ES2094923T3 - Procedimiento de preparacion de medicamentos conservados que contienen proteinas humanas, para fines de infusion o inyeccion. - Google Patents

Procedimiento de preparacion de medicamentos conservados que contienen proteinas humanas, para fines de infusion o inyeccion.

Info

Publication number
ES2094923T3
ES2094923T3 ES92916938T ES92916938T ES2094923T3 ES 2094923 T3 ES2094923 T3 ES 2094923T3 ES 92916938 T ES92916938 T ES 92916938T ES 92916938 T ES92916938 T ES 92916938T ES 2094923 T3 ES2094923 T3 ES 2094923T3
Authority
ES
Spain
Prior art keywords
preservative
prepn
infusion
human protein
sodium
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.)
Expired - Lifetime
Application number
ES92916938T
Other languages
English (en)
Inventor
Heinrich Woog
Werner Gruber
Hans-Jorg Markl
Gerhard Winter
Fritz Demmer
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.)
Roche Diagnostics GmbH
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=ES2094923(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 ES2094923T3 publication Critical patent/ES2094923T3/es
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
    • 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)

Abstract

LA PRESENTE INVENCION SE REFIERE A UN PROCESO PARA LA ELABORACION DE SOLUCIONES QUE CONTIENEN PROTEINAS HUMANAS FACILMENTE TOLERADAS, CONSERVADAS PARA SU UTILIZACION EN INYECCION O INFUSION.
ES92916938T 1991-08-15 1992-08-10 Procedimiento de preparacion de medicamentos conservados que contienen proteinas humanas, para fines de infusion o inyeccion. Expired - Lifetime ES2094923T3 (es)

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
ES2094923T3 true ES2094923T3 (es) 1997-02-01

Family

ID=6438353

Family Applications (1)

Application Number Title Priority Date Filing Date
ES92916938T Expired - Lifetime ES2094923T3 (es) 1991-08-15 1992-08-10 Procedimiento de preparacion de medicamentos conservados que contienen proteinas humanas, para fines de infusion o inyeccion.

Country Status (25)

Country Link
US (2) US5503827A (es)
EP (2) EP0528313A1 (es)
JP (1) JP3670660B2 (es)
KR (1) KR100263282B1 (es)
AT (1) ATE145138T1 (es)
AU (2) AU678756B2 (es)
CA (1) CA2115348C (es)
CZ (1) CZ284853B6 (es)
DE (2) DE4126983A1 (es)
DK (1) DK0607156T3 (es)
ES (1) ES2094923T3 (es)
FI (1) FI112169B (es)
GE (1) GEP19981289B (es)
GR (1) GR3022037T3 (es)
HU (1) HU227421B1 (es)
IL (1) IL102775A (es)
MX (1) MX9204636A (es)
NO (1) NO309844B1 (es)
RU (1) RU2091068C1 (es)
SG (1) SG66226A1 (es)
SK (1) SK281910B6 (es)
TW (1) TW351677B (es)
UA (1) UA26343C2 (es)
WO (1) WO1993003744A1 (es)
ZA (1) ZA926122B (es)

