WO2002055101A3 - Storage stable powder compositions of interleukin-4 receptor - Google Patents

Storage stable powder compositions of interleukin-4 receptor Download PDF

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Publication number
WO2002055101A3
WO2002055101A3 PCT/US2001/050592 US0150592W WO02055101A3 WO 2002055101 A3 WO2002055101 A3 WO 2002055101A3 US 0150592 W US0150592 W US 0150592W WO 02055101 A3 WO02055101 A3 WO 02055101A3
Authority
WO
WIPO (PCT)
Prior art keywords
powder compositions
interleukin
receptor
storage stable
stable powder
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
PCT/US2001/050592
Other languages
French (fr)
Other versions
WO2002055101A2 (en
WO2002055101A9 (en
Inventor
Jayne E. Hastedt
Kirsten M. Cabot
David Gong
Dennis M. Hester
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.)
Nektar Therapeutics
Original Assignee
Inhale Therapeutics Systems 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
Application filed by Inhale Therapeutics Systems Inc filed Critical Inhale Therapeutics Systems Inc
Priority to JP2002555835A priority Critical patent/JP2004521103A/en
Priority to EP01988413A priority patent/EP1351704B1/en
Priority to CA2432175A priority patent/CA2432175C/en
Priority to AU2002241723A priority patent/AU2002241723A1/en
Priority to DE60127175T priority patent/DE60127175T2/en
Publication of WO2002055101A2 publication Critical patent/WO2002055101A2/en
Publication of WO2002055101A3 publication Critical patent/WO2002055101A3/en
Publication of WO2002055101A9 publication Critical patent/WO2002055101A9/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/177Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/1793Receptors; Cell surface antigens; Cell surface determinants for cytokines; for lymphokines; for interferons
    • 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
    • A61K9/1688Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

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  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Pulmonology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Dermatology (AREA)
  • Rheumatology (AREA)
  • Cell Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The present invention provides storage stable dry powder compositions of IL-4R. The powder compositions demonstrate superior chemical and physical stability over their solution counterparts, particularly upon storage under varying conditions of temperature and humidity. Moreover, the powders, as prepared, possess good aerosol properties, which are maintained upon storage.
PCT/US2001/050592 2000-12-21 2001-12-21 Storage stable powder compositions of interleukin-4 receptor Ceased WO2002055101A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2002555835A JP2004521103A (en) 2000-12-21 2001-12-21 Storage stable powder composition of interleukin 4 receptor
EP01988413A EP1351704B1 (en) 2000-12-21 2001-12-21 Storage stable powder compositions of interleukin-4 receptor
CA2432175A CA2432175C (en) 2000-12-21 2001-12-21 Storage stable powder compositions of interleukin-4 receptor
AU2002241723A AU2002241723A1 (en) 2000-12-21 2001-12-21 Storage stable powder compositions of interleukin-4 receptor
DE60127175T DE60127175T2 (en) 2000-12-21 2001-12-21 STORAGE-STABLE POWDER COMPOSITIONS WITH INTERLEUKIN-4 RECEPTOR

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25678600P 2000-12-21 2000-12-21
US60/256,786 2000-12-21

Publications (3)

Publication Number Publication Date
WO2002055101A2 WO2002055101A2 (en) 2002-07-18
WO2002055101A3 true WO2002055101A3 (en) 2003-01-30
WO2002055101A9 WO2002055101A9 (en) 2003-10-16

Family

ID=22973579

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/050592 Ceased WO2002055101A2 (en) 2000-12-21 2001-12-21 Storage stable powder compositions of interleukin-4 receptor

Country Status (9)

Country Link
US (4) US6896906B2 (en)
EP (1) EP1351704B1 (en)
JP (3) JP2004521103A (en)
AT (1) ATE355849T1 (en)
AU (1) AU2002241723A1 (en)
CA (1) CA2432175C (en)
DE (1) DE60127175T2 (en)
ES (1) ES2281458T3 (en)
WO (1) WO2002055101A2 (en)

