IL318957A - Pharmaceutical compositions comprising granulated bempedoic acid - Google Patents

Pharmaceutical compositions comprising granulated bempedoic acid

Info

Publication number
IL318957A
IL318957A IL318957A IL31895725A IL318957A IL 318957 A IL318957 A IL 318957A IL 318957 A IL318957 A IL 318957A IL 31895725 A IL31895725 A IL 31895725A IL 318957 A IL318957 A IL 318957A
Authority
IL
Israel
Prior art keywords
ezetimibe
bempedoic acid
dissolution
tablet
product
Prior art date
Application number
IL318957A
Other languages
English (en)
Hebrew (he)
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 IL318957A publication Critical patent/IL318957A/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)
IL318957A 2017-05-26 2018-05-25 Pharmaceutical compositions comprising granulated bempedoic acid IL318957A (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 (1)

Publication Number Publication Date
IL318957A true IL318957A (en) 2025-04-01

Family

ID=62621055

Family Applications (2)

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

Family Applications After (1)

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

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
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
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

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5631365A (en) 1993-09-21 1997-05-20 Schering Corporation Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents
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
ES2855426T3 (es) * 2008-09-17 2021-09-23 Mylan Inc Granulados, proceso de preparación de los mismos y productos farmacéuticos que los contienen
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
EP2229938B9 (en) * 2009-03-13 2012-04-25 Sanovel Ilac Sanayi ve Ticaret A.S. Ezetimibe compositions
KR101665395B1 (ko) * 2009-03-13 2016-10-12 토야마 케미칼 컴퍼니 리미티드 6-플루오로-3-히드록시-2-피라진카르복사미드 함유 정제 및 조립분말
US8927021B2 (en) * 2009-07-28 2015-01-06 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszventarsasag Granulating process and thus prepared granulate
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
AR086675A1 (es) * 2011-06-14 2014-01-15 Merck Sharp & Dohme Composiciones farmaceuticas de combinaciones de inhibidores de la dipeptidil peptidasa-4 con simvastatina
EP2744496A4 (en) * 2011-08-16 2015-04-08 Baker Idi Heart And Diabetes Inst Holdings Ltd FORMULATIONS WITH TAXED RELEASE
CN105916598B (zh) * 2014-01-21 2020-07-17 Bpsi控股有限责任公司 含有中链甘油酯的即释型膜包衣及用其包被的基质
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
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
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
CA3000016A1 (en) * 2015-11-06 2017-05-11 Gemphire Therapeutics Inc. Gemcabene combinations for the treatment of cardiovascular disease

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
JP7187488B2 (ja) 2022-12-12
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
CN110996914A (zh) 2020-04-10
RU2019142143A3 (enExample) 2021-07-19

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