NO309844B1 - Konserverte, humanproteinholdige legemidler for anvendelse som injeksjons- eller infusjonsoppløsning i form av flerdosepreparater - Google Patents

Konserverte, humanproteinholdige legemidler for anvendelse som injeksjons- eller infusjonsoppløsning i form av flerdosepreparater Download PDF

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Publication number
NO309844B1
NO309844B1 NO940499A NO940499A NO309844B1 NO 309844 B1 NO309844 B1 NO 309844B1 NO 940499 A NO940499 A NO 940499A NO 940499 A NO940499 A NO 940499A NO 309844 B1 NO309844 B1 NO 309844B1
Authority
NO
Norway
Prior art keywords
preservative
injection
solution
human protein
medicines according
Prior art date
Application number
NO940499A
Other languages
English (en)
Norwegian (no)
Other versions
NO940499L (no
NO940499D0 (no
Inventor
Heinrich Woog
Werner Gruber
Hans-Joerg Markl
Gerhard Winter
Fritz Demmer
Original Assignee
Roche Diagnostics 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=NO309844(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Roche Diagnostics Gmbh filed Critical Roche Diagnostics Gmbh
Publication of NO940499L publication Critical patent/NO940499L/no
Publication of NO940499D0 publication Critical patent/NO940499D0/no
Publication of NO309844B1 publication Critical patent/NO309844B1/no

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)
NO940499A 1991-08-15 1994-02-14 Konserverte, humanproteinholdige legemidler for anvendelse som injeksjons- eller infusjonsoppløsning i form av flerdosepreparater NO309844B1 (no)

Applications Claiming Priority (2)

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
PCT/EP1992/001822 WO1993003744A1 (de) 1991-08-15 1992-08-10 Verfahren zur herstellung von humanproteinhaltigen, konservierten arzneimitteln für infusions- oder injektionszwecke

Publications (3)

Publication Number Publication Date
NO940499L NO940499L (no) 1994-02-14
NO940499D0 NO940499D0 (no) 1994-02-14
NO309844B1 true NO309844B1 (no) 2001-04-09

Family

ID=6438353

Family Applications (1)

Application Number Title Priority Date Filing Date
NO940499A NO309844B1 (no) 1991-08-15 1994-02-14 Konserverte, humanproteinholdige legemidler for anvendelse som injeksjons- eller infusjonsoppløsning i form av flerdosepreparater

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
DE4242919A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF
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
US5888968A (en) * 1995-06-07 1999-03-30 Chiron Corporation TFPI formulation
EP0837883B1 (en) * 1995-06-07 2005-08-10 Chiron Corporation Method of solubilizing, purifying, and refolding protein
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
US6776983B1 (en) 1998-03-06 2004-08-17 Chugai Seiyaku Kabushiki Kaisha Protein free formulations
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
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US7851433B2 (en) * 2003-08-13 2010-12-14 Novartis Vaccines And Diagnostics, Inc. Method of purifying TFPI and TFPI analogs
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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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HUE052280T2 (hu) 2014-12-03 2021-04-28 Csl Behring Ag Immunoglobulinokat tartalmazó megnövelt stabilitású gyógyszerészeti termék
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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
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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
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
DK0607156T3 (da) 1997-04-07
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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