CA2244767A1 - Process for the production of powdered pulmonary surfactant preparations - Google Patents

Process for the production of powdered pulmonary surfactant preparations

Info

Publication number
CA2244767A1
CA2244767A1 CA002244767A CA2244767A CA2244767A1 CA 2244767 A1 CA2244767 A1 CA 2244767A1 CA 002244767 A CA002244767 A CA 002244767A CA 2244767 A CA2244767 A CA 2244767A CA 2244767 A1 CA2244767 A1 CA 2244767A1
Authority
CA
Canada
Prior art keywords
pulmonary surfactant
production
powdered
surfactant preparations
hydrophobic protein
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.)
Granted
Application number
CA002244767A
Other languages
French (fr)
Other versions
CA2244767C (en
Inventor
Klaus Eistetter
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.)
Takeda GmbH
Original Assignee
Byk Gulden Lomberg Chemische Fabrik Gmbh
Klaus Eistetter
Altana Pharma Ag
Nycomed Gmbh
Takeda Gmbh
Nycomed Asset Management Gmbh
Nycomed Germany Holding Gmbh
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
Priority claimed from DE19602332A external-priority patent/DE19602332A1/en
Application filed by Byk Gulden Lomberg Chemische Fabrik Gmbh, Klaus Eistetter, Altana Pharma Ag, Nycomed Gmbh, Takeda Gmbh, Nycomed Asset Management Gmbh, Nycomed Germany Holding Gmbh filed Critical Byk Gulden Lomberg Chemische Fabrik Gmbh
Publication of CA2244767A1 publication Critical patent/CA2244767A1/en
Application granted granted Critical
Publication of CA2244767C publication Critical patent/CA2244767C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/1703—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • A61K38/1709—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • 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
    • A61K9/0082—Lung surfactant, artificial mucus
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system

Abstract

The invention concerns a process for the production of a powdered pulmonary surfactant preparation containing a hydrophobic protein serving as a pulmonary surfactant characterized by the fact that an organic solution or suspension containing a hydrophobic protein serving as a pulmonary surfactant and possibly other components is subject to spray drying. Powder preparations are obtained that exhibit very good stability under storage, are easy to reconstitute and which are also suitable for administration by inhalation.
CA002244767A 1996-01-24 1997-01-18 Process for the production of powdered pulmonary surfactant preparations Expired - Lifetime CA2244767C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE19602332.7 1996-01-24
DE19602332A DE19602332A1 (en) 1996-01-24 1996-01-24 Production of lung surfactant preparation in powder form
EP96103442.8 1996-03-06
EP96103442 1996-03-06
PCT/EP1997/000230 WO1997026863A1 (en) 1996-01-24 1997-01-18 Process for the production of powdered pulmonary surfactant preparations

Publications (2)

Publication Number Publication Date
CA2244767A1 true CA2244767A1 (en) 1997-07-31
CA2244767C CA2244767C (en) 2005-11-22

Family

ID=26022286

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002244767A Expired - Lifetime CA2244767C (en) 1996-01-24 1997-01-18 Process for the production of powdered pulmonary surfactant preparations

Country Status (15)

Country Link
US (1) US6315983B1 (en)
EP (1) EP0877602B1 (en)
JP (1) JP3725166B2 (en)
KR (1) KR100449789B1 (en)
AT (1) ATE212220T1 (en)
CA (1) CA2244767C (en)
CY (1) CY2366B1 (en)
CZ (1) CZ292186B6 (en)
DE (1) DE59706180D1 (en)
DK (1) DK0877602T3 (en)
ES (1) ES2171883T3 (en)
PT (1) PT877602E (en)
TR (1) TR199801408T2 (en)
UA (1) UA59358C2 (en)
WO (1) WO1997026863A1 (en)

