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KR950007872A - 안정화된 약제학적 조성물 및 안정화용매 - Google Patents

안정화된 약제학적 조성물 및 안정화용매 Download PDF

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KR950007872A
KR950007872A KR1019940025248A KR19940025248A KR950007872A KR 950007872 A KR950007872 A KR 950007872A KR 1019940025248 A KR1019940025248 A KR 1019940025248A KR 19940025248 A KR19940025248 A KR 19940025248A KR 950007872 A KR950007872 A KR 950007872A
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나라하리 아그하카르 쉬레르함
에스. 고게이트 우데이
카바나크 토마스
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니콜라스 피. 말라테스티닉
브리스톨-마이어스 스퀴브 캄파니
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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract

1. 청구범위에 기재된 발명이 속하는 기술분야
카르복실레이트 음이온 함량을 감소시킨 용매계
2. 발명이 해결하려고 하는 기술적 과제
약제학적 물질의 분해를 억제
3. 발명의 해결방법의 요지
폴리옥시에틸화된 피마자유를 산으로 처리 또는 알루미나와 접촉
4. 발명의 중요한 용도
안정화된 약제학적 조성물

Description

안정화된 약제학적 조성물 및 안정화용매
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (42)

  1. 알킬렌 옥사이드의 축합생성물을 함유하고, 약제학적 물질의 분해를 실질적으로 방지하기에 충분히 낮은 카르복실레이트 음이온 함량을 갖는 용매.
  2. 제1항에 있어서, 용매의 카르복실레이트 음이온 함량이 mL당 카르복실레이트 음이은의 0.6×10-6g당량 미만 또는 이와 동일량인 용매.
  3. 제1항에 있어서, 축합생성물이 알킬렌옥사이드와 지질의 축합생성물인 용매.
  4. 제3항에 있어서, 축합생성물이 폴리옥시에틸화 피마자유인 용매.
  5. 제3항에 있어서, 용매가 폴리에톡실화 12-하이드록시 스테아린산인 용매.
  6. 제1항에 있어서, 용매가 추가로 알콜을 함유하는 용매.
  7. 제6항에 있어서, 알콜이 에탄올 및 폴리에틸렌 글리콜로 이루어진 그룹중에서 선택되는 용매.
  8. 하나 이상의 약제학적 화합물 : 및 이 약제학적 화합물을 분산시키거나 용해시킬 수 있고 약제학적 화합물의 촉매화 분해를 방지하기에 충분히 낮은 카르복실레이트 음이온 함량을 갖는 유효량의 가용화제를 함유하는 용매를 함유한 안정화된 조성물.
  9. 제8항에 있어서, 가용화제가 알킬렌옥사이드 변형지질인 조성물.
  10. 제8항에 있어서, 용매가 알콜과 폴리옥시에틸화 피마자유의 혼합물인 조성물.
  11. 제10항에 있어서, 용매가 에틸알콜과 폴리옥시에틸화 피마자유가 약 50 : 50용량비로 이루어진 혼합물인 조성물.
  12. 제8항에 있어서, 약제학적 화합물이 테니포시드, 파클리텍셀, 캠프토테신 및 이들의 유도체로 이루어진 그룹중에서 선택된 항종양화합물인 조성물.
  13. 제8항에 있어서, 약제학적 화합물이 카르복실레이트 옴이온의 존재하에서 분해에 민감한 화합물인 조성물.
  14. 제8항에 있어서, 용매가 용매 mL당 약 0.6×10-6g당량의 카르복실레이트 음이온 함량을 갖는 조성물.
  15. 제8항에 있어서, 용매가 용매 mL당 약 0.6×10-6g당량 미만 또는 이와 동일량의 카르복실레이트 음이온 항량을 유지하기에 효과적인 양의 산을 함유하는 조성물.
  16. 제15항에 있어서, 산이 무기산인 조성물.
  17. 제15항에 있어서, 산이 HCl, HBr, HI, HF, H2SO4, HNO3로 이루어진 그룹중에서 선택되는 조성물.
  18. 제8항에 있어서, 가용화제가 피마자유와 피마자유 1몰당 20내지 40몰의 에틸렌옥사이드의 폴리옥시에틸화 피마자유 축합생성물인 조성물.
  19. 제8항에 있어서, 용매가 용매 mL당 약 5.6×10-6g 내지 8.4×10-6g의 H+를 제공하는 양으로 무기산을 함유하는 조성물.
  20. 제8항에 있어서, 가용화제가 폴리옥시에틸화 지질, 폴리옥시에틸화 12-하이드록시 스테아린산 및 폴리에틸렌 글리콜로 이루어진 그룹중에서 선택되는 조성물.
