WO1995003034A1 - Stabilisation de proteines administrees dans un aerosol - Google Patents

Stabilisation de proteines administrees dans un aerosol Download PDF

Info

Publication number
WO1995003034A1
WO1995003034A1 PCT/US1994/008136 US9408136W WO9503034A1 WO 1995003034 A1 WO1995003034 A1 WO 1995003034A1 US 9408136 W US9408136 W US 9408136W WO 9503034 A1 WO9503034 A1 WO 9503034A1
Authority
WO
WIPO (PCT)
Prior art keywords
protein
aqueous solution
peg
aerosolized
polar organic
Prior art date
Application number
PCT/US1994/008136
Other languages
English (en)
Inventor
Tsutomu Arakawa
Ralph W. Niven
Steven J. Prestrelski
Original Assignee
Amgen 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 Amgen Inc. filed Critical Amgen Inc.
Priority to EP94924473A priority Critical patent/EP0710102A1/fr
Priority to AU74732/94A priority patent/AU691514B2/en
Priority to NZ271181A priority patent/NZ271181A/en
Priority to JP7505271A priority patent/JPH09501418A/ja
Publication of WO1995003034A1 publication Critical patent/WO1995003034A1/fr
Priority to NO960217A priority patent/NO960217L/no
Priority to FI960253A priority patent/FI960253A/fi

Links

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
    • A61K9/0078—Sprays 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/52—Cytokines; Lymphokines; Interferons
    • C07K14/53—Colony-stimulating factor [CSF]
    • C07K14/535—Granulocyte CSF; Granulocyte-macrophage CSF
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates

Abstract

Procédé de protection de protéines contre la dégradation due à la pulvérisation sous forme d'aérosol et la perte de leur activité protéique. On stabilise les protéines comprises dans l'aérosol en ajoutant à la solution aqueuse, avant sa pulvérisation, un composé polaire organique hydrosoluble, par exemple le polyéthylène-glycol, ou un tensioactif. On a également prévu une solution aqueuse de protéines stabilisées renfermant un composé polaire organique ou un tensioactif, ainsi qu'un système de pulvérisation sous forme d'aérosol de la solution aqueuse renfermant les protéines stabilisées.
PCT/US1994/008136 1993-07-19 1994-07-19 Stabilisation de proteines administrees dans un aerosol WO1995003034A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
EP94924473A EP0710102A1 (fr) 1993-07-19 1994-07-19 Stabilisation de proteines administrees dans un aerosol
AU74732/94A AU691514B2 (en) 1993-07-19 1994-07-19 Stabilization of aerosolized proteins
NZ271181A NZ271181A (en) 1993-07-19 1994-07-19 Protein protection; method for stabilising aerosolised proteins by adding a water-soluble polar organic compound to the aqueous solution prior to aerosolisation
JP7505271A JPH09501418A (ja) 1993-07-19 1994-07-19 エアゾル化タンパク質の安定化
NO960217A NO960217L (no) 1993-07-19 1996-01-18 Stabilisering av aerosoliserte proteiner
FI960253A FI960253A (fi) 1993-07-19 1996-01-18 Aerosolisoitujen proteiinien stabilointi

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US9384093A 1993-07-19 1993-07-19
US08/093,840 1993-07-19

Publications (1)

Publication Number Publication Date
WO1995003034A1 true WO1995003034A1 (fr) 1995-02-02

Family

ID=22241106

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/008136 WO1995003034A1 (fr) 1993-07-19 1994-07-19 Stabilisation de proteines administrees dans un aerosol

Country Status (8)

Country Link
EP (1) EP0710102A1 (fr)
JP (1) JPH09501418A (fr)
AU (1) AU691514B2 (fr)
CA (1) CA2167538A1 (fr)
FI (1) FI960253A (fr)
NO (1) NO960217L (fr)
NZ (1) NZ271181A (fr)
WO (1) WO1995003034A1 (fr)

