KR950702409A - 방출 조절 모르핀 제제(controlled release morphine preparation) - Google Patents

방출 조절 모르핀 제제(controlled release morphine preparation) Download PDF

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Publication number
KR950702409A
KR950702409A KR1019950700300A KR19950700300A KR950702409A KR 950702409 A KR950702409 A KR 950702409A KR 1019950700300 A KR1019950700300 A KR 1019950700300A KR 19950700300 A KR19950700300 A KR 19950700300A KR 950702409 A KR950702409 A KR 950702409A
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South Korea
Prior art keywords
morphine
formulation
hours
formulation according
vitro release
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KR1019950700300A
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English (en)
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KR0156038B1 (ko
Inventor
페르손 크리스티안
왁세가르드 스타판
쿨스타드 쇠렌
프리그렌 렌나르트
Original Assignee
페르아케 올덴토프트
가셀 라보라토리에스 에이비
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Publication of KR950702409A publication Critical patent/KR950702409A/ko
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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
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/282—Organic compounds, e.g. fats
    • A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Abstract

본 발명은 적어도 8시간, 바람직하게는 적어도 12시간 동안 모르핀의 실제로 완전한 생물학적 이용성 및 용해의 대부분에 대해, 실질적으로 제로 차수 및 실제적으로 pH 비의존성 방출을 가지며, 그 기간중에 100%이하가 용해되는 경우 모르핀 제제에 관한 것이다. 그 제제에 있어서, 모르핀은 쉽게 녹는 염의 형태로, 확산 멤브레인으로서 코팅된 제제에서 완충제와 조합하여 존재한다.

Description

방출 조절 모르핀 제제(CONTROLLED RELEASE MORPHINE PREPARATION)
본 내용은 요부공개 건이므로 전문내용을 수록하지 않았음

Claims (11)

  1. 적어도 8시간, 바람직하게는 적어도 12시간 동안 모르핀의 실제로 완전한 생물학적 이용성 및 용해의 대부분에 대해, 실제로 제로 차수 및 실제로 pH 비의존성 시험관내 방출을 특징으로 하며, 그 기간중에 모르핀 총량의 100%이하, 및 50%이상, 바람직하게는 60%이상이 용해되며, 이에 의해 모르핀이 완충제와 조합하여 쉽게 녹는 염의 형태로 존재하며 제제가 확산 멤브레인으로 코팅된 경구 모르핀 제제.
  2. 제1항에 있어서, 8시간 후에 모르핀의 시험관내 방출이 30-85, 바람직하게는 40-80인 것이 특징인 제제.
  3. 제1항 또는 2항에 있어서, 12h후에 모르핀이 시험관내 방출이 50-100, 바람직하게는 60-100 및 가장 바람직하게는 80-100인 것이 특징인 제제.
  4. 제1-3항중의 어느 한항에 있어서, 정체 상태에서 적어도 12시간의 기간 동안 유효 플라즈마 수준을 제공하는 것이 특징인 제제.
  5. 제1-4항중 어느 한항에 있어서, 정체 상태에서 적어도 24시간의 기간 동안 유효 플라즈마 수준을 제공하는 것이 특징인 제제.
  6. 제1-5항중 어느 한항에 있어서, 정체로서 배합되고, 모르핀과 완충제가 정제 코어에 포함되는 것이 특징인 제제.
  7. 제6항에 있어서, 실제로 물과 위장액에서 불용성인 폴리머로 이루어진 확산 멤브레인에 의해 코어를 코팅하고 폴리머에 수용성, 기공-생성제가 랜덤하게 분석되는 것이 특징인 제제.
  8. 제1-7항중 어느 한항에 있어서, 모르핀 염이 모르핀 술페이트 또는 모르핀 클로라이드 또는 의약용으로 허용되는 다른 수용성 염인 것이 특징인 제제.
  9. 제1-8항중 어느 한항에 있어서, 완중제가 숙신산, 타르타르산, 시트르산 도는 의약용으로 허용되는 다른 유기산인 것이 특징인 제제.
  10. 제1-5 또는 7-9항중 어느 한항에 있어서, 복수 유니트 제제로서 배합되는 것이 특징인 제제.
  11. 전항중의 어느 한항에 있어서, 12-24시간 간격의 투여를 위한 제제
    ※ 참고사항 : 최초출원 내용에 의하여 공개하는 것임.
KR1019950700300A 1992-07-29 1993-07-28 방출 조절 모르핀 제제 KR0156038B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9202250A SE9202250D0 (sv) 1992-07-29 1992-07-29 Controlled release morphine preparation
SE9202250-8 1992-07-29
PCT/SE1993/000642 WO1994003161A1 (en) 1992-07-29 1993-07-28 Controlled release morphine preparation