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US20030203036A1 (en) 2000-03-17 2003-10-30 Gordon Marc S. Systems and processes for spray drying hydrophobic drugs with hydrophilic excipients
US6077543A (en) * 1996-12-31 2000-06-20 Inhale Therapeutic Systems Systems and processes for spray drying hydrophobic drugs with hydrophilic excipients
US6565885B1 (en) * 1997-09-29 2003-05-20 Inhale Therapeutic Systems, Inc. Methods of spray drying pharmaceutical compositions
US20060165606A1 (en) 1997-09-29 2006-07-27 Nektar Therapeutics Pulmonary delivery particles comprising water insoluble or crystalline active agents
ES2289823T3 (en) * 1998-08-25 2008-02-01 Advanced Inhalation Research, Inc. STABLE PROTEIC FORMULATIONS DRIED BY ATOMIZATION.
EP1767195A3 (en) * 1998-08-25 2007-04-04 Advanced Inhalation Research, Inc. Stable spray-dried protein formulations
AU1161300A (en) * 1998-11-10 2000-05-29 Byk Gulden Lomberg Chemische Fabrik Gmbh Treatment set containing lungsurfactant compositions
WO2000076535A1 (en) * 1999-06-11 2000-12-21 Byk Gulden Lomberg Chemische Fabrik Gmbh Pharmaceutical preparation containing modifications of surfactant protein b (sp-b) and surfactant protein c (sp-c)
US6749835B1 (en) 1999-08-25 2004-06-15 Advanced Inhalation Research, Inc. Formulation for spray-drying large porous particles
ATE285755T1 (en) * 1999-08-25 2005-01-15 Advanced Inhalation Res Inc LARGE POROUS PARTICLES AVAILABLE BY SPRAY DRYING AND SUITABLE FOR PULMONARY USE
US7678364B2 (en) 1999-08-25 2010-03-16 Alkermes, Inc. Particles for inhalation having sustained release properties
WO2001019392A1 (en) 1999-09-16 2001-03-22 Byk Gulden Lomberg Chemische Fabrik Gmbh Combination of c1-inh and lung surfactant for the treatment of respiratory disorders
DE19957898A1 (en) * 1999-12-01 2001-06-07 Byk Gulden Lomberg Chem Fab Treatment of legionnaire's disease using pulmonary surfactant preparation, preventing acute lung injury or adult respiratory distress syndrome without risk of development of resistance
MXPA02001323A (en) 2000-05-10 2004-07-16 Alliance Pharma Phospholipid-based powders for drug delivery.
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
US7575761B2 (en) 2000-06-30 2009-08-18 Novartis Pharma Ag Spray drying process control of drying kinetics
EP1435994B1 (en) 2001-10-11 2010-05-19 Nycomed GmbH Novel use of pulmonary surfactant
WO2003043603A1 (en) * 2001-11-20 2003-05-30 Advanced Inhalation Research, Inc. Particulate compositions for improving solubility of poorly soluble agents
CA2468958C (en) 2001-12-19 2012-07-03 Nektar Therapeutics Pulmonary delivery of aminoglycosides
US20030170223A1 (en) * 2002-02-01 2003-09-11 Board Of Trustees Of Michigan State University Pulmonary vasodilator surfactant compositions and method of use
JPWO2003077891A1 (en) * 2002-03-18 2005-07-14 アステラス製薬株式会社 Powder pharmaceutical composition for inhalation and method for producing the same
US20040184995A1 (en) * 2003-03-17 2004-09-23 Yamanouchi Pharmaceutical Co., Ltd. Novel dry powder inhalation for lung-delivery and manufacturing method thereof
EP1755720A1 (en) * 2004-05-20 2007-02-28 Discovery Laboratories, Inc. Methods , systems and devices for noninvasive pulmonary delivery
JP5108515B2 (en) 2004-08-06 2012-12-26 ニコメッド ゲゼルシャフト ミット ベシュレンクテル ハフツング Composition comprising pulmonary surfactant and TNF-derived peptide
US8337815B2 (en) 2004-12-23 2012-12-25 Discovery Laboratories, Inc. Pulmonary surfactant formulations
EP1830810A4 (en) * 2004-12-30 2011-02-02 Dobeel Co Ltd Spray-dried composition containing collectin family proteins or variants therof and process for preparing the same
US8028697B2 (en) 2005-04-28 2011-10-04 Trudell Medical International Ventilator circuit and method for the use thereof
EP2009023A1 (en) * 2007-06-04 2008-12-31 Rentschler Beteiligungs GmbH Novel peptides and their use for the treatment of edema
NZ588478A (en) * 2008-03-17 2013-06-28 Discovery Lab Inc Ventilation circuit surrounding proximal aerosol delivery channel
ES2402241T3 (en) 2008-10-22 2013-04-30 Trudell Medical International Modular Spray Supply System
AU2009324637B2 (en) 2008-12-10 2016-09-08 Paka Pulmonary Pharmaceuticals, Inc. Methods and compositions for delivery of medicaments to the lungs
CA2754691C (en) * 2009-03-26 2019-07-30 Pulmatrix, Inc. Dry powder formulations and methods for treating pulmonary diseases
EP2711004A1 (en) * 2009-10-05 2014-03-26 Nutri-Fit GmbH & Co. KG Methods for increasing physical capacity of mammalian livestock
CN103052380B (en) 2010-08-23 2015-11-25 塔科达有限责任公司 Comprise the wet particle of therapeutic active substance
NZ630219A (en) 2012-03-28 2016-09-30 Discovery Lab Inc Lyophilization of synthetic liposomal pulmonary surfactant
AU2015226289B8 (en) 2014-03-05 2019-10-31 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Device for providing a constant amount of aerosol
CN106163600B (en) 2014-03-05 2019-03-22 弗劳恩霍夫应用研究促进协会 Humidifier for being humidified to aerosol
KR102316762B1 (en) * 2014-03-18 2021-10-26 아펩티코 포어슝 운트 엔트빅크룽 게엠베하 Dry-powder peptide medicament
JP7240178B2 (en) * 2016-06-24 2023-03-15 シヴィタス セラピューティクス、インコーポレイテッド Surfactant formulation for inhalation
MX2020006634A (en) 2017-12-21 2021-01-15 Civitas Therapeutics Inc Surfactant formulations for inhalation.
WO2019126283A1 (en) * 2017-12-21 2019-06-27 Civitas Therapeutics, Inc. Surfactant formulations for inhalation

