KR950031046A - 장내 목표 부위에서 의약적 유효 성분을 방출하도록 조정된 약학적 제제 - Google Patents

장내 목표 부위에서 의약적 유효 성분을 방출하도록 조정된 약학적 제제 Download PDF

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KR950031046A
KR950031046A KR1019950005014A KR19950005014A KR950031046A KR 950031046 A KR950031046 A KR 950031046A KR 1019950005014 A KR1019950005014 A KR 1019950005014A KR 19950005014 A KR19950005014 A KR 19950005014A KR 950031046 A KR950031046 A KR 950031046A
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active ingredient
pharmaceutically active
pharmaceutical formulation
compression
pharmaceutical
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KR100305234B1 (ko
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요시유끼 하라까와
히로유끼 요시노
에이지 후꾸이
다미 하나모리
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지바따 이찌로
다나베세이야꾸 가부시끼가이샤
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    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/554—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

장관(intestinal tract)내의 목표 부위에서 의약 활성 성분이 방출되도록 조절되며 (a)의약적 유효성분을 함유 하는 핵 및 (b)장 고분자를 함유하는 압축-피복층으로 핵주위에 제공되는 층을 함유하는 경구 투여용 약학적 제제.
본 발명의 약학적 제제에서 의약 활성 성분은 위(stomach)에 머무르는 동안이나 위를 벗어난 이후에도 장내의 목표 부위에 도달하기 전까지는 방출되지 않고 도달된 이후에는 신속히 방출되어 의약적 유효 성분이 장관내의 목표부위에 효과적으로 전달된다.

Description

장내 목표 부위에서 의약적 유효 성분을 방출하도록 조성된 약학적 제제
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도는 실시예 1의 약학적 제제를 사용하여, 일본국 약전 XⅡ(이하 JPXⅡ)라 칭함의 용해 시험의 1차액과 2차액으로 수행한 용해 시험의 결과를 보여주는 그래프이다. 제2도는 JPXⅡ 용해서힘과 1차액에 실험 실시예 1에 나오는 시간동안 담근 후에 약학적 제제를 사용하여 JPXⅡ 용해시험의 2차액으로 수행한 용해시험의 결과를 보여주는 그래프이다.

Claims (9)

  1. 장관(intestinal tract)내의 목표 부위에서 의약적 유효 성분이 방출되도록 조절되며 (a)의약적 유효 성분을 함유하는 핵 및 (b)장 고분자를 함유하는 층으로, 핵 둘레에 제공되는 압축-피복층을 함유하는 경구 투여용 약학적 제제.
  2. 제1항에 있어서, 압축-피복층(b)는 약학적 제제가 장관내의 목표 부위 근처에 도달할 때까지 의약적 유효 성분의 방출을 억제할 수 있는 약학적 제제.
  3. 제1항에 있어서, 의약적 유효 성분의 방출은 용해 시험이 수행될때 일본국 약전 XⅡ에 따른 용해 시험의 1차액에서 10시간 이상 동안 실질적으로 억제되고, 시험의 2차액에서 2시간이상 동안 실질적으로 억제되는 약학적 제제.
  4. 제1항에 있어서, 압축-피복층(b)의 피복량이 핵(a)이 중량에 기초하여 150∼600중량%인 약학적 제제.
  5. 제1항에 있어서, 장 고분자가 카르복시메틸에틸셀룰로스, 히드록시프로필메틸셀룰로스 아세테이트 숙시네이트, 히드록시프로필메틸셀룰로스 포탈레이트 및 폴리(메타크릴산, 메틸메타크릴레이트)로 이루어진 군으로부터 선택되는 한 종류 이상의 화합물인 약학적 제제.
  6. 제1항에 있어서, 친유성 또는 소수성 물질이 압축-피복층에 함유된 약학적 제제.
  7. 제6항에 있어서, 친유성 또는 소수성 물질이 가소제, 고급지방산 및 고급 지방산의 금속염으로 이루어진 군으로부터 선택되는 한 종류 이상의 물질인 약학적 제제.
  8. 제6항에 있어서, 친유성 또는 소수성 물질이 마그네슘 스테아레이트, 칼슘 스테아레이트, 트리아세틴, 라우릭산, 카프릭산, 트리에틸시트레이트 및 아세틸 트리에틸 시트레이트로 이루어진 군으로부터 선택되는 한 종류 이상의 물질인 약학적 제제.
  9. 제6항에 있어서, 압축-피복층에 포함되는 친유성 또는 소수성 물질의 양이 장 고분자의 중량에 기초해서 5∼100중량%인 약학적 제제.
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950005014A 1994-03-11 1995-03-10 장내목표부위에서의약적유효성분을방출하도록조정된약학적제제 KR100305234B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP94-40911 1994-03-11
JP6040911A JP2917799B2 (ja) 1994-03-11 1994-03-11 消化管内適所放出型製剤

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KR950031046A true KR950031046A (ko) 1995-12-18
KR100305234B1 KR100305234B1 (ko) 2002-04-24

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US (1) US5725880A (ko)
EP (1) EP0671168B1 (ko)
JP (1) JP2917799B2 (ko)
KR (1) KR100305234B1 (ko)
CN (1) CN1116523A (ko)
AT (1) ATE193439T1 (ko)
CA (1) CA2144094C (ko)
DE (1) DE69517218T2 (ko)
DK (1) DK0671168T3 (ko)
ES (1) ES2148365T3 (ko)
GR (1) GR3033593T3 (ko)
PT (1) PT671168E (ko)
SG (1) SG34210A1 (ko)
TW (1) TW422708B (ko)

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US5725880A (en) 1998-03-10
SG34210A1 (en) 1996-12-06
JPH07247222A (ja) 1995-09-26
DK0671168T3 (da) 2000-08-07
CA2144094C (en) 2004-01-27
ES2148365T3 (es) 2000-10-16
GR3033593T3 (en) 2000-09-29
JP2917799B2 (ja) 1999-07-12
DE69517218T2 (de) 2000-11-30
CA2144094A1 (en) 1995-09-12
EP0671168B1 (en) 2000-05-31
PT671168E (pt) 2000-09-29
ATE193439T1 (de) 2000-06-15
CN1116523A (zh) 1996-02-14
KR100305234B1 (ko) 2002-04-24
TW422708B (en) 2001-02-21
DE69517218D1 (de) 2000-07-06
EP0671168A1 (en) 1995-09-13

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