  21. 폴리옥시에틸화 피마자유를 함유한 용매를 카르복실레이트 음이온 함량이 감소되도록 처리하여 항종양화합물의 촉매화 분해를 방지하기에 충분히 낮은 카르복실레이트 음이온 함량을 갖는 용매를 제조하고, 항종양화합물을 용매중에 분산시켜 안정화된 조성물을 제조하는 방법.
  22. 제21항에 있어서, 용매가 에탄올 및 폴리에털렌 글리콜로 이루어진 그룹중에서 선택된 알콜을 함유하는 방법.
  23. 제21항에 있어서, 용매가 에탄올과 폴리옥시에틸화 피마자유가 약 50 : 50용량이로 이루어진 혼합물인 방법.
  24. 제21항에 있어서, 항종양화합물이 테니포시드, 파클리텍셀, 캠프로테신 및 이들의 유도체로 이루어진 그룹중에서 선택되는 방법.
  25. 제21항에 있어서, 처리단계가 폴릭옥시에틸화 피마자유를 알루미늄 옥사이드와 접촉시켜 용매의 카르복실레이트 음이온 함량을 감소시키는 방법.
  26. 제21항에 있어서, 용매가 용매 mL당 약 0.6×10-6g당량 이하의 카르복실레이트 음이온 함량을 갖는 방법.
  27. 제21항에 있어서, 처리단계가 용매 mL당 5.6×10-6g이상의 H+을 제공하는 양으로 산을 첨가하는 방법.
  28. 제21항에 있어서, 처리단계가 용매 mL당 5.6×10-6내지 8.6×10-6g의 H+을 제공하는 양으로 첨가하는 방법.
  29. 제28항에 있어서, 산이 무기산인 방법.
  30. 제28항에 있어서, 산이 HCl, HBr, HF, HI, H2SO4및 HNO3로 이루어진 그룹중에서 선택되는 조성물인 방법.
  31. 카르복실레이트 음이온의 존재하에 분해될 수 있는 하나이상의 약제학적 물질과 알킬렌옥사이드의 축합생성물을 함유하는 약제학적 조성물을 정제하여 카르복실레이트 음이온 함량을 약제학적 물질의 촉매화 분해를 실질적으로 방지하기에 충분한 양으로 감소시켜, 언급된 약제학적 조성물을 안정화하는 방법.
  32. 제31항에 있어서, 약제학적 조성물이 에탄올과 폴리옥시에틸화 피마자유를 약 50 : 50용적의 양으로 함유하는 방법.
  33. 제31항에 있어서, 약제학적 물질이 파클리텍셀, 테니포시드. 캠프토테신 및 이들의 유도체로 이루어진 그룹중에서 선택되는 방법.
  34. 제32항에 있어서, 정제단계가 산을 폴리옥시에틸화 피마자유에 카르복실화 음이온의 양을 감소시켜 약제학적 물질의 분해를 방지하는 양으로 첨가하는 방법.
  35. 제34항에 있어서, 산이 약제학적 조성물 mL당 5.6×10-6g 내지 8.4×10-6g의 H+을 제공하는 양으로 첨가되는 방법.
  36. 제34항에 있어서, 정제단계가 카르복실레이트 음이온 함량을 약제학적 조성물 mL당 0.6×10-6g당량 미만으로 낮쳐주는 방법.
  37. 에탄올과 용해량의 가용화제 하나이상을 함유한 용매를 처리하여 카르복실레이트 음이온 함량을 파크릴텍셀, 테니포시드, 캠프토테신 및 이들의 유도체로 이루어진 그룹중에서 선택된 약제학적 물질의 분해를 실질적으로 방지하기에 충분히 낮은 수준으로 감소시켜, 언급된 약제학적 물질과 용매를 함유한 약제학적 조성물을 안정화시키는 방법.
  38. 제37항에 있어서, 가용화재가 폴리옥시에틸화 지질, 폴리에톡실화 12-하이드록시 스테아린산 및 폴리에틸렌 글리콜로 이루어진 그룹중에서 선택되는 방법.
  39. 제37항에 있어서, 가용화제가 폴리옥시에틸화 피마자유인 방법.
  40. 제37항에 있어서, 폴리옥시에틸화 피마자유가 피마자유와 피마자유 1몰당 약 20 내지 40몰의 에틸렌옥사이드의 축합생성물인 방법.
  41. 제37항에 있어서, 처리단계가 용매를 산과 혼합함을 포함하고, 산이 약제학적 조성몰 mL당 5.6×10-6내피 8.4×10-6g의 H+을 제공하는 양인 방법.
  42. 제38항에 있어서, 처리단계가 용매를 알루미늄 옥사이드와 접촉시켜 카르복실레이트 함량을 감소시켜 약제학적 물질의 분해를 방지하는 방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019940025248A 1993-09-29 1994-09-29 안정화된약제학적조성물및안정화용매 Expired - Fee Related KR100515631B1 (ko)

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US12802693A 1993-09-29 1993-09-29
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KR100515631B1 KR100515631B1 (ko) 2005-12-08

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