KR20070078272A - 유비데카레논의 고체분산체와 그 제조방법 및 이를포함하는 약제학적 조성물 - Google Patents
유비데카레논의 고체분산체와 그 제조방법 및 이를포함하는 약제학적 조성물 Download PDFInfo
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- coq10
- solid dispersion
- emulsifier
- fatty acid
- hydrophilic polymer
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- A—HUMAN NECESSITIES
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- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B66—HOISTING; LIFTING; HAULING
- B66B—ELEVATORS; ESCALATORS OR MOVING WALKWAYS
- B66B13/00—Doors, gates, or other apparatus controlling access to, or exit from, cages or lift well landings
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- A61K31/122—Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
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- A—HUMAN NECESSITIES
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- 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
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Abstract
Description
Claims (20)
- CoQ10과 유화제 및 친수성 고분자를 포함하는 CoQ10의 고체분산체.
- 제1항에 있어서, 항산화제 또는 무기성 담체를 추가로 포함하는 고체분산체.
- 제1항에 있어서, 유화제가 상온에서 반고형 또는 고형인 고체분산체.
- 제3항에 있어서, 유화제가 폴리글리세린 지방산 에스테르, 수크로오스 지방산 에스테르, 폴리옥시에틸렌-폴리옥시프로필렌 블록 공중합체, 소르비탄 지방산 에스테르, 폴리에틸렌글리콜 지방산 에스테르와 모노-, 디- 또는 트리- 글리세리드의 혼합물, 카프릴릭/카프릭산 모노- 또는 디-글리세리드와 같은 모노-, 디- 또는 모노/디-글리세리드, 폴리옥시에틸렌 글리콜화된 천연 또는 수소화된 피마자유, 폴리옥시에틸렌 지방산 에스테르, 프로필렌글리콜 모노- 또는 디- 지방산 에스테르, 또는 유기산인 고체분산체.
- 제4항에 있어서, 유화제가 폴리글리세린 지방산 에스테르 또는 폴리옥시에틸렌-폴리옥시프로필렌 블록 공중합체인 고체분산체.
- 제1항에 있어서, 유화제가 CoQ10의 1 중량부에 대하여 0.2 내지 10 중량부로 포함된 고체분산체.
- 제1항에 있어서, 친수성 고분자가 히드록시프로필메틸셀룰로오즈(HPMC), 히드록시프로필셀룰로오즈(HPC), 폴리비닐피롤리돈(PVP), 폴리비닐알코올(PVA), 폴리에틸렌글리콜 폴리비닐알코올 에스테르, 덱스트린(dextrin), 사이클로덱스트린(CyD), 말토덱스트린 및 이들의 혼합물로 구성되는 군으로부터 선택되는 하나 이상인 고체분산체.
- 제1항에 있어서, 친수성 고분자가 CoQ10의 1 중량부에 대하여 0.2 내지 10 중량부인 고체분산체.
- 제2항에 있어서, 항산화제가 토코페롤 또는 이의 유사체 또는 부틸레이트 히 드록시톨루엔인 고체분산체.
- 제2항에 있어서, 항산화제가 CoQ10의 1 중량부에 대하여 0.0001 내지 0.1 중량부로 포함되는 고체분산체.
- 제2항에 있어서, 무기성 담체가 이산화 규소, 탈크, 하이드로탈사이트, 알루미늄 마그네슘 실리케이트, 이산화 티탄, 스테아린산, 마그네슘 스테아린산 또는 이들의 혼합물인 고체분산체.
- 제2항에 있어서, 무기성 담체가 CoQ10의 1 중량부에 대하여 0.001 내지 2 중량부인 고체분산체.
- (A) CoQ10과 유화제 및 친수성 고분자를 적절한 용매에 함께 용해 또는 분산시키는 단계, 및 (B) 상기 용해물 또는 분산물에서 용매를 제거하는 단계를 포함하는 CoQ10의 고체분산체를 제조하는 방법.
- 제 13 항에 있어서, 상기 (B) 단계의 용매를 제거하는 과정은 분무건조에 의한 것인 방법.
- 제13항에 있어서, (A) 단계에서 항산화제 또는 유화제를 추가로 용해 또는 분산시키는 것을 포함하는 방법.
- 제13항에 있어서, (A) 단계에서 40 내지 50℃로 가온하면서 용해 또는 분산시키는 것을 포함하는 방법.
- (A) CoQ10과 유화제 및 친수성 고분자를 200 내지 240℃의 온도로 가열하여 균질하게 용융시키는 단계; 및 (B) 상기 용융 혼합물을 급속하게 냉각시키고 분쇄하는 단계를 포함하는 CoQ10의 고체분산체를 제조하는 방법.
- 제1항의 CoQ10 고체분산체를 포함하는 유비데카레논의 약제학적 조성물.
- 제2항의 CoQ10 고체분산체를 포함하는 유비데카레논의 약제학적 조성물.
- 제13항 또는 제17항의 방법에 따라 제조되는 CoQ10 고체분산체.
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KR1020060008379A KR100956583B1 (ko) | 2006-01-26 | 2006-01-26 | 유비데카레논의 고체분산체와 그 제조방법 및 이를포함하는 약제학적 조성물 |
PCT/KR2007/000436 WO2007086689A1 (en) | 2006-01-26 | 2007-01-25 | A solid dispersion comprising ubidecarenone, a process for preparing the same and a pharmaceutical composition comprising the same |
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KR1020060008379A KR100956583B1 (ko) | 2006-01-26 | 2006-01-26 | 유비데카레논의 고체분산체와 그 제조방법 및 이를포함하는 약제학적 조성물 |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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KR100821105B1 (ko) * | 2006-11-16 | 2008-04-08 | 광동제약 주식회사 | 유비데카레논 코팅입자 및 아스코르빈산 함유 경구투여용복합제제 |
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US10071059B2 (en) | 2009-12-18 | 2018-09-11 | Frieslandcampina Nederland Holding B.V. | Co-processed tablet excipient composition its preparation and use |
WO2012129072A1 (en) * | 2011-03-18 | 2012-09-27 | Particle Dynamics International, Llc | Solid particulate compositions comprising coenzyme q10 |
ITUD20110196A1 (it) * | 2011-12-02 | 2013-06-03 | Asoltech S R L | Composizione a base di ubidecarenone |
SI3220893T1 (sl) | 2014-11-14 | 2023-09-29 | Asoltech Srl | Sestavek na osnovi COQ10 |
EP3103440A1 (en) | 2015-06-12 | 2016-12-14 | INDENA S.p.A. | Solid dispersions of coenzyme q10 |
EP3165218A1 (en) * | 2015-11-06 | 2017-05-10 | INDENA S.p.A. | Water dispersible granulates containing oxidized or reduced forms of coenzyme q10 |
CN117835971A (zh) | 2021-08-25 | 2024-04-05 | 巴斯夫欧洲公司 | 直接压片用辅料组合物 |
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JPS5951214A (ja) * | 1982-09-16 | 1984-03-24 | Taiho Yakuhin Kogyo Kk | バイオアベイラビリテイの高い薬剤の製造方法 |
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KR100821105B1 (ko) * | 2006-11-16 | 2008-04-08 | 광동제약 주식회사 | 유비데카레논 코팅입자 및 아스코르빈산 함유 경구투여용복합제제 |
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