TWI798228B - 固定劑量調配物 - Google Patents

固定劑量調配物 Download PDF

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Publication number
TWI798228B
TWI798228B TW107118013A TW107118013A TWI798228B TW I798228 B TWI798228 B TW I798228B TW 107118013 A TW107118013 A TW 107118013A TW 107118013 A TW107118013 A TW 107118013A TW I798228 B TWI798228 B TW I798228B
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TW
Taiwan
Prior art keywords
acid
bempedelic
ezetimibe
composition
weight
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TW107118013A
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English (en)
Chinese (zh)
Other versions
TW201900154A (zh
Inventor
穆罕默德 阿布達爾奈紗
普拉提哈 S 皮爾高克
安尼庫瑪 S 甘地
Original Assignee
美商伊斯比瑞恩治療公司
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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
    • A61K9/2072—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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • 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
    • 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
    • A61K9/1629—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
    • A61K9/2009—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
    • A61K9/20—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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • 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
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • 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
    • A61K9/2813—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
    • A61K9/20—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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
TW107118013A 2017-05-26 2018-05-25 固定劑量調配物 TWI798228B (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201762511889P 2017-05-26 2017-05-26
US62/511,889 2017-05-26
US15/859,279 US20180338922A1 (en) 2017-05-26 2017-12-29 Fixed dose formulations
US15/859,279 2017-12-29

Publications (2)

Publication Number Publication Date
TW201900154A TW201900154A (zh) 2019-01-01
TWI798228B true TWI798228B (zh) 2023-04-11

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TW107118013A TWI798228B (zh) 2017-05-26 2018-05-25 固定劑量調配物
TW112108490A TW202400126A (zh) 2017-05-26 2018-05-25 固定劑量調配物

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Application Number Title Priority Date Filing Date
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Country Status (15)

Country Link
US (2) US20180338922A1 (enExample)
EP (1) EP3630070A1 (enExample)
JP (3) JP7187488B2 (enExample)
KR (3) KR102830720B1 (enExample)
CN (1) CN110996914A (enExample)
AU (2) AU2018272040A1 (enExample)
BR (1) BR112019024747A2 (enExample)
CA (1) CA3064895A1 (enExample)
CL (1) CL2019003437A1 (enExample)
IL (2) IL318957A (enExample)
MX (2) MX2019014122A (enExample)
PH (1) PH12019502782A1 (enExample)
TW (2) TWI798228B (enExample)
UA (1) UA126451C2 (enExample)
WO (1) WO2018218147A1 (enExample)

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CN107530307A (zh) 2015-03-13 2018-01-02 艾斯柏伦治疗公司 包含etc1002和依泽替米贝的固定剂量组合和制剂以及治疗心血管疾病或降低心血管疾病风险的方法
MX2020008527A (es) * 2018-02-16 2020-09-18 Esperion Therapeutics Inc Formulaciones de liberacion sostenida de acido bempedoico.
WO2020046836A1 (en) * 2018-08-27 2020-03-05 Esperion Therapeutics, Inc. Combination drug formulations for treating patients with cardiovascular disease and associated conditions
EP3666750A1 (en) * 2018-12-10 2020-06-17 Sandoz AG Crystalline form of bempedoic acid
PH12021552553A1 (en) * 2019-04-16 2022-06-20 Celagenex Res India Pvt Ltd Synergistic lipid controlling compositions
MX2021015935A (es) 2019-06-21 2022-04-26 Esperion Therapeutics Inc Formas de sal de acido bempedoico y metodos para utilizar el mismo.
US20220348531A1 (en) 2019-10-03 2022-11-03 Synthon B.V. Crystalline forms of bempedoic acid
WO2021110929A1 (en) 2019-12-06 2021-06-10 Synthon B.V. Crystalline forms of sodium salt of bempedoic acid
US20230149313A1 (en) * 2020-04-10 2023-05-18 Japan Vam & Poval Co., Ltd. Sustained-release base
WO2021220236A1 (en) * 2020-05-01 2021-11-04 Cadila Healthcare Limited Pharmaceutical compositions for combination therapy
CN111559961A (zh) * 2020-05-26 2020-08-21 杭州科巢生物科技有限公司 一种贝派地酸晶型及其制备方法
WO2021255180A1 (en) 2020-06-19 2021-12-23 Synthon B.V. Salts of bempedoic acid
EP4401708A1 (en) * 2021-09-13 2024-07-24 Synthon B.V. Pharmaceutical composition of bempedoic acid
WO2023217694A1 (en) 2022-05-09 2023-11-16 Renata Pharmaceutical (Ireland) Ltd Pharmaceutical composition of bempedoic acid

