DK0607156T3 - Fremgangsmåde til fremstilling af konserverede lægemidler indeholdende humane proteiner til infusions- eller injektionsformål - Google Patents

Fremgangsmåde til fremstilling af konserverede lægemidler indeholdende humane proteiner til infusions- eller injektionsformål

Info

Publication number
DK0607156T3
DK0607156T3 DK92916938.1T DK92916938T DK0607156T3 DK 0607156 T3 DK0607156 T3 DK 0607156T3 DK 92916938 T DK92916938 T DK 92916938T DK 0607156 T3 DK0607156 T3 DK 0607156T3
Authority
DK
Denmark
Prior art keywords
preservative
prepn
infusion
human protein
sodium
Prior art date
Application number
DK92916938.1T
Other languages
Danish (da)
English (en)
Inventor
Heinrich Woog
Werner Gruber
Hans-J Markl
Gerhard Winter
Fritz Demmer
Original Assignee
Boehringer Mannheim 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=6438353&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK0607156(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Mannheim Gmbh filed Critical Boehringer Mannheim Gmbh
Application granted granted Critical
Publication of DK0607156T3 publication Critical patent/DK0607156T3/da

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186—Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • 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
    • A61K38/18—Growth factors; Growth regulators
    • A61K38/1816—Erythropoietin [EPO]
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827—Proteins from mammals or birds
    • Y10S530/829—Blood

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Dermatology (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)
DK92916938.1T 1991-08-15 1992-08-10 Fremgangsmåde til fremstilling af konserverede lægemidler indeholdende humane proteiner til infusions- eller injektionsformål DK0607156T3 (da)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE4126983A DE4126983A1 (de) 1991-08-15 1991-08-15 Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke

Publications (1)

Publication Number Publication Date
DK0607156T3 true DK0607156T3 (da) 1997-04-07

Family

ID=6438353

Family Applications (1)

Application Number Title Priority Date Filing Date
DK92916938.1T DK0607156T3 (da) 1991-08-15 1992-08-10 Fremgangsmåde til fremstilling af konserverede lægemidler indeholdende humane proteiner til infusions- eller injektionsformål

Country Status (25)

Country Link
US (2) US5503827A (no)
EP (2) EP0607156B1 (no)
JP (1) JP3670660B2 (no)
KR (1) KR100263282B1 (no)
AT (1) ATE145138T1 (no)
AU (2) AU678756B2 (no)
CA (1) CA2115348C (no)
CZ (1) CZ284853B6 (no)
DE (2) DE4126983A1 (no)
DK (1) DK0607156T3 (no)
ES (1) ES2094923T3 (no)
FI (1) FI112169B (no)
GE (1) GEP19981289B (no)
GR (1) GR3022037T3 (no)
HU (1) HU227421B1 (no)
IL (1) IL102775A (no)
MX (1) MX9204636A (no)
NO (1) NO309844B1 (no)
RU (1) RU2091068C1 (no)
SG (1) SG66226A1 (no)
SK (1) SK281910B6 (no)
TW (1) TW351677B (no)
UA (1) UA26343C2 (no)
WO (1) WO1993003744A1 (no)
ZA (1) ZA926122B (no)

