KR920007632A - 지효성 방출 제제 및 그의 중합체 - Google Patents

지효성 방출 제제 및 그의 중합체 Download PDF

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KR920007632A
KR920007632A KR1019910018235A KR910018235A KR920007632A KR 920007632 A KR920007632 A KR 920007632A KR 1019910018235 A KR1019910018235 A KR 1019910018235A KR 910018235 A KR910018235 A KR 910018235A KR 920007632 A KR920007632 A KR 920007632A
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acid
polymer
sustained release
hydroxycarboxylic
release formulation
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KR1019910018235A
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KR100199119B1 (ko
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미노루 야마다
세이꼬 이시구로
야스아끼 오가와
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모리다 가쯔라
다께다야꾸힝고오교 가부시끼가이샤
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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
    • A61K31/74—Synthetic polymeric materials
    • A61K31/745—Polymers of hydrocarbons
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/04—Polyesters derived from hydroxycarboxylic acids, e.g. lactones

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Polyesters Or Polycarbonates (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Polymers With Sulfur, Phosphorus Or Metals In The Main Chain (AREA)
  • Macromolecular Compounds Obtained By Forming Nitrogen-Containing Linkages In General (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

내용 없음

Description

지효성 방출 제제 및 그의 중합체
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (25)

  1. (A)플리락트산 및 (B)글리콜산과 하기식의 히드록시카르복실산
    (식중, R은 2내지 8개의 탄소를 갖는 알킬기를 나타낸다)의 공중합체를 (A)와(B)의 중량비가 10/90 내지 90/10의 범위 이내로 되도록 함유하는 지효성 방출 제제용 중합체.
  2. 제1항에 있어서, 폴리락트산이 D-락트산 및 L-락트산의 중합체인 중합체.
  3. 제1항에 있어서, 폴리락트산이 D-락트산 및 L-락트산의 중합체이고, D-및 L-락트산의 몰비가 45/55 내지 25/75인 중합체.
  4. 제1항에 있어서, 폴리락트산이 GPC로 측정한 5000 내지 30000의 분자량 피이크 수치(peak value)를 갖는 중합체.
  5. 제1항에 있어서, 하이드록시카르복실산이 2-히드록시부티르산, 2-히드록시발레르산, 2-히드록시-3-메틸부티르산, 2-히드록시카프로산, 2-히드록시이소카프로산 및 2-히드록시카프릴산으로 구성된 군으로 부터 선택된 것인 중합체.
  6. 제1항에 있어서, 공중합체가 각각 글리콜산의 비가 40 내지 70몰 %범위내이고 상기 히드록시카르복실산의 비가 60 내지 30몰 %범위 이내인 공중합체인 중합체.
  7. 제1항에 있어서, 공합체가 GPC로 측정한 5000 내지 20000의 분자량 피이크 수치를 갖는 중합체.
  8. (A)플리락트산 및 (B)글리콜산과 하기식의 히드록시카르복실산.
    (식중, R은 2내지 8개의 탄소를 갖는 알킬기를 나타낸다)의 공중합체를 10/90 내지 90/10의 중량비로 혼합함을 특징으로 하는 지효성 방출 제제용 중합체의 제조방법.
  9. 제8항에 있어서, 플리락트산이 D-락트산 및 L-락트산의 중합체인 방법.
  10. 제8항에 있어서, 플리락트산이 D-락트산 및 L-락트산의 중합체이고 D-및 L-락트산의 몰비가 45/55 내지 25/75인 방법.
  11. 제8항에 있어서, 폴리락트산이 GPC로 측정한 5000 내지 30000의 분자량 피이크 수지를 갖는 방법.
