020088463A1 (en) * 2000-06-23 2002-07-11 Lawrence Keane De-agglomerator for breath-actuated dry powder inhaler
US20130064870A1 (en) * 2010-05-20 2013-03-14 Sun Pharma Advanced Research Company Limited Dry powder inhalation composition
WO2015054124A2 (en) * 2013-10-07 2015-04-16 Teva Branded Pharmaceutical Products R&D, Inc. Dry powder inhaler

Family Cites Families (17)

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US5270305A (en) * 1989-09-08 1993-12-14 Glaxo Group Limited Medicaments
US6395300B1 (en) 1999-05-27 2002-05-28 Acusphere, Inc. Porous drug matrices and methods of manufacture thereof
GB0008660D0 (en) * 2000-04-07 2000-05-31 Arakis Ltd The treatment of respiratory diseases
AR030516A1 (es) * 2000-08-31 2003-08-20 Glaxo Group Ltd Uso de una combinacion de salmeterol y fluticasona
ES2474199T3 (es) * 2000-11-30 2014-07-08 Vectura Limited Composiciones farmacéuticas para inhalaci�n
GB0124523D0 (en) * 2001-10-12 2001-12-05 Glaxo Group Ltd Pharmaceutical combination
US20040105821A1 (en) 2002-09-30 2004-06-03 Howard Bernstein Sustained release pharmaceutical formulation for inhalation
US9114081B2 (en) * 2007-05-07 2015-08-25 Insmed Incorporated Methods of treating pulmonary disorders with liposomal amikacin formulations
PL3111927T3 (pl) * 2009-05-29 2020-06-29 Pearl Therapeutics, Inc. Kompozycje do wziewnego podawania środków aktywnych oraz związane z nimi sposoby i systemy
WO2011035128A1 (en) * 2009-09-17 2011-03-24 Mutual Pharmaceutical Company, Inc. Method of treating asthma with antiviral agents
GB0919465D0 (en) 2009-11-06 2009-12-23 Norton Healthcare Ltd Airflow adaptor for a breath-actuated dry powder inhaler
MX339742B (es) * 2010-05-18 2016-06-07 Teva Pharma Ireland Contadores de dosis para inhaladores, inhaladores y flechas de los mismos.
KR20130140358A (ko) * 2012-06-14 2013-12-24 한미약품 주식회사 살메테롤 지나포산염, 플루티카손 프로피오네이트 및 티오트로피움 브로마이드를 포함하는 흡입 제형용 건조 분말 및 이의 제조방법
MX2015015150A (es) * 2013-04-29 2016-02-18 Sanofi Sa Composiciones farmaceuticas inhalables y los dispositivos inhaladores que las contienen.
CA2910976C (en) * 2013-05-03 2021-03-30 Dow Global Technologies Llc Process for equilibrium-limited reactions
BR112017007587A2 (pt) * 2014-10-16 2018-01-30 Teva Branded Pharmaceutical Products R&D Inc processo para preparar uma formulação farmacêutica em pó seca e inalável
MA41378A (fr) * 2015-01-20 2017-11-28 Teva Branded Pharmaceutical Prod R & D Inc Inhalateur de poudre sèche comprenant du propionate de fluticasone et du xinafoate de salmétérol

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020078950A1 (en) * 2000-06-23 2002-06-27 O'leary David Reservoir pressure system for medicament inhaler
US20020088463A1 (en) * 2000-06-23 2002-07-11 Lawrence Keane De-agglomerator for breath-actuated dry powder inhaler
US20130064870A1 (en) * 2010-05-20 2013-03-14 Sun Pharma Advanced Research Company Limited Dry powder inhalation composition
WO2015054124A2 (en) * 2013-10-07 2015-04-16 Teva Branded Pharmaceutical Products R&D, Inc. Dry powder inhaler

Also Published As

Publication number Publication date
CO2017008395A2 (es) 2018-01-05
TW201628607A (zh) 2016-08-16
CA2974125A1 (en) 2016-07-28
PE20171258A1 (es) 2017-08-28
IL253499A0 (en) 2017-09-28
US20160206559A1 (en) 2016-07-21
AR104771A1 (es) 2017-08-16
WO2016118589A1 (en) 2016-07-28
US20180015035A1 (en) 2018-01-18
MX2021006751A (es) 2021-07-15
US9415008B2 (en) 2016-08-16
AU2021202784A1 (en) 2021-05-27
JP2018503687A (ja) 2018-02-08
MX2017009122A (es) 2017-10-12
AU2016209363A1 (en) 2017-08-24
CL2017001859A1 (es) 2018-04-06
CN107530357A (zh) 2018-01-02
HK1245125A1 (zh) 2018-08-24
EP3247331A1 (en) 2017-11-29
KR20170103975A (ko) 2017-09-13
EA201791632A1 (ru) 2017-12-29
MA41378A (fr) 2017-11-28
MX383344B (es) 2025-03-13
BR112017015353A2 (en) 2018-01-16

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