CA2511523C - Pharmaceutical formulation with an insoluble active agent for pulmonary administration - Google Patents

Pharmaceutical formulation with an insoluble active agent for pulmonary administration Download PDF

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Publication number
CA2511523C
CA2511523C CA2511523A CA2511523A CA2511523C CA 2511523 C CA2511523 C CA 2511523C CA 2511523 A CA2511523 A CA 2511523A CA 2511523 A CA2511523 A CA 2511523A CA 2511523 C CA2511523 C CA 2511523C
Authority
CA
Canada
Prior art keywords
pharmaceutical formulation
active agent
particles
phospholipid
particulates
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.)
Expired - Fee Related
Application number
CA2511523A
Other languages
English (en)
French (fr)
Other versions
CA2511523A1 (en
Inventor
Thomas E. Tarara
Jeffry G. 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=32713146&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2511523(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis AG filed Critical Novartis AG
Publication of CA2511523A1 publication Critical patent/CA2511523A1/en
Application granted granted Critical
Publication of CA2511523C publication Critical patent/CA2511523C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • 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
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • 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
    • A61K9/0078Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
    • 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
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1611Inorganic compounds
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • A61K9/1694Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CA2511523A 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration Expired - Fee Related CA2511523C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US43721002P 2002-12-31 2002-12-31
US60/437,210 2002-12-31
PCT/US2003/041703 WO2004060351A2 (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration

Publications (2)

Publication Number Publication Date
CA2511523A1 CA2511523A1 (en) 2004-07-22
CA2511523C true CA2511523C (en) 2013-10-15

Family

ID=32713146

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2511523A Expired - Fee Related CA2511523C (en) 2002-12-31 2003-12-31 Pharmaceutical formulation with an insoluble active agent for pulmonary administration

Country Status (18)

Country Link
US (1) US20040156792A1 (enExample)
EP (1) EP1589947B2 (enExample)
JP (1) JP2006513236A (enExample)
KR (1) KR20050095838A (enExample)
CN (1) CN1741789A (enExample)
AU (1) AU2003300137A1 (enExample)
BR (1) BR0317810A (enExample)
CA (1) CA2511523C (enExample)
EA (1) EA200501001A1 (enExample)
ES (1) ES2589578T5 (enExample)
HU (1) HUP0500846A3 (enExample)
MX (1) MXPA05007158A (enExample)
NO (1) NO20053076L (enExample)
PL (1) PL378270A1 (enExample)
PT (1) PT1589947T (enExample)
TR (1) TR200502522T2 (enExample)
WO (1) WO2004060351A2 (enExample)
ZA (1) ZA200505155B (enExample)