  12. 제8항에 있어서, 히드록시카르복실산이 2-히드록시부티르산, 2-히드록시발레르산, 2-히드록시-3-메틸부티르산, 2-히드록시카프로산, 2-히드록시이소카프로산 및 2-히드록시카프릴산으로 구성된 군으로 부터 선택된 것인 방법.
  13. 제8항에 있어서, 공중합체가 각각 글리콜산의 비가 40 내지 70몰 % 범위내이고 상기 히드록시카르복실산의 비가 60내지 30몰 %범위 이내인 공중합체인 방법.
  14. 제8항에 있어서, 공중합체가 GPC를 측정한 5000 내지 20000의 분자량 피이크 수치를 갖는 방법.
  15. (A)플리락트산 및 (B)글리콜산과 하기식의 히드록시카르복실산.
    (식중, R은 2내지 8개의 탄소를 갖는 알킬기를 나타낸다)의 공중합체를(A)와(B) 중량비가 10/90 내지 90/10 의 범위 이내로 되도록 함유하는 지효성 방출 제제용 중합체에 분산된 수용성 약제를 함유하는 지효성 방출 제제.
  16. 제15항에 있어서 플리락트산이 D-락트산 및 L-락트산의 중합체인 지효성 방출 제제.
  17. 제15항에 있어서 플리락트산이 D-락트산 및 L-락트산의 중합체이고 D-및 L-락트산의 몰비가 45/55 내지 25/75인 지효성 방출 제제.
  18. 제15항에 있어서 폴리락트산이 GPC로 측정한 5000내지 30000의 분라량 피이크 수치를 갖는 지효성 방출 제제.
  19. 제15항에 있어서, 히드록시카르복실산이 2-히드록시부티르산, 2-히드록시발레르산, 2-히드록시-3-메틸부티르산, 2-히드록시카프로산, 2-히드록시이소카프로산 및 2-히드록시카프릴산으로 구성된 군으로 부터 선택된 것인 지효성 방출 제제.
  20. 제15항에 있어서, 공중합체가 각각 글리콜산의 비가 40 내지 70몰 %범위내이고, 상기 히드록시카르복실산의 비가 60 내지 30몰 % 범위 이내인 공중합체인 지효성 방출 제제.
  21. 제15항에 있어서, 공중합체가 GPC를 측정한 5000 내지 20000의 분자량 피이크 수치를 갖는 지효성 방출 제제.
  22. 제15항에 있어서, 수용성 약제가 생리학적 활성 폴리펩티드인 지효성 방출 제제.
  23. 제22항에 있어서 생리학적 활성폴리펩티드가 황체화(leutenizing)호르몬-분지(releasing)호르몬 또는 그의 작용 유사체인 지효성 방출 제제.
  24. 제23항에 있어서, 항체화 호르몬-분비호르몬의 작용 유사체가 하기식의 화합물 또는그의 염인 지효성 방출 제제.
    (Pyr)Glu-R1-Trp-Ser-R2-R3-R4-Arg-Pro-R5
    [식중, R1은 His, Tyr, Trp 또는 p-NH2-Phe를 의미하며; R2는 Tyr 또는 Phe를 의미하고; R3은 Gly또는 D-아미노산 잔류물을 의미하며; R4는 Leu, Ile 또는 Nle를 의미하고; R5는 Gly-NH-R6(R6은 히드록실기를 임의로 가질수 있는 저급 알킬기 또는 수소이다.) 또는 NH-R6(R6은 상기에서 정의된 바와 같다)을 의미한다,]
  25. 제22항에 있어서, 생리학적 활성 폴리펩티드가 (Pyr)Glu-His-Trp-Ser-Trp-D-Leu-Leu-Arg-Pro-NH-C2H5또는 그의 아세트산 염인 지효성 방출 제제.
    ※ 참고사항 : 최초출원 내용에 의하여 공개되는 것임.
KR1019910018235A 1990-10-16 1991-10-16 서방성 제제 및 그의 중합체 KR100199119B1 (ko)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP27803790 1990-10-16
JP90-278037 1990-10-16
JP21704591 1991-08-28
JP91-217045 1991-08-28

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KR920007632A true KR920007632A (ko) 1992-05-27
KR100199119B1 KR100199119B1 (ko) 1999-06-15

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US (1) US5304377A (ko)
EP (1) EP0481732B1 (ko)
JP (1) JP3196035B2 (ko)
KR (1) KR100199119B1 (ko)
CN (2) CN1043189C (ko)
AT (1) ATE119035T1 (ko)
AU (1) AU644019B2 (ko)
CA (1) CA2053468C (ko)
DE (1) DE69107773T2 (ko)
DK (1) DK0481732T3 (ko)
EE (1) EE02958B1 (ko)
ES (1) ES2069221T3 (ko)
FI (1) FI101454B1 (ko)
GE (1) GEP19981287B (ko)
IE (1) IE66705B1 (ko)
LT (1) LT3277B (ko)
LV (1) LV10055B (ko)
MX (1) MX9101595A (ko)
NO (1) NO302481B1 (ko)
NZ (1) NZ240214A (ko)
PT (1) PT99236B (ko)
RU (1) RU2103005C1 (ko)
UA (1) UA27707C2 (ko)
ZA (1) ZA918168B (ko)

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