DK1107743T3 - Stabile, spraytörrede proteinformuleringer - Google Patents

Stabile, spraytörrede proteinformuleringer

Info

Publication number
DK1107743T3
DK1107743T3 DK99945175T DK99945175T DK1107743T3 DK 1107743 T3 DK1107743 T3 DK 1107743T3 DK 99945175 T DK99945175 T DK 99945175T DK 99945175 T DK99945175 T DK 99945175T DK 1107743 T3 DK1107743 T3 DK 1107743T3
Authority
DK
Denmark
Prior art keywords
spray
stable
protein formulations
dried protein
phospholipid
Prior art date
Application number
DK99945175T
Other languages
English (en)
Inventor
David A Edwards
Jeffrey S Hrkach
Original Assignee
Advanced Inhalation Res 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 Advanced Inhalation Res Inc filed Critical Advanced Inhalation Res Inc
Application granted granted Critical
Publication of DK1107743T3 publication Critical patent/DK1107743T3/da

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
    • 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
    • A61K9/0012Galenical 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
    • 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
    • A61P11/06Antiasthmatics
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Glanulating (AREA)
  • Peptides Or Proteins (AREA)
DK99945175T 1998-08-25 1999-08-25 Stabile, spraytörrede proteinformuleringer DK1107743T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US9779698P 1998-08-25 1998-08-25
PCT/US1999/019306 WO2000010541A1 (en) 1998-08-25 1999-08-25 Stable spray-dried protein formulations

Publications (1)

Publication Number Publication Date
DK1107743T3 true DK1107743T3 (da) 2007-10-22

Family

ID=22265177

Family Applications (1)

Application Number Title Priority Date Filing Date
DK99945175T DK1107743T3 (da) 1998-08-25 1999-08-25 Stabile, spraytörrede proteinformuleringer

Country Status (11)

Country Link
EP (1) EP1107743B1 (da)
JP (1) JP4416325B2 (da)
AT (1) ATE365547T1 (da)
AU (1) AU758351B2 (da)
CA (1) CA2341624C (da)
CY (1) CY1107488T1 (da)
DE (1) DE69936386T2 (da)
DK (1) DK1107743T3 (da)
ES (1) ES2289823T3 (da)
PT (1) PT1107743E (da)
WO (1) WO2000010541A1 (da)

Families Citing this family (47)

