JP2005538104A - コレステロール吸収阻害剤、ＨＭＧ−ＣｏＡレダクターゼ阻害剤および安定化剤を含有する組成物 - Google Patents

コレステロール吸収阻害剤、ＨＭＧ−ＣｏＡレダクターゼ阻害剤および安定化剤を含有する組成物 Download PDF

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Publication number
JP2005538104A
JP2005538104A JP2004524692A JP2004524692A JP2005538104A JP 2005538104 A JP2005538104 A JP 2005538104A JP 2004524692 A JP2004524692 A JP 2004524692A JP 2004524692 A JP2004524692 A JP 2004524692A JP 2005538104 A JP2005538104 A JP 2005538104A
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Japan
Prior art keywords
composition
weight
simvastatin
dosage unit
ezetimibe
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
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JP2004524692A
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Japanese (ja)
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JP2005538104A5 (cg-RX-API-DMAC10.html
Inventor
ムーア，ウイリアム・デイー
フイツツパトリツク，シヨーン
ザイラー，クリスチヤン
サクラトバラ，ロバート
ペツツ，キヤサリン・アール
チヨー，ウイン−キー・フイリツプ
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Merck Sharp & Dohme LLC
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Schering Corp
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Application filed by Schering Corp filed Critical Schering Corp
Publication of JP2005538104A publication Critical patent/JP2005538104A/ja
Publication of JP2005538104A5 publication Critical patent/JP2005538104A5/ja
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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
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
    • 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
    • A61K31/397—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having four-membered rings, e.g. azetidine
    • 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
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • 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
    • A61P9/10—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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pyrane Compounds (AREA)
JP2004524692A 2002-07-26 2003-07-22 コレステロール吸収阻害剤、ＨＭＧ−ＣｏＡレダクターゼ阻害剤および安定化剤を含有する組成物 Pending JP2005538104A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US39869102P 2002-07-26 2002-07-26
PCT/US2003/022889 WO2004010993A1 (en) 2002-07-26 2003-07-22 Composition comprising a cholesterol absorption inhibitor, an hmg-coa reductase inhibitor and a stabilizing agent

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2008150227A Division JP2008291034A (ja) 2002-07-26 2008-06-09 コレステロール吸収阻害剤、ＨＭＧ−ＣｏＡレダクターゼ阻害剤および安定化剤を含有する組成物

Publications (2)

Publication Number Publication Date
JP2005538104A true JP2005538104A (ja) 2005-12-15
JP2005538104A5 JP2005538104A5 (cg-RX-API-DMAC10.html) 2008-07-17

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ID=31188454

Family Applications (2)

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JP2004524692A Pending JP2005538104A (ja) 2002-07-26 2003-07-22 コレステロール吸収阻害剤、ＨＭＧ−ＣｏＡレダクターゼ阻害剤および安定化剤を含有する組成物
JP2008150227A Withdrawn JP2008291034A (ja) 2002-07-26 2008-06-09 コレステロール吸収阻害剤、ＨＭＧ−ＣｏＡレダクターゼ阻害剤および安定化剤を含有する組成物

Family Applications After (1)

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JP2008150227A Withdrawn JP2008291034A (ja) 2002-07-26 2008-06-09 コレステロール吸収阻害剤、ＨＭＧ−ＣｏＡレダクターゼ阻害剤および安定化剤を含有する組成物

Country Status (38)

