KR970706017A - 안정한 알파 인터페론 수용액 제형(Stable, aqueous alfainterfer on solution for mulations) - Google Patents

안정한 알파 인터페론 수용액 제형(Stable, aqueous alfainterfer on solution for mulations)

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KR970706017A
KR970706017A KR1019970702346A KR19970702346A KR970706017A KR 970706017 A KR970706017 A KR 970706017A KR 1019970702346 A KR1019970702346 A KR 1019970702346A KR 19970702346 A KR19970702346 A KR 19970702346A KR 970706017 A KR970706017 A KR 970706017A
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alpha
formulation
interferon
sodium phosphate
type
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푸이-호 씨 옌
더글라스 에프 클린
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딕커 에릭 에스
쉐링 코포레이션
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Abstract

본원에는 알파-형 인터페론, 예를들면 인터페론 알파-2a 및 인터페론 알파-2b, pH를 4.5 내지 7.1 범위로 유지시키기 위한 완충제, 안정화제로서의 폴리소르베이트 80, 킬레이트제로서의 에데테이트 이나트륨, 삼투제로서의 염화나트륨, 및 항균 방부제로서의 m-크레졸을 함유하고, 24개월 이상 동안의 장기간 보관시 높은 화학적, 물리적 및 생물학적 안정서을 유지하는 안정한 알파-형 인터페론 수용액 제형이 기술되어 있다.

Description

안정한 알파 인터페론 수용액 제형(Stable, aqueous alfainterfer on solution for mulations)
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (13)

  1. a. 알파-형 인터레론 0.1×106내지 100×106IU/mL; b, pH를 4.5 내지 7.1의 범위로 유지시키기 위한 완충액 시스템; c. 킬레이트제의 유료량; d. 알파-형 인터페론의 상실로부터 알파-형 인터페론을 안정화시키기에 충분한 양의 소르비탄 모노-9-옥타데세노에이트 폴리(옥시-1.2-에탄디일)유도체; e. 삼투제의 유효량; f. 항균 방부제의 유효량; 및 g. 상기 성분의 용액을 제조하기에 충분한 양의 주사용수를 포함하여, 높은 생물학적 알파-형 인터페론 활성을 유지하고 사람 혈액에서 유래된 산물이 제거된 안정한 알파-형 인터페론 수용액 제형.
  2. 제1항에 있어서, 완충액 시스템이 이염기성 인산나트륨 및 일염기성 인산나트륨인 제형.
  3. 제1항에 있어서, 킬레이트제가 에데테이트 이나트륨 또는 시트르산인 제형.
  4. 제1항에 있어서, 삼투제가 염화나트륨인 제형.
  5. 제1항에 있어서, 방부제가 m-크레졸, 페놀, 메틸파리벤, 프로필라벤 또는 이의 혼합물로부터 선택되는 제형.
  6. 제1항에 있어서, 알파-형 인터페론이 인터페론 알파-2인 제형.
  7. a. 5×106내지 50×106IU/mL의 인터페론 알파-2; b. 1.8㎎/mL의 이염기성 무수 인산나트륨; c. 1.3㎎/mL의 일염기성 인산나트륨 일수화물; d. 0.1㎎/mL의 이나트륨 이수소 에틸렌디아민 테트라아세테이트; e.0.1㎎/mL의 소르비탄 모노 -9-옥타데세노에이트 폴리(옥사-1,2-에틴디일)유도체;f. 1.2㎎/mL의 메틸페라벤; g. 0.12㎎/mL의 프로필라벤; h.7.5㎎/mL의 염화나트륨; 및 i. 상기 성분들을 포함하여 1mL가 되게 하는 주사용수를 포함하여, 높은 생물학적 인터페론 알파-2 활성을 갖고 사람 혈청 알부민이 제거된 안정한 인터페론 알파-2 수용액 제형.
  8. a. 5×106내지 50×106IU/mL의 인터페론 알파-2; b. 1.8㎎/mL의 이염기성 무수 인산나트륨; c. 1.3㎎/mL의 일염기성 인산나트륨 일수화물; d. 0.1㎎/mL의 이나트륨 이수소 에틸렌디아민 테트라아세테이트; e.0.1㎎/mL의 소르비탄 모노 -9-옥타데세노에이트 폴리(옥사-1,2-에틴디일)유도체;f. 1.5㎎/mL의 m-크레졸; g.7.5㎎/mL의 염화나트륨; 및 h. 상기 성분들을 포함하여 1mL가 되게 하는 양의 주사용수를 포함하여, 높은 생물학적 인터페론 알파-2 활성을 갖고 사람 혈청 알부민이 제거된 안정한 인터페론 알파-2 수용액 제형.
  9. 다용량 유리 비이알인 패킹재 및 제1항 내지 제8항 중의 어느 한 항의 제형을 포함하는 제품.
  10. 제1항 내지 제8항 중 어느 한 항의 제형의 유효량을 함유하는 예비충전된 주사기를 포함하는 제품.
  11. 1회-용량 바이알인 패킹재 및 제1항 내지 제8항 중의 어느 한 항의 제형을 포함하는 제품.
  12. 유효량의 알파-형 인터페론을 pH를 4.5 내지 7.1의 범위로 유지시킬 수 있는 완충액 시스템, 킬레이트제, 소르비탄 모노-9-옥타데세노에이트 폴리(혹시-1,2-에탄디일) 유도체, 삼투제, 항균 방부제 및 수용액을 형성하기에 충분한 물과 혼합하는 단계를 포함하여, 높은 생물학적 알파-형 인터페론 수용액 제형을 제조 하는 방법.
  13. 제12항에 있어서, 수용액이 용존 산소가 실질적으로 제거된 상태로 제조되고 유지되는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019970702346A 1994-10-11 1995-10-10 안정한알파인터페론수용액제형 KR100401401B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/329,813 US5766582A (en) 1994-10-11 1994-10-11 Stable, aqueous alfa interferon solution formulations
US08/329,813 1994-10-11

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KR970706017A true KR970706017A (ko) 1997-11-03
KR100401401B1 KR100401401B1 (ko) 2004-02-18

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US (2) US5766582A (ko)
EP (2) EP0970703B1 (ko)
JP (2) JP3978228B2 (ko)
KR (1) KR100401401B1 (ko)
CN (1) CN1102408C (ko)
AT (2) ATE194774T1 (ko)
AU (1) AU708337B2 (ko)
BR (1) BR9509313A (ko)
CA (1) CA2201749C (ko)
CZ (1) CZ296961B6 (ko)
DE (2) DE69531314T2 (ko)
DK (1) DK0777495T3 (ko)
ES (2) ES2148568T3 (ko)
FI (2) FI116558B (ko)
GR (1) GR3034619T3 (ko)
HK (1) HK1008813A1 (ko)
HU (1) HU225494B1 (ko)
NO (1) NO320604B1 (ko)
NZ (1) NZ294464A (ko)
PL (1) PL183797B1 (ko)
PT (1) PT777495E (ko)
RU (1) RU2157236C2 (ko)
SK (1) SK282949B6 (ko)
UA (1) UA42028C2 (ko)
WO (1) WO1996011018A1 (ko)

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ATE245033T1 (de) 2003-08-15
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