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KR100449789B1 (ko) 1996-01-24 2005-02-03 알타나 파마 아게 분말형폐계면활성제제의제조방법
US20060165606A1 (en) 1997-09-29 2006-07-27 Nektar Therapeutics Pulmonary delivery particles comprising water insoluble or crystalline active agents
US6630121B1 (en) 1999-06-09 2003-10-07 The Regents Of The University Of Colorado Supercritical fluid-assisted nebulization and bubble drying
US6858199B1 (en) 2000-06-09 2005-02-22 Advanced Inhalation Research, Inc. High efficient delivery of a large therapeutic mass aerosol
CA2382821A1 (en) * 1999-08-25 2001-03-01 Advanced Inhalation Research, Inc. Modulation of release from dry powder formulations
US7871598B1 (en) 2000-05-10 2011-01-18 Novartis Ag Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
FR2809309B1 (fr) * 2000-05-23 2004-06-11 Mainelab Microspheres a liberation prolongee pour administration injectable
JP2004515467A (ja) 2000-08-07 2004-05-27 ネクター セラピューティックス 吸入可能な、噴霧乾燥した、最少の凝集物を有する4−ヘリックスバンドルタンパク質粉末
JP4931282B2 (ja) * 2000-10-02 2012-05-16 日本ケミカルリサーチ株式会社 生理活性ペプチド含有粉末
US8658202B2 (en) * 2001-04-25 2014-02-25 Western University Of Health Sciences Coated drug delivery formulations
AU2002255181A1 (en) * 2001-05-21 2002-12-03 Britannia Pharmaceuticals Limited Use of phospholipids in the treatment of degenerative lung disease such as copd or cystic fibrosis and to enhance delivery of drugs
GB0120123D0 (en) * 2001-08-17 2001-10-10 Upperton Ltd Preparation of microparticles
DE60227691D1 (de) 2001-11-01 2008-08-28 Nektar Therapeutics Sprühtrocknungsverfahren
US20030166509A1 (en) * 2001-11-20 2003-09-04 Advanced Inhalation Research, Inc. Compositions for sustained action product delivery and methods of use thereof
CA2468958C (en) 2001-12-19 2012-07-03 Nektar Therapeutics Pulmonary delivery of aminoglycosides
US7008644B2 (en) 2002-03-20 2006-03-07 Advanced Inhalation Research, Inc. Method and apparatus for producing dry particles
EP1485068A2 (en) * 2002-03-20 2004-12-15 Advanced Inhalation Research, Inc. hGH (HUMAN GROWTH HORMONE) FORMULATIONS FOR PULMONARY ADMINISTRATION
US9339459B2 (en) 2003-04-24 2016-05-17 Nektar Therapeutics Particulate materials
US7425618B2 (en) 2002-06-14 2008-09-16 Medimmune, Inc. Stabilized anti-respiratory syncytial virus (RSV) antibody formulations
US7132100B2 (en) 2002-06-14 2006-11-07 Medimmune, Inc. Stabilized liquid anti-RSV antibody formulations
JP2006511617A (ja) * 2002-12-13 2006-04-06 アダーギット 製薬用多孔質粒子
ATE461954T1 (de) * 2003-01-31 2010-04-15 Zeon Corp Polymerisierbare zusammensetzung, thermoplastische harzzusammensetzung, vernetztes harz und vernetztes harz enthaltende verbundwerkstoffe
JP4707937B2 (ja) * 2003-02-28 2011-06-22 ホソカワミクロン株式会社 薬物含有複合粒子の製造方法および経肺製剤
EP1635786A2 (en) 2003-05-28 2006-03-22 Nektar Therapeutics Spray drying of an alcoholic aqueous solution for the manufacture of a water-insoluble active agent microparticle with a partial or complete amino acid and/or phospholipid coat
DE10339197A1 (de) * 2003-08-22 2005-03-24 Boehringer Ingelheim Pharma Gmbh & Co. Kg Sprühgetrocknete amorphe Pulver mit geringer Restfeuchte und guter Lagerstabilität
US7723306B2 (en) 2004-05-10 2010-05-25 Boehringer Ingelheim Pharma Gmbh & Co. Kg Spray-dried powder comprising at least one 1,4 O-linked saccharose-derivative and methods for their preparation
US7611709B2 (en) 2004-05-10 2009-11-03 Boehringer Ingelheim Pharma Gmbh And Co. Kg 1,4 O-linked saccharose derivatives for stabilization of antibodies or antibody derivatives
US7727962B2 (en) 2004-05-10 2010-06-01 Boehringer Ingelheim Pharma Gmbh & Co. Kg Powder comprising new compositions of oligosaccharides and methods for their preparation
JP5115951B2 (ja) 2006-03-17 2013-01-09 学校法人東京理科大学 ナノコンポジット粒子
EP2049149B1 (en) 2006-07-31 2015-04-15 Novo Nordisk A/S Pegylated extended insulins
JP5864834B2 (ja) 2006-09-22 2016-02-17 ノボ・ノルデイスク・エー/エス プロテアーゼ耐性のインスリンアナログ
US9387176B2 (en) 2007-04-30 2016-07-12 Novo Nordisk A/S Method for drying a protein composition, a dried protein composition and a pharmaceutical composition comprising the dried protein
JP5762001B2 (ja) 2008-03-14 2015-08-12 ノボ・ノルデイスク・エー/エス プロテアーゼ安定化インスリンアナログ
PT2254906T (pt) 2008-03-18 2017-01-03 Novo Nordisk As Análogos de insulina acilados, estabilizados contra proteases
JP5158436B2 (ja) * 2008-09-18 2013-03-06 国立大学法人 鹿児島大学 抗菌剤およびその製造方法、化粧料ならびに医薬品
US20100183876A1 (en) * 2008-12-23 2010-07-22 Hell Andre Process for the Preparation of a Peptide Powder Form
KR20120116421A (ko) * 2009-11-25 2012-10-22 주식회사 메디진바이오 성장 호르몬을 포함하는 흡입형 분말 제제의 nmda 수용체 기능저하-관련 질환을 예방 또는 치료하기 위한 용도
US20150010527A1 (en) 2012-02-01 2015-01-08 Protalix Ltd. Dnase i polypeptides, polynucleotides encoding same, methods of producing dnase i and uses thereof in therapy
CA2870313A1 (en) 2012-04-11 2013-10-17 Novo Nordisk A/S Insulin formulations
CN105163735B (zh) 2013-02-01 2018-12-11 格力尔罗格克斯股份有限公司 用于治疗神经退行性疾病和其他疾病的组合物和方法
AU2014333979B2 (en) 2013-10-07 2018-02-15 Novo Nordisk A/S Novel derivative of an insulin analogue
US20170304459A1 (en) 2014-10-10 2017-10-26 Alnylam Pharmaceuticals, Inc. Methods and compositions for inhalation delivery of conjugated oligonucleotide
CA2965759C (en) 2014-10-31 2023-12-12 Glaxosmithkline Intellectual Property Development Limited Powdered polypeptides with decreased disulfide impurities comprising divalent cationic materials
US20180110760A1 (en) 2016-10-21 2018-04-26 Glialogix, Inc. Compositions and methods for the treatmentof neurodegenerative and other diseases
CN110087674B (zh) 2016-12-16 2023-01-03 诺和诺德股份有限公司 含胰岛素的药物组合物
WO2020223237A1 (en) 2019-04-29 2020-11-05 Insmed Incorporated Dry powder compositions of treprostinil prodrugs and methods of use thereof
WO2023150747A1 (en) 2022-02-07 2023-08-10 Insmed Incorporated Dry powder compositions of bedaquiline and salts and methods of use thereof

