UA103221C2 - Стабільний склад рекомбінантного альбуміну людини-гранулоцитарного колонієстимулюючого фактора людини - Google Patents

Стабільний склад рекомбінантного альбуміну людини-гранулоцитарного колонієстимулюючого фактора людини

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Publication number
UA103221C2
UA103221C2 UAA201109963A UAA201109963A UA103221C2 UA 103221 C2 UA103221 C2 UA 103221C2 UA A201109963 A UAA201109963 A UA A201109963A UA A201109963 A UAA201109963 A UA A201109963A UA 103221 C2 UA103221 C2 UA 103221C2
Authority
UA
Ukraine
Prior art keywords
stimulating factor
colony stimulating
granulocyte colony
stable formulation
recombinant human
Prior art date
Application number
UAA201109963A
Other languages
English (en)
Russian (ru)
Inventor
Джейсон Бенджамін Бок
Ксіа Луо
Original Assignee
Тева Фармасьютікал Індастріз Лтд.
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 Тева Фармасьютікал Індастріз Лтд. filed Critical Тева Фармасьютікал Індастріз Лтд.
Publication of UA103221C2 publication Critical patent/UA103221C2/uk

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/193Colony stimulating factors [CSF]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Винахід стосується фармацевтичної композиції, що містить рекомбінантний альбумін людини-гранулоцитарний колонієстимулюючий фактор людини і щонайменше один фармацевтично прийнятний носій, де композиція має рН від 4 до 6,4, а концентрація рекомбінантного гібридного білка становить від 30 до 120 мг/мл.
UAA201109963A 2009-01-16 2010-01-15 Стабільний склад рекомбінантного альбуміну людини-гранулоцитарного колонієстимулюючого фактора людини UA103221C2 (uk)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US14544009P 2009-01-16 2009-01-16
US14543609P 2009-01-16 2009-01-16
PCT/US2010/021235 WO2010083434A2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor

Publications (1)

Publication Number Publication Date
UA103221C2 true UA103221C2 (uk) 2013-09-25

Family

ID=42260335

Family Applications (2)

Application Number Title Priority Date Filing Date
UAA201109961A UA105201C2 (uk) 2009-01-16 2010-01-15 Застосування рекомбінантного альбуміну людини-гранулоцитарного колонієстимулюючого фактора людини для запобігання нейтропенії або лейкопенії
UAA201109963A UA103221C2 (uk) 2009-01-16 2010-01-15 Стабільний склад рекомбінантного альбуміну людини-гранулоцитарного колонієстимулюючого фактора людини

Family Applications Before (1)

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UAA201109961A UA105201C2 (uk) 2009-01-16 2010-01-15 Застосування рекомбінантного альбуміну людини-гранулоцитарного колонієстимулюючого фактора людини для запобігання нейтропенії або лейкопенії

Country Status (16)

Country Link
US (4) US8323634B2 (uk)
EP (2) EP2387419A2 (uk)
JP (2) JP5753095B2 (uk)
KR (2) KR20110132327A (uk)
CN (2) CN102378635A (uk)
AU (2) AU2010204547B2 (uk)
BR (2) BRPI1004940A2 (uk)
CA (2) CA2749802C (uk)
EA (2) EA023344B1 (uk)
IL (2) IL214051A0 (uk)
MX (2) MX2011007582A (uk)
NZ (2) NZ594055A (uk)
SG (3) SG172941A1 (uk)
UA (2) UA105201C2 (uk)
WO (2) WO2010083439A2 (uk)
ZA (1) ZA201105171B (uk)

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Also Published As

Publication number Publication date
EP2387420A2 (en) 2011-11-23
WO2010083439A2 (en) 2010-07-22
JP2012515222A (ja) 2012-07-05
SG196821A1 (en) 2014-02-13
AU2010204547A1 (en) 2011-07-28
AU2010204547B2 (en) 2014-01-23
CA2749786A1 (en) 2010-07-22
CN102395379B (zh) 2015-07-22
BRPI1004940A2 (pt) 2018-06-19
US20150202268A1 (en) 2015-07-23
IL214051A0 (en) 2011-08-31
JP5753095B2 (ja) 2015-07-22
KR20110132326A (ko) 2011-12-07
SG172940A1 (en) 2011-08-29
EA201190079A1 (ru) 2013-02-28
US8993519B2 (en) 2015-03-31
NZ594055A (en) 2013-03-28
MX2011007583A (es) 2011-12-14
IL214052A0 (en) 2011-08-31
EP2387419A2 (en) 2011-11-23
ZA201105171B (en) 2015-12-23
CA2749802C (en) 2016-08-23
KR20110132327A (ko) 2011-12-07
WO2010083434A2 (en) 2010-07-22
NZ594056A (en) 2013-03-28
US20100227818A1 (en) 2010-09-09
EA023344B1 (ru) 2016-05-31
AU2010204552B2 (en) 2014-05-01
CN102378635A (zh) 2012-03-14
US8323634B2 (en) 2012-12-04
SG172941A1 (en) 2011-08-29
MX2011007582A (es) 2011-12-14
JP2012515221A (ja) 2012-07-05
EA201190080A1 (ru) 2014-03-31
CA2749802A1 (en) 2010-07-22
BRPI1005159A2 (pt) 2018-04-03
UA105201C2 (uk) 2014-04-25
CN102395379A (zh) 2012-03-28
US20100297062A1 (en) 2010-11-25
WO2010083434A3 (en) 2010-09-10
WO2010083439A3 (en) 2010-09-10
US20130129669A1 (en) 2013-05-23
AU2010204552A1 (en) 2011-08-04

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