Publications (2)

Publication Number Publication Date
KR950702409A true KR950702409A (ko) 1995-07-29
KR0156038B1 KR0156038B1 (ko) 1998-11-16

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KR1019950700300A KR0156038B1 (ko) 1992-07-29 1993-07-28 방출 조절 모르핀 제제

Country Status (22)

Country Link
US (1) US5520931A (ko)
EP (1) EP0652747B1 (ko)
JP (2) JPH08501081A (ko)
KR (1) KR0156038B1 (ko)
CN (1) CN1053339C (ko)
AT (1) ATE176398T1 (ko)
AU (1) AU662239B2 (ko)
CA (1) CA2140254C (ko)
DE (1) DE69323428T2 (ko)
DK (1) DK0652747T3 (ko)
ES (1) ES2130278T3 (ko)
FI (1) FI950319A0 (ko)
GR (1) GR3030106T3 (ko)
HU (1) HU221683B1 (ko)
IL (1) IL106477A (ko)
NO (1) NO307407B1 (ko)
NZ (1) NZ254314A (ko)
PL (1) PL172571B1 (ko)
RU (1) RU2114613C1 (ko)
SE (1) SE9202250D0 (ko)
WO (1) WO1994003161A1 (ko)
ZA (1) ZA935488B (ko)

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Also Published As

Publication number Publication date
HU221683B1 (hu) 2002-12-28
AU4595593A (en) 1994-03-03
HUT71527A (en) 1995-12-28
CN1089472A (zh) 1994-07-20
FI950319A (fi) 1995-01-25
ATE176398T1 (de) 1999-02-15
IL106477A0 (en) 1993-11-15
NO307407B1 (no) 2000-04-03
JP4976011B2 (ja) 2012-07-18
US5520931A (en) 1996-05-28
ES2130278T3 (es) 1999-07-01
KR0156038B1 (ko) 1998-11-16
JPH08501081A (ja) 1996-02-06
RU95105449A (ru) 1997-06-10
PL307262A1 (en) 1995-05-15
WO1994003161A1 (en) 1994-02-17
ZA935488B (en) 1994-02-28
CA2140254C (en) 2004-01-20
GR3030106T3 (en) 1999-07-30
EP0652747B1 (en) 1999-02-03
JP2006096771A (ja) 2006-04-13
DK0652747T3 (da) 1999-09-20
SE9202250D0 (sv) 1992-07-29
FI950319A0 (fi) 1995-01-25
NZ254314A (en) 1996-09-25
CA2140254A1 (en) 1994-02-17
IL106477A (en) 1999-08-17
NO950318L (no) 1995-03-13
HU9500260D0 (en) 1995-03-28
DE69323428T2 (de) 1999-09-02
DE69323428D1 (de) 1999-03-18
PL172571B1 (pl) 1997-10-31
EP0652747A1 (en) 1995-05-17
AU662239B2 (en) 1995-08-24
RU2114613C1 (ru) 1998-07-10
CN1053339C (zh) 2000-06-14
NO950318D0 (no) 1995-01-27

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