CA3064895A1 - Fixed dose formulations - Google Patents

Fixed dose formulations Download PDF

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Publication number
CA3064895A1
CA3064895A1 CA3064895A CA3064895A CA3064895A1 CA 3064895 A1 CA3064895 A1 CA 3064895A1 CA 3064895 A CA3064895 A CA 3064895A CA 3064895 A CA3064895 A CA 3064895A CA 3064895 A1 CA3064895 A1 CA 3064895A1
Authority
CA
Canada
Prior art keywords
ezetimibe
composition
bempedoic acid
tablet
dissolution
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.)
Pending
Application number
CA3064895A
Other languages
English (en)
French (fr)
Inventor
Mohamed ABDELNASSER
Pratibha S. Pilgaonkar
Anilkumar S. Gandhi
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
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 CA3064895A1 publication Critical patent/CA3064895A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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

Landscapes

  • 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)
CA3064895A 2017-05-26 2018-05-25 Fixed dose formulations Pending CA3064895A1 (en)

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 US20180338922A1 (en) 2017-05-26 2017-12-29 Fixed dose formulations
US15/859,279 2017-12-29
PCT/US2018/034646 WO2018218147A1 (en) 2017-05-26 2018-05-25 Fixed dose formulations

Publications (1)

Publication Number Publication Date
CA3064895A1 true CA3064895A1 (en) 2018-11-29

Family

ID=62621055

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3064895A Pending CA3064895A1 (en) 2017-05-26 2018-05-25 Fixed dose formulations

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)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (21)

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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
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
US7335799B2 (en) 2003-01-23 2008-02-26 Esperion Therapeutics, Inc. Hydroxyl compounds and compositions for cholesterol management and related uses
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
NZ595071A (en) * 2009-03-13 2013-01-25 Toyama Chemical Co Ltd Tablet and granulated powder containing 6-fluoro-3-hydroxy-2-pyrazinecarboxamide
EP2229938B9 (en) * 2009-03-13 2012-04-25 Sanovel Ilac Sanayi ve Ticaret A.S. Ezetimibe compositions
BR112012002069B8 (pt) 2009-07-28 2021-05-25 Egis Gyogyszergyar Nyilvanosan Muekodo Reszvenytarsasag processo para a fabricação de um granulado contendo ezetimibe microcristalino
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
RU2686183C2 (ru) * 2014-01-21 2019-04-24 БиПиЭсАй ХОЛДИНГЗ, ЭлЭлСи Пленочные покрытия быстрого высвобождения, содержащие среднецепочечные глицериды, и покрытые ими субстраты
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
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
SG10201912754UA (en) * 2015-11-06 2020-02-27 Gemphire Therapeutics Inc Treatment of mixed dyslipidemia

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
TWI798228B (zh) 2023-04-11
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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