IL270866B2 - Pharmaceutical compositions comprising granulated bempedoic acid - Google Patents

Pharmaceutical compositions comprising granulated bempedoic acid

Info

Publication number
IL270866B2
IL270866B2 IL270866A IL27086619A IL270866B2 IL 270866 B2 IL270866 B2 IL 270866B2 IL 270866 A IL270866 A IL 270866A IL 27086619 A IL27086619 A IL 27086619A IL 270866 B2 IL270866 B2 IL 270866B2
Authority
IL
Israel
Prior art keywords
ezetimibe
bempedoic acid
dissolution
tablet
bempedoic
Prior art date
Application number
IL270866A
Other languages
English (en)
Hebrew (he)
Other versions
IL270866A (en
IL270866B1 (en
Original Assignee
Esperion Therapeutics Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Esperion Therapeutics Inc filed Critical Esperion Therapeutics Inc
Publication of IL270866A publication Critical patent/IL270866A/en
Publication of IL270866B1 publication Critical patent/IL270866B1/en
Publication of IL270866B2 publication Critical patent/IL270866B2/en

Links

Classifications

    • 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
    • A61K9/2072—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

Landscapes

  • 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)
IL270866A 2017-05-26 2018-05-25 Pharmaceutical compositions comprising granulated bempedoic acid IL270866B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762511889P 2017-05-26 2017-05-26
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

Publications (3)

Publication Number Publication Date
IL270866A IL270866A (en) 2020-01-30
IL270866B1 IL270866B1 (en) 2025-03-01
IL270866B2 true IL270866B2 (en) 2025-07-01

Family

ID=62621055

Family Applications (2)

Application Number Title Priority Date Filing Date
IL270866A IL270866B2 (en) 2017-05-26 2018-05-25 Pharmaceutical compositions comprising granulated bempedoic acid
IL318957A IL318957A (en) 2017-05-26 2018-05-25 Pharmaceutical compositions comprising granulated bempedoic acid

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL318957A IL318957A (en) 2017-05-26 2018-05-25 Pharmaceutical compositions comprising granulated bempedoic acid

Country Status (15)

Country Link
US (2) US20180338922A1 (https=)
EP (1) EP3630070A1 (https=)
JP (3) JP7187488B2 (https=)
KR (3) KR20250109242A (https=)
CN (1) CN110996914A (https=)
AU (2) AU2018272040A1 (https=)
BR (1) BR112019024747A2 (https=)
CA (1) CA3064895A1 (https=)
CL (1) CL2019003437A1 (https=)
IL (2) IL270866B2 (https=)
MX (2) MX2019014122A (https=)
PH (1) PH12019502782A1 (https=)
TW (1) TWI798228B (https=)
UA (1) UA126451C2 (https=)
WO (1) WO2018218147A1 (https=)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3267989A4 (en) 2015-03-13 2018-11-07 Esperion Therapeutics, Inc. Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
AU2019221765A1 (en) * 2018-02-16 2020-09-10 Esperion Therapeutics, Inc. Sustained release formulations of bempedoic acid
US20210322375A1 (en) * 2018-08-27 2021-10-21 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
WO2020213010A1 (en) * 2019-04-16 2020-10-22 Celagenex Research (India) Pvt. Ltd. Synergistic lipid controlling compositions
MX2021015936A (es) 2019-06-21 2022-04-26 Esperion Therapeutics Inc Metodos para preparar acido bempedoico y composiciones del mismo.
US12528759B2 (en) 2019-10-03 2026-01-20 Synthon B.V. Crystalline forms of bempedoic acid
US12516013B2 (en) 2019-12-06 2026-01-06 Synthon B.V. Crystalline forms of sodium salt of Bempedoic acid
CN115379861A (zh) * 2020-04-10 2022-11-22 日本瓦姆&珀巴尔株式会社 缓释性主剂
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
US20250134841A1 (en) 2021-09-13 2025-05-01 Synthon B.V. Pharmaceutical composition of bempedoic acid
CA3256768A1 (en) 2022-05-09 2023-11-16 Renata Pharmaceutical (Ireland) Ltd PHARMACEUTICAL COMPOSITION OF BEMPEDOIC ACID
JP2024116544A (ja) * 2023-02-16 2024-08-28 株式会社三共 遊技機
JP2024116545A (ja) * 2023-02-16 2024-08-28 株式会社三共 遊技機

