MX2019014122A - Formulaciones de dosis fija. - Google Patents

Formulaciones de dosis fija.

Info

Publication number
MX2019014122A
MX2019014122A MX2019014122A MX2019014122A MX2019014122A MX 2019014122 A MX2019014122 A MX 2019014122A MX 2019014122 A MX2019014122 A MX 2019014122A MX 2019014122 A MX2019014122 A MX 2019014122A MX 2019014122 A MX2019014122 A MX 2019014122A
Authority
MX
Mexico
Prior art keywords
fixed dose
dose formulations
formulations
bempedoic acid
novel compositions
Prior art date
Application number
MX2019014122A
Other languages
English (en)
Inventor
S Pilgaonkar Pratibha
Abdelnasser Mohamed
S Gandhi Anikumar
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 MX2019014122A publication Critical patent/MX2019014122A/es

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)

Abstract

La presente invención se refiere composiciones que comprenden: ácido Bempedoico y ácido Bempedoico y Ezetimiba, kits, métodos de uso y procesos para elaborar tales composiciones novedosas. Notablemente, las formulaciones de la presente proporcionan composiciones farmacéuticas que tienen excelentes propiedades de liberación y estabilidad para ambos productos de fármaco. Estas formulaciones mejoradas son útiles en el tratamiento y prevención de enfermedad cardiovascular.
MX2019014122A 2017-05-26 2018-05-25 Formulaciones de dosis fija. MX2019014122A (es)

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
MX2019014122A true MX2019014122A (es) 2020-02-07

Family

ID=62621055

Family Applications (2)

Application Number Title Priority Date Filing Date
MX2019014122A MX2019014122A (es) 2017-05-26 2018-05-25 Formulaciones de dosis fija.
MX2023006541A MX2023006541A (es) 2017-05-26 2019-11-26 Formulaciones de dosis fija.

Family Applications After (1)

Application Number Title Priority Date Filing Date
MX2023006541A MX2023006541A (es) 2017-05-26 2019-11-26 Formulaciones de dosis fija.

Country Status (14)

Country Link
US (2) US20180338922A1 (es)
EP (1) EP3630070A1 (es)
JP (2) JP7187488B2 (es)
KR (1) KR20200032044A (es)
CN (1) CN110996914A (es)
AU (2) AU2018272040A1 (es)
BR (1) BR112019024747A2 (es)
CA (1) CA3064895A1 (es)
CL (1) CL2019003437A1 (es)
IL (1) IL270866A (es)
MX (2) MX2019014122A (es)
TW (2) TW202400126A (es)
UA (1) UA126451C2 (es)
WO (1) WO2018218147A1 (es)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2978204A1 (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
CA3091259A1 (en) * 2018-02-16 2019-08-22 Esperion Therapeutics, Inc. Sustained release formulations of bempedoic acid
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
WO2020213010A1 (en) * 2019-04-16 2020-10-22 Celagenex Research (India) Pvt. Ltd. Synergistic lipid controlling compositions
EP3986859A1 (en) * 2019-06-21 2022-04-27 Esperion Therapeutics, Inc. Methods of making bempedoic acid and compositions of the same
EP4038045A1 (en) 2019-10-03 2022-08-10 Synthon B.V. Crystalline forms of bempedoic acid
US20230036336A1 (en) 2019-12-06 2023-02-02 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
WO2023036980A1 (en) 2021-09-13 2023-03-16 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

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SK287988B6 (sk) 2001-01-26 2012-09-03 Schering Corporation Composition, oral dosage form and use thereof
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
US20100209495A1 (en) * 2008-09-17 2010-08-19 Mylan Laboratories, 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
EP2229938B9 (en) * 2009-03-13 2012-04-25 Sanovel Ilac Sanayi ve Ticaret A.S. Ezetimibe compositions
SI2407166T1 (sl) * 2009-03-13 2013-12-31 Toyama Chemical Co., Ltd. Tableta in granuliran praĺ ek, vsebujoäśa 6-fluoro-3-hidroksi-2-pirazinkarboksamid
EP2459175B1 (en) 2009-07-28 2017-11-01 Egis Gyógyszergyár Zrt. New 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
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CN104023725B (zh) * 2011-08-16 2019-04-26 卡迪欧拉有限公司 控释制剂
CA2933202C (en) * 2014-01-21 2022-05-31 Jason Teckoe Immediate release film coatings containing medium chain glycerides and substrates coated therewith
CA2978204A1 (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
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
KR20180073597A (ko) * 2015-11-06 2018-07-02 젬파이어 세러퓨틱스 인코포레이티드 혼합 이상지질혈증의 치료

Also Published As

Publication number Publication date
JP7187488B2 (ja) 2022-12-12
IL270866A (en) 2020-01-30
KR20200032044A (ko) 2020-03-25
TW201900154A (zh) 2019-01-01
UA126451C2 (uk) 2022-10-05
US20220249380A1 (en) 2022-08-11
TWI798228B (zh) 2023-04-11
JP2020521763A (ja) 2020-07-27
TW202400126A (zh) 2024-01-01
CL2019003437A1 (es) 2020-07-10
MX2023006541A (es) 2023-06-16
BR112019024747A2 (pt) 2020-06-09
RU2019142143A3 (es) 2021-07-19
CA3064895A1 (en) 2018-11-29
CN110996914A (zh) 2020-04-10
AU2018272040A1 (en) 2019-12-19
RU2019142143A (ru) 2021-06-28
JP2023022224A (ja) 2023-02-14
AU2024204369A1 (en) 2024-07-11
US20180338922A1 (en) 2018-11-29
WO2018218147A1 (en) 2018-11-29
EP3630070A1 (en) 2020-04-08

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