Cited By (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999007340A1 (fr) * 1997-08-04 1999-02-18 Boehringer Ingelheim Pharma Kg Preparations d'aerosols aqueuses contenant des macromolecules biologiquement actives et procede de production des aerosols correspondants
WO2001049274A2 (fr) * 1999-12-30 2001-07-12 Chiron Corporation Procedes d'administration pulmonaire d'interleukine-2
US6497869B2 (en) 2000-02-29 2002-12-24 Pfizer Inc. Stabilized granulocyte colony stimulating factor
WO2004058186A2 (fr) * 1997-01-29 2004-07-15 Stringer Kathleen A Formulations pour administration pulmonaire
US6908902B2 (en) 2001-02-02 2005-06-21 Ortho-Mcneil Pharmaceutical, Inc. Treatment of neurological dysfunction comprising fructopyranose sulfamates and erythropoietin
KR101086091B1 (ko) 2002-08-23 2011-11-25 가부시키가이샤 산샤덴키세이사쿠쇼 전원 장치
US8201554B2 (en) 2001-02-23 2012-06-19 Injet Digital Aerosols Limited Inhalation device having an optimized air flow path
WO2013017494A1 (fr) 2011-08-02 2013-02-07 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Composition pharmaceutique d'avidine oxydée adaptée à l'inhalation
US9545487B2 (en) 2012-04-13 2017-01-17 Boehringer Ingelheim International Gmbh Dispenser with encoding means
US9682202B2 (en) 2009-05-18 2017-06-20 Boehringer Ingelheim International Gmbh Adapter, inhalation device, and atomizer
US9724482B2 (en) 2009-11-25 2017-08-08 Boehringer Ingelheim International Gmbh Nebulizer
US9744313B2 (en) 2013-08-09 2017-08-29 Boehringer Ingelheim International Gmbh Nebulizer
US9757750B2 (en) 2011-04-01 2017-09-12 Boehringer Ingelheim International Gmbh Medicinal device with container
US9827384B2 (en) 2011-05-23 2017-11-28 Boehringer Ingelheim International Gmbh Nebulizer
US9943654B2 (en) 2010-06-24 2018-04-17 Boehringer Ingelheim International Gmbh Nebulizer
US10004857B2 (en) 2013-08-09 2018-06-26 Boehringer Ingelheim International Gmbh Nebulizer
US10011906B2 (en) 2009-03-31 2018-07-03 Beohringer Ingelheim International Gmbh Method for coating a surface of a component
US10016568B2 (en) 2009-11-25 2018-07-10 Boehringer Ingelheim International Gmbh Nebulizer
US10099022B2 (en) 2014-05-07 2018-10-16 Boehringer Ingelheim International Gmbh Nebulizer
US10124125B2 (en) 2009-11-25 2018-11-13 Boehringer Ingelheim International Gmbh Nebulizer
US10124129B2 (en) 2008-01-02 2018-11-13 Boehringer Ingelheim International Gmbh Dispensing device, storage device and method for dispensing a formulation
US10195374B2 (en) 2014-05-07 2019-02-05 Boehringer Ingelheim International Gmbh Container, nebulizer and use
US10722666B2 (en) 2014-05-07 2020-07-28 Boehringer Ingelheim International Gmbh Nebulizer with axially movable and lockable container and indicator

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2002310054B2 (en) * 2001-05-21 2007-02-01 Injet Digital Aerosols Limited Compositions for protein delivery via the pulmonary route
EA201000785A1 (ru) * 2007-12-13 2011-02-28 Глаксо Груп Лимитед Композиции для доставки в легкие

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1991004011A1 (fr) * 1989-09-20 1991-04-04 Riker Laboratories, Inc. Formulations aerosols medicinales
EP0510731A1 (fr) * 1986-11-25 1992-10-28 Abbott Laboratories Formulations analogues de LH-RH
WO1993003708A1 (fr) * 1991-08-21 1993-03-04 Oleg Petrovich Zhyrnov Preparation pharmaceutique en aerosol et son utilisation dans le traitement et la prophylaxie de maladies virales

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0510731A1 (fr) * 1986-11-25 1992-10-28 Abbott Laboratories Formulations analogues de LH-RH
WO1991004011A1 (fr) * 1989-09-20 1991-04-04 Riker Laboratories, Inc. Formulations aerosols medicinales
WO1993003708A1 (fr) * 1991-08-21 1993-03-04 Oleg Petrovich Zhyrnov Preparation pharmaceutique en aerosol et son utilisation dans le traitement et la prophylaxie de maladies virales
EP0563389A1 (fr) * 1991-08-21 1993-10-06 ZHIRNOV, Oleg Petrovich Preparation pharmaceutique en aerosol et son utilisation dans le traitement et la prophylaxie de maladies virales

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
R W NIVEN ET AL: "Protein nebulization: I. Stability of lactate dehydrogenase and recombinant granulocyte-colony stimulating factor to air-jet nebulization", INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 109, no. 1, 1994, AMSTERDAM, NL, pages 17 - 26 *

