KR920005978A - 안정화된 고형화학 조성물 - Google Patents

안정화된 고형화학 조성물 Download PDF

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Publication number
KR920005978A
KR920005978A KR1019910015896A KR910015896A KR920005978A KR 920005978 A KR920005978 A KR 920005978A KR 1019910015896 A KR1019910015896 A KR 1019910015896A KR 910015896 A KR910015896 A KR 910015896A KR 920005978 A KR920005978 A KR 920005978A
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water
soluble
chemical composition
stabilizer
group
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KR1019910015896A
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KR100196209B1 (ko
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데 한 피에테르
요세푸스 마리아 반 데어 벤 코르넬루스
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에프. 지엠. 헤르만스, 에이. 지. 제이. 베르미렌
악조 엔. 브이
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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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
    • 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
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Developing Agents For Electrophotography (AREA)
  • Lubricants (AREA)

Abstract

내용 없음

Description

안정화된 고형화학 조성물
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (10)

  1. 난용성의 염기성 화합물의 수용성산부가염, 조성물 총중량의 약 30 내지 80중량%정도의 미세결정형 셀룰로오즈, 락토오즈 및 칼슘 히드로젠 포스페이트로 구성된 군에서 선택된 부형제 및 과립화중에 조성물을 안정화시키는데 사용되는, 조성물 총중량의 약 0.5 내지 약 10중량%정도의 수용성 알칼리성 안정제를 포함하는 과립화된 건조 화학조성물.
  2. 제1항에 있어서, 상기 난용성의 염기성 화합물이 아포몰핀, 클로르프로마진, 이미프라민, 프로메타진 및 미안세린으로 구성되는 군으로부터 선택되는 건조 화학조성물.
  3. 제2항에 있어서, 상기 난용성의 염기성 화합물이 미안세린인 건조 화학조성물.
  4. 제3항에 있어서, 건조화학 조성물의 약 1 내지 약 5중량%의 수용성의 알칼리성 안정제를 함유하는 건조 화학조성물.
  5. 제1항에 있어서, 상기 안정제가 소디움비카르보네이트, 암모니움카르보네이트, 소디움시트레이트, 2가의 소디움 포스페이트, 무수2가 소디움 비포스페이트, 디암모니움 히드로젠포스페이트, 소디움피로포스페이트 및 그 혼합물로 구성된 군으로부터 선택되는 건조 화학조성물.
  6. 45℃이상의 온도를 이용하고, 난용성의 염기성 화합물의 수용성 산부가염과 미결정형 셀룰로오즈, 락토오즈, 칼슘하이드로젠포스페인트 및 그 혼합물로 구성된 군에서 선택된 부형제의 혼합물을 사용하며, 과립화전에 상기 혼합물에 적어도 2mg/ml의 수용해도를 갖는 알칼리성 화합물을 첨가하고, 이 알카리성 화합물은 과립화 혼합물 건조용량의 약 0.5 내지 약 10중량%의 양이 존재하는 과립화공정의 안정성을 증가시키는 방법.
  7. 제6항에 있어서, 상기 알칼리성 화합물이 적어도 4mg/ml의 물에 대한 용해도를 가지는 방법.
  8. 제7항에 있어서, 상기 알칼리성 화합물이 과립화 혼합물의 약 1 내지 약 5중량%의 양이 존재하는 방법.
  9. 난용성의 염기성 화합물의 수용성 산부가염과 미세결정형 셀룰로오즈, 락토오즈, 칼슘히드로젠포스페이트 및 그 혼합물로부터 선택된 부형제의 혼합물을 함유하는 조성물을 사용하는 고온 과립화 공정에서 안정화제로서 적어도 2mg/ml의 물에 대한 용해도를 가지는 알칼리성 화합물을 사용하는 방법.
  10. 아포몰핀, 클로르포로마진, 이미프라민 및 프로메타진으로 구성된 군으로부터 선택된 난용성의 염기성 약물의 수용성 산부가염, 건조약학제제의 약 30 내지 약 80중량%의, 미세결정형 셀룰로오즈, 락토오즈 및 칼슘히드로젠포스페이트로부터 선택된 부형제 건조약학제제의 약 0.5 내지 약 10중량%의 소디움비카르보네이트, 암모니움, 카르보네이트, 소디움시트레이트, 2가의 소디움 포스페이트, 무수2가의 소디움포스페이트, 디암모늄 히드로젠 포스페이트, 소디움피로포스페이트 및 그 혼합물로 구성된 군으로부터 선택된 수용성의 알칼리성 안정제를 포함하고, 이 안정제가 과립화 공정중에 제제를 안정화시키는데 사용되는 것인 안정화된 건조약학제제.
    ※ 참고사항 : 최초출원 내용에 의하여 공개되는 것임.
KR1019910015896A 1990-09-13 1991-09-12 안정화된 고형화학 조성물 KR100196209B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US58185990A 1990-09-13 1990-09-13
US7/581,859 1990-09-13
US07/581,859 1990-09-13

Publications (2)

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KR920005978A true KR920005978A (ko) 1992-04-27
KR100196209B1 KR100196209B1 (ko) 1999-06-15

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EP (1) EP0475482B1 (ko)
JP (1) JP3153577B2 (ko)
KR (1) KR100196209B1 (ko)
AT (1) ATE112491T1 (ko)
AU (1) AU643920B2 (ko)
CA (1) CA2049811C (ko)
DE (1) DE69104453T2 (ko)
DK (1) DK0475482T3 (ko)
ES (1) ES2064887T3 (ko)
FI (1) FI104361B (ko)
IE (1) IE65274B1 (ko)
NZ (1) NZ239753A (ko)
PT (1) PT98955B (ko)
ZA (1) ZA916661B (ko)

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ZA916661B (en) 1992-06-24
IE65274B1 (en) 1995-10-18
CA2049811C (en) 2002-11-05
AU8341691A (en) 1992-03-19
JPH0578236A (ja) 1993-03-30
DK0475482T3 (da) 1995-04-03
IE913054A1 (en) 1992-02-25
NZ239753A (en) 1992-10-28
AU643920B2 (en) 1993-11-25
CA2049811A1 (en) 1992-03-14
PT98955B (pt) 1999-02-26
DE69104453D1 (de) 1994-11-10
FI914147A0 (fi) 1991-09-03
FI104361B (fi) 2000-01-14
ATE112491T1 (de) 1994-10-15
FI914147A (fi) 1992-03-14
DE69104453T2 (de) 1995-03-16
EP0475482B1 (en) 1994-10-05
PT98955A (pt) 1992-08-31
ES2064887T3 (es) 1995-02-01
EP0475482A1 (en) 1992-03-18
JP3153577B2 (ja) 2001-04-09
KR100196209B1 (ko) 1999-06-15

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