UY25790A1 - PHARMACEUTICAL FORMS OF RECOMBINANT HUMAN ERYTHROPOYETIN STABLE AT ROOM TEMPERATURE AND SUITABLE FOR USE IN HUMANS, FORMULATIONS AND FREEZE PROCEDURES FOR THEIR OBTAINING. - Google Patents

PHARMACEUTICAL FORMS OF RECOMBINANT HUMAN ERYTHROPOYETIN STABLE AT ROOM TEMPERATURE AND SUITABLE FOR USE IN HUMANS, FORMULATIONS AND FREEZE PROCEDURES FOR THEIR OBTAINING.

Info

Publication number
UY25790A1
UY25790A1 UY25790A UY25790A UY25790A1 UY 25790 A1 UY25790 A1 UY 25790A1 UY 25790 A UY25790 A UY 25790A UY 25790 A UY25790 A UY 25790A UY 25790 A1 UY25790 A1 UY 25790A1
Authority
UY
Uruguay
Prior art keywords
recombinant human
humans
stable
room temperature
formulations
Prior art date
Application number
UY25790A
Other languages
Spanish (es)
Inventor
Vidal Alejandro
Melo Carlos
Criscuolo Marcelo
Carcagno Miguel
Original Assignee
Bio Sidus S A
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 Bio Sidus S A filed Critical Bio Sidus S A
Publication of UY25790A1 publication Critical patent/UY25790A1/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
    • A61K38/18—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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein

Landscapes

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

Abstract

La peresente invención se refiere a formas farmacéuticas de Eritropoyetina (EPO) Humana Recombinante que se caracterizan porque: a) son estables a temperatura ambiente, b) son liofilizadas, c) son apropiadas para su uso en humanos y d) contienen un sacárido, NaCl, NaH2PO4, NaHPO4.12 H2O, albúmina humana, Eritropoyetina Humana Recombinante y agua. La EPO es una proteína que ha demostrado gran eficacia para el tratamiento de anemias. Las formulaciones reivindicadas contienen 1000 UI, 2000 UI, 4000 UI y 10000 UI de EPO con el agregado de excipientes específicos que aseguran la isotonicidad y estabilidad del producto.The permanent invention relates to pharmaceutical forms of Recombinant Human Erythropoietin (EPO) characterized in that: a) they are stable at room temperature, b) they are lyophilized, c) they are suitable for use in humans and d) they contain a saccharide, NaCl, NaH2PO4, NaHPO4.12 H2O, Human Albumin, Recombinant Human Erythropoietin and water. EPO is a protein that has shown great efficacy for the treatment of anemias. The claimed formulations contain 1000 IU, 2000 IU, 4000 IU and 10000 IU of EPO with the addition of specific excipients that ensure the isotonicity and stability of the product.

UY25790A 1998-11-06 1999-11-05 PHARMACEUTICAL FORMS OF RECOMBINANT HUMAN ERYTHROPOYETIN STABLE AT ROOM TEMPERATURE AND SUITABLE FOR USE IN HUMANS, FORMULATIONS AND FREEZE PROCEDURES FOR THEIR OBTAINING. UY25790A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AR9805608 1998-11-06
AR9900677 1999-02-23

Publications (1)

Publication Number Publication Date
UY25790A1 true UY25790A1 (en) 2000-08-21

Family

ID=25590825

Family Applications (1)

Application Number Title Priority Date Filing Date
UY25790A UY25790A1 (en) 1998-11-06 1999-11-05 PHARMACEUTICAL FORMS OF RECOMBINANT HUMAN ERYTHROPOYETIN STABLE AT ROOM TEMPERATURE AND SUITABLE FOR USE IN HUMANS, FORMULATIONS AND FREEZE PROCEDURES FOR THEIR OBTAINING.

Country Status (3)

Country Link
AU (1) AU1520800A (en)
UY (1) UY25790A1 (en)
WO (1) WO2000027419A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR9905868A (en) 1998-11-06 2001-01-23 Bio Sidus S A Mass culture procedure for mammalian cells to obtain recombinant human erythropoietin and recombinant human erythropoietin obtained with such procedure
US6777205B1 (en) 1998-11-06 2004-08-17 Sterrenbeld Biotechnologie North America, Inc. Host cells expressing recombinant human erythropoietin
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
SI1311285T1 (en) 2000-05-15 2005-08-31 Hoffmann La Roche
US7772182B2 (en) 2004-08-05 2010-08-10 Alza Corporation Stable suspension formulations of erythropoietin receptor agonists
CN108606955B (en) * 2016-12-09 2021-10-26 江苏豪森药业集团有限公司 Medicinal composition of cultivated hippocampus japonicus peptide and preparation method thereof

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6197229A (en) * 1984-10-18 1986-05-15 Chugai Pharmaceut Co Ltd Stable erythropoietin preparation
SE9300105D0 (en) * 1993-01-15 1993-01-15 Kabi Pharmacia Ab STABLE PROTEIN SOLUTION
US5876992A (en) * 1996-07-03 1999-03-02 Molecular Biology Resources, Inc. Method and formulation for stabilization of enzymes

Also Published As

Publication number Publication date
WO2000027419A1 (en) 2000-05-18
AU1520800A (en) 2000-05-29

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Legal Events

Date Code Title Description
ABAN Application deemed to be withdrawn (no publication fee paid)

Effective date: 20090413