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU598958B2 (en) * 1987-11-12 1990-07-05 Vestar, Inc. Improved amphotericin b liposome preparation
CA2081474A1 (en) * 1990-05-08 1991-11-09 Manzer Durrani Direct spray-dried drug/lipid powder composition
EP0655237A1 (de) * 1993-11-27 1995-05-31 Hoechst Aktiengesellschaft Medizinische Aerosolformulierung
KR100449789B1 (ko) * 1996-01-24 2005-02-03 알타나 파마 아게 분말형폐계면활성제제의제조방법
GB9610341D0 (en) * 1996-05-17 1996-07-24 Andaris Ltd Formulation for inhalation
US5855913A (en) * 1997-01-16 1999-01-05 Massachusetts Instite Of Technology Particles incorporating surfactants for pulmonary drug delivery
CA2277801C (en) * 1997-01-16 2002-10-15 Massachusetts Institute Of Technology Preparation of particles for inhalation

Also Published As

Publication number Publication date
AU5784299A (en) 2000-03-14
JP4416325B2 (ja) 2010-02-17
CA2341624C (en) 2008-12-02
ATE365547T1 (de) 2007-07-15
EP1107743B1 (en) 2007-06-27
CA2341624A1 (en) 2000-03-02
EP1107743A1 (en) 2001-06-20
DE69936386D1 (de) 2007-08-09
CY1107488T1 (el) 2013-03-13
JP2002523360A (ja) 2002-07-30
WO2000010541A1 (en) 2000-03-02
AU758351B2 (en) 2003-03-20
ES2289823T3 (es) 2008-02-01
PT1107743E (pt) 2007-10-01
DE69936386T2 (de) 2008-03-06

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