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US8404217B2 (en) 2000-05-10 2013-03-26 Novartis Ag Formulation for pulmonary administration of antifungal agents, and associated methods of manufacture and use
US7871598B1 (en) 2000-05-10 2011-01-18 Novartis Ag Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
CA2382133C (en) 2000-05-10 2010-11-23 Alliance Pharmaceutical Corporation Phospholipid-based powders for drug delivery
WO2003053411A1 (en) 2001-12-19 2003-07-03 Nektar Therapeutics Pulmonary delivery of aminoglycosides
TW200503781A (en) * 2002-12-31 2005-02-01 Nektar Therapeutics Aerosolizable pharmaceutical formulation for fungal infection therapy
MXPA05012821A (es) 2003-05-28 2006-02-13 Nektar Therapeutics Formulacion farmaceutica que comprende un agente activo insoluble en agua.
US8513204B2 (en) * 2004-06-21 2013-08-20 Novartis Ag Compositions comprising amphotericin B, mehods and systems
US9061027B2 (en) 2004-08-27 2015-06-23 Board Of Regents, The University Of Texas System Enhanced delivery of drug compositions to treat life threatening infections
US20090032427A1 (en) * 2005-09-29 2009-02-05 Nektar Therapeutics Receptacles and Kits, Such as for Dry Powder Packaging
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US20120128728A1 (en) * 2005-12-28 2012-05-24 Novartis Pharma Ag Compositions Comprising Amphotericin B
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EP2050437A1 (en) * 2007-10-15 2009-04-22 Laboratoires SMB Improved pharmaceutical dry powder compositions for inhalation.
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KR101621986B1 (ko) 2008-05-15 2016-05-17 노파르티스 아게 플루오로퀴놀론의 폐 전달
CA2835771C (en) 2009-03-18 2017-01-24 Incarda Therapeutics, Inc. Unit doses, aerosols, kits, and methods for treating heart conditions by pulmonary administration
EP2411137B1 (en) 2009-03-27 2016-09-07 Bend Research, Inc. Spray-drying process
GB0908129D0 (en) * 2009-05-12 2009-06-24 Innovata Ltd Composition
TR200904500A2 (tr) 2009-06-10 2009-10-21 Öner Levent Ezetimib nanokristallerinin hazırlanması için yöntem ve farmasötik formülasyonları.
EP2611530B1 (en) 2010-09-03 2019-01-16 Bend Research, Inc. Spray-drying apparatus and methods of using the same
US9084976B2 (en) 2010-09-03 2015-07-21 Bend Research, Inc. Spray-drying apparatus and methods of using the same
EP2618924A1 (en) 2010-09-24 2013-07-31 Bend Research, Inc. High-temperature spray drying process and apparatus
CN103228266B (zh) 2010-10-29 2017-11-14 健康科学西部大学 三元混合物制剂
JOP20120023B1 (ar) 2011-02-04 2022-03-14 Novartis Ag صياغات مساحيق جافة من جسيمات تحتوي على واحد أو اثنين من المواد الفعالة لعلاج امراض ممرات الهواء الانسدادية او الالتهابية
US20150224202A1 (en) * 2014-02-03 2015-08-13 The Board Of Trustees Of The Leland Stanford Junior University Formulations and uses for microparticle delivery of zinc protoporphyrins
US11364203B2 (en) 2014-10-31 2022-06-21 Bend Reserch, Inc. Process for forming active domains dispersed in a matrix
CN104587457B (zh) * 2015-01-13 2017-03-22 广东海大畜牧兽医研究院有限公司 一种利用难溶或不溶蛋白、多肽抗原制备纳米微粒疫苗的方法
SG11201805204WA (en) * 2015-12-24 2018-07-30 Philip Morris Products Sa Nicotine particle capsule
SG11201805788WA (en) 2016-02-01 2018-08-30 Incarda Therapeutics Inc Combining electronic monitoring with inhaled pharmacological therapy to manage cardiac arrhythmias including atrial fibrillation
CA3060702A1 (en) 2017-05-10 2018-11-15 Incarda Therapeutics, Inc. Unit doses, aerosols, kits, and methods for treating heart conditions by pulmonary administration
JP2020527377A (ja) * 2017-06-28 2020-09-10 フィリップ・モーリス・プロダクツ・ソシエテ・アノニム 吸入器と併用するための粒子を含む容器
WO2019183470A2 (en) 2018-03-22 2019-09-26 Incarda Therapeutics, Inc. A novel method to slow ventricular rate
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US11020384B2 (en) 2019-08-01 2021-06-01 Incarda Therapeutics, Inc. Antiarrhythmic formulation
CA3250825A1 (en) 2022-03-21 2023-09-28 Cystetic Medicines Inc PROSTHETIC COMPOSITIONS WITH ION CHANNELS COMPRISING AMPHOTEROTIN B LIPID-COATED CRYSTALS

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Also Published As

Publication number Publication date
EP1589947B1 (en) 2016-06-15
MXPA05007158A (es) 2005-09-21
ES2589578T5 (es) 2019-07-23
US20040156792A1 (en) 2004-08-12
HUP0500846A3 (en) 2008-10-28
EA200501001A1 (ru) 2005-12-29
KR20050095838A (ko) 2005-10-04
JP2006513236A (ja) 2006-04-20
WO2004060351A2 (en) 2004-07-22
ZA200505155B (en) 2006-04-26
ES2589578T3 (es) 2016-11-15
EP1589947A2 (en) 2005-11-02
PT1589947T (pt) 2016-09-05
WO2004060351A3 (en) 2004-09-30
BR0317810A (pt) 2005-11-29
NO20053076D0 (no) 2005-06-23
CA2511523A1 (en) 2004-07-22
AU2003300137A1 (en) 2004-07-29
PL378270A1 (pl) 2006-03-20
EP1589947B2 (en) 2019-01-30
EP1589947B8 (en) 2016-08-24
NO20053076L (no) 2005-09-13
CN1741789A (zh) 2006-03-01
HUP0500846A2 (en) 2008-05-28
TR200502522T2 (tr) 2005-09-21

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