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DE4242919A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF
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SE9300105D0 (sv) * 1993-01-15 1993-01-15 Kabi Pharmacia Ab Stable protein solution
US5482931A (en) * 1993-06-29 1996-01-09 Ferring Ab Stabilized pharmaceutical peptide compositions
JP3541054B2 (ja) * 1994-04-21 2004-07-07 ユニ・チャーム株式会社 使い捨ておむつ
US5766582A (en) * 1994-10-11 1998-06-16 Schering Corporation Stable, aqueous alfa interferon solution formulations
TW426523B (en) * 1995-04-06 2001-03-21 Hoffmann La Roche Interferon solution
DE69637012T2 (de) * 1995-06-07 2009-01-08 G.D. Searle Llc (N.D.Ges.D. Staates Delaware) Waessrige Formulierung enthaltend TFPI und Lösungsvermittlers
US5888968A (en) * 1995-06-07 1999-03-30 Chiron Corporation TFPI formulation
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
EP0784979A3 (en) * 1996-01-19 1999-03-03 Eli Lilly And Company Obesity protein formulations
WO1997026011A1 (en) * 1996-01-19 1997-07-24 Eli Lilly And Company Obesity protein formulations
TWI240627B (en) * 1996-04-26 2005-10-01 Chugai Pharmaceutical Co Ltd Erythropoietin solution preparation
US20030190307A1 (en) * 1996-12-24 2003-10-09 Biogen, Inc. Stable liquid interferon formulations
US6410511B2 (en) * 1997-01-08 2002-06-25 Amylin Pharmaceuticals, Inc. Formulations for amylin agonist peptides
US7312196B2 (en) * 1997-01-08 2007-12-25 Amylin Pharmaceuticals, Inc. Formulations for amylin agonist peptides
DE19716154A1 (de) * 1997-04-18 1998-10-22 Boehringer Mannheim Gmbh Stabile pharmazeutische Darreichungsform für Peptide, Proteine und Nukleinsäuren
EP0917879B1 (de) * 1997-11-22 2002-07-17 Boehringer Mannheim Gmbh Verbessertes Verfahren zur Stabilisierung von Proteinen
CA2312009A1 (en) * 1997-11-28 1999-06-10 Roche Diagnostics Gmbh An active hedgehog-protein-mutant, a process for its preparation and its use for pharmaceutical purposes
JP3723857B2 (ja) * 1998-02-04 2005-12-07 日本ケミカルリサーチ株式会社 ヒト成長ホルモン含有水性医薬組成物
JP3895109B2 (ja) * 1998-03-06 2007-03-22 中外製薬株式会社 蛋白非添加製剤
US20050203187A1 (en) * 1998-06-01 2005-09-15 Verbiscar Anthony J. Formulations useful for the treatment of varicella zoster virus infections and methods for the use thereof
DK0978285T3 (da) 1998-08-07 2006-03-27 Curis Inc Stabilt farmaceutisk præparat af hedgehogproteiner og anvendelse deraf
US6979442B1 (en) * 1998-08-17 2005-12-27 Pfizer Inc. Stabilized protein compositions
MXPA01010208A (es) * 1999-04-09 2003-07-21 Johnson & Johnson Composiciones farmaceuticas de eritropoyetina.
AU777397B2 (en) * 1999-07-22 2004-10-14 Aventisub Ii Inc. Multi-dose erythropoietin formulations
YU4602A (sh) 1999-07-22 2005-06-10 Aventis Pharmaceuticals Inc. Farmaceutske formulacije zaštićene od dejstva mikroorganizama
EP1129720B1 (en) 2000-02-29 2004-06-23 Pfizer Products Inc. Stabilized granulocyte colony stimulating factor
US20020141970A1 (en) * 2001-03-05 2002-10-03 Pettit Dean K. Stable aqueous solutions of granulocyte macrophage colony-stimulating factor
US6818613B2 (en) * 2001-11-07 2004-11-16 Ortho-Mcneil Pharmaceutical, Inc. Aqueous sustained-release formulations of proteins
KR20050012224A (ko) * 2002-05-21 2005-01-31 다이이찌 산토리 파마 가부시키가이샤 그렐린 함유 의약 조성물
SI21257A (sl) * 2002-07-17 2004-02-29 LEK farmacevtska dru�ba d.d. Stabilni farmacevtski pripravek, ki vsebuje eritropoietin
WO2004084859A2 (en) * 2003-03-21 2004-10-07 Nastech Pharmaceutical Company Inc. Nasal calcitonin formulations containing chlorobutanol
AU2003901515A0 (en) * 2003-04-02 2003-04-17 Norika Holdings Sterilisation process for pharmaceutical product
KR100610003B1 (ko) * 2003-06-10 2006-08-08 주식회사 엘지생명과학 혈청 알부민을 함유하지 않는 안정한 인 에리쓰로포이에틴용액 제형
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
WO2005019265A1 (en) * 2003-08-13 2005-03-03 Chiron Corporation Improved method of purifying tfpi and tfpi analogs
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
EP1800689B1 (en) * 2004-08-24 2016-12-28 Daiichi Sankyo Company, Limited Liquid preparation of physiologically active peptide
CA2915270C (en) * 2005-08-05 2017-07-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
DE202006020194U1 (de) * 2006-03-01 2007-12-06 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung
PT2076243E (pt) 2007-08-27 2014-12-05 Ratiopharm Gmbh Formulação líquida de g-csf
KR20100052501A (ko) * 2007-08-27 2010-05-19 바이오제너릭스 에이지 Ｇ―ｃｓｆ 콘주게이트의 액상 포뮬레이션
US8796206B2 (en) * 2007-11-15 2014-08-05 Amgen Inc. Aqueous formulation of erythropoiesis stimulating protein stabilised by antioxidants for parenteral administration
EP2249869B1 (en) * 2008-02-08 2011-09-07 BioGeneriX AG Liquid formulation of fsh
US8120369B2 (en) 2009-03-02 2012-02-21 Harris Corporation Dielectric characterization of bituminous froth
KR101838759B1 (ko) 2009-09-25 2018-03-14 가부시키가이샤 아루떼꾸 우에노 점안제
ES2716088T3 (es) 2010-02-04 2019-06-10 Csl Behring Ag Preparado de inmunoglobulina
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
MA48047A (fr) * 2017-04-05 2020-02-12 Modernatx Inc Réduction ou élimination de réponses immunitaires à des protéines thérapeutiques administrées par voie non intraveineuse, par exemple par voie sous-cutanée
KR20200143416A (ko) * 2018-04-09 2020-12-23 보드 오브 리전츠, 더 유니버시티 오브 텍사스 시스템 엑소좀을 사용하는 종양 유전자의 치료학적 표적화

