AU2019212586C1 - High dose delivery of inhaled therapeutics - Google Patents

High dose delivery of inhaled therapeutics Download PDF

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Publication number
AU2019212586C1
AU2019212586C1 AU2019212586A AU2019212586A AU2019212586C1 AU 2019212586 C1 AU2019212586 C1 AU 2019212586C1 AU 2019212586 A AU2019212586 A AU 2019212586A AU 2019212586 A AU2019212586 A AU 2019212586A AU 2019212586 C1 AU2019212586 C1 AU 2019212586C1
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AU
Australia
Prior art keywords
powder
particles
density
receptacle
dose
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.)
Ceased
Application number
AU2019212586A
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English (en)
Other versions
AU2019212586B2 (en
AU2019212586A1 (en
Inventor
Daniel Huang
Danforth Miller
Yoen-Ju Son
Jeffry Weers
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.)
Novartis AG
Original Assignee
Novartis AG
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
Application filed by Novartis AG filed Critical Novartis AG
Publication of AU2019212586A1 publication Critical patent/AU2019212586A1/en
Publication of AU2019212586B2 publication Critical patent/AU2019212586B2/en
Priority to AU2022202278A priority Critical patent/AU2022202278A1/en
Application granted granted Critical
Publication of AU2019212586C1 publication Critical patent/AU2019212586C1/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K9/0075—Sprays 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
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • A61K31/7036—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin having at least one amino group directly attached to the carbocyclic ring, e.g. streptomycin, gentamycin, amikacin, validamycin, fortimicins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5015—Organic compounds, e.g. fats, sugars
    • 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
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/0045—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters
    • A61M15/0046—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier
    • A61M15/0051—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using multiple prepacked dosages on a same carrier, e.g. blisters characterized by the type of carrier the dosages being arranged on a tape, e.g. strips
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/06—Solids
    • A61M2202/064—Powder
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Organic Chemistry (AREA)
  • Pulmonology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Otolaryngology (AREA)
  • Emergency Medicine (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2019212586A 2018-01-26 2019-01-24 High dose delivery of inhaled therapeutics Ceased AU2019212586C1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022202278A AU2022202278A1 (en) 2018-01-26 2022-04-05 High Dose Delivery of Inhaled Therapeutics

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862622464P 2018-01-26 2018-01-26
US62/622,464 2018-01-26
PCT/IB2019/050607 WO2019145897A1 (en) 2018-01-26 2019-01-24 High dose delivery of inhaled therapeutics

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022202278A Division AU2022202278A1 (en) 2018-01-26 2022-04-05 High Dose Delivery of Inhaled Therapeutics

Publications (3)

Publication Number Publication Date
AU2019212586A1 AU2019212586A1 (en) 2020-07-09
AU2019212586B2 AU2019212586B2 (en) 2022-01-06
AU2019212586C1 true AU2019212586C1 (en) 2022-04-28

Family

ID=65635769

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2019212586A Ceased AU2019212586C1 (en) 2018-01-26 2019-01-24 High dose delivery of inhaled therapeutics
AU2022202278A Abandoned AU2022202278A1 (en) 2018-01-26 2022-04-05 High Dose Delivery of Inhaled Therapeutics

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2022202278A Abandoned AU2022202278A1 (en) 2018-01-26 2022-04-05 High Dose Delivery of Inhaled Therapeutics

Country Status (14)

