KR950031103A - 단백질 함유의 안정한 동결-건조 제제 - Google Patents

단백질 함유의 안정한 동결-건조 제제 Download PDF

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Publication number
KR950031103A
KR950031103A KR1019950011157A KR19950011157A KR950031103A KR 950031103 A KR950031103 A KR 950031103A KR 1019950011157 A KR1019950011157 A KR 1019950011157A KR 19950011157 A KR19950011157 A KR 19950011157A KR 950031103 A KR950031103 A KR 950031103A
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South Korea
Prior art keywords
formulation
mannitol
alanine
protein
buffer
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KR1019950011157A
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English (en)
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KR100273053B1 (ko
Inventor
베욜 알랭
부를 띠에르
뒤팽 빠뜨리스
포레 필리페
Original Assignee
로날드 샤피라
사노피 (소시에떼 아노님)
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Publication of KR950031103A publication Critical patent/KR950031103A/ko
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Publication of KR100273053B1 publication Critical patent/KR100273053B1/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
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/81—Packaged device or kit

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Immunology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
  • Enzymes And Modification Thereof (AREA)

Abstract

본 발명은 안정하고 동결-건조이며 약학적으로 수용가능한 제제 및 그를 함유하는 분석 키트에 관한 것으로서, 이는 만니톨의 질량/알라닌의 질량 비율 R 내지 0.1 내지 1인 알라닌 및 만니톨, 단백질, 완충액으로 구성되어 있는 것이며, 상기 단백질은 호르몬, 특히 hGH, 효소 또는 사이토카인과 같이 생물학적으로 활성이 있는 단백질인 것을 특징으로 한다.

Description

단백질 함유의 안정한 동결-건조제제
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 "dhf 머+폴리머의 %"와 R의 관계를 나타내는 그래프.
(스캔)

Claims (11)

  1. 만니톨의 질량/알라닌의 질량 비율 R 내지 0.1 내지 1인 단백질, 완충액, 알라닌 및 만니톨을 함유하는 것을 특징으로 하는 안정하고 동결건조되었으며 약학적으로 수용가능한 제제.
  2. 제1항에 있어서, 상기 단백질이 호르몬, 효소 또는 사이토카인인 것을 특징으로 하는 제제.
  3. 제1항에 있어서, 주입가능한 용액을 재구성하는 것을 특징으로 하는 제제.
  4. 제1항에 있어서, 인간 또는 동물내로 피하적, 정맥내 또는 근육내로 주입가능한 용액을 재구성하는 것을 특징으로 하는 제제.
  5. 제2항에 있어서, 상기 호르몬이 hGH인 것을 특징으로 하는 제제
  6. 제2항에 있어서, 상기 효소가 우레이트 옥시다아제인 것을 특징으로하는 제제.
  7. 제2항에 잇어서, 사이토카인이 인터로킨-13인 것을 특징으로 하는 제제.
  8. 제1항에 있어서, 알라닌이 결정화 형태이고 만니톨이 무정형 형태인 것을 특징으로 하는 제제.
  9. 제1항에 있어서, 동결-건조된 생성물이 무정형상 및 결정화상으로 구성되어 있으며, 무정형상은 주로 만니톨과 단백질로 구성되어 있으며, 결정화상은 주로 알라닌으로 구성된 것을 특징으로 하는 제제.
  10. 제2항에 있어서, 완충액이 포스페이트의 완충액인 것을 특징으로 하는 제제.
  11. 제1항에 있어서, 분석 키트가 제1항에 따른 제제로 구성된 것을 특징으로 하는 분석 키트.
    ※ 참고사항 ; 최초출원 내용에 의하여 공개하는 것임.
KR1019950011157A 1994-05-04 1995-05-04 단백질 함유의 안정한 동결-건조 제제 KR100273053B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR94-05486 1994-05-04
FR9405486A FR2719479B1 (fr) 1994-05-04 1994-05-04 Formulation stable lyophilisée comprenant une protéine: kit de dosage.

Publications (2)

Publication Number Publication Date
KR950031103A true KR950031103A (ko) 1995-12-18
KR100273053B1 KR100273053B1 (ko) 2000-12-01

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KR1019950011157A KR100273053B1 (ko) 1994-05-04 1995-05-04 단백질 함유의 안정한 동결-건조 제제

Country Status (25)

Country Link
US (1) US5763409A (ko)
EP (1) EP0682944B1 (ko)
JP (1) JP2948125B2 (ko)
KR (1) KR100273053B1 (ko)
CN (1) CN1088583C (ko)
AT (1) ATE178484T1 (ko)
AU (1) AU694763B2 (ko)
CA (1) CA2148537C (ko)
CZ (1) CZ286195B6 (ko)
DE (1) DE69508837T2 (ko)
DK (1) DK0682944T3 (ko)
ES (1) ES2131781T3 (ko)
FI (1) FI117321B (ko)
FR (1) FR2719479B1 (ko)
GR (1) GR3030146T3 (ko)
HU (1) HU220220B (ko)
IL (1) IL113578A (ko)
MX (1) MX9502034A (ko)
NO (1) NO320364B1 (ko)
NZ (1) NZ272045A (ko)
PL (1) PL179240B1 (ko)
RU (1) RU2136306C1 (ko)
SI (1) SI0682944T1 (ko)
TW (1) TW397687B (ko)
ZA (1) ZA953596B (ko)

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Also Published As

Publication number Publication date
HU9501276D0 (en) 1995-06-28
KR100273053B1 (ko) 2000-12-01
AU1777495A (en) 1995-11-16
IL113578A0 (en) 1995-08-31
FR2719479B1 (fr) 1996-07-26
FI952119A (fi) 1995-11-05
JP2948125B2 (ja) 1999-09-13
AU694763B2 (en) 1998-07-30
PL179240B1 (pl) 2000-08-31
DK0682944T3 (da) 1999-10-18
ES2131781T3 (es) 1999-08-01
ZA953596B (en) 1996-11-04
US5763409A (en) 1998-06-09
CA2148537A1 (en) 1995-11-05
CZ286195B6 (cs) 2000-02-16
DE69508837T2 (de) 1999-11-04
PL308416A1 (en) 1995-11-13
NO320364B1 (no) 2005-11-28
EP0682944A1 (fr) 1995-11-22
GR3030146T3 (en) 1999-08-31
FI117321B (fi) 2006-09-15
FR2719479A1 (fr) 1995-11-10
NO951724L (no) 1995-11-06
IL113578A (en) 1999-10-28
CN1116522A (zh) 1996-02-14
FI952119A0 (fi) 1995-05-03
SI0682944T1 (en) 1999-08-31
EP0682944B1 (fr) 1999-04-07
CZ108195A3 (en) 1996-02-14
JPH0853361A (ja) 1996-02-27
HU220220B (hu) 2001-11-28
RU2136306C1 (ru) 1999-09-10
HUT72325A (en) 1996-04-29
DE69508837D1 (de) 1999-05-12
CN1088583C (zh) 2002-08-07
CA2148537C (en) 2002-07-16
ATE178484T1 (de) 1999-04-15
NZ272045A (en) 1996-02-27
MX9502034A (es) 1997-02-28
TW397687B (en) 2000-07-11
NO951724D0 (no) 1995-05-03

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