KR950703987A - G-csf의 안정한 동결건조된 약제학적 제제(stable lyophilized pharma ceutical preparations g-csf) - Google Patents

G-csf의 안정한 동결건조된 약제학적 제제(stable lyophilized pharma ceutical preparations g-csf)

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Publication number
KR950703987A
KR950703987A KR1019950702588A KR19950702588A KR950703987A KR 950703987 A KR950703987 A KR 950703987A KR 1019950702588 A KR1019950702588 A KR 1019950702588A KR 19950702588 A KR19950702588 A KR 19950702588A KR 950703987 A KR950703987 A KR 950703987A
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KR
South Korea
Prior art keywords
lyophilized
formulation
csf
raffinose
trehalose
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KR1019950702588A
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English (en)
Other versions
KR100266145B1 (ko
Inventor
미하엘리스 우베
루돌프 라이너
빈터 게르하르트
보오크 하인리히
Original Assignee
헤르베르트 포우퀘트·라인홀트 밍크
뵈링거 만하임 게엠베하
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Publication of KR950703987A publication Critical patent/KR950703987A/ko
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Publication of KR100266145B1 publication Critical patent/KR100266145B1/ko

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • 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
    • 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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/193—Colony stimulating factors [CSF]
    • 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
    • A61K47/26—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators

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

Abstract

본 발명은 안정화 성분으로서 말토오스, 라피노오스, 슈크로오스, 트레할로오스 또는 아미노 당을 함유하는 G-CSF의 동결건조된 약제학적 제제에 관한 것이다. 또한 본 발명은 안정하나 동결건조물의 제조 방법 뿐만이 아니라 G-CSF를 함유하는 약제학적 제제의 안정화제로서 말토오스, 라피노오스, 슈크로오스, 트레할로오스 또는 아미노 당을 사용하는 방법에도 관한 것이다.

Description

G-CSF의 안정한 동결건조된 약제학적 제제(STABLE LYOPHILIZED PHARMA CEUTICAL PREPARATIONS G-CSF)
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (13)

  1. 말토오스, 라피노오스, 슈크로오스, 트레할로오스 또는 아미노 당을 함유하는 G-CSF의 동결건조된 약제학적 제제.
  2. 제1항에 있어서, 사용된 G-CSF 단백질의 양보다 적은 또는 거의 동일한 양의 생리적으로 허용되는 양의 계면활성제를 추가로 함유하는 것을 특징으로 하는 동결건조된 제제.
  3. 제2항에 있어서, 0.5㎎/㎖ 바람직하게는 0.01 내지 0.1㎎/㎖의 계면활성제를 함유하는 것을 특징으로 하는 동결건조된 제제.
  4. 제1항 내지 3항중 어느 한 항에 있어서, 생리적으로 허용되는 양의 아미노 산을 추가로 함유하는 것을 특징으로 하는 동결건조된 제제.
  5. 제4항에 있어서, 아르기닌 및/또는 페닐알라닌을 함유하는 것을 특징으로 하는 동결건조된 제제.
  6. 제1항 내지 5항 중 어느 한 항에 있어서, 산화방지제, 복잡체화제, 완충제, 산, 염기 또는 등장화제로 이루어지는 군으로부터 선택되는 생리적으로 허용되는 보조물질을 함유하는 것을 특징으로 하는 동결건조된 제제.
  7. 제1항 내지 6항 중 어느 한 항에 있어서, 인산염 또는 아세트산염 환충제를 함유하는 것을 특징으로 하는 동결건조된 제제.
  8. 제1항 내지 6항 중 어느 한 항에 있어서, 바람직하게는 7-8의 pH의 인산 아르기닌, 염화 아르기닌 또는 시트르산 아르기닌을 함유하는 것을 특징으로 하는 동결건조된 제제.
  9. 제1항 내지 8항 중 어느 한 항에 있어서, 실질적으로 단백질-유사 보조 물질 또는 중합체 보조 물질이 없는 것을 특징으로 하는 동결건조된 제제.
  10. 제1항 내지 9항 중 어느 한 항의 동결건조물을 재용해시킴으로써 얻을 수 있는 수성 약제학적 제제.
  11. 제10항에 있어서, 용액이 6.5-8 또는 3-5, 바람직하게는 7.0-7.5의 pH값을 가지는 것을 특징으로 하는 수성 약제학적 제제.
  12. 활성 물질로서 G-CSF를 함유하고 보조 물질로서 말토오스, 라피노오스. 슈크로오스, 트레할로오스 또는 아미노 당을 함유하며, 추가의 약제학적 보조 물질을 함유하는 수성 제제를 제조하고, 계속해서 이 용액을 동결건조시키는 것으로 이루어지는, 재1항 내지 9항중 어느 한 항의 동결건조된 약제학적 제제의 제조 방법.
  13. 활성 물질로서 G-CSF를 함유하는 안정한 동결건조된 약재학적 제제를 제조하기 위하여 말토오스, 라피노오스, 슈크로오스, 트레할로오스 또는 아미노 당을 사용하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950702588A 1992-12-18 1993-12-15 G-csf의 안정한 동결건조된 약제학적 제제 KR100266145B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DEP4242863.7 1992-12-18
DE4242863A DE4242863A1 (de) 1992-12-18 1992-12-18 Stabile lyophilisierte pharmazeutische Zubereitungen von G-CSF
PCT/EP1993/003543 WO1994014465A1 (de) 1992-12-18 1993-12-15 Stabile lyophilisierte pharmazeutische zubereitungen von g-csf

Publications (2)

Publication Number Publication Date
KR950703987A true KR950703987A (ko) 1995-11-17
KR100266145B1 KR100266145B1 (ko) 2000-09-15

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Country Status (14)

Country Link
US (1) US5919443A (ko)
EP (1) EP0674524B1 (ko)
JP (1) JPH08504784A (ko)
KR (1) KR100266145B1 (ko)
AT (1) ATE165007T1 (ko)
AU (1) AU676573B2 (ko)
CA (1) CA2151732C (ko)
DE (2) DE4242863A1 (ko)
DK (1) DK0674524T3 (ko)
ES (1) ES2117781T3 (ko)
HU (1) HU220256B (ko)
NZ (1) NZ258912A (ko)
SG (1) SG66740A1 (ko)
WO (1) WO1994014465A1 (ko)

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Also Published As

Publication number Publication date
AU676573B2 (en) 1997-03-13
ATE165007T1 (de) 1998-05-15
DK0674524T3 (da) 1999-02-01
WO1994014465A1 (de) 1994-07-07
EP0674524B1 (de) 1998-04-15
JPH08504784A (ja) 1996-05-21
HU220256B (hu) 2001-11-28
HU9501764D0 (en) 1995-08-28
ES2117781T3 (es) 1998-08-16
HUT74269A (en) 1996-11-28
US5919443A (en) 1999-07-06
NZ258912A (en) 1997-06-24
AU6808694A (en) 1994-07-19
SG66740A1 (en) 1999-09-21
KR100266145B1 (ko) 2000-09-15
EP0674524A1 (de) 1995-10-04
DE4242863A1 (de) 1994-06-23
CA2151732A1 (en) 1994-07-07
CA2151732C (en) 2008-02-12
DE59308415D1 (de) 1998-05-20

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