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
preserved
infusion
procedure
preparation
containing human
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)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (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) EP0607156B1 (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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DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
DE4242919A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Verfahren zur Herstellung von lagerstabilen wässrigen pharmazeutischen Zubereitungen von G-CSF
DE4242863A1 (de) * 1992-12-18 1994-06-23 Boehringer Mannheim Gmbh Stabile lyophilisierte pharmazeutische 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
CA2223745C (en) * 1995-06-07 2004-03-16 Chiron Corporation Method of solubilizing, purifying, and refolding protein
US5888968A (en) * 1995-06-07 1999-03-30 Chiron Corporation TFPI formulation
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
JP2000504319A (ja) * 1996-01-19 2000-04-11 イーライ・リリー・アンド・カンパニー 肥満症タンパク質製剤
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
ES2179414T3 (es) * 1997-11-22 2003-01-16 Roche Diagnostics Gmbh Procedimiento mejorado de estabilizacion de proteinas.
EP1034269A1 (en) * 1997-11-28 2000-09-13 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
KR100389726B1 (ko) * 1998-03-06 2003-06-27 쥬가이 세이야쿠 가부시키가이샤 안정한 과립구 콜로니-자극 인자 함유 제제
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
ES2253851T3 (es) 1998-08-07 2006-06-01 Curis, Inc. Composicion farmaceutica estable de proteinas hedgehog y uso de la misma.
US6979442B1 (en) * 1998-08-17 2005-12-27 Pfizer Inc. Stabilized protein compositions
KR100740794B1 (ko) * 1999-04-09 2007-07-20 오르토-맥네일 파마슈티칼, 인코퍼레이티드 에리트로포이에틴의 약제학적 제형
IL147756A (en) 1999-07-22 2005-12-18 Aventis Pharma Inc Preserved pharmaceutical formulations
KR100693263B1 (ko) * 1999-07-22 2007-03-13 아벤티스 파마슈티칼스 인크. 다중 투여형 에리트로포이에틴 제형
ATE269716T1 (de) 2000-02-29 2004-07-15 Pfizer Prod Inc Stabilisierter granulozyten-kolonie- stimulierender 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
RU2218151C2 (ru) * 2001-12-11 2003-12-10 Замаев Ильяс Амсудинович Способ консервации растворов лекарственных средств
JP5000848B2 (ja) * 2002-05-21 2012-08-15 第一三共株式会社 グレリン含有医薬組成物
SI21257A (sl) * 2002-07-17 2004-02-29 LEK farmacevtska dru�ba d.d. Stabilni farmacevtski pripravek, ki vsebuje eritropoietin
US7812120B2 (en) 2003-03-21 2010-10-12 Par Pharmaceutical, Inc. Nasal calcitonin formulations containing chlorobutanol
AU2003901515A0 (en) * 2003-04-02 2003-04-17 Norika Holdings Sterilisation process for pharmaceutical product
CN1802171B (zh) * 2003-06-10 2010-10-13 株式会社Lg生命科学 不包含血清白蛋白的人红细胞生成素的稳定水溶液
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
BRPI0514408B8 (pt) * 2004-08-24 2021-05-25 Asubio Pharma Co Ltd preparação liquida de peptídeo fisiologicamente ativo
DE202005005094U1 (de) * 2005-03-31 2005-07-28 Dr. Gerhard Mann Chem.-Pharm. Fabrik Gmbh Ophthalmische Zusammensetzung
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
UA100245C2 (uk) 2007-08-27 2012-12-10 Біогенерікс Аг Рідка форма г-ксф
US8546328B2 (en) * 2007-08-27 2013-10-01 Biogenerix Ag Liquid formulation of G-CSF conjugate
US8796206B2 (en) 2007-11-15 2014-08-05 Amgen Inc. Aqueous formulation of erythropoiesis stimulating protein stabilised by antioxidants for parenteral administration
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US8120369B2 (en) 2009-03-02 2012-02-21 Harris Corporation Dielectric characterization of bituminous froth
EA022927B1 (ru) * 2009-09-25 2016-03-31 Р-Тек Уено, Лтд. Стабильные глазные капли для заживления повреждений роговицы
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CN121371151A (zh) 2014-12-03 2026-01-23 瑞士杰特贝林生物制品有限公司 具有增加的稳定性的包含免疫球蛋白的药物产品
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
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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
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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
DE4126983A1 (de) 1993-02-18
AU1633997A (en) 1997-05-22
KR100263282B1 (ko) 2000-08-01
UA26343C2 (uk) 1999-08-30
CA2115348A1 (en) 1993-03-04
US6303113B1 (en) 2001-10-16
US5503827A (en) 1996-04-02
CA2115348C (en) 2007-07-17
HUT67379A (en) 1995-04-28
TW351677B (en) 1999-02-01
GR3022037T3 (en) 1997-03-31
IL102775A0 (en) 1993-01-31
SG66226A1 (en) 1999-07-20
EP0528313A1 (de) 1993-02-24
FI940674L (fi) 1994-02-14
MX9204636A (es) 1993-02-01
AU678756B2 (en) 1997-06-12
SK281910B6 (sk) 2001-09-11
RU94016163A (ru) 1996-08-10
DE59207523D1 (de) 1996-12-19
IL102775A (en) 1999-12-22
EP0607156A1 (de) 1994-07-27
HU9400416D0 (en) 1994-05-30
JPH06510031A (ja) 1994-11-10
EP0607156B1 (de) 1996-11-13
AU710768B2 (en) 1999-09-30
RU2091068C1 (ru) 1997-09-27
AU2409492A (en) 1993-03-16
NO309844B1 (no) 2001-04-09
WO1993003744A1 (de) 1993-03-04
NO940499D0 (no) 1994-02-14
FI112169B (fi) 2003-11-14
DE59207523C5 (de) 2006-11-16
CZ284853B6 (cs) 1999-03-17
FI940674A0 (fi) 1994-02-14
NO940499L (no) 1994-02-14
JP3670660B2 (ja) 2005-07-13
SK14894A3 (en) 1994-11-09
ZA926122B (en) 1994-02-14
ATE145138T1 (de) 1996-11-15
CZ28794A3 (en) 1994-08-17
DK0607156T3 (da) 1997-04-07
GEP19981289B (en) 1998-05-01
HU227421B1 (en) 2011-05-30

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