KR20070068658A - 암로디핀 캠실레이트 및 심바스타틴을 포함하는 복합제제,및 이의 제조방법 - Google Patents
암로디핀 캠실레이트 및 심바스타틴을 포함하는 복합제제,및 이의 제조방법 Download PDFInfo
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- KR20070068658A KR20070068658A KR1020050130531A KR20050130531A KR20070068658A KR 20070068658 A KR20070068658 A KR 20070068658A KR 1020050130531 A KR1020050130531 A KR 1020050130531A KR 20050130531 A KR20050130531 A KR 20050130531A KR 20070068658 A KR20070068658 A KR 20070068658A
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- South Korea
- Prior art keywords
- amlodipine
- simvastatin
- amlodipine camsylate
- film layer
- stabilizer
- Prior art date
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- 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
- A61K9/1617—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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
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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
- A61K9/2004—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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- 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
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P3/06—Antihyperlipidemics
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
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Abstract
Description
Claims (12)
- 암로디핀 캠실레이트, 심바스타틴 및 안정화제를 포함하는 경구용 복합제제.
- 제 1 항에 있어서,암로디핀 캠실레이트가 복합제제 총량을 기준으로 0.5 내지 20 중량%의 양으로 사용되는 것을 특징으로 하는 복합제제.
- 제 1 항에 있어서,심바스타틴이 복합제제 총량을 기준으로 0.5 내지 50 중량%의 양으로 사용되는 것을 특징으로 하는 복합제제.
- 제 1 항에 있어서,안정화제가 부틸레이티드 하이드록시 톨루엔(BHT), 부틸레이티드 하이드록시 아니솔(BHA), 에리소르브산, 아스코르브산, 토코페롤 및 이들의 혼합물로 이루어진 군에서 선택되는 것을 특징으로 하는 복합제제.
- 제 1 항에 있어서,안정화제가 암로디핀 캠실레이트의 중량을 기준으로 0.001 내지 100 중량%의 양으로 사용되는 것을 특징으로 하는 복합제제.
- 제 1 항에 있어서,미결정 셀룰로오스, 인산일수소칼슘, 글리콜산전분나트륨, 스테아린산 마그네슘 및 이들의 혼합물로 이루어진 군으로부터 선택되는 약학적으로 허용가능한 첨가제를 추가로 포함하는 것을 특징으로 하는 복합제제.
- 1) 암로디핀 캠실레이트 및 안정화제를 유기용매에 용해시킨 후 사용된 유기용매를 제거하여 고체분산체를 형성하는 단계; 및2) 단계 1)에서 얻어진 고체분산체에 심바스타틴 및 약학적으로 허용가능한 첨가제를 혼합하고, 생성된 혼합물을 습식밀링하여 과립화한 후 제제화하는 단계를 포함하는, 제 1 항의 복합제제의 제조방법.
- 제 7 항에 있어서,단계 1)에서의 유기용매 제거가 분무건조법, 용매증발법, 미분쇄습식법, 용융법 또는 동결건조법에 의해 수행되는 것을 특징으로 하는 방법.
- 제 1 항에 있어서,복합제제의 외부 표면에 필름층을 피복하는 공정을 추가로 포함하는 것을 특징으로 하는 방법.
- 제 9 항에 있어서,외부 필름층이 하이드록시프로필메틸셀룰로오스(HPMC), 하이드록시 프로필셀룰로오스(HPC), 하이드록시에틸셀룰로오스(HEC), 셀루로오스아세테이트프탈레이트(CAP), 에틸셀룰로오스(EC), 메틸셀룰로오스(MC), 폴리메타아크릴레이크, 콜리코트(Kollicoat®; BASF, Germany), 오파드라이(Opadry®; Colorcon, USA) 또는 이들의 혼합물로 이루어진 군으로부터 선택되는 수용성 물질로 형성되는 것을 특징으로 하는 방법.
- 제 9 항에 있어서,외부 필름층이 차광 필름층, 방습 필름층 또는 당 필름층인 것을 특징으로 하는 방법.
- 제 9 항에 있어서,외부 필름층이 복합제제 총량의 0.5 내지 20 중량%를 차지하는 것을 특징으로 하는 방법.
