KR950005325A - 제약 조성물 - Google Patents

제약 조성물 Download PDF

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Publication number
KR950005325A
KR950005325A KR1019940019883A KR19940019883A KR950005325A KR 950005325 A KR950005325 A KR 950005325A KR 1019940019883 A KR1019940019883 A KR 1019940019883A KR 19940019883 A KR19940019883 A KR 19940019883A KR 950005325 A KR950005325 A KR 950005325A
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KR
South Korea
Prior art keywords
aqueous solution
stable aqueous
concentration
interferon
buffer
Prior art date
Application number
KR1019940019883A
Other languages
English (en)
Other versions
KR100351495B1 (ko
Inventor
로우더 니콜라스
더글라스 알렌 존
하우웨스 콜린
Original Assignee
베르너 발데크
시바-가이기 아게
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
Priority claimed from GB939316849A external-priority patent/GB9316849D0/en
Priority claimed from GB9405879A external-priority patent/GB9405879D0/en
Application filed by 베르너 발데크, 시바-가이기 아게 filed Critical 베르너 발데크
Publication of KR950005325A publication Critical patent/KR950005325A/ko
Application granted granted Critical
Publication of KR100351495B1 publication Critical patent/KR100351495B1/ko

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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
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K38/21—Interferons [IFN]
    • A61K38/212—IFN-alpha
    • 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
    • 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
    • A61K47/26—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

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

Abstract

본 발명은 pH 3.0 내지 5.0의 완충액을 안정화제로서 함유하는 안정한 하이브리드 α-인터페론 수용액을 제공한다.

Description

제약 조성물
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (12)

  1. pH 3.0 내지 5.0의 완충액을 안정화제로서 함유하는 안정한 하이브리드 α-인터페론 수용액.
  2. 제1항에 있어서, 4.0 내지 4.5의 pH를 갖는 안정한 수용액.
  3. 제1항 또는 2항에 있어서, 완충액이 글리신/HCl 또는 시트르산 나트륨인 안정한 수용액.
  4. 제1항 내지 3항 중 어느 한 항에 있어서, 완충액이 20 내지 400mM의 농도로 존재하는 안정한 수용액.
  5. 제1항 내지 4항 중 어느 한 항에 있어서, 완충액이 50 내지 150mM의 농도로 존재하는 글리신/HCl인 안정한 수용액.
  6. 제1항 내지 5항 중 어느 한 항에 있어서, 하이브리드 α-인터페론이 α-인터페론 BDBB(서열번호 1)인 안정한 수용액.
  7. 제1항 내지 6항 중 어느 한 항에 있어서, 하이브리드 α-인터페론의 농도가 0.1 내지 1.5㎎/㎖인 안정한 수용액.
  8. 제7항에 있어서, 하이브리드 α인터페론의 농도가 약 0.2 내지 0.4㎎/㎖인 안정한 수용액.
  9. 제1항 내지 8항 중 어느 한 항에 있어서, 제약학상 허용되는 폴리올을 더 함유하는 안정한 수용액.
  10. 제9항에 있어서, 폴리올이 만니톨, 글루코스 또는 수크로스인 안정한 수용액.
  11. 제9항 또는 10항에 있어서, 폴리올이 20 내지 500mM의 농도로 존재하는 안정한 수용액.
  12. 제9항에 있어서, 폴리올이 100 내지 250mM 농도로 존재하는 만니톨인 안정한 수용액.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019940019883A 1993-08-13 1994-08-12 α-인터페론BDBB를포함하는수성액상제제 KR100351495B1 (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
GB9316849.0 1993-08-13
GB939316849A GB9316849D0 (en) 1993-08-13 1993-08-13 Pharmaceutical compositions
GB9405879A GB9405879D0 (en) 1994-03-24 1994-03-24 Pharmaceutical compositions
GB9405879.9 1994-03-24

Publications (2)

Publication Number Publication Date
KR950005325A true KR950005325A (ko) 1995-03-20
KR100351495B1 KR100351495B1 (ko) 2003-02-19

Family

ID=26303371

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1019940019883A KR100351495B1 (ko) 1993-08-13 1994-08-12 α-인터페론BDBB를포함하는수성액상제제

Country Status (19)