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DE3729863A1 (de) * 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh Stabilisierte erythropoietin-lyophilisate
AU648509B2 (en) * 1989-07-14 1994-04-28 Wyeth Holdings Corporation Stable vaccine compositions containing interleukins
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
US5661125A (en) 1992-08-06 1997-08-26 Amgen, Inc. Stable and preserved erythropoietin compositions

Also Published As

Publication number Publication date
IL102775A0 (en) 1993-01-31
EP0528313A1 (de) 1993-02-24
SG66226A1 (en) 1999-07-20
HU9400416D0 (en) 1994-05-30
FI940674A (fi) 1994-02-14
RU2091068C1 (ru) 1997-09-27
ZA926122B (en) 1994-02-14
EP0607156A1 (de) 1994-07-27
HU227421B1 (en) 2011-05-30
NO309844B1 (no) 2001-04-09
MX9204636A (es) 1993-02-01
CZ284853B6 (cs) 1999-03-17
IL102775A (en) 1999-12-22
AU1633997A (en) 1997-05-22
RU94016163A (ru) 1996-08-10
US6303113B1 (en) 2001-10-16
SK281910B6 (sk) 2001-09-11
JP3670660B2 (ja) 2005-07-13
EP0607156B1 (de) 1996-11-13
DE4126983A1 (de) 1993-02-18
SK14894A3 (en) 1994-11-09
CA2115348C (en) 2007-07-17
HUT67379A (en) 1995-04-28
FI112169B (fi) 2003-11-14
ATE145138T1 (de) 1996-11-15
TW351677B (en) 1999-02-01
ES2094923T3 (es) 1997-02-01
GEP19981289B (en) 1998-05-01
WO1993003744A1 (de) 1993-03-04
DE59207523C5 (de) 2006-11-16
AU2409492A (en) 1993-03-16
US5503827A (en) 1996-04-02
GR3022037T3 (en) 1997-03-31
AU710768B2 (en) 1999-09-30
NO940499L (no) 1994-02-14
NO940499D0 (no) 1994-02-14
DE59207523D1 (de) 1996-12-19
UA26343C2 (uk) 1999-08-30
KR100263282B1 (ko) 2000-08-01
AU678756B2 (en) 1997-06-12
CA2115348A1 (en) 1993-03-04
FI940674A0 (fi) 1994-02-14
JPH06510031A (ja) 1994-11-10
CZ28794A3 (en) 1994-08-17

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