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US9006175B2 (en) 1999-06-29 2015-04-14 Mannkind Corporation Potentiation of glucose elimination
US7678364B2 (en) 1999-08-25 2010-03-16 Alkermes, Inc. Particles for inhalation having sustained release properties
US6749835B1 (en) 1999-08-25 2004-06-15 Advanced Inhalation Research, Inc. Formulation for spray-drying large porous particles
EP1351704B1 (en) * 2000-12-21 2007-03-07 Nektar Therapeutics Storage stable powder compositions of interleukin-4 receptor
US6777000B2 (en) 2001-02-28 2004-08-17 Carrington Laboratories, Inc. In-situ gel formation of pectin
US7494669B2 (en) 2001-02-28 2009-02-24 Carrington Laboratories, Inc. Delivery of physiological agents with in-situ gels comprising anionic polysaccharides
AU2002352836B2 (en) 2001-11-20 2005-09-29 Alkermes, Inc. Improved particulate compositions for pulmonary delivery
WO2003080149A2 (en) 2002-03-20 2003-10-02 Mannkind Corporation Inhalation apparatus
DE10339197A1 (en) * 2003-08-22 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Spray-dried amorphous powder with low residual moisture and good storage stability
EP1685160A1 (en) * 2003-11-10 2006-08-02 Arriva-Prometic Inc. Dry recombinant human alpha 1-antitrypsin formulation
EP1713441A2 (en) * 2004-02-12 2006-10-25 Nektar Therapeutics Interleukin-13 antagonist powders, spray-dried particles, and methods
DE102004022926A1 (en) * 2004-05-10 2005-12-15 Boehringer Ingelheim Pharma Gmbh & Co. Kg Spray-dried powders containing at least one 1,4 O-linked sucrose derivative and process for their preparation
DE102004022928A1 (en) * 2004-05-10 2005-12-08 Boehringer Ingelheim Pharma Gmbh & Co. Kg Powder containing novel oligosaccharide mixtures and process for their preparation
PL1786784T3 (en) 2004-08-20 2011-04-29 Mannkind Corp Catalysis of diketopiperazine synthesis
KR101644250B1 (en) 2004-08-23 2016-07-29 맨카인드 코포레이션 Diketopiperazine salts, diketomorpholine salts or diketodioxane salts for drug delivery
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WO2006055950A1 (en) * 2004-11-18 2006-05-26 Nektar Therapeutics Pharmaceutical dry powder formulation on the basis particles comprising multiple active agents
CN104324362B (en) 2005-09-14 2018-04-24 曼金德公司 Method for preparation of drug based on improving affinity of the active agent to crystalline microparticle surfaces
IN2015DN00888A (en) 2006-02-22 2015-07-10 Mannkind Corp
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US20100029832A1 (en) * 2007-01-05 2010-02-04 Board Of Trustees Of Michigan State University Composites comprising polymer and mesoporous silicate
KR20100047866A (en) * 2007-07-11 2010-05-10 애로반스, 인코포레이티드 Pharmaceutical polypeptide dry powder aerosol formulation and method of preparation
WO2009136541A1 (en) * 2008-05-09 2009-11-12 アークレイ株式会社 Method for production of insoluble carrier particle, insoluble carrier particle, measurement reagent, sample analysis tool, and immunology turbidimetric method
US8485180B2 (en) 2008-06-13 2013-07-16 Mannkind Corporation Dry powder drug delivery system
ES2929343T3 (en) 2008-06-13 2022-11-28 Mannkind Corp Suction Actuated Dry Powder Inhaler for Drug Delivery
KR101628410B1 (en) 2008-06-20 2016-06-08 맨카인드 코포레이션 An interactive apparatus and method for real-time profiling of inhalation efforts
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US8314106B2 (en) 2008-12-29 2012-11-20 Mannkind Corporation Substituted diketopiperazine analogs for use as drug delivery agents
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Also Published As

Publication number Publication date
US7172768B2 (en) 2007-02-06
JP2012153719A (en) 2012-08-16
US7449201B2 (en) 2008-11-11
US20090035264A1 (en) 2009-02-05
ES2281458T3 (en) 2007-10-01
US20070122354A1 (en) 2007-05-31
EP1351704A2 (en) 2003-10-15
EP1351704B1 (en) 2007-03-07
US20050129625A1 (en) 2005-06-16
US6896906B2 (en) 2005-05-24
JP2009102362A (en) 2009-05-14
US7767198B2 (en) 2010-08-03
JP2004521103A (en) 2004-07-15
CA2432175C (en) 2010-08-10
DE60127175T2 (en) 2007-11-08
AU2002241723A1 (en) 2002-07-24
CA2432175A1 (en) 2002-07-18
WO2002055101A2 (en) 2002-07-18
US20020176846A1 (en) 2002-11-28
DE60127175D1 (en) 2007-04-19
WO2002055101A9 (en) 2003-10-16
ATE355849T1 (en) 2007-03-15

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