KR960033469A - 단일주사 백신 제형 - Google Patents

단일주사 백신 제형 Download PDF

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Publication number
KR960033469A
KR960033469A KR1019950005424A KR19950005424A KR960033469A KR 960033469 A KR960033469 A KR 960033469A KR 1019950005424 A KR1019950005424 A KR 1019950005424A KR 19950005424 A KR19950005424 A KR 19950005424A KR 960033469 A KR960033469 A KR 960033469A
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KR
South Korea
Prior art keywords
oil
antigen
microparticle
mixture
microparticles
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Application number
KR1019950005424A
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English (en)
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KR100201352B1 (ko
Inventor
이현국
박정환
최남석
김명진
김수헌
Original Assignee
성재갑
주식회사 Lg 화학
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Application filed by 성재갑, 주식회사 Lg 화학 filed Critical 성재갑
Priority to KR1019950005424A priority Critical patent/KR100201352B1/ko
Priority to US08/613,830 priority patent/US5753234A/en
Priority to MXPA/A/1996/000938A priority patent/MXPA96000938A/xx
Priority to TW085103077A priority patent/TW495361B/zh
Priority to BR9601032A priority patent/BR9601032A/pt
Priority to PE1996000176A priority patent/PE57797A1/es
Priority to JP8085962A priority patent/JP2739570B2/ja
Priority to CNB961027282A priority patent/CN1213736C/zh
Priority to ARP960101761A priority patent/AR002969A1/es
Priority to CA002171881A priority patent/CA2171881A1/en
Priority to EP96104177A priority patent/EP0737472A1/en
Publication of KR960033469A publication Critical patent/KR960033469A/ko
Application granted granted Critical
Publication of KR100201352B1 publication Critical patent/KR100201352B1/ko

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55555Liposomes; Vesicles, e.g. nanoparticles; Spheres, e.g. nanospheres; Polymers
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2730/00Reverse transcribing DNA viruses
    • C12N2730/00011Details
    • C12N2730/10011Hepadnaviridae
    • C12N2730/10111Orthohepadnavirus, e.g. hepatitis B virus
    • C12N2730/10134Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

본 발명은 항원을 수용성 고분자로 일차 코팅하고 제조된 일차 입자를 생분해성 고분자로 이차 코팅한 미세입자 및 이를 주사제 용액에 분산시킨 백신 제형으로서 체내에서 수개월에 걸쳐 펄스(pulse) 또는 연속적으로 항원을 방출함으로써 단일주사로 면역을 완성시키는 단일주사 백신 제형에 관한 것이다.

Description

단일주사 백신 제형
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (19)

  1. 단일 또는 혼합 항원을 수용성 고분자로 일차 코팅하고, 제조된 일차 입자를 소수성인 생분해성 고분자로 이차 코팅하여 제조된 입경 0.5~300㎛의 미세입자.
  2. 제1항에 있어서, 상기 항원이 약독화(attenuated) 되었거나 죽은(killed) 항원 또는 유전자 재조합(recombinant) 항원인 미세입자.
  3. 제1항에 있어서, 상기 항원이 항원 자체이거나 항원과 보조제 또는 무기염의 혼합물인 미세입자.
  4. 제1항에 있어서, 상기 항원인 간염, 디프테리아, 수두, 장티푸스, 백일해, 파상풍, 결핵, 살모넬라증, 콜레라, HIV, 허피스, 황열, 홍역, 회백수염, 풍진, 유행성 이하선염, 광견병, 플라크, 주혈흡충병, 인플루엔자, 종양, 트리파노소마병, 레이슈마니아증, 나병, 수막염, 및 말라리아 중 하나 이상의 질병을 예방할 수 있는 항원인 미세입자.
  5. 제3항에 있어서, 상기 보조제가 앨럼(alum), 뮤라밀 디펩티드(muramyl dipeptide), 뮤라밀 트리펩티드(muramyl tripeptide)와 이들의 유도체, 타이모신 알파(tymosin alpha), 모노포스포릴 리피드 A(monophosphoryl lipid A), 사포닌(saponins), 면역자극 복합체(immunostimulating complex), 폴리옥시에틸렌(polyoxyethylene)과 폴리옥시프로필렌(polyoxypropylene)의 공중합체 같은 고분자전해질(polyeletroyte) 또는 이들의 혼합물인 미세입자.
  6. 제1항에 있어서, 상기 수용성 고분자의 양이 항원의 중량을 기준으로 1~50배인 미세입자.
  7. 제1항에 있어서, 상기 수용성 고분자가 당류, 단백질, 아미노산 또는 이들의 혼합물인 미세입자.
  8. 제7항에 있어서, 상기 당류가 셀룰로즈, 글루코즈, 크실로우즈, 갈락토오즈, 프럭토오즈, 락토오즈, 말토오즈, 사카로오즈, 알지네이트, 덱스트란, 히아루론산, 콘드로이틴 설페이트 또는 이들의 혼합물인 미세입자.
  9. 제8항에 있어서, 상기 셀룰로즈가 하이드록시 프로필 셀룰로즈, 카복시메틸 셀룰로즈, 소디움 카복시메틸 셀룰로즈 또는 이들의 혼합물인 미세입자.
  10. 제7항에 있어서, 상기 단백질이 젤라틴, 알부민 또는 이들의 혼합물인 미세입자.
  11. 제7항에 있어서, 상기 아미노산이 글리신, 알리닌, 글루탐산, 아르기닌, 리신, 또는 이들의 염 또는 혼합물인 미세입자.
  12. 제1항에 있어서, 상기 일차 입자의 입경이 0.1~200㎛인 미세입자.
  13. 제1항에 있어서, 상기 생분해성 고분자의 양이 일차 입자의 중량을 기준으로 1~100배인 미세입자.
  14. 제1항에 있어서, 상기 생분해성 고분자가 폴리글라이코라이드, 폴리락타이드, 글라이코라이드와 락타이드의 공중합체 또는 이들의 혼합물인 미세입자.
  15. 제1항에 있어서, 상기 생분해성 고분자가 코폴리옥살레이트, 폴리카프로락톤, 락타이드와 카프로락톤의 공중합체, 폴리에스터라마이드, 폴리오르토에스테르, 폴리베타하이드록시부티르산, 폴리안하이드라이드 또는 이들의 혼합물인 미세입자.
  16. 제1항 내지 제15항 중 어느 한 항의 미세입자 또는 이들의 혼합물을 주사제 용액에 분산시킨 단일주사 백신 제형.
  17. 제16항에 있어서, 상기 주사제 용액이 완충용액 자체이거나, 분산제 또는 방부제를 포함하는 완충용액인 제형.
  18. 제17항에 있어서, 상기 주사제 용액이 식용유, 미네랄 오일(mineral oil), 스쿠알렌(squalene), 스쿠알란(squalane), 대구 간유(cod liver oil), 모노(mono)-, 디(di)- 및 트리글리세라이드(triglyceride) 또는 이들의 혼합물인 제형.
  19. 제18항에 있어서, 상기 식용유가 옥배유(corn oil), 호마유(sesame oil), 올리브유(olive oil), 대두유(soybean oil), 홍화유(safflower oil), 면실유(cotton seed oil), 땅콩유(peanut oil) 또는 이들의 혼합물인 제형.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950005424A 1995-03-15 1995-03-16 단일주사 백신 제형 KR100201352B1 (ko)

