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PE20020050A1 - Composicion farmaceutica liquida que contiene eritropoyetina y un anion inorganico - Google Patents

Composicion farmaceutica liquida que contiene eritropoyetina y un anion inorganico

Info

Publication number
PE20020050A1
PE20020050A1 PE2001000421A PE2001000421A PE20020050A1 PE 20020050 A1 PE20020050 A1 PE 20020050A1 PE 2001000421 A PE2001000421 A PE 2001000421A PE 2001000421 A PE2001000421 A PE 2001000421A PE 20020050 A1 PE20020050 A1 PE 20020050A1
Authority
PE
Peru
Prior art keywords
erythropoyetin
linked
antioxidane
phosphate
sequence
Prior art date
Application number
PE2001000421A
Other languages
English (en)
Inventor
Apollon Papadimitriou
Original Assignee
Hoffmann La Roche
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=8168722&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20020050(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of PE20020050A1 publication Critical patent/PE20020050A1/es

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
    • 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
    • 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
    • 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
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • 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
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06—Antianaemics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Virology (AREA)
  • Biochemistry (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • AIDS & HIV (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Endocrinology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

SE REFIERE A UNA COMPOSICION LIQUIDA (SOLUCION ACUOSA, ISOTONICA) QUE CONTIENE ERITROPOYETINA HUMANA QUE SE EXPRESA POR ACTIVACION GENETICA ENDOGENA O ES UNA SECUENCIA DE 165 o 166 AMINOACIDOS O ES MODIFICADA i)POR ADICION DE 1 A 6 SITIOS DE GLICOSILACION, ii)POR UN REORDENAMIENTO DE POR LO MENOS UN SITIO DE GLICOSILACION QUE CONSISTE EN LA ELIMINACION DE LOS SITIOS DE GLICOSILACION UNIDO MEDIANTE N DE LA ERITROPOYETINA Y EN LA ADICION DE UN SITIO DE GLICOSILACION UNIDO MEDIANTE N DE LA POSICION 88 DE LA SECUENCIA DE ERITROPOYEINA, UN ANION (DE 10 MMOLES/L A 200 MMOLES/L DE SULFATO, CITRATO, FOSFATO) DE UN ACIDO INORGANICO FUERTE Y PROVISTO DE CARGA MULTIPLE EN UN TAMPON (FOSFATO DE 10 A 50 NMOLAR, ARGININA /H2SO4/Na2SO4); PARA MANTENER EL pH DE 5,5 Y 7,0 Y OPCIONALMENTE EXCIPIENTES COMO SALES DILUYENTES, CONSERVANTES, AGENTES TONIFICADORES, POLIOLES (MANITA, SORBITA, GLICERINA, TREHALOSA, SACAROSA), 1% DE ANTIOXIDANTRES (METIONINA), DETERGENTES NO IONICOS (POLISORBATO 80, 20). LA ERITROPOYETINA ES PEGILADA O ES UN CONJUGADO DE ERITROPOYETINA CON UN GRUPO AMINO LIBRE UNIDA POR ENLACES COVALENTES A n GRUPOS DE POLIETILENGLICOL DE FORMULA -CO-(CH2)x-(OCH2CH2)m-OR; R ES ALQUILO, x ES 2-3; m ES 450 A 900; n ES 1-3; n Y m SE ELIJEN DE TAL MANERA QUE EL PESO MOLECULAR DEL CONJUGADO MENOS LA GLICOPROTEINA ERITROPOYETINA SEA ENTRE 20 Y 100 KILODALTONES. LA COMPOSICION PUEDE SER UTIL PARA EL TRATAMIENTO DE ANEMIA EN PACIENTES CON INSUFICIENCIA RENAL CRONICA, SIDA, CANCER
PE2001000421A 2000-05-15 2001-05-11 Composicion farmaceutica liquida que contiene eritropoyetina y un anion inorganico PE20020050A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP00110355 2000-05-15

Publications (1)

Publication Number Publication Date
PE20020050A1 true PE20020050A1 (es) 2002-02-01

Family

ID=8168722

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2001000421A PE20020050A1 (es) 2000-05-15 2001-05-11 Composicion farmaceutica liquida que contiene eritropoyetina y un anion inorganico

Country Status (36)

Country Link
US (2) US7169754B2 (es)
EP (2) EP1525889A1 (es)
JP (1) JP3967594B2 (es)
KR (3) KR20070032815A (es)
CN (1) CN1309416C (es)
AR (2) AR035034A1 (es)
AT (1) ATE291436T2 (es)
AU (1) AU784091B2 (es)
BR (1) BRPI0110914B8 (es)
CA (1) CA2408685C (es)
CZ (1) CZ304855B6 (es)
DE (1) DE60109625T3 (es)
DK (1) DK1311285T4 (es)
EC (2) ECSP024352A (es)
ES (1) ES2237574T5 (es)
HK (1) HK1056683A1 (es)
HR (1) HRP20020880B1 (es)
HU (1) HU230874B1 (es)
IL (2) IL152659A0 (es)
JO (1) JO3404B1 (es)
MA (1) MA26901A1 (es)
ME (1) MEP90708A (es)
MX (1) MXPA02011303A (es)
MY (1) MY128654A (es)
NO (1) NO330934B1 (es)
NZ (1) NZ522030A (es)
PE (1) PE20020050A1 (es)
PL (1) PL219131B1 (es)
PT (1) PT1311285E (es)
RS (1) RS51292B (es)
RU (1) RU2281116C2 (es)
SI (1) SI1311285T1 (es)
TW (2) TWI288643B (es)
UY (1) UY26704A1 (es)
WO (1) WO2001087329A1 (es)
ZA (1) ZA200208500B (es)

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