JP7187488B2 - 固定用量製剤 - Google Patents

固定用量製剤 Download PDF

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Publication number
JP7187488B2
JP7187488B2 JP2019565302A JP2019565302A JP7187488B2 JP 7187488 B2 JP7187488 B2 JP 7187488B2 JP 2019565302 A JP2019565302 A JP 2019565302A JP 2019565302 A JP2019565302 A JP 2019565302A JP 7187488 B2 JP7187488 B2 JP 7187488B2
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JP
Japan
Prior art keywords
ezetimibe
bempedoic acid
tablet
amount
pharmaceutical composition
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.)
Active
Application number
JP2019565302A
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English (en)
Japanese (ja)
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JP2020521763A (ja
Inventor
アブデルナセール，モハメド
ピルガオンカル，プラティバ，エス．
エス． ガンディー，アニルクマール
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Esperion Therapeutics Inc
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Esperion Therapeutics Inc
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Publication date
Application filed by Esperion Therapeutics Inc filed Critical Esperion Therapeutics Inc
Publication of JP2020521763A publication Critical patent/JP2020521763A/ja
Priority to JP2022191728A priority Critical patent/JP7561814B2/ja
Application granted granted Critical
Publication of JP7187488B2 publication Critical patent/JP7187488B2/ja
Priority to JP2024164776A priority patent/JP2024178341A/ja
Active legal-status Critical Current
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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
    • A61K9/14—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
    • 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
    • A61K9/1617—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
    • A61K9/2072—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
    • 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)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Inorganic Chemistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Cardiology (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)
JP2019565302A 2017-05-26 2018-05-25 固定用量製剤 Active JP7187488B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022191728A JP7561814B2 (ja) 2017-05-26 2022-11-30 固定用量製剤
JP2024164776A JP2024178341A (ja) 2017-05-26 2024-09-24 固定用量製剤

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201762511889P 2017-05-26 2017-05-26
US62/511,889 2017-05-26
US15/859,279 2017-12-29
US15/859,279 US20180338922A1 (en) 2017-05-26 2017-12-29 Fixed dose formulations
PCT/US2018/034646 WO2018218147A1 (en) 2017-05-26 2018-05-25 Fixed dose formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022191728A Division JP7561814B2 (ja) 2017-05-26 2022-11-30 固定用量製剤

Publications (2)

Publication Number Publication Date
JP2020521763A JP2020521763A (ja) 2020-07-27
JP7187488B2 true JP7187488B2 (ja) 2022-12-12

Family

ID=62621055

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2019565302A Active JP7187488B2 (ja) 2017-05-26 2018-05-25 固定用量製剤
JP2022191728A Active JP7561814B2 (ja) 2017-05-26 2022-11-30 固定用量製剤
JP2024164776A Pending JP2024178341A (ja) 2017-05-26 2024-09-24 固定用量製剤

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2022191728A Active JP7561814B2 (ja) 2017-05-26 2022-11-30 固定用量製剤
JP2024164776A Pending JP2024178341A (ja) 2017-05-26 2024-09-24 固定用量製剤

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) TW202400126A (enExample)
UA (1) UA126451C2 (enExample)
WO (1) WO2018218147A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
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WO2016149191A1 (en) 2015-03-13 2016-09-22 Esperion Therapeutics, Inc. Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
EP3752133A1 (en) * 2018-02-16 2020-12-23 Esperion Therapeutics, Inc. Sustained release formulations of bempedoic acid
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
EP4438114A3 (en) * 2019-06-21 2024-12-25 Esperion Therapeutics, Inc. Methods of making bempedoic acid and compositions of the same
CN114746389A (zh) 2019-10-03 2022-07-12 斯索恩有限公司 贝派地酸的晶形
EP4069668A1 (en) 2019-12-06 2022-10-12 Synthon B.V. Crystalline forms of sodium salt of bempedoic acid
WO2021205887A1 (ja) * 2020-04-10 2021-10-14 日本酢ビ・ポバール株式会社 徐放性基剤
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 (1)

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Publication number Priority date Publication date Assignee Title
WO2016149191A1 (en) 2015-03-13 2016-09-22 Esperion Therapeutics, Inc. Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease

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MEP27808A (en) 2001-01-26 2010-10-10 Schering Corp Combinations of peroxisome proliferator-activated receptor (ppar) activator(s) and sterol absorption inhibitor(s) and treatments for vascular indications
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
HUE036646T2 (hu) 2003-01-23 2018-07-30 Esperion Therapeutics Inc Hidroxilvegyületek és kompozícióik koleszterin szabályozására és kapcsolódó alkalmazásokra
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Also Published As

Publication number Publication date
RU2019142143A (ru) 2021-06-28
MX2019014122A (es) 2020-02-07
UA126451C2 (uk) 2022-10-05
AU2024204369A1 (en) 2024-07-11
BR112019024747A2 (pt) 2020-06-09
MX2023006541A (es) 2023-06-16
JP7561814B2 (ja) 2024-10-04
JP2023022224A (ja) 2023-02-14
TW201900154A (zh) 2019-01-01
IL270866A (en) 2020-01-30
CL2019003437A1 (es) 2020-07-10
AU2018272040A1 (en) 2019-12-19
KR20200032044A (ko) 2020-03-25
KR102830720B1 (ko) 2025-07-08
JP2020521763A (ja) 2020-07-27
JP2024178341A (ja) 2024-12-24
TW202400126A (zh) 2024-01-01
AU2024204369B2 (en) 2025-09-11
TWI798228B (zh) 2023-04-11
WO2018218147A1 (en) 2018-11-29
IL270866B1 (en) 2025-03-01
KR20240130156A (ko) 2024-08-28
IL270866B2 (en) 2025-07-01
KR102698987B1 (ko) 2024-08-28
PH12019502782A1 (en) 2020-10-26
US20220249380A1 (en) 2022-08-11
US20180338922A1 (en) 2018-11-29
CA3064895A1 (en) 2018-11-29
KR20250109242A (ko) 2025-07-16
EP3630070A1 (en) 2020-04-08
IL318957A (en) 2025-04-01
CN110996914A (zh) 2020-04-10
RU2019142143A3 (enExample) 2021-07-19

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