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CY1107488T1 - Σταθερα ξηραμενα δια ψεκασμου πρωτεϊνικα σκευασματα - Google Patents

Σταθερα ξηραμενα δια ψεκασμου πρωτεϊνικα σκευασματα

Info

Publication number
CY1107488T1
CY1107488T1 CY20071101112T CY071101112T CY1107488T1 CY 1107488 T1 CY1107488 T1 CY 1107488T1 CY 20071101112 T CY20071101112 T CY 20071101112T CY 071101112 T CY071101112 T CY 071101112T CY 1107488 T1 CY1107488 T1 CY 1107488T1
Authority
CY
Cyprus
Prior art keywords
dried protein
spray
stable dried
protein spray
spray sprayers
Prior art date
Application number
CY20071101112T
Other languages
English (en)
Inventor
David A Edwards
Jeffrey S Hrkach
Original Assignee
Alkermes, 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 Alkermes, Inc. filed Critical Alkermes, Inc.
Publication of CY1107488T1 publication Critical patent/CY1107488T1/el

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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Otolaryngology (AREA)
  • Endocrinology (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)

Abstract

Ξηραμένα δια ψεκασμού σωματίδια τα οποία έχουν βελτιωμένη πρωτεϊνική σταθερότητα παράγονται μέσω ξήρανσης δια ψεκασμού ενός μείγματος το οποίο περιλαμβάνει μια πρωτεΐνη, ένα φωσφολιπίδιο και έναν οργανικό-υδατικό συν-διαλύτη. Ξηραμένα δια ψεκασμού σωματίδια τα οποία περιλαμβάνουν τουλάχιστον 1% κατά βάρος φωσφολιπιδίου, τα οποία έχουν μια πυκνότητα μετά από συμπίεση μικρότερη από 0.4 g/cm3 μπορεί να παρασκευαστούν. Τα σωματίδια μπορεί να παρασχεθούν στο πνευμονικό σύστημα ενός ασθενούς.
CY20071101112T 1998-08-25 2007-08-30 Σταθερα ξηραμενα δια ψεκασμου πρωτεϊνικα σκευασματα CY1107488T1 (el)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US9779698P 1998-08-25 1998-08-25
EP99945175A EP1107743B1 (en) 1998-08-25 1999-08-25 Stable spray-dried protein formulations

Publications (1)

Publication Number Publication Date
CY1107488T1 true CY1107488T1 (el) 2013-03-13

Family

ID=22265177

Family Applications (1)

Application Number Title Priority Date Filing Date
CY20071101112T CY1107488T1 (el) 1998-08-25 2007-08-30 Σταθερα ξηραμενα δια ψεκασμου πρωτεϊνικα σκευασματα

Country Status (11)

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

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JP3725166B2 (ja) 1996-01-24 2005-12-07 アルタナ ファルマ アクチエンゲゼルシャフト 粉末状肺サーファクタント製剤の製造方法
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
EP1210067A2 (en) * 1999-08-25 2002-06-05 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
MXPA03001092A (es) 2000-08-07 2003-09-25 Nektar Therapeutics Al Corp Polvos de proteina de haz de 4 helices secados por rocio, inhalables, que tienen agregacion minimizada.
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
EP1992335A1 (en) 2001-11-01 2008-11-19 Nektar Therapeutics Spray drying methods and compositions thereof
WO2003043586A2 (en) * 2001-11-20 2003-05-30 Advanced Inhalation Research, Inc. Compositions for sustained action product delivery
TWI324518B (en) 2001-12-19 2010-05-11 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
WO2003079993A2 (en) * 2002-03-20 2003-10-02 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
CA2509216A1 (en) 2002-12-13 2004-07-01 Adagit Pharmaceutical porous particles
WO2004067601A1 (ja) * 2003-01-31 2004-08-12 Zeon Corporation 重合性組成物、熱可塑性樹脂組成物、架橋樹脂及び架橋樹脂複合材料
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
JP2007500234A (ja) * 2003-05-28 2007-01-11 ネクター セラピューティクス 水に不溶な活性剤を含む医薬的成形
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
US20090306337A1 (en) 2006-07-31 2009-12-10 Novo Nordisk A/S Pegylated, Extended Insulins
ES2601839T3 (es) 2006-09-22 2017-02-16 Novo Nordisk A/S Análogos de insulina resistentes a proteasas
JP5496082B2 (ja) 2007-04-30 2014-05-21 ノボ・ノルデイスク・エー/エス タンパク質組成物を乾燥させる方法、乾燥タンパク質組成物、及び乾燥タンパク質を含有する薬学的組成物
WO2009112583A2 (en) 2008-03-14 2009-09-17 Novo Nordisk A/S Protease-stabilized insulin analogues
ES2609288T3 (es) 2008-03-18 2017-04-19 Novo Nordisk A/S Análogos de insulina acilada, estabilizados frente a proteasas
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
US20120289465A1 (en) * 2009-11-25 2012-11-15 Gcbio Corp. Use of inhalable powder formulation comprising growth hormone for preventing or treating nmda receptor hypofunction-related diseases
WO2013114374A1 (en) 2012-02-01 2013-08-08 Protalix Ltd. Dnase i polypeptides, polynucleotides encoding same, methods of producing dnase i and uses thereof in therapy
BR112014025132A2 (pt) 2012-04-11 2017-07-11 Novo Nordisk As formulações de insulina
AU2014212109B2 (en) 2013-02-01 2018-05-31 Glialogix, Inc. Compositions and methods for the treatment of neurodegenerative and other diseases
BR112016007166A2 (pt) 2013-10-07 2017-09-12 Novo Nordisk As derivado de um análogo de insulina
US20170304459A1 (en) 2014-10-10 2017-10-26 Alnylam Pharmaceuticals, Inc. Methods and compositions for inhalation delivery of conjugated oligonucleotide
CN107106641B (zh) 2014-10-31 2021-12-21 葛兰素史密斯克莱知识产权发展有限公司 粉末制剂
RU2731212C2 (ru) * 2015-09-09 2020-08-31 Новартис Аг Направленная доставка высушенных распылением композиций в легкие
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
EP3962472A4 (en) 2019-04-29 2023-01-25 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

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AU598958B2 (en) * 1987-11-12 1990-07-05 Vestar, Inc. Improved amphotericin b liposome preparation
AU7908791A (en) * 1990-05-08 1991-11-27 Liposome Technology, Inc. Direct spray-dried drug/lipid powder composition
EP0655237A1 (de) * 1993-11-27 1995-05-31 Hoechst Aktiengesellschaft Medizinische Aerosolformulierung
JP3725166B2 (ja) * 1996-01-24 2005-12-07 アルタナ ファルマ アクチエンゲゼルシャフト 粉末状肺サーファクタント製剤の製造方法
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
ES2236832T3 (es) * 1997-01-16 2005-07-16 Massachusetts Institute Of Technology Preparacion de particulas para inhalacion.

Also Published As

Publication number Publication date
AU5784299A (en) 2000-03-14
ES2289823T3 (es) 2008-02-01
DE69936386T2 (de) 2008-03-06
EP1107743A1 (en) 2001-06-20
AU758351B2 (en) 2003-03-20
CA2341624A1 (en) 2000-03-02
EP1107743B1 (en) 2007-06-27
DE69936386D1 (de) 2007-08-09
JP2002523360A (ja) 2002-07-30
ATE365547T1 (de) 2007-07-15
JP4416325B2 (ja) 2010-02-17
WO2000010541A1 (en) 2000-03-02
DK1107743T3 (da) 2007-10-22
CA2341624C (en) 2008-12-02
PT1107743E (pt) 2007-10-01

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