KR920017656A - 저 용량 건조 약학 제제 - Google Patents

저 용량 건조 약학 제제 Download PDF

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Publication number
KR920017656A
KR920017656A KR1019920003956A KR920003956A KR920017656A KR 920017656 A KR920017656 A KR 920017656A KR 1019920003956 A KR1019920003956 A KR 1019920003956A KR 920003956 A KR920003956 A KR 920003956A KR 920017656 A KR920017656 A KR 920017656A
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weight
drug
mixture
steroidal
parts
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KR1019920003956A
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English (en)
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KR100198017B1 (ko
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드 한 피에테르
요한네스 듀르루 마르쿠스
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에프. 지.엠.헤르만스·에이.지.제이.베르미렌
악조 엔. 브이
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Application filed by 에프. 지.엠.헤르만스·에이.지.제이.베르미렌, 악조 엔. 브이 filed Critical 에프. 지.엠.헤르만스·에이.지.제이.베르미렌
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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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

내용 없음

Description

저 용량 건조 약학 제제
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음
제1도 내지 제3도는 각각 과립화된 α-락토오스 모노히드레이트, β-락토오스, 분무 건조된 락토오스 및 결정상의 α-락토오스 모노 히드레이트의 다양한 체 분류물 중에서의 저용량 성분(0.05% EE w/w)의 상대적인 분포를 도시한 것이다.

Claims (10)

  1. 적어도 하나의 미분화된 스테로이드계 약물을 0.005 내지 0.5중량% 함유하는 약학투여 단위를 제조하는 방법에 있어서; 상기 스테로이드계 약물 1 내지 100중량부를 상기 스테로이드계 약물에 대해 80%이상으로 결합이 가능하고, 탈 혼합 잠재도가 10%이하인 부형제 2000 내지 20,000중량부와 건조 혼합하는 단계를 포함하는 방법.
  2. 제1항에 있어서, 상기 약물/락토오스 혼합물 중량의 9배에 이르는 분량의 부가의 부형제를 첨가하여 0.005 내지 0.5중량%의 약물을 함유하는 혼합물을 형성시키는 단계를 부가적으로 포함하는 방법.
  3. 제1항에 있어서, 상기 혼합물을 0.5중량%이하의 약물을 함유하는 정제로 압착하는 단계를 부가적으로 포함하는 방법.
  4. 제2항에 있어서, 상기 혼합물을 0.5중량%이하의 약물을 정제로 압착하는 단계를 부가적으로 포함하는 방법.
  5. 제1항에 있어서, 상기 스테로이드계 약물에 대한 높은 결합 친화도 및 낮은 탈혼합 잠재도를 지닌 부형제가 분무건조된 폴리 알코올, 과립화된 α-락토오스 모노 히드레이트 또는 이들의 혼합물로 이루어진 군중에서 선택된 것인 방법.
  6. 스테로이드계 약물에 대해 80%이상으로 결합 할 수 있으며 탈 혼합 잠재도가 10%이하인 2000 내지 20,000중량부의 부형제 전체에 균일하게 분포된 적어도 하나의 상기 스테로이드계 약물 1 내 지 100중량부를 주성분으로 하는 건조 혼합물.
  7. 제6항의 건조 혼합물을 정제, 캅셀, 분말 및 슬럭 과립으로 이루어진 군중에서 선택된 투여 단위로 성형하는 단계를 포함하는 약학투여 단위의 제조방법.
  8. 제1항에 있어서, 상기 약물이 데소게스트렐, 3-케토데소게스트렐, 에티닐 에스트라디올, 게스토덴 및 이들의 혼합물로 이루어진 군중에서 선택된 것인 방법.
  9. 제7항에 있어서, 상기 약물이 데소게스트렌, 3-케토데소게스트렐, 에티닐 에스트라디올, 게스토덴 및 이들의 혼합물로 이루어진 군중에서 선택된 것인 방법.
  10. 상기 스테로이드계 약물에 대해 80%이상으로 결합할 수 있으며 탈 혼합 잠재도가 10%이하인 2000 내지 20,000 중량부의 부형제와 1 내지 100중량부의 상기 스테로이드계 약물을 건조 혼합하는 단계; 상기 약물/락토오스 혼합물 중량의 9배에 이르는 분량의 부가의 부형제를 첨가하여 0.005 내지 0.5중량%의 약물을 함유하는 혼합물을 형성시키는 단계; 및 상기 혼합물을 0.5중량%이하의 약물을 함유하는 정제로 압착시키는 단계를 포함하고, 제조된 정제의 스테로이드계 약물함량이 이와같은 방법으로 제조된 모든 정제들의 상대 표준 편차 4%이내인 것을 특징으로 하는 정제의 제조방법.
    ※ 참고사항 : 최초출원 내용에 의하여 공개되는 것임.
KR1019920003956A 1991-03-12 1992-03-11 저 용량 건조약학 제제 KR100198017B1 (ko)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP91200524.6 1991-03-12
EP91200524 1991-03-12

Publications (2)

Publication Number Publication Date
KR920017656A true KR920017656A (ko) 1992-10-21
KR100198017B1 KR100198017B1 (ko) 1999-06-15

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KR1019920003956A KR100198017B1 (ko) 1991-03-12 1992-03-11 저 용량 건조약학 제제

Country Status (18)

Country Link
US (1) US5382434A (ko)
EP (1) EP0503521B2 (ko)
JP (1) JP3474210B2 (ko)
KR (1) KR100198017B1 (ko)
CN (1) CN1039086C (ko)
AT (1) ATE125155T1 (ko)
AU (1) AU651869B2 (ko)
CA (1) CA2062428C (ko)
DE (1) DE69203488T3 (ko)
DK (1) DK0503521T4 (ko)
ES (1) ES2077897T5 (ko)
FI (1) FI100770B (ko)
GR (1) GR3017737T3 (ko)
HK (1) HK1002018A1 (ko)
IE (1) IE67345B1 (ko)
NO (1) NO305055B1 (ko)
NZ (1) NZ241915A (ko)
ZA (1) ZA921659B (ko)

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Also Published As

Publication number Publication date
EP0503521B1 (en) 1995-07-19
EP0503521A1 (en) 1992-09-16
IE920634A1 (en) 1992-09-23
JP3474210B2 (ja) 2003-12-08
DE69203488D1 (de) 1995-08-24
DE69203488T2 (de) 1996-01-11
ATE125155T1 (de) 1995-08-15
HK1002018A1 (en) 1998-07-24
AU651869B2 (en) 1994-08-04
NO920958L (no) 1992-09-14
DE69203488T3 (de) 2006-07-06
NZ241915A (en) 1994-04-27
ES2077897T3 (es) 1995-12-01
FI921023A (fi) 1992-09-13
DK0503521T3 (da) 1995-11-27
GR3017737T3 (en) 1996-01-31
EP0503521B2 (en) 2005-11-09
CA2062428C (en) 2002-07-30
NO920958D0 (no) 1992-03-11
FI921023A0 (fi) 1992-03-09
US5382434A (en) 1995-01-17
IE67345B1 (en) 1996-03-20
ZA921659B (en) 1992-11-25
CN1039086C (zh) 1998-07-15
KR100198017B1 (ko) 1999-06-15
NO305055B1 (no) 1999-03-29
CA2062428A1 (en) 1992-09-13
JPH0578251A (ja) 1993-03-30
ES2077897T5 (es) 2006-06-16
FI100770B (fi) 1998-02-27
DK0503521T4 (da) 2005-12-05
AU1211992A (en) 1992-09-17
CN1064810A (zh) 1992-09-30

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