Priority Applications (11)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020050130531A KR100742432B1 (ko) | 2005-12-27 | 2005-12-27 | 암로디핀 캠실레이트 및 심바스타틴을 포함하는 복합제제,및 이의 제조방법 |
CNA2006800492048A CN101346140A (zh) | 2005-12-27 | 2006-12-22 | 含有右旋樟脑磺酸氨氯地平和辛伐他汀的复合制剂及其制备方法 |
US12/159,418 US20090005425A1 (en) | 2005-12-27 | 2006-12-22 | Complex Formulation Comprising Amlodipine Camsylate And Simvastatin and Method For Preparation Thereof |
PCT/KR2006/005658 WO2007075009A1 (en) | 2005-12-27 | 2006-12-22 | Complex formulation comprising amlodipine camsylate and simvastatin and method for preparation thereof |
EP06835362A EP1978956A4 (en) | 2005-12-27 | 2006-12-22 | COMPLEX FORMULATION WITH AMLODIPINCAMSYLATE AND SIMVASTATIN AND METHOD OF MANUFACTURING THEREOF |
BRPI0620790-1A BRPI0620790A2 (pt) | 2005-12-27 | 2006-12-22 | formulação complexa que compreende cansilato de amlodipina e sinvastatina e método para a sua preparação |
AU2006330199A AU2006330199A1 (en) | 2005-12-27 | 2006-12-22 | Complex formulation comprising amlodipine camsylate and simvastatin and method for preparation thereof |
CA002634639A CA2634639A1 (en) | 2005-12-27 | 2006-12-22 | Complex formulation comprising amlodipine camsylate and simvastatin and method for preparation thereof |
RU2008130873/15A RU2008130873A (ru) | 2005-12-27 | 2006-12-22 | Комбинированный состав, включающий амлодипина камсилат и симвастатин и способ его приготовления |
JP2008548399A JP2009521526A (ja) | 2005-12-27 | 2006-12-22 | カンシル酸アムロジピン及びシンバスタチンを含む複合製剤及びその製造方法 |
IL192148A IL192148A0 (en) | 2005-12-27 | 2008-06-12 | A complex formulation for oral administration containing amlodipine camsylate and simvastatin |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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KR1020050130531A KR100742432B1 (ko) | 2005-12-27 | 2005-12-27 | 암로디핀 캠실레이트 및 심바스타틴을 포함하는 복합제제,및 이의 제조방법 |
Publications (2)
Publication Number | Publication Date |
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KR20070068658A true KR20070068658A (ko) | 2007-07-02 |
KR100742432B1 KR100742432B1 (ko) | 2007-07-24 |
Family
ID=38218207
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Application Number | Title | Priority Date | Filing Date |
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KR1020050130531A KR100742432B1 (ko) | 2005-12-27 | 2005-12-27 | 암로디핀 캠실레이트 및 심바스타틴을 포함하는 복합제제,및 이의 제조방법 |
Country Status (11)
Country | Link |
---|---|
US (1) | US20090005425A1 (ko) |
EP (1) | EP1978956A4 (ko) |
JP (1) | JP2009521526A (ko) |
KR (1) | KR100742432B1 (ko) |
CN (1) | CN101346140A (ko) |
AU (1) | AU2006330199A1 (ko) |
BR (1) | BRPI0620790A2 (ko) |
CA (1) | CA2634639A1 (ko) |
IL (1) | IL192148A0 (ko) |
RU (1) | RU2008130873A (ko) |
WO (1) | WO2007075009A1 (ko) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20190043076A (ko) | 2017-10-17 | 2019-04-25 | 한미약품 주식회사 | 암로디핀, 로자탄 및 로수바스타틴을 포함하는 당뇨병을 동반한 심혈관계 질환의 예방 또는 치료용 약학 조성물 및 이를 포함하는 복합제제 |
KR20200009101A (ko) | 2017-10-17 | 2020-01-29 | 한미약품 주식회사 | 암로디핀, 로자탄 및 로수바스타틴을 포함하는 당뇨병을 동반한 심혈관계 질환의 예방 또는 치료용 약학 조성물 및 이를 포함하는 복합제제 |
KR20210064011A (ko) | 2019-11-25 | 2021-06-02 | 성균관대학교산학협력단 | 구멍쇠미역으로부터 분리된 신규 화합물을 유효성분으로 포함하는 당뇨병 예방 및 치료용 조성물 |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102292085B (zh) * | 2009-01-23 | 2017-01-18 | 韩美科学株式会社 | 包含氨氯地平和氯沙坦的固体药物组合物及其制备方法 |
JP6081058B2 (ja) * | 2009-03-19 | 2017-02-15 | 第一三共株式会社 | 包装により安定保存された固形製剤 |
CN101836981B (zh) * | 2009-12-01 | 2011-12-14 | 严洁 | 复方缬沙坦苯磺酸氨氯地平药物组合物及其制备方法 |
EP2545376A4 (en) | 2010-03-11 | 2013-08-28 | Univ Louisville Res Found | PROCESS FOR PREDICTING AND REDUCING THE RISK OF PREGNANCY LOSSES |
