CL2020002101A1 - Sustained release formulations of bempedoic acid. - Google Patents

Sustained release formulations of bempedoic acid.

Info

Publication number
CL2020002101A1
CL2020002101A1 CL2020002101A CL2020002101A CL2020002101A1 CL 2020002101 A1 CL2020002101 A1 CL 2020002101A1 CL 2020002101 A CL2020002101 A CL 2020002101A CL 2020002101 A CL2020002101 A CL 2020002101A CL 2020002101 A1 CL2020002101 A1 CL 2020002101A1
Authority
CL
Chile
Prior art keywords
sustained release
release formulations
bempedoic acid
formulation
bempedoic
Prior art date
Application number
CL2020002101A
Other languages
Spanish (es)
Inventor
Mohamed Abdelnasser
Narendra Dhanraj Lalwani
Stephen Lawrence Pinkosky
Clay Thomas Cramer
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 CL2020002101A1 publication Critical patent/CL2020002101A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/20Carboxylic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1652Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4858Organic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841Filling excipients; Inactive ingredients
    • A61K9/4866Organic macromolecular compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

FORMULACIÓN QUE COMPRENDE ÁCIDO BEMPEDOICO, UN RELLENO, UN DILUYENTE O SOLUBILIZANTE Y UN AGLUTINANTE, EN DONDE LA FORMULACIÓN ES DE LIBERACIÓN SOSTENIDA; Y SU USO PARA TRATAR UNA ENFERMEDAD CARDIOVASCULAR O REDUCIR SU RIESGO. .FORMULATION THAT INCLUDES BEMPEDOIC ACID, A FILLER, A DILUENT OR SOLUBILIZER AND A BINDER, WHERE THE FORMULATION IS SUSTAINED RELEASE; AND ITS USE TO TREAT A CARDIOVASCULAR DISEASE OR REDUCE ITS RISK. .

CL2020002101A 2018-02-16 2020-08-13 Sustained release formulations of bempedoic acid. CL2020002101A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862710417P 2018-02-16 2018-02-16
US201862774083P 2018-11-30 2018-11-30

Publications (1)

Publication Number Publication Date
CL2020002101A1 true CL2020002101A1 (en) 2021-02-19

Family

ID=65685995

Family Applications (1)

Application Number Title Priority Date Filing Date
CL2020002101A CL2020002101A1 (en) 2018-02-16 2020-08-13 Sustained release formulations of bempedoic acid.

Country Status (15)

Country Link