Country Link
US (1) US5609868A (ko)
EP (1) EP0641567B1 (ko)
JP (1) JP3745395B2 (ko)
KR (1) KR100351495B1 (ko)
AT (1) ATE190498T1 (ko)
AU (1) AU679233B2 (ko)
CA (1) CA2129921C (ko)
CY (1) CY2230B1 (ko)
DE (1) DE69423402T2 (ko)
DK (1) DK0641567T3 (ko)
ES (1) ES2144034T3 (ko)
FI (1) FI111222B (ko)
GR (1) GR3033239T3 (ko)
HU (1) HU224613B1 (ko)
IL (1) IL110566A (ko)
NO (1) NO315843B1 (ko)
NZ (1) NZ264218A (ko)
PT (1) PT641567E (ko)
TW (1) TW249202B (ko)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020102236A1 (en) * 1994-12-08 2002-08-01 Taylor Peter William Liposomal interferon hybrid compositions
US20030190307A1 (en) * 1996-12-24 2003-10-09 Biogen, Inc. Stable liquid interferon formulations
CN1222315C (zh) * 1996-12-24 2005-10-12 拜奥根有限公司 稳定的液体干扰素制剂
KR19990075253A (ko) * 1998-03-18 1999-10-15 성재갑 약학적으로 안정한 인터페론 제
US6685933B1 (en) 1998-07-28 2004-02-03 The United States Of America As Represented By The Department Of Health And Human Services Interferon α hybrids
ES2167189B1 (es) * 1999-12-17 2003-04-01 Lipotec Sa Formulacion farmaceutica estable para la administracion intravenosa o intramuscular, de principios activos peptidicos
AU3070702A (en) * 2000-11-07 2002-05-21 Chiron Corp Stabilized inteferon compositions
US6887462B2 (en) 2001-04-09 2005-05-03 Chiron Corporation HSA-free formulations of interferon-beta
AR044302A1 (es) * 2003-05-13 2005-09-07 Ares Trading Sa Formulaciones con proteinas liquidas estabilizadas en recipientes farmaceuticos
JP5208733B2 (ja) * 2005-06-29 2013-06-12 イエダ リサーチ アンド デベロップメント カンパニー リミテッド 組換えインターフェロンα２（ＩＦＮα２）変異体

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59196823A (ja) * 1983-04-20 1984-11-08 Sunstar Inc 皮膚および粘膜の真菌症治療用外用剤
US4855238A (en) * 1983-12-16 1989-08-08 Genentech, Inc. Recombinant gamma interferons having enhanced stability and methods therefor
AU592552B2 (en) * 1985-03-25 1990-01-18 Schering Corporation Stable gamma interferon formulation
DE3685996T2 (de) * 1985-06-11 1993-01-14 Ciba Geigy Ag Hybrid-interferone.
US4847079A (en) * 1985-07-29 1989-07-11 Schering Corporation Biologically stable interferon compositions comprising thimerosal
IL88233A (en) * 1987-11-03 1993-08-18 Genentech Inc Gamma interferon formulation
EP0331635A3 (en) * 1988-02-29 1990-02-28 The Board of Regents of the University of Texas System Preparations for treating bladder cancer

Also Published As

Publication number Publication date
FI943705A (fi) 1995-02-14
DK0641567T3 (da) 2000-08-14
AU679233B2 (en) 1997-06-26
CA2129921A1 (en) 1995-02-14
HU224613B1 (hu) 2005-11-28
KR100351495B1 (ko) 2003-02-19
DE69423402T2 (de) 2000-08-03
EP0641567B1 (en) 2000-03-15
US5609868A (en) 1997-03-11
NO942983L (no) 1995-02-14
FI943705A0 (fi) 1994-08-10
GR3033239T3 (en) 2000-09-29
PT641567E (pt) 2000-08-31
IL110566A (en) 1999-12-22
NO315843B1 (no) 2003-11-03
NO942983D0 (no) 1994-08-12
CY2230B1 (en) 2003-04-18
EP0641567A1 (en) 1995-03-08
CA2129921C (en) 2006-12-05
JP3745395B2 (ja) 2006-02-15
JPH07145070A (ja) 1995-06-06
NZ264218A (en) 1995-07-26
DE69423402D1 (de) 2000-04-20
ATE190498T1 (de) 2000-04-15
HU9402356D0 (en) 1994-10-28
ES2144034T3 (es) 2000-06-01
HUT68692A (en) 1995-07-28
IL110566A0 (en) 1995-01-24
FI111222B (fi) 2003-06-30
AU6893994A (en) 1995-02-23
TW249202B (ko) 1995-06-11

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