KR20120068277A (ko) * | 2010-12-17 | 2012-06-27 | 한미사이언스 주식회사 | HMG-CoA 환원효소 억제제 및 아스피린을 포함하는 약제학적 복합제제 |
WO2013024425A1 (en) * | 2011-08-15 | 2013-02-21 | Technion Research And Development Foundation Ltd. | Combinations of corroles and statins |
TWI586353B (zh) * | 2012-10-12 | 2017-06-11 | Ea Pharma Co Ltd | Pharmaceutical preparations containing calcium antagonists and angiotensin II receptor antagonists |
Family Cites Families (8)
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EA002705B1 (ru) * | 1997-08-29 | 2002-08-29 | Пфайзер Продактс Инк. | Комбинационная терапия, включающая в себя амлодипин и статиновое соединение |
US20030092745A1 (en) | 2000-02-25 | 2003-05-15 | Pfizer Inc. | Combination therapy |
EP1314425A4 (en) | 2000-08-30 | 2004-06-02 | Sankyo Co | MEDICINAL COMPOSITIONS FOR THE PREVENTION OR TREATMENT OF HEART FAILURE |
DE10224612A1 (de) | 2002-06-04 | 2003-12-24 | Lohmann Therapie Syst Lts | Wirkstoffhaltige filmförmige Zubereitungen mit verbesserter chemischer Stabilität, und Verfahren zu deren Herstellung |
EP1587792B1 (en) * | 2003-01-27 | 2014-08-27 | Hanmi Science Co., Ltd. | Stable amorphous amlodipine camsylate, process for preparing same and composition for oral administration thereof |
US7611728B2 (en) | 2003-09-05 | 2009-11-03 | Supernus Pharmaceuticals, Inc. | Osmotic delivery of therapeutic compounds by solubility enhancement |
WO2006059217A1 (en) * | 2004-12-01 | 2006-06-08 | Ranbaxy Laboratories Limited | Stable solid dosage forms of amlodipine besylate and processes for their preparation |
KR100582347B1 (ko) * | 2004-12-30 | 2006-05-22 | 한미약품 주식회사 | 3-하이드록시-3-메틸글루타릴 조효소 a 환원효소 억제제및 고혈압 치료제의 복합제제 및 그의 제조방법 |
-
2005
- 2005-12-27 KR KR1020050130531A patent/KR100742432B1/ko active IP Right Grant
-
2006
- 2006-12-22 RU RU2008130873/15A patent/RU2008130873A/ru not_active Application Discontinuation
- 2006-12-22 US US12/159,418 patent/US20090005425A1/en not_active Abandoned
- 2006-12-22 WO PCT/KR2006/005658 patent/WO2007075009A1/en active Application Filing
- 2006-12-22 CA CA002634639A patent/CA2634639A1/en not_active Abandoned
- 2006-12-22 JP JP2008548399A patent/JP2009521526A/ja not_active Withdrawn
- 2006-12-22 EP EP06835362A patent/EP1978956A4/en not_active Withdrawn
- 2006-12-22 BR BRPI0620790-1A patent/BRPI0620790A2/pt not_active IP Right Cessation
- 2006-12-22 CN CNA2006800492048A patent/CN101346140A/zh active Pending
- 2006-12-22 AU AU2006330199A patent/AU2006330199A1/en not_active Abandoned
-
2008
- 2008-06-12 IL IL192148A patent/IL192148A0/en unknown
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR20190043076A (ko) | 2017-10-17 | 2019-04-25 | 한미약품 주식회사 | 암로디핀, 로자탄 및 로수바스타틴을 포함하는 당뇨병을 동반한 심혈관계 질환의 예방 또는 치료용 약학 조성물 및 이를 포함하는 복합제제 |
KR20200009101A (ko) | 2017-10-17 | 2020-01-29 | 한미약품 주식회사 | 암로디핀, 로자탄 및 로수바스타틴을 포함하는 당뇨병을 동반한 심혈관계 질환의 예방 또는 치료용 약학 조성물 및 이를 포함하는 복합제제 |
KR20210064011A (ko) | 2019-11-25 | 2021-06-02 | 성균관대학교산학협력단 | 구멍쇠미역으로부터 분리된 신규 화합물을 유효성분으로 포함하는 당뇨병 예방 및 치료용 조성물 |
KR20210064010A (ko) | 2019-11-25 | 2021-06-02 | 성균관대학교산학협력단 | 구멍쇠미역으로부터 분리된 신규 화합물을 유효성분으로 포함하는 동맥경화 예방 및 치료용 조성물 |
Also Published As
Publication number | Publication date |
---|---|
JP2009521526A (ja) | 2009-06-04 |
EP1978956A4 (en) | 2009-08-19 |
AU2006330199A1 (en) | 2007-07-05 |
BRPI0620790A2 (pt) | 2011-11-22 |
KR100742432B1 (ko) | 2007-07-24 |
CN101346140A (zh) | 2009-01-14 |
IL192148A0 (en) | 2009-08-03 |
CA2634639A1 (en) | 2007-07-05 |
EP1978956A1 (en) | 2008-10-15 |
WO2007075009A1 (en) | 2007-07-05 |
US20090005425A1 (en) | 2009-01-01 |
RU2008130873A (ru) | 2010-02-10 |
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