NO301805B1 - Process for the preparation of a stable galenic aqueous preparation of erythropoietin - Google Patents

Process for the preparation of a stable galenic aqueous preparation of erythropoietin

Info

Publication number
NO301805B1
NO301805B1 NO911788A NO911788A NO301805B1 NO 301805 B1 NO301805 B1 NO 301805B1 NO 911788 A NO911788 A NO 911788A NO 911788 A NO911788 A NO 911788A NO 301805 B1 NO301805 B1 NO 301805B1
Authority
NO
Norway
Prior art keywords
preparation
erythropoietin
aqueous
physiologically tolerated
epo
Prior art date
Application number
NO911788A
Other languages
Norwegian (no)
Other versions
NO911788D0 (en
NO911788L (en
Inventor
Dieter Brazel
Bernhard Siebold
Dorothee Krumwieh
Thomas Brune
Original Assignee
Behringwerke Ag
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
Application filed by Behringwerke Ag filed Critical Behringwerke Ag
Publication of NO911788D0 publication Critical patent/NO911788D0/en
Publication of NO911788L publication Critical patent/NO911788L/en
Publication of NO301805B1 publication Critical patent/NO301805B1/en

Links

Classifications

    • 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
    • A61K38/22—Hormones
    • 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
    • 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
    • A61K47/02—Inorganic compounds
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Zoology (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)

Abstract

Aqueous pharmaceutical formulations of proteins with erythropoietin action, especially of natural human and recombinant human erythropoietin (EPO), are described. Highly purified EPO without foreign proteins or other conventional stabilisers retains at least about 78 % of its original activity at room temperature for at least 1 year in a physiologically tolerated aqueous phosphate buffer which contains a physiologically tolerated alkali metal halide but no other stabilising additives and has a pH of 6 to 8. The products in this aqueous pharmaceutical formulation are particularly suitable for subcutaneous or intramuscular administration.
NO911788A 1990-05-08 1991-05-07 Process for the preparation of a stable galenic aqueous preparation of erythropoietin NO301805B1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE4014654A DE4014654A1 (en) 1990-05-08 1990-05-08 GALENIC AQUEOUS FORMULATIONS OF ERYTHROPOIETIN AND THEIR USE

Publications (3)

Publication Number Publication Date
NO911788D0 NO911788D0 (en) 1991-05-07
NO911788L NO911788L (en) 1991-11-11
NO301805B1 true NO301805B1 (en) 1997-12-15

Family

ID=6405907

Family Applications (1)

Application Number Title Priority Date Filing Date
NO911788A NO301805B1 (en) 1990-05-08 1991-05-07 Process for the preparation of a stable galenic aqueous preparation of erythropoietin

Country Status (13)

Country Link
EP (1) EP0456153B1 (en)
JP (1) JP2922331B2 (en)
KR (1) KR100203546B1 (en)
AT (1) ATE120646T1 (en)
AU (1) AU652361B2 (en)
CA (1) CA2041989C (en)
DE (2) DE4014654A1 (en)
DK (1) DK0456153T3 (en)
ES (1) ES2073063T3 (en)
IE (1) IE65925B1 (en)
NO (1) NO301805B1 (en)
PT (1) PT97584B (en)
ZA (1) ZA913435B (en)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR9917606A (en) * 1998-11-06 2002-12-31 Bio Sidus S A Procedure for the purification of recombinant human erythropoietin from cell culture supernatants and recombinant human erythropoietin obtained with such procedure
EP1311285B2 (en) 2000-05-15 2017-04-12 F. Hoffmann-La Roche AG Liquid pharmaceutical composition containing an erythropoietin derivative
DE10234192B4 (en) 2002-07-26 2009-11-26 Epoplus Gmbh Co.Kg Use of erythropoietin
EP1537876A1 (en) * 2003-12-01 2005-06-08 BioGeneriX AG Erythropoietin solution formulation

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS57149228A (en) * 1981-03-11 1982-09-14 Ajinomoto Co Inc Novel erythropoietin and its preparation
JPH0686480B2 (en) * 1983-02-21 1994-11-02 雪印乳業株式会社 Monoclonal antibody for erythropoietin production
JPS6191131A (en) * 1984-10-09 1986-05-09 Chugai Pharmaceut Co Ltd Method and composition for preventing adsorption of pharmaceutical
JPS6197229A (en) * 1984-10-18 1986-05-15 Chugai Pharmaceut Co Ltd Stable erythropoietin preparation
DE3729863A1 (en) * 1987-09-05 1989-03-16 Boehringer Mannheim Gmbh STABILIZED ERYTHROPOIETIN LYOPHILISATES

Also Published As

Publication number Publication date
JP2922331B2 (en) 1999-07-19
JPH04225923A (en) 1992-08-14
PT97584A (en) 1992-01-31
KR100203546B1 (en) 1999-06-15
DE4014654A1 (en) 1991-11-14
PT97584B (en) 1998-08-31
AU652361B2 (en) 1994-08-25
DE59105075D1 (en) 1995-05-11
IE65925B1 (en) 1995-11-29
EP0456153A1 (en) 1991-11-13
DK0456153T3 (en) 1995-08-07
EP0456153B1 (en) 1995-04-05
AU7618391A (en) 1991-11-14
CA2041989A1 (en) 1991-11-09
NO911788D0 (en) 1991-05-07
NO911788L (en) 1991-11-11
CA2041989C (en) 2001-07-31
ES2073063T3 (en) 1995-08-01
IE911549A1 (en) 1991-11-20
KR910019636A (en) 1991-12-19
ZA913435B (en) 1992-02-26
ATE120646T1 (en) 1995-04-15

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Legal Events

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MK1K Patent expired