KR890004721A - 성장인자를 함유하는 동결건조된 안정한 제형 - Google Patents

성장인자를 함유하는 동결건조된 안정한 제형 Download PDF

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KR890004721A
KR890004721A KR1019880011969A KR880011969A KR890004721A KR 890004721 A KR890004721 A KR 890004721A KR 1019880011969 A KR1019880011969 A KR 1019880011969A KR 880011969 A KR880011969 A KR 880011969A KR 890004721 A KR890004721 A KR 890004721A
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growth factor
composition
kit
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엘·핀케노어 에이미
엠·코헨 조나단
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원본미기재
에티콘 인코포레이티드
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    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
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    • 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
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    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/32—Proteins, polypeptides; Degradation products or derivatives thereof, e.g. albumin, collagen, fibrin, gelatin
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    • A61L26/00—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form
    • A61L26/0009—Chemical aspects of, or use of materials for, wound dressings or bandages in liquid, gel or powder form containing macromolecular materials
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    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
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Abstract

내용 없음

Description

성장인자를 함유하는 동결건조된 안정한 제형
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (28)

  1. 사람의 유사분열 또는 맥관형성 활성을 갖는 폴리펩타이드 성장인자, 및 조성물의 재구성된 용액에 점도를 부여할 수 있는 수용성 또는 수팽윤성의, 약제학적으로 허용되는 중합체를 함유함을 특징으로 하는 동결건조된 안정한 조성물.
  2. 제1항에 있어서, 성장인자 표피 성장인자 또는 그의 생물학적 활성 단편인 조성물.
  3. 제1항에 있어서, 성장인자가 전환(transforming) 성장인자-알파, 전환성장인자-베타, 산성 섬유 아세포 성장인자, 염기성 섬유 아세포 성장인자, 안지오게닌, 혈소판 유도된 성장인자, 신경 성장인자, 인슐린-유사 성장인자, 그들의 생물학적 활성 단편, 및 그들의 혼합물로 이루어진 그룹중에서 선택되는 조성물.
  4. 제1항에 있어서, 중합체가 다당류, 비닐중합체, 단백질 및 아크릴산 중합체로 이루어진 그룹중에서 선택되는 조성물.
  5. 제1항에 있어서, 비닐중합체가 폴리비닐 알콜 또는 폴리비닐 피롤리돈인 조성물.
  6. 제1항에 있어서, 다당류가 메틸 셀룰로오즈, 카복시메틸 셀룰로오즈 및 하이드록시 프로필메틸 셀룰로오즈로 이루어진 그룹중에서 선택되는 셀룰로오즈 유도체인 조성물.
  7. 제1항에 있어서, 동결건조를 위해 수용성 중량제를 추가로 함유함을 특징으로하는 조성물.
  8. 제7항에 있어서, 중량제의 중량에 대한 성장인자의 중량비가 약 0.00001: 약 0.5인 조성물.
  9. 제7항에 있어서, 중량제가 단당류, 이당류, 다당류, 아미노산, 단쇄(C3 내지 C6) 트리카복실산 및 무기산염으로 이루어진 그룹 중에서 선택되는 조성물.
  10. 제1항에 있어서, 조성물의 수분함량이 약 5.0중량% 미만인 조성물.
  11. a)사람의 유사분열 또는 맥관형성 활성을 갖는 동결건조된 폴리펩타이드 성장인자를 함유하는 제1바이알: 및 b) 완충된 수성 희석제를 함유하는 제2바이알을 함유함을 특징으로 하는, 성장인자 용액을 제조하기 위한 키트(kit).
  12. 제11항에 있어서, 성장인자 표피성장인자 또는 그의 생물학적 활성 단편인 키트.
  13. 제11항에 있어서, 성장인자가 전환 성장인자-알파, 전환 성장인자-베타, 산성 섬유 아세포 성장인자, 염기성 섬유 아세포 성장인자, 안지오게닌, 혈소판 유도된 성장인자, 신경 성장인자, 인슐린-유사 성장인자, 그들의 생물학적 활성 단편, 및 그들의 혼합물로 이루어진 그룹 중에서 선택되는 키트.
  14. 제11항에 있어서, 제1바이알이 동결 건조를 위한 수용성 중량제를 추가로 함유하는 키트.
  15. 제14항에 있어서, 중량제가 단당류, 이당류, 다당류, 아미노산, 단쇄(C3내지 C6) 트리카복실산 및 무기산 염으로 이루어진 그룹 중에서 선택되는 키트.
  16. 제14항에 있어서, 중량제의 중량에 대한 성장인자의 중량비가 약 0.00001:약0.5인 키트.
  17. 제11항에 있어서, 액상 희석제가 약 pH 5.0 내지 약 pH 8.0으로 완충된 키트.
  18. 제11항에 있어서, 액상 희석제가 수용성의 약제학적으로 허용되는 점도 중진 중합체를 함유하는 키트.
  19. 제11항에 있어서, 중합체가 다당류, 비닐중합체, 단백질, 플루로닉스(Pluronics), 폴리에틸렌글리콜 및 아크릴산 중합체로 이루어진 그룹 중에서 선택되는 키트.
  20. 제11항에 있어서, 제1바이알이 조성물의 재구성된 용액의 점도를 증진시킬 수 있는 동결건조된 중합체를 추가로 함유하는 키트.
  21. 제11항에 있어서, 액상 희석제가 추가로 보존제를 함유하는 키트.
  22. 제21항에 있어서, 보존제가 티메로살, 소르브산, 클로로부탄올, 이미다졸리디닐 우레아 및 파라벤으로 이루어진 그룹 중에서 선택되는 키트.
  23. 제11항에 있어서, 희석제가 인산염 완충액, 시트로산염 완충액, 붕산염 완충액 및 아세트산염 완충액으로 이루어진 그룹 중에서 선택된 완충액을 함유하는 키트.
  24. a) 제1항의 동결건조된 조성물을 제조하고; b) 동결건조된 조성물을 수성 희석제와 혼합시킴을 특징으로 하여, 성장인자 수용액을 제조하는 방법.
  25. 유사분열 또는 맥관형성 활성을 갖는 동결건조된 사람의 폴리펩타이드 성장인자를 상처 치유 유효량으로 상처에 직접 접촉시킴을 특징으로 하여, 상처 치유 속도를 증가시키는 방법.
  26. 제25항에 있어서, 성장인자가 표피 성장인자 또는 그의 생물학적 활성 단편인 방법.
  27. 제11항에 있어서, 바이알이 동결건조화 압력에 견딜 수 있고, 바이알의 외부로부터 바이알의 내부로 열을 전달시킬 수 있는 키드.
  28. 제11항에 있어서, 바이알을 무균적으로 충진 및 밀봉시킨 키트.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019880011969A 1987-09-18 1988-09-16 성장인자를 함유하는 동결건조된 안정한 제형 KR890004721A (ko)

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US9881787A 1987-09-18 1987-09-18
US098,817 1987-09-18

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EP (1) EP0308238A1 (ko)
JP (1) JPH01121223A (ko)
KR (1) KR890004721A (ko)
AU (1) AU2223688A (ko)
DK (1) DK516788A (ko)
GR (1) GR1000247B (ko)
NZ (1) NZ226170A (ko)
PT (1) PT88538A (ko)
ZA (1) ZA886943B (ko)

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PT88538A (pt) 1989-07-31
ZA886943B (en) 1990-05-30
DK516788D0 (da) 1988-09-16
EP0308238A1 (en) 1989-03-22
AU2223688A (en) 1989-03-23

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