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100234342A1 (en) * 2009-03-13 2010-09-16 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Ezetimibe compositions
WO2017023165A1 (en) * 2015-08-04 2017-02-09 Dezima Pharma B.V. Pharmaceutical composition and therapeutic combination comprising a cholesteryl ester transfer protein inhibitor and an atp citrate lyase inhibitor – ampk activator

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HU230253B1 (hu) 2001-01-26 2015-11-30 Merck Sharp & Dohme Corp Peroxiszóma proliferátor-aktivált receptor (PPAR) aktivátor(ok) és szterin-abszorpció inhibitor(ok) kombinációi és alkalmazásuk vaszkuláris indikációk kezelésére
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
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ES2625429T3 (es) 2003-01-23 2017-07-19 Esperion Therapeutics Inc. Compuestos de hidroxilo y composiciones para el control del colesterol y utilizaciones correspondientes
AU2009292615B2 (en) * 2008-09-17 2015-12-03 Mylan Inc. Granulates, process for preparing them and pharmaceutical products containing them
JO3239B1 (ar) * 2008-09-22 2018-03-08 Novartis Ag تركيبات جالينية من مركبات عضوية
EP2168573A1 (en) * 2008-09-30 2010-03-31 LEK Pharmaceuticals D.D. Formulations comprising ezetimibe
CA2755274C (en) * 2009-03-13 2017-02-28 Sahoe Kakuda Tablet and granulated powder containing 6-fluoro-3-hydroxy-2-pyrazinecarboxamide
PT2459175T (pt) * 2009-07-28 2018-02-07 Egyt Gyogyszervegyeszeti Gyar Novo processo de granulação e o granulado assim preparado
CN101926756B (zh) * 2010-08-12 2012-01-18 北京赛科药业有限责任公司 一种氯吡格雷或其药学上可接受盐的固体制剂
AR083417A1 (es) * 2010-10-14 2013-02-21 Novartis Ag Composiciones farmaceuticas que contienen un dgat1 inhibidor
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
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EP3267989A4 (en) 2015-03-13 2018-11-07 Esperion Therapeutics, Inc. Fixed dose combinations and formulations comprising etc1002 and ezetimibe and methods of treating or reducing the risk of cardiovascular disease
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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Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100234342A1 (en) * 2009-03-13 2010-09-16 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Ezetimibe compositions
WO2017023165A1 (en) * 2015-08-04 2017-02-09 Dezima Pharma B.V. Pharmaceutical composition and therapeutic combination comprising a cholesteryl ester transfer protein inhibitor and an atp citrate lyase inhibitor – ampk activator

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Title
THOMPSON, PAUL D ET AL.,, TREATMENT WITH ETC-1002 ALONE AND IN COMBINATION WITH EZETIMIBE LOWERS LDL CHOLESTEROL IN HYPERCHOLESTEROLEMIC PATIENTS WITH OR WITHOUT STATIN INTOLERANCE, 6 January 2016 (2016-01-06) *

Also Published As

Publication number Publication date
JP7561814B2 (ja) 2024-10-04
RU2019142143A (ru) 2021-06-28
TW201900154A (zh) 2019-01-01
UA126451C2 (uk) 2022-10-05
TWI798228B (zh) 2023-04-11
AU2018272040A1 (en) 2019-12-19
JP2024178341A (ja) 2024-12-24
IL270866A (en) 2020-01-30
KR102830720B1 (ko) 2025-07-08
KR102698987B1 (ko) 2024-08-28
US20180338922A1 (en) 2018-11-29
MX2023006541A (es) 2023-06-16
JP2023022224A (ja) 2023-02-14
MX2019014122A (es) 2020-02-07
IL318957A (en) 2025-04-01
KR20250109242A (ko) 2025-07-16
PH12019502782A1 (en) 2020-10-26
KR20200032044A (ko) 2020-03-25
KR20240130156A (ko) 2024-08-28
RU2019142143A3 (https=) 2021-07-19
AU2024204369A1 (en) 2024-07-11
WO2018218147A1 (en) 2018-11-29
EP3630070A1 (en) 2020-04-08
BR112019024747A2 (pt) 2020-06-09
JP7187488B2 (ja) 2022-12-12
US20220249380A1 (en) 2022-08-11
IL270866B1 (en) 2025-03-01
CL2019003437A1 (es) 2020-07-10
JP2020521763A (ja) 2020-07-27
TW202400126A (zh) 2024-01-01
CN110996914A (zh) 2020-04-10
CA3064895A1 (en) 2018-11-29
AU2024204369B2 (en) 2025-09-11

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