KR970704434A - 약학적으로 안정한 옥살리플라티늄 제제(pharmaceutically stable oxaliplatinum preparation) - Google Patents

약학적으로 안정한 옥살리플라티늄 제제(pharmaceutically stable oxaliplatinum preparation) Download PDF

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KR970704434A
KR970704434A KR1019970700780A KR19970700780A KR970704434A KR 970704434 A KR970704434 A KR 970704434A KR 1019970700780 A KR1019970700780 A KR 1019970700780A KR 19970700780 A KR19970700780 A KR 19970700780A KR 970704434 A KR970704434 A KR 970704434A
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formulation
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pharmaceutically stable
preparation
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KR100365171B1 (ko
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후쌈 이브라임
롤랜드-이베스 모베르네이
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롤랜드-이베스 모베르네이
드바이오팜 에스.아.
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/28—Compounds containing heavy metals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/28—Compounds containing heavy metals
    • A61K31/282—Platinum compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/243—Platinum; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

본 발명은 비경구적으로 투약되고 농도가 1-5mg/ml이며 pH는 4.5-6인 옥살리플라티늄 수성 용액을 포함하는 약학적으로 안정한 옥살리플라티늄 제제에 관한다.상기 옥살리플라티늄 수성 용액은 유리하게는 밀봉된 용기내에 즉시 사용 가능한(ready-to-use) 형태로 제공된다.

Description

약학적으로 안정한 옥살리플라티늄 제제(PHARMACEUTICALLY STABLE OX-ALIPLATINUM PREPARATION)
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (9)

  1. 농도가 1-5mg/ml이며 pH는 4.5-인 수중 옥살리플라티늄 용액으로 이루어진 약학적으로 안정한 비경구적 투약용 옥살리플라티늄 제제로서,제제 내 옥살리플라티늄 함량은 최초 함량의 95% 이상이며 약학적으로 허용가능한 지속 기간동안 저장한 이후에도 용액이 맑고 ,무색이며 침전 물질이 형성되지 않는 약학적으로 안정한 옥살리플라티늄제제.
  2. 제1항에 있어서,옥살리플라티늄의 농도는 물 1ml당 약 2mg이며 상기 용액의 pH는 평균 약 5.3인 제제.
  3. 제1항 또는 제2항에 있어서, 옥살리플라티늄의 특정 광회전력(specific rotatory power) dl +74.5-+78.00인 제제.
  4. 제1항 내지 제3항에 있어서, 즉시 사용될 수 있으며 용접 밀봉된 용기내에 함유된 옥살리플라티늄 수성용액 형태의 제제.
  5. 제4항에 있어서, 상기 용기가 주입에 의하여 투약될수 있는 활성 단위 투약량(active unit dose)인 50-100mg의 옥살리플라티늄을 함유하는 것을 특징으로 하는 제제.
  6. 제4항 또는 제5항에 있어서, 상기 용기가 약학적으로 사용하기 위한 유리병으로서, 최소한 유리병의 내부로 뻗은 마개의 표면이 상기 용액에 대하여 비활성인 마개로 밀봉된 것을 특징으로 하는 제제.
  7. 제6항에 있어서, 상기 용액 및 상기 마개 사이의 공간이 비활성 기체로 충전된 제제
  8. 제4항 또는 제5항에 있어서, 상기 용기가 주입용 유연 주머니(flexible pouch)이거나 또는 앰플인 것을 특징으로 하는 제제.
  9. 제4항 또는 제5항에 있어서, 상기 용기가 주사 마이크로펌프(injection micropump)가 장착된 주입장치의 구성 부분인 것을 특징으로 하는 제제.
    ※참고사항:최초출원 내용에 의하여 공개하는 것임.
KR1019970700780A 1994-08-08 1995-08-07 약학적으로안정한옥살리플라티늄제제 KR100365171B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CH2462/94-6 1994-08-08
CH246294 1994-08-08

Publications (2)

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KR970704434A true KR970704434A (ko) 1997-09-06
KR100365171B1 KR100365171B1 (ko) 2003-02-19

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US (1) US5716988A (ko)
EP (1) EP0774963B1 (ko)
JP (1) JP3547755B2 (ko)
KR (1) KR100365171B1 (ko)
CN (1) CN1138541C (ko)
AT (1) ATE197249T1 (ko)
AU (2) AU2989695A (ko)
BR (1) BR9508554A (ko)
CA (1) CA2196922C (ko)
CZ (1) CZ286714B6 (ko)
DE (1) DE69519300T2 (ko)
DK (1) DK0774963T3 (ko)
ES (1) ES2152412T3 (ko)
IL (1) IL114852A (ko)
RU (1) RU2148400C1 (ko)
UA (1) UA42779C2 (ko)
WO (1) WO1996004904A1 (ko)

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DE69519300T2 (de) 2001-05-31
US5716988A (en) 1998-02-10
DE69519300D1 (de) 2000-12-07
IL114852A (en) 2000-02-29
DK0774963T3 (da) 2001-01-29
CN1154654A (zh) 1997-07-16
JPH10508289A (ja) 1998-08-18
BR9508554A (pt) 1997-11-25
RU2148400C1 (ru) 2000-05-10
CZ286714B6 (en) 2000-06-14
AU2252499A (en) 2000-03-23
ATE197249T1 (de) 2000-11-15
CA2196922A1 (fr) 1996-02-22
EP0774963A1 (fr) 1997-05-28
CA2196922C (fr) 2004-06-01
AU2989695A (en) 2000-03-07
WO1996004904A1 (fr) 1996-02-22
CZ37997A3 (en) 1997-06-11
AU731981B2 (en) 2001-04-12
CN1138541C (zh) 2004-02-18
IL114852A0 (en) 1995-12-08
ES2152412T3 (es) 2001-02-01
EP0774963B1 (fr) 2000-11-02
KR100365171B1 (ko) 2003-02-19
UA42779C2 (uk) 2001-11-15
JP3547755B2 (ja) 2004-07-28

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