CA2041989A1 - Aqueous pharmaceutical formulations of erythropoietin and the use thereof - Google Patents

Aqueous pharmaceutical formulations of erythropoietin and the use thereof

Info

Publication number
CA2041989A1
CA2041989A1 CA002041989A CA2041989A CA2041989A1 CA 2041989 A1 CA2041989 A1 CA 2041989A1 CA 002041989 A CA002041989 A CA 002041989A CA 2041989 A CA2041989 A CA 2041989A CA 2041989 A1 CA2041989 A1 CA 2041989A1
Authority
CA
Canada
Prior art keywords
erythropoietin
aqueous pharmaceutical
pharmaceutical formulations
physiologically tolerated
epo
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.)
Granted
Application number
CA002041989A
Other languages
French (fr)
Other versions
CA2041989C (en
Inventor
Dieter Brazel
Bernhard Siebold
Dorothee Krumwieh
Thomas Brune
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.)
Siemens Healthcare Diagnostics GmbH Germany
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 CA2041989A1 publication Critical patent/CA2041989A1/en
Application granted granted Critical
Publication of CA2041989C publication Critical patent/CA2041989C/en
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
    • 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 activity, especially of human native and of recombinant human erythropoietin (EPO) are described.
Highly purified EPO without foreign proteins or other customary stabilizers retains at least about 78% of its original activity for at least 1 year at room temperature in a physiologically tolerated aqueous phosphate buffer which contains a physiologically tolerated alkali metal halide but otherwise no stabilizing additives and has a pH of 6 to 8. The products in this aqueous pharmaceutical formulation are particularly suitable for subcutaneous or intramuscular administration.
CA002041989A 1990-05-08 1991-05-07 Aqueous pharmaceutical formulations of erythropoietin and the use thereof Expired - Lifetime CA2041989C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DEP4014654.5 1990-05-08
DE4014654A DE4014654A1 (en) 1990-05-08 1990-05-08 GALENIC AQUEOUS FORMULATIONS OF ERYTHROPOIETIN AND THEIR USE

Publications (2)

Publication Number Publication Date
CA2041989A1 true CA2041989A1 (en) 1991-11-09
CA2041989C CA2041989C (en) 2001-07-31

Family

ID=6405907

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002041989A Expired - Lifetime CA2041989C (en) 1990-05-08 1991-05-07 Aqueous pharmaceutical formulations of erythropoietin and the use thereof

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
BRPI0110914B8 (en) 2000-05-15 2021-05-25 Hoffmann La Roche 'liquid pharmaceutical composition, process for its preparation and use of a pharmaceutical composition'
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
NO911788D0 (en) 1991-05-07
EP0456153A1 (en) 1991-11-13
DE4014654A1 (en) 1991-11-14
PT97584B (en) 1998-08-31
JP2922331B2 (en) 1999-07-19
KR910019636A (en) 1991-12-19
CA2041989C (en) 2001-07-31
DE59105075D1 (en) 1995-05-11
PT97584A (en) 1992-01-31
NO911788L (en) 1991-11-11
JPH04225923A (en) 1992-08-14
ZA913435B (en) 1992-02-26
ES2073063T3 (en) 1995-08-01
ATE120646T1 (en) 1995-04-15
EP0456153B1 (en) 1995-04-05
AU7618391A (en) 1991-11-14
DK0456153T3 (en) 1995-08-07
IE911549A1 (en) 1991-11-20
IE65925B1 (en) 1995-11-29
KR100203546B1 (en) 1999-06-15
AU652361B2 (en) 1994-08-25
NO301805B1 (en) 1997-12-15

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