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

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/186Quaternary ammonium compounds, e.g. benzalkonium chloride or cetrimide
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/193Colony stimulating factors [CSF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S530/00Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
    • Y10S530/827Proteins from mammals or birds
    • Y10S530/829Blood

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 (cs)
EP (2) EP0528313A1 (cs)
JP (1) JP3670660B2 (cs)
KR (1) KR100263282B1 (cs)
AT (1) ATE145138T1 (cs)
AU (2) AU678756B2 (cs)
CA (1) CA2115348C (cs)
CZ (1) CZ284853B6 (cs)
DE (2) DE4126983A1 (cs)
DK (1) DK0607156T3 (cs)
ES (1) ES2094923T3 (cs)
FI (1) FI112169B (cs)
GE (1) GEP19981289B (cs)
GR (1) GR3022037T3 (cs)
HU (1) HU227421B1 (cs)
IL (1) IL102775A (cs)
MX (1) MX9204636A (cs)
NO (1) NO309844B1 (cs)
RU (1) RU2091068C1 (cs)
SG (1) SG66226A1 (cs)
SK (1) SK281910B6 (cs)
TW (1) TW351677B (cs)
UA (1) UA26343C2 (cs)
WO (1) WO1993003744A1 (cs)
ZA (1) ZA926122B (cs)

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DE4242863A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
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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
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US5888968A (en) * 1995-06-07 1999-03-30 Chiron Corporation TFPI formulation
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US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
AU1750997A (en) * 1996-01-19 1997-08-11 Eli Lilly And Company Obesity protein formulations
WO1997026011A1 (en) * 1996-01-19 1997-07-24 Eli Lilly And Company Obesity protein formulations
TW518219B (en) 1996-04-26 2003-01-21 Chugai Pharmaceutical Co Ltd Erythropoietin solution preparation
US20030190307A1 (en) * 1996-12-24 2003-10-09 Biogen, Inc. Stable liquid interferon formulations
US7312196B2 (en) * 1997-01-08 2007-12-25 Amylin Pharmaceuticals, Inc. Formulations for amylin agonist peptides
US6410511B2 (en) * 1997-01-08 2002-06-25 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
DK0917879T3 (da) * 1997-11-22 2002-11-04 Roche Diagnostics Gmbh Forbedret fremgangsmåde til stabilisering af proteiner
JP2001525341A (ja) * 1997-11-28 2001-12-11 ロッシュ ディアグノスティクス ゲゼルシャフト ミット ベシュレンクテル ハフツング 活性ヘッジホッグタンパク質変異体、その調製方法及び医薬への適用
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
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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
RU2234942C2 (ru) * 1998-07-14 2004-08-27 Корикса Корпорейшн Выделенный опухолевый полипептид предстательной железы и кодирующий его полинуклеотид
US6207718B1 (en) 1998-08-07 2001-03-27 Ontogeny, Inc. Pharmaceutical compositions containing hedgehog protein
US6979442B1 (en) * 1998-08-17 2005-12-27 Pfizer Inc. Stabilized protein compositions
ATE401908T1 (de) * 1999-04-09 2008-08-15 Ortho Mcneil Pharm Inc Pharmazeutische zusammensetzungen von erythropoietin
BR0012674A (pt) 1999-07-22 2002-09-17 Aventis Pharma Inc Formulações farmacêuticas preservadas
CZ302750B6 (cs) * 1999-07-22 2011-10-19 Aventis Holdings Inc. Farmaceutická kompozice a ampulka na bázi erythropoietinu a zpusob inhibování mikrobiálního rustu v roztoku obsahujícím tuto látku
TR200401573T4 (tr) 2000-02-29 2004-08-23 Pfizer Products Inc. Stabilize edilmiş granülosit koloni uyarıcı faktör
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
RU2218151C2 (ru) * 2001-12-11 2003-12-10 Замаев Ильяс Амсудинович Способ консервации растворов лекарственных средств
ES2615484T3 (es) * 2002-05-21 2017-06-07 Daiichi Sankyo Company, Limited Composiciones medicinales que contienen grelina
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
ATE553747T1 (de) * 2003-06-10 2012-05-15 Lg Life Sciences Ltd Stabile wässrige lösung von human-erythropoietin, die kein serumalbumin enthält
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
US7851433B2 (en) * 2003-08-13 2010-12-14 Novartis Vaccines And Diagnostics, Inc. Method of purifying TFPI and TFPI analogs
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
KR101149454B1 (ko) * 2004-08-24 2012-05-25 간가와 겐지 생리활성 펩티드의 액상 제제
DE202005005094U1 (de) * 2005-03-31 2005-07-28 Dr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh Ophthalmische Zusammensetzung
AU2006295340B2 (en) * 2005-08-05 2010-11-11 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
DK2197919T3 (da) * 2007-08-27 2014-07-07 Ratiopharm Gmbh Flydende formulering af g-csf-konjugat
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EP3381445B1 (en) 2007-11-15 2023-10-25 Amgen Inc. Aqueous formulation of antibody stablised by antioxidants for parenteral administration
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JP6125141B2 (ja) 2009-09-25 2017-05-10 株式会社アールテック・ウエノ 点眼剤
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HUE052280T2 (hu) 2014-12-03 2021-04-28 Csl Behring Ag Immunoglobulinokat tartalmazó megnövelt stabilitású gyógyszerészeti termék
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AU2019242912B2 (en) 2018-03-28 2025-07-17 Board Of Regents, The University Of Texas System Identification of epigenetic alterations in DNA isolated from exosomes
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DE3106073A1 (de) * 1981-02-19 1982-08-19 Boehringer Mannheim Gmbh, 6800 Mannheim Verfahren zur herstellung von sterilen zubereitungen hochviskoser loesungen und substanzen
GB2177914B (en) * 1985-06-04 1989-10-25 Chugai Pharmaceutical Co Ltd A pharmaceutical composition containing human erythropoietin and a surface active agent for nasal administration for the treatment of anemia
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
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Also Published As