Priority Applications (11)

Application Number Priority Date Filing Date Title
KR1019950005424A KR100201352B1 (ko) 1995-03-16 1995-03-16 단일주사 백신 제형
US08/613,830 US5753234A (en) 1995-03-16 1996-03-11 Single-shot vaccine formulation
MXPA/A/1996/000938A MXPA96000938A (en) 1995-03-16 1996-03-12 Single application vaccination formulation
TW085103077A TW495361B (en) 1995-03-16 1996-03-14 Single-shot vaccine formulation
BR9601032A BR9601032A (pt) 1995-03-16 1996-03-15 Micropartícula e formulação de vacina de dose única
PE1996000176A PE57797A1 (es) 1995-03-16 1996-03-15 Formulacion para vacunas en dosis unica
JP8085962A JP2739570B2 (ja) 1995-03-16 1996-03-15 単一注射ワクチン剤形
CNB961027282A CN1213736C (zh) 1995-03-16 1996-03-15 一次注射疫苗的配制品
ARP960101761A AR002969A1 (es) 1995-03-16 1996-03-15 UNA MICROPARTICULA DE 0,5 A 300 µM DE TAMANO PREPARADA POR EL RECUBRIMIENTO DE UN ANTIGENO CON UNA SUSTANCIA SOLUBLE EN AGUA Y EL RECUBRIMIENTO DEL NUCLEO OBTENIDO CON UN POLIMERO BIODEGRADABLE; Y UNA FORMULACION DE VACUNA DE DOSIS UNICA PREPARADA POR LA DISPERSION DE DICHA MICROPARTICULA EN UN MEDIO DE INYECCION
CA002171881A CA2171881A1 (en) 1995-03-15 1996-03-15 Single-shot vaccine formulation
EP96104177A EP0737472A1 (en) 1995-03-16 1996-03-15 Single-shot vaccine formulation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
KR1019950005424A KR100201352B1 (ko) 1995-03-16 1995-03-16 단일주사 백신 제형

Publications (2)

Publication Number Publication Date
KR960033469A true KR960033469A (ko) 1996-10-22
KR100201352B1 KR100201352B1 (ko) 1999-06-15

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KR1019950005424A KR100201352B1 (ko) 1995-03-15 1995-03-16 단일주사 백신 제형

Country Status (10)

Country Link
US (1) US5753234A (ko)
EP (1) EP0737472A1 (ko)
JP (1) JP2739570B2 (ko)
KR (1) KR100201352B1 (ko)
CN (1) CN1213736C (ko)
AR (1) AR002969A1 (ko)
BR (1) BR9601032A (ko)
CA (1) CA2171881A1 (ko)
PE (1) PE57797A1 (ko)
TW (1) TW495361B (ko)

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