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004058186A2 (fr) * 1997-01-29 2004-07-15 Stringer Kathleen A Formulations pour administration pulmonaire
WO2004058186A3 (fr) * 1997-01-29 2004-10-14 Kathleen A Stringer Formulations pour administration pulmonaire
WO1999007340A1 (fr) * 1997-08-04 1999-02-18 Boehringer Ingelheim Pharma Kg Preparations d'aerosols aqueuses contenant des macromolecules biologiquement actives et procede de production des aerosols correspondants
WO2001049274A2 (fr) * 1999-12-30 2001-07-12 Chiron Corporation Procedes d'administration pulmonaire d'interleukine-2
WO2001049274A3 (fr) * 1999-12-30 2002-02-14 Chiron Corp Procedes d'administration pulmonaire d'interleukine-2
CN100333790C (zh) * 1999-12-30 2007-08-29 希龙公司 含白细胞介素－2的药物组合物在制药中的应用
US6497869B2 (en) 2000-02-29 2002-12-24 Pfizer Inc. Stabilized granulocyte colony stimulating factor
US6908902B2 (en) 2001-02-02 2005-06-21 Ortho-Mcneil Pharmaceutical, Inc. Treatment of neurological dysfunction comprising fructopyranose sulfamates and erythropoietin
US8201554B2 (en) 2001-02-23 2012-06-19 Injet Digital Aerosols Limited Inhalation device having an optimized air flow path
KR101086091B1 (ko) 2002-08-23 2011-11-25 가부시키가이샤 산샤덴키세이사쿠쇼 전원 장치
US10124129B2 (en) 2008-01-02 2018-11-13 Boehringer Ingelheim International Gmbh Dispensing device, storage device and method for dispensing a formulation
US10011906B2 (en) 2009-03-31 2018-07-03 Beohringer Ingelheim International Gmbh Method for coating a surface of a component
US9682202B2 (en) 2009-05-18 2017-06-20 Boehringer Ingelheim International Gmbh Adapter, inhalation device, and atomizer
US10016568B2 (en) 2009-11-25 2018-07-10 Boehringer Ingelheim International Gmbh Nebulizer
US9724482B2 (en) 2009-11-25 2017-08-08 Boehringer Ingelheim International Gmbh Nebulizer
US10124125B2 (en) 2009-11-25 2018-11-13 Boehringer Ingelheim International Gmbh Nebulizer
US9943654B2 (en) 2010-06-24 2018-04-17 Boehringer Ingelheim International Gmbh Nebulizer
US9757750B2 (en) 2011-04-01 2017-09-12 Boehringer Ingelheim International Gmbh Medicinal device with container
US9827384B2 (en) 2011-05-23 2017-11-28 Boehringer Ingelheim International Gmbh Nebulizer
WO2013017494A1 (fr) 2011-08-02 2013-02-07 Sigma-Tau Industrie Farmaceutiche Riunite S.P.A. Composition pharmaceutique d'avidine oxydée adaptée à l'inhalation
US10220163B2 (en) 2012-04-13 2019-03-05 Boehringer Ingelheim International Gmbh Nebuliser with coding means
US9545487B2 (en) 2012-04-13 2017-01-17 Boehringer Ingelheim International Gmbh Dispenser with encoding means
US9744313B2 (en) 2013-08-09 2017-08-29 Boehringer Ingelheim International Gmbh Nebulizer
US10004857B2 (en) 2013-08-09 2018-06-26 Boehringer Ingelheim International Gmbh Nebulizer
US10894134B2 (en) 2013-08-09 2021-01-19 Boehringer Ingelheim International Gmbh Nebulizer
US11642476B2 (en) 2013-08-09 2023-05-09 Boehringer Ingelheim International Gmbh Nebulizer
US10716905B2 (en) 2014-02-23 2020-07-21 Boehringer Lngelheim International Gmbh Container, nebulizer and use
US10099022B2 (en) 2014-05-07 2018-10-16 Boehringer Ingelheim International Gmbh Nebulizer
US10195374B2 (en) 2014-05-07 2019-02-05 Boehringer Ingelheim International Gmbh Container, nebulizer and use
US10722666B2 (en) 2014-05-07 2020-07-28 Boehringer Ingelheim International Gmbh Nebulizer with axially movable and lockable container and indicator

Also Published As

Publication number Publication date
EP0710102A1 (fr) 1996-05-08
AU7473294A (en) 1995-02-20
NO960217L (no) 1996-03-18
JPH09501418A (ja) 1997-02-10
NZ271181A (en) 1998-06-26
FI960253A (fi) 1996-03-18
AU691514B2 (en) 1998-05-21
FI960253A0 (fi) 1996-01-18
CA2167538A1 (fr) 1995-02-02
NO960217D0 (no) 1996-01-18

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