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DE3939346A1 (de) * 1989-11-29 1991-06-06 Behringwerke Ag Arzneimitel zur subkutanen oder intramuskulaeren applikation enthaltend polypeptide
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
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
JP2758154B2 (ja) * 1995-04-06 1998-05-28 エフ・ホフマン−ラ ロシユ アーゲー インターフェロンを含む液体製剤
US5888968A (en) * 1995-06-07 1999-03-30 Chiron Corporation TFPI formulation
PT1602667E (pt) * 1995-06-07 2007-07-13 Searle Llc Formulação aquosa que compreende tfpi e agentes de solubilização
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
WO1997026011A1 (en) * 1996-01-19 1997-07-24 Eli Lilly And Company Obesity protein formulations
EP0784979A3 (en) * 1996-01-19 1999-03-03 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
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
ATE220558T1 (de) * 1997-11-22 2002-08-15 Roche Diagnostics Gmbh Verbessertes verfahren zur stabilisierung von proteinen
AU752816B2 (en) * 1997-11-28 2002-10-03 Curis, Inc. 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
EP1060746A4 (en) * 1998-03-06 2002-06-19 Chugai Pharmaceutical Co Ltd PROTEIN-FREE PREPARATIONS
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
EP0978285B1 (en) 1998-08-07 2005-11-23 F. Hoffmann-La Roche Ag Stable pharmaceutical composition of hedgehog proteins and use thereof.
US6979442B1 (en) * 1998-08-17 2005-12-27 Pfizer Inc. Stabilized protein compositions
IL145816A0 (en) * 1999-04-09 2002-07-25 Ortho Mcneil Pharm Inc Pharmaceutical compositions of erythropoietin
BR0012667A (pt) * 1999-07-22 2002-07-02 Aventis Pharma Inc Formulações de eritropoietina de multi-doses
IL147756A (en) 1999-07-22 2005-12-18 Aventis Pharma Inc Preserved pharmaceutical formulations
DK1129720T3 (da) 2000-02-29 2004-09-27 Pfizer Prod Inc Stabiliseret granulocyt-kolonistimulerende faktor
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
BRPI0411114B8 (pt) * 2003-06-10 2021-05-25 Lg Chemical Ltd solução aquosa estável de eritropoetina humana, não contendo albumina de soro
DE10333317A1 (de) * 2003-07-22 2005-02-17 Biotecon Therapeutics Gmbh Formulierung für Proteinarzneimittel ohne Zusatz von humanem Serumalbumin (HSA)
ATE516306T1 (de) * 2003-08-13 2011-07-15 Novartis Vaccines & Diagnostic Verbessertes verfahren zur reinigung von tfpi und tfpi-analogen
EP1532983A1 (en) * 2003-11-18 2005-05-25 ZLB Bioplasma AG Immunoglobulin preparations having increased stability
JP4951344B2 (ja) * 2004-08-24 2012-06-13 第一三共株式会社 生理活性ペプチド液状製剤
CA2618068C (en) 2005-08-05 2016-02-16 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
DE102006009437A1 (de) 2006-03-01 2007-09-13 Bioceuticals Arzneimittel Ag G-CSF-Flüssigformulierung
PT2197919E (pt) * 2007-08-27 2014-07-17 Ratiopharm Gmbh Formulação líquida de conjugado de g-csf
EP2076243B9 (de) 2007-08-27 2015-01-14 ratiopharm GmbH Flüssigformulierung von g-csf
EP3381445B1 (en) 2007-11-15 2023-10-25 Amgen Inc. Aqueous formulation of antibody stablised by antioxidants for parenteral administration
DE202009009905U1 (de) * 2008-02-08 2009-10-29 Biogenerix Ag Flüssig-Formulierung von FSH
US8120369B2 (en) 2009-03-02 2012-02-21 Harris Corporation Dielectric characterization of bituminous froth
NZ599517A (en) * 2009-09-25 2013-07-26 Santen Pharmaceutical Co Ltd Eye drops containing a partial peptide of an insulin-like groth factor I (FGLM) and a tetrapeptide (SSSR)
AU2011212440B2 (en) 2010-02-04 2015-01-22 Csl Behring Ag Immunoglobulin preparation
EP2361636A1 (en) 2010-02-26 2011-08-31 CSL Behring AG Immunoglobulin preparation and storage system for an immunoglobulin preparation
WO2018187590A1 (en) * 2017-04-05 2018-10-11 Modernatx, Inc. Reduction or elimination of immune responses to non-intravenous, e.g., subcutaneously administered therapeutic proteins
AU2019253689A1 (en) * 2018-04-09 2020-11-12 Board Of Regents, The University Of Texas System Therapeutic targeting of oncogenes using 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
JP3485184B2 (ja) * 1989-07-14 2004-01-13 アメリカン サイアナミド カンパニー インターロイキン含有安定ワクチン組成物
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
CZ28794A3 (en) 1994-08-17
FI940674A0 (fi) 1994-02-14
IL102775A0 (en) 1993-01-31
GEP19981289B (en) 1998-05-01
HUT67379A (en) 1995-04-28
SK14894A3 (en) 1994-11-09
RU94016163A (ru) 1996-08-10
HU9400416D0 (en) 1994-05-30
DK0607156T3 (da) 1997-04-07
EP0607156B1 (de) 1996-11-13
JP3670660B2 (ja) 2005-07-13
RU2091068C1 (ru) 1997-09-27
NO940499D0 (no) 1994-02-14
JPH06510031A (ja) 1994-11-10
UA26343C2 (uk) 1999-08-30
DE4126983A1 (de) 1993-02-18
KR100263282B1 (ko) 2000-08-01
ATE145138T1 (de) 1996-11-15
CZ284853B6 (cs) 1999-03-17
DE59207523D1 (de) 1996-12-19
DE59207523C5 (de) 2006-11-16
AU710768B2 (en) 1999-09-30
SG66226A1 (en) 1999-07-20
AU678756B2 (en) 1997-06-12
WO1993003744A1 (de) 1993-03-04
FI940674A (fi) 1994-02-14
IL102775A (en) 1999-12-22
SK281910B6 (sk) 2001-09-11
EP0528313A1 (de) 1993-02-24
FI112169B (fi) 2003-11-14
GR3022037T3 (en) 1997-03-31
ZA926122B (en) 1994-02-14
NO309844B1 (no) 2001-04-09
MX9204636A (es) 1993-02-01
CA2115348A1 (en) 1993-03-04
US5503827A (en) 1996-04-02
NO940499L (no) 1994-02-14
AU1633997A (en) 1997-05-22
US6303113B1 (en) 2001-10-16
HU227421B1 (en) 2011-05-30
EP0607156A1 (de) 1994-07-27
AU2409492A (en) 1993-03-16
CA2115348C (en) 2007-07-17
TW351677B (en) 1999-02-01

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