Citations (2)

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US20100234342A1 (en) * 2009-03-13 2010-09-16 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Ezetimibe compositions
WO2017079755A1 (en) * 2015-11-06 2017-05-11 Gemphire Therapeutics Inc. Gemcabene combinations for the treatment of cardiovascular disease

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SI1413331T1 (sl) 2001-01-26 2008-02-29 Schering Corp Kombinacije fenofibrata peroksisomskega proliferator aktivirajocega receptorja (PPAR) z ezetimib zaviralcem absorpcije sterola za vaskularne indikacije
JP4438268B2 (ja) 2001-03-07 2010-03-24 大日本住友製薬株式会社 薬物顆粒の製造方法、および薬物顆粒、ならびにそれを用いた医薬製剤
US7053080B2 (en) * 2001-09-21 2006-05-30 Schering Corporation Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors
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JO3239B1 (ar) * 2008-09-22 2018-03-08 Novartis Ag تركيبات جالينية من مركبات عضوية
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BR112012002069B8 (pt) 2009-07-28 2021-05-25 Egis Gyogyszergyar Nyilvanosan Muekodo Reszvenytarsasag processo para a fabricação de um granulado contendo ezetimibe microcristalino
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CN107530307A (zh) * 2015-03-13 2018-01-02 艾斯柏伦治疗公司 包含etc1002和依泽替米贝的固定剂量组合和制剂以及治疗心血管疾病或降低心血管疾病风险的方法
MA41793A (fr) 2015-03-16 2018-01-23 Esperion Therapeutics Inc Associations de doses fixes comprenant du etc1002 et une ou plusieurs statines permettant de traiter ou de réduire un risque cardiovasculaire
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US20100234342A1 (en) * 2009-03-13 2010-09-16 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Ezetimibe compositions
WO2017079755A1 (en) * 2015-11-06 2017-05-11 Gemphire Therapeutics Inc. Gemcabene combinations for the treatment of cardiovascular disease

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Also Published As

Publication number Publication date
KR20240130156A (ko) 2024-08-28
MX2019014122A (es) 2020-02-07
IL270866A (en) 2020-01-30
TW201900154A (zh) 2019-01-01
IL318957A (en) 2025-04-01
IL270866B1 (en) 2025-03-01
KR102698987B1 (ko) 2024-08-28
TW202400126A (zh) 2024-01-01
JP7187488B2 (ja) 2022-12-12
JP7561814B2 (ja) 2024-10-04
EP3630070A1 (en) 2020-04-08
RU2019142143A3 (enExample) 2021-07-19
KR20200032044A (ko) 2020-03-25
CN110996914A (zh) 2020-04-10
AU2018272040A1 (en) 2019-12-19
KR20250109242A (ko) 2025-07-16
US20220249380A1 (en) 2022-08-11
MX2023006541A (es) 2023-06-16
AU2024204369B2 (en) 2025-09-11
WO2018218147A1 (en) 2018-11-29
IL270866B2 (en) 2025-07-01
JP2023022224A (ja) 2023-02-14
CA3064895A1 (en) 2018-11-29
JP2024178341A (ja) 2024-12-24
KR102830720B1 (ko) 2025-07-08
RU2019142143A (ru) 2021-06-28
US20180338922A1 (en) 2018-11-29
CL2019003437A1 (es) 2020-07-10
UA126451C2 (uk) 2022-10-05
AU2024204369A1 (en) 2024-07-11
BR112019024747A2 (pt) 2020-06-09
PH12019502782A1 (en) 2020-10-26
JP2020521763A (ja) 2020-07-27

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