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CL2019003437A1 - Formulaciones de dosis fija. - Google Patents

Formulaciones de dosis fija.

Info

Publication number
CL2019003437A1
CL2019003437A1 CL2019003437A CL2019003437A CL2019003437A1 CL 2019003437 A1 CL2019003437 A1 CL 2019003437A1 CL 2019003437 A CL2019003437 A CL 2019003437A CL 2019003437 A CL2019003437 A CL 2019003437A CL 2019003437 A1 CL2019003437 A1 CL 2019003437A1
Authority
CL
Chile
Prior art keywords
fixed dose
dose formulations
granulated composition
ezetimiba
cardiovacular
Prior art date
Application number
CL2019003437A
Other languages
English (en)
Inventor
Mohamed Abdelnasser
Pratibha S Pilgaonkar
Anilkumar S Gandhi
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 CL2019003437A1 publication Critical patent/CL2019003437A1/es

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)

Abstract

COMPOSICION GRANULADA QU COMPRENDE: ACIDO BEMPEDOICO MEZCLADO CON UN LUBRICANTE SELECCIONADO DE DIOXIDO DE SILICIO COLOIDAL, FUMARATO DE ESTREARILO DE SODIO Y ESTEARATO DE MAGNESIO; COMPOSICION FARMACEUTICA QUE COMPRENDE LA COMPOSICIPONGRANULADA Y EZETIMIBA; UN PROCESO DE GRANULACION; UNA TABLETA BICAPA; UTIL PARA TRATAR O REDUCIR EL RIESGO CARDIOVACULAR.
CL2019003437A 2017-05-26 2019-11-25 Formulaciones de dosis fija. CL2019003437A1 (es)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
CL2019003437A1 true CL2019003437A1 (es) 2020-07-10

Family

ID=62621055

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2019003437A CL2019003437A1 (es) 2017-05-26 2019-11-25 Formulaciones de dosis fija.

Country Status (15)

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

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* Cited by examiner, † Cited by third party
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MX392182B (es) 2015-03-13 2025-03-21 Esperion Therapeutics Inc Combinaciones de dosis fija y formulaciones que comprenden ácido 8-hidroxi-2,2,14,14 tetrametilpentadecanodioico (etc1002) y ezetimiba y métodos para tratar o reducir el riesgo de enfermedad cardiovascular.
BR112020016494A2 (pt) * 2018-02-16 2020-12-15 Esperion Therapeutics, Inc. Formulações de liberação prolongada de ácido bempedoico
EP3844168A4 (en) * 2018-08-27 2022-05-18 Esperion Therapeutics, Inc. COMBINATION DRUG PREPARATIONS FOR THE TREATMENT OF 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
US12344578B2 (en) * 2019-06-21 2025-07-01 Esperion Therapeutics, Inc. Salt forms of bempedoic acid and methods for using 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
EP4134102A4 (en) * 2020-04-10 2024-06-26 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
CA3231425A1 (en) * 2021-09-13 2023-03-16 Marta VIVANCOS MARTINEZ Pharmaceutical composition of bempedoic acid
US20250302750A1 (en) 2022-05-09 2025-10-02 Renata Pharmaceuticals (Ireland) Ltd Pharmaceutical composition of bempedoic acid

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SK288217B6 (sk) 2001-01-26 2014-08-05 Merck Sharp & Dohme Corp. Zmes, terapeutická kombinácia, farmaceutický prostriedok a ich použitie
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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MX392182B (es) * 2015-03-13 2025-03-21 Esperion Therapeutics Inc Combinaciones de dosis fija y formulaciones que comprenden ácido 8-hidroxi-2,2,14,14 tetrametilpentadecanodioico (etc1002) y ezetimiba y métodos para tratar o reducir el riesgo de enfermedad cardiovascular.
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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Also Published As

Publication number Publication date
JP2020521763A (ja) 2020-07-27
RU2019142143A (ru) 2021-06-28
TW201900154A (zh) 2019-01-01
CN110996914A (zh) 2020-04-10
EP3630070A1 (en) 2020-04-08
JP2024178341A (ja) 2024-12-24
AU2024204369A1 (en) 2024-07-11
IL318957A (en) 2025-04-01
KR20250109242A (ko) 2025-07-16
US20220249380A1 (en) 2022-08-11
TWI798228B (zh) 2023-04-11
KR20240130156A (ko) 2024-08-28
PH12019502782A1 (en) 2020-10-26
BR112019024747A2 (pt) 2020-06-09
JP7561814B2 (ja) 2024-10-04
JP2023022224A (ja) 2023-02-14
KR20200032044A (ko) 2020-03-25
KR102830720B1 (ko) 2025-07-08
MX2023006541A (es) 2023-06-16
RU2019142143A3 (es) 2021-07-19
UA126451C2 (uk) 2022-10-05
MX2019014122A (es) 2020-02-07
TW202400126A (zh) 2024-01-01
US20180338922A1 (en) 2018-11-29
IL270866A (en) 2020-01-30
AU2024204369B2 (en) 2025-09-11
AU2018272040A1 (en) 2019-12-19
CA3064895A1 (en) 2018-11-29
KR102698987B1 (ko) 2024-08-28
WO2018218147A1 (en) 2018-11-29
IL270866B1 (en) 2025-03-01
JP7187488B2 (ja) 2022-12-12
IL270866B2 (en) 2025-07-01

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