Publication number Publication date
NO940499L (no) 1994-02-14
AU710768B2 (en) 1999-09-30
CZ284853B6 (cs) 1999-03-17
SK281910B6 (sk) 2001-09-11
NO309844B1 (no) 2001-04-09
KR100263282B1 (ko) 2000-08-01
IL102775A0 (en) 1993-01-31
UA26343C2 (uk) 1999-08-30
AU678756B2 (en) 1997-06-12
HU227421B1 (en) 2011-05-30
EP0607156A1 (de) 1994-07-27
FI940674L (fi) 1994-02-14
CZ28794A3 (en) 1994-08-17
RU94016163A (ru) 1996-08-10
AU1633997A (en) 1997-05-22
JP3670660B2 (ja) 2005-07-13
IL102775A (en) 1999-12-22
CA2115348C (en) 2007-07-17
ZA926122B (en) 1994-02-14
HU9400416D0 (en) 1994-05-30
GR3022037T3 (en) 1997-03-31
TW351677B (en) 1999-02-01
EP0607156B1 (de) 1996-11-13
SG66226A1 (en) 1999-07-20
SK14894A3 (en) 1994-11-09
FI112169B (fi) 2003-11-14
DE4126983A1 (de) 1993-02-18
HUT67379A (en) 1995-04-28
DE59207523C5 (de) 2006-11-16
DE59207523D1 (de) 1996-12-19
WO1993003744A1 (de) 1993-03-04
ATE145138T1 (de) 1996-11-15
CA2115348A1 (en) 1993-03-04
NO940499D0 (no) 1994-02-14
AU2409492A (en) 1993-03-16
FI940674A0 (fi) 1994-02-14
EP0528313A1 (de) 1993-02-24
JPH06510031A (ja) 1994-11-10
US5503827A (en) 1996-04-02
RU2091068C1 (ru) 1997-09-27
MX9204636A (es) 1993-02-01
US6303113B1 (en) 2001-10-16
ES2094923T3 (es) 1997-02-01
GEP19981289B (en) 1998-05-01

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