Country Link
US (1) US20210069106A1 (https=)
EP (1) EP3743045A1 (https=)
JP (1) JP2021510723A (https=)
KR (1) KR20200115560A (https=)
CN (1) CN111526870A (https=)
AR (1) AR114308A1 (https=)
AU (2) AU2019212586C1 (https=)
BR (1) BR112020014793A2 (https=)
CA (1) CA3089439A1 (https=)
CL (1) CL2020001939A1 (https=)
IL (1) IL276241A (https=)
MX (1) MX2020007745A (https=)
RU (1) RU2020127882A (https=)
WO (1) WO2019145897A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12233177B2 (en) 2019-09-16 2025-02-25 Amgen Inc. Method for external sterilization of drug delivery device
LT4051708T (lt) 2019-10-28 2025-04-10 Medimmune Limited Užkrūčio liaukos stromos limfopoetiną (tslp) surišančių antikūnų sausų miltelių pavidalo vaisto formos ir jų panaudojimo būdai
CN119306869B (zh) * 2024-12-13 2025-05-16 万华化学集团股份有限公司 一种乙烯/α-烯烃共聚物及其制备方法、采用其的封装胶膜

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012106575A1 (en) * 2011-02-04 2012-08-09 Novartis Ag Dry powder formulations of particles that contain two or more active ingredients for treating obstructive or inflammatory airways diseases
US20170066823A1 (en) * 2015-09-09 2017-03-09 Matthew John EDWARDS Thymic stromal lymphopoietin (tslp)-binding molecules and methods of using the molecules
WO2017042696A1 (en) * 2015-09-09 2017-03-16 Novartis Ag Targeted delivery of spray-dried formulations to the lungs

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003037303A1 (en) 2001-11-01 2003-05-08 Nektar Therapeutics Spray drying methods and compositions thereof
MXPA05007154A (es) 2002-12-30 2005-09-21 Nektar Therapeutics Atomizador prepeliculizacion.
KR20130066695A (ko) * 2004-08-23 2013-06-20 맨카인드 코포레이션 약물 전달용 디케토피페라진염, 디케토모르포린염 또는 디케토디옥산염
EP2076242B8 (en) * 2006-07-27 2013-02-20 Nektar Therapeutics Aerosolizable formulation comprising insulin for pulmonary delivery
TR200907236A2 (tr) * 2009-09-23 2011-04-21 Bi̇lgi̇ç Mahmut Tiotropyum kuru toz formülasyonunun blister ambalajda taşınması.
CN107596518B (zh) * 2012-02-29 2021-04-23 普马特里克斯营业公司 可吸入干粉剂
WO2014144364A1 (en) * 2013-03-15 2014-09-18 Children's Medical Center Corporation Gas-filled stabilized particles and methods of use
PE20181307A1 (es) * 2016-01-19 2018-08-10 Novartis Ag Inhalador multidosis
WO2017132601A1 (en) * 2016-01-29 2017-08-03 Mannkind Corporation Dry powder inhaler

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012106575A1 (en) * 2011-02-04 2012-08-09 Novartis Ag Dry powder formulations of particles that contain two or more active ingredients for treating obstructive or inflammatory airways diseases
US20170066823A1 (en) * 2015-09-09 2017-03-09 Matthew John EDWARDS Thymic stromal lymphopoietin (tslp)-binding molecules and methods of using the molecules
WO2017042696A1 (en) * 2015-09-09 2017-03-16 Novartis Ag Targeted delivery of spray-dried formulations to the lungs

Also Published As

Publication number Publication date
CA3089439A1 (en) 2019-08-01
AR114308A1 (es) 2020-08-19
IL276241A (en) 2020-09-30
EP3743045A1 (en) 2020-12-02
AU2019212586B2 (en) 2022-01-06
KR20200115560A (ko) 2020-10-07
RU2020127882A (ru) 2022-02-28
RU2020127882A3 (https=) 2022-02-28
AU2022202278A1 (en) 2022-04-21
CN111526870A (zh) 2020-08-11
US20210069106A1 (en) 2021-03-11
WO2019145897A1 (en) 2019-08-01
AU2019212586A1 (en) 2020-07-09
BR112020014793A2 (pt) 2020-12-08
JP2021510723A (ja) 2021-04-30
MX2020007745A (es) 2020-09-25
CL2020001939A1 (es) 2021-01-04

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DA3 Amendments made section 104

Free format text: THE NATURE OF THE AMENDMENT IS AS SHOWN IN THE STATEMENT FILED 21 DEC 2021

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