JP2007508249A - フィブラートとスタチンを含む固体剤型 - Google Patents

フィブラートとスタチンを含む固体剤型 Download PDF

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Publication number
JP2007508249A
JP2007508249A JP2006529649A JP2006529649A JP2007508249A JP 2007508249 A JP2007508249 A JP 2007508249A JP 2006529649 A JP2006529649 A JP 2006529649A JP 2006529649 A JP2006529649 A JP 2006529649A JP 2007508249 A JP2007508249 A JP 2007508249A
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Japan
Prior art keywords
dosage form
solid dosage
particulate material
fenofibrate
pharmaceutically acceptable
Prior art date
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Pending
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JP2006529649A
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English (en)
Japanese (ja)
Inventor
ホルム，ペル
ノルリング，トーマス
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ライフサイクル ファーマ アクティーゼルスカブ
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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
    • A61K31/33—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
    • 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
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • 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
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • A61K31/395—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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K9/14—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
    • A61K9/1611—Inorganic compounds
    • 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
    • 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
    • A61K9/14—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
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • 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
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/2004—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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • 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
JP2006529649A 2003-10-10 2004-10-01 フィブラートとスタチンを含む固体剤型 Pending JP2007508249A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DKPA200301503 2003-10-10
DKPA200400464 2004-03-23
PCT/DK2004/000668 WO2005034908A2 (en) 2003-10-10 2004-10-01 A solid dosage form comprising a fibrate and a statin

Publications (1)

Publication Number Publication Date
JP2007508249A true JP2007508249A (ja) 2007-04-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
JP2006529649A Pending JP2007508249A (ja) 2003-10-10 2004-10-01 フィブラートとスタチンを含む固体剤型

Country Status (10)

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US (3) US20060068015A1 (US20060068015A1-20060330-C00002.png)
EP (1) EP1680086A2 (US20060068015A1-20060330-C00002.png)
JP (1) JP2007508249A (US20060068015A1-20060330-C00002.png)
KR (1) KR20060085682A (US20060068015A1-20060330-C00002.png)
AU (1) AU2009201881A1 (US20060068015A1-20060330-C00002.png)
BR (1) BRPI0415121A (US20060068015A1-20060330-C00002.png)
CA (1) CA2541382A1 (US20060068015A1-20060330-C00002.png)
MX (1) MXPA06003813A (US20060068015A1-20060330-C00002.png)
RU (1) RU2343905C2 (US20060068015A1-20060330-C00002.png)
WO (1) WO2005034908A2 (US20060068015A1-20060330-C00002.png)

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WO2009113522A1 (ja) * 2008-03-11 2009-09-17 あすか製薬株式会社 固体分散体とその医薬組成物、並びにそれらの製造方法
JP2010523673A (ja) * 2007-04-11 2010-07-15 マッカーティ，ジョン，エイ． メラトニンタブレットならびに調剤及び使用方法
WO2010092925A1 (ja) * 2009-02-12 2010-08-19 あすか製薬株式会社 固体分散体とその医薬組成物、並びにそれらの製造方法
WO2010098482A1 (ja) * 2009-02-27 2010-09-02 興和株式会社 安定なカプセル製剤及びその製造方法
JP2013224285A (ja) * 2012-06-27 2013-10-31 Kowa Co 医薬
JP2015500330A (ja) * 2011-12-14 2015-01-05 エルテーエス ローマン テラピー−ジステーメ アーゲー フェノフィブラートのための強化された溶解速度を備えたウェーハ及びカプセル製剤

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WO2006037344A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical compositions comprising fenofibrate and atorvastatin
JPWO2006011495A1 (ja) * 2004-07-30 2008-05-01 興和株式会社 高コレステロール血症及び／又は高トリグリセリド血症治療剤
JP2008509154A (ja) 2004-08-06 2008-03-27 トランスフオーム・フアーマシユーチカルズ・インコーポレーテツド 新規なスタチン薬剤組成物および関連治療方法
WO2006037345A1 (en) * 2004-10-01 2006-04-13 Lifecycle Pharma A/S Pharmaceutical composition comprising fenofibrate and simvastatin
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KR101302243B1 (ko) * 2010-07-28 2013-09-02 씨제이제일제당 (주) 로수바스타틴 또는 이의 약학적 허용염을 포함하는 약학 조성물
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HUE037732T2 (hu) * 2012-04-18 2018-09-28 Contera Pharma Aps A mozgászavarok fejlett kezelésére alkalmas, szájon át szedhetõ gyógyszerészeti készítmény
RU2547574C2 (ru) * 2013-07-09 2015-04-10 Общество с ограниченной ответственностью "Трейдсервис" Лекарственная форма гиполипидемического действия и способ ее изготовления
RU2572705C1 (ru) * 2014-11-25 2016-01-20 Татьяна Георгиевна Неустроева Композиция для полоскания полости рта
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BR112019002031A2 (pt) * 2016-08-05 2019-05-14 Taurus Development Company Llc formulação de calcitonina oral estável em temperatura ambiente
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JP2022542004A (ja) 2019-07-31 2022-09-29 インタス ファーマシューティカルズ リミテッド ＨＭＧ－ＣｏＡレダクターゼ阻害剤及びフェノフィブラートを含む医薬組成物
PE20240141A1 (es) * 2020-09-29 2024-02-01 Laboratorios Silanes S A De C V Combinaciones farmaceuticas de estatinas y fibratos para el tratamiento y prevencion de hiperlipidemias y enfermedades cardiovasculares
CN113143882A (zh) * 2021-04-30 2021-07-23 海南通用三洋药业有限公司 一种瑞舒伐他汀钙胶囊的制备方法和瑞舒伐他汀钙胶囊
KR102501636B1 (ko) * 2021-12-07 2023-02-21 에이스바이오팜 주식회사 페노피브린산을 포함하는 경구용 정제 및 이의 제조방법
WO2023146320A1 (ko) * 2022-01-28 2023-08-03 동광제약 주식회사 로수바스타틴 또는 이의 약학적으로 허용되는 염 및 페노피브레이트를 함유하는 캡슐 제제

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