Country Link
US (4) US7229982B2 (cg-RX-API-DMAC10.html)
EP (2) EP1992343A1 (cg-RX-API-DMAC10.html)
JP (2) JP2005538104A (cg-RX-API-DMAC10.html)
KR (2) KR20050045993A (cg-RX-API-DMAC10.html)
CN (2) CN101069684A (cg-RX-API-DMAC10.html)
AR (2) AR040588A1 (cg-RX-API-DMAC10.html)
AT (1) ATE393628T1 (cg-RX-API-DMAC10.html)
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ES (1) ES2303603T3 (cg-RX-API-DMAC10.html)
GE (1) GEP20084443B (cg-RX-API-DMAC10.html)
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MY (1) MY148689A (cg-RX-API-DMAC10.html)
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PE (1) PE20050128A1 (cg-RX-API-DMAC10.html)
PL (1) PL375065A1 (cg-RX-API-DMAC10.html)
PT (1) PT1531805E (cg-RX-API-DMAC10.html)
RS (2) RS20080072A (cg-RX-API-DMAC10.html)
SI (1) SI1531805T1 (cg-RX-API-DMAC10.html)
TN (1) TNSN05022A1 (cg-RX-API-DMAC10.html)
TW (2) TW200412944A (cg-RX-API-DMAC10.html)
UA (1) UA82489C2 (cg-RX-API-DMAC10.html)
WO (1) WO2004010993A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA200500196B (cg-RX-API-DMAC10.html)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2012510447A (ja) * 2008-12-01 2012-05-10 レツク・フアーマシユーテイカルズ・デー・デー エゼチミブおよびシンバスタチンを含む医薬組成物
JP2018536710A (ja) * 2015-11-06 2018-12-13 ジェンファイア・セラピューティクス・インコーポレイテッドＧｅｍｐｈｉｒｅ Ｔｈｅｒａｐｅｕｔｉｃｓ Ｉｎｃ． 混合型脂質異常症の治療
JP2019043880A (ja) * 2017-09-01 2019-03-22 興和株式会社 医薬組成物
JP2019526403A (ja) * 2016-08-09 2019-09-19 テレフレックス、ライフ、サイエンシーズ、アンリミテッド、カンパニーＴｅｌｅｆｌｅｘ Ｌｉｆｅ Ｓｃｉｅｎｃｅｓ Ｕｎｌｉｍｉｔｅｄ Ｃｏｍｐａｎｙ 湿潤剤調合物

Families Citing this family (45)

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GB0215579D0 (en) 2002-07-05 2002-08-14 Astrazeneca Ab Chemical compounds
AR040588A1 (es) * 2002-07-26 2005-04-13 Schering Corp Formulacion farmaceutica que comprende un inhibidor de la absorcion del colesterol y un inhibidor de una hmg- co a reductasa
DE602004008100T2 (de) * 2003-11-10 2008-04-30 Microbia Inc., Cambridge 4-biarylyl-1-phenylazetidin-2-one
ATE485267T1 (de) 2003-12-23 2010-11-15 Astrazeneca Ab Diphenylazetidinonderivate mit die cholesterinabsorption hemmender wirkung
KR100598326B1 (ko) * 2004-04-10 2006-07-10 한미약품 주식회사 ＨＭＧ-ＣｏＡ 환원효소 억제제의 경구투여용 서방형 제제및 이의 제조방법
US20060046996A1 (en) * 2004-08-31 2006-03-02 Kowa Co., Ltd. Method for treating hyperlipidemia
SA06270191B1 (ar) 2005-06-22 2010-03-29 استرازينيكا ايه بي مشتقات من 2- أزيتيدينون جديدة باعتبارها مثبطات لامتصاص الكوليسترول لعلاج حالات فرط نسبة الدهون في الدم
EP1741427A1 (en) 2005-07-06 2007-01-10 KRKA, D.D., Novo Mesto Pharmaceutical composition comprising simvastatin and ezetimibe
EP1905424A3 (en) * 2006-02-02 2008-04-30 Ranbaxy Laboratories Limited Process for the preparation of a pharmaceutical composition comprising stabilized statin particles
WO2007103453A1 (en) * 2006-03-06 2007-09-13 Teva Pharmaceutical Industries Ltd. Ezetimibe compositions
AR060623A1 (es) 2006-04-27 2008-07-02 Astrazeneca Ab Compuestos derivados de 2-azetidinona y un metodo de preparacion
SI2484346T1 (sl) 2006-06-19 2017-05-31 Alpharma Pharmaceuticals Llc Farmacevtski sestavki
CN1994296B (zh) * 2006-08-02 2010-06-16 浙江京新药业股份有限公司 一种含有辛伐他汀的药物制剂
GB0713707D0 (en) 2007-07-13 2007-08-22 Generics Uk Ltd Stable compositions
KR20100051667A (ko) * 2007-07-27 2010-05-17 씨아이피엘에이 엘티디. 약제학적 조성물 및 그의 제조방법
WO2009024889A2 (en) 2007-08-21 2009-02-26 Ranbaxy Laboratories Limited Pharmaceutical composition comprising a hmg-coa reductase inhibitor and ezetimibe
EP2231118B2 (en) * 2007-12-17 2017-05-17 KRKA, tovarna zdravil, d.d., Novo mesto Suspension comprising non-micronized ezetimibe micro-particles
US20090233898A1 (en) * 2008-03-11 2009-09-17 Glenmark Generics Ltd Pharmaceutical Compositions Comprising Simvastatin and Ezetimibe
TR200806302A2 (tr) * 2008-08-22 2010-03-22 Bi̇lgi̇ç Mahmut Çözünürlük ve stabilite artırıcı farmasötik formülasyon.
EP2168573A1 (en) * 2008-09-30 2010-03-31 LEK Pharmaceuticals D.D. Formulations comprising ezetimibe
MX344885B (es) * 2008-11-10 2017-01-10 Psicofarma S A De C V Proceso para la obtencion de una composicion de rosuvastatina calcica y producto obtenido.
WO2010066687A2 (en) * 2008-12-11 2010-06-17 Dsm Ip Assets B.V. Stabalized statin-comprising compositions
EP2216016A1 (en) 2009-02-06 2010-08-11 LEK Pharmaceuticals d.d. Process for the preparation of a pharmaceutical composition comprising ezetimibe
WO2011002422A2 (en) * 2009-07-02 2011-01-06 Bilgic Mahmut Solubility enhancing pharmaceutical formulation
WO2011002424A2 (en) * 2009-07-02 2011-01-06 Bilgic Mahmut Solubility and stability enchancing pharmaceutical formulation
WO2011019326A2 (en) * 2009-07-02 2011-02-17 Mahmut Bilgic Solubility and stability enchancing pharmaceutical formulation
EP2368543A1 (en) * 2010-03-25 2011-09-28 KRKA, tovarna zdravil, d.d., Novo mesto Method of preparing a granulated pharmaceutical composition comprising simvastatin and/or ezetimibe
KR101302243B1 (ko) * 2010-07-28 2013-09-02 씨제이제일제당 (주) 로수바스타틴 또는 이의 약학적 허용염을 포함하는 약학 조성물
CN101978953A (zh) * 2010-10-11 2011-02-23 上海交通大学 基于易吸湿性辅料的固体制剂
EP2468258A1 (en) 2010-12-22 2012-06-27 LEK Pharmaceuticals d.d. Process for the preparation of a pharmaceutical composition comprising a low soluble pharmaceutically active ingredient
RU2013136350A (ru) 2011-02-02 2015-03-27 АЛФАРМА ФАРМАСЬЮТИКЭЛЗ, ЭлЭлСи Фармацевтическая композиция, содержащая опиоидный агонист и секвестрированный антагонист
CN102266323B (zh) * 2011-08-04 2013-03-27 海南锦瑞制药股份有限公司 依折麦布和辛伐他汀组合物及其制备方法
US9592296B2 (en) 2011-09-08 2017-03-14 Hexal Ag Pharmaceutical composition for oral administration with a statin
HUE052300T2 (hu) * 2012-05-01 2021-04-28 Althera Life Sciences Llc Orális tablettakészítmény, amely a rozuvastatin és az ezetimib rögzített kombinációjából áll, hiperlipidémia és kardiovaszkuláris betegségek kezelésére
WO2013166114A1 (en) * 2012-05-01 2013-11-07 Althera Life Sciences, Llc Oral tablet formulation consisting of fixed combination of atorvastatin and ezetimibe
RU2547574C2 (ru) * 2013-07-09 2015-04-10 Общество с ограниченной ответственностью "Трейдсервис" Лекарственная форма гиполипидемического действия и способ ее изготовления
CN103585146B (zh) * 2013-11-09 2015-04-01 北京中申专利科技有限公司 辛伐他汀的药物组合物
TWI586380B (zh) * 2013-12-18 2017-06-11 夢製藥公司 包含ＨＭＧ－ＣｏＡ還原酶抑制劑及膽固醇吸收抑制劑之醫藥組合製劑
CN104306348B (zh) * 2014-09-30 2017-05-31 地奥集团成都药业股份有限公司 一种辛伐他汀片及其制备方法
CN106937952A (zh) * 2016-01-04 2017-07-11 重庆华邦制药有限公司 依折麦布和辛伐他汀的制剂
US11622939B2 (en) * 2017-11-23 2023-04-11 Zhejiang Hisun Pharmaceutical Co., Ltd. HS-25 tablet and preparation method therefor
TWI760067B (zh) * 2020-08-13 2022-04-01 友霖生技醫藥股份有限公司 固態口服醫藥組成物
US11833133B2 (en) * 2020-08-13 2023-12-05 Orient Pharma Co., Ltd. Solid oral pharmaceutical composition
CN112168801A (zh) * 2020-10-22 2021-01-05 哈药集团技术中心 一种辛伐他汀片的制备方法
CN115227659B (zh) * 2022-08-19 2023-05-02 北京百奥药业有限责任公司 一种依折麦布辛伐他汀组合物及其制备方法

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