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Publication number Priority date Publication date Assignee Title
JPS58183621A (en) * 1982-04-22 1983-10-26 Teijin Ltd Dust preparation containing substance activating lung surface as active ingredient
DE3229179C2 (en) 1982-08-05 1986-04-17 A. Nattermann & Cie GmbH, 5000 Köln Pulmonary surfactant
JPS59164724A (en) 1983-03-10 1984-09-17 Tokyo Tanabe Co Ltd Surfactant and remedy for respiratory distress syndrome containing the same
US5260273A (en) 1988-01-06 1993-11-09 The Scripps Research Institute Pulmonary surfactant protein and related polypeptide
US5164369A (en) 1988-01-06 1992-11-17 The Scripps Research Institute Pulmonary surfactant protein and related polypeptide
DE69033745T2 (en) 1989-07-11 2002-02-28 Genentech Inc SURFACE-ACTIVE COMPOSITIONS AND METHODS
IN172208B (en) * 1990-04-02 1993-05-01 Sint Sa
ATE192930T1 (en) 1990-10-17 2000-06-15 Liposome Co Inc SYNTHETIC SURFACE-ACTIVE AGENTS ON THE LUNGS
US6582728B1 (en) * 1992-07-08 2003-06-24 Inhale Therapeutic Systems, Inc. Spray drying of macromolecules to produce inhaleable dry powders
EP0655237A1 (en) * 1993-11-27 1995-05-31 Hoechst Aktiengesellschaft Medicinal aerosol formulation
WO1995024183A1 (en) 1994-03-07 1995-09-14 Inhale Therapeutic Systems Methods and compositions for pulmonary delivery of insulin
US6051256A (en) * 1994-03-07 2000-04-18 Inhale Therapeutic Systems Dispersible macromolecule compositions and methods for their preparation and use
US5780014A (en) * 1995-04-14 1998-07-14 Inhale Therapeutic Systems Method and apparatus for pulmonary administration of dry powder alpha 1-antitrypsin
AU706195B2 (en) * 1995-04-14 1999-06-10 Inhale Therapeutic Systems Powdered pharmaceutical formulations having improved dispersibility
US6019968A (en) 1995-04-14 2000-02-01 Inhale Therapeutic Systems, Inc. Dispersible antibody compositions and methods for their preparation and use
US6077543A (en) * 1996-12-31 2000-06-20 Inhale Therapeutic Systems Systems and processes for spray drying hydrophobic drugs with hydrophilic excipients
GB9814172D0 (en) 1998-06-30 1998-08-26 Andaris Ltd Formulation for inhalation
ES2289823T3 (en) 1998-08-25 2008-02-01 Advanced Inhalation Research, Inc. STABLE PROTEIC FORMULATIONS DRIED BY ATOMIZATION.

Also Published As

Publication number Publication date
ATE212220T1 (en) 2002-02-15
CY2366B1 (en) 2004-06-04
EP0877602A1 (en) 1998-11-18
DE59706180D1 (en) 2002-03-14
DK0877602T3 (en) 2002-05-06
JP2000503976A (en) 2000-04-04
US6315983B1 (en) 2001-11-13
CA2244767C (en) 2005-11-22
PT877602E (en) 2002-07-31
KR19990081886A (en) 1999-11-15
KR100449789B1 (en) 2005-02-03
CZ233898A3 (en) 1999-02-17
JP3725166B2 (en) 2005-12-07
ES2171883T3 (en) 2002-09-16
TR199801408T2 (en) 1998-10-21
CZ292186B6 (en) 2003-08-13
EP0877602B1 (en) 2002-01-23
UA59358C2 (en) 2003-09-15
WO1997026863A1 (en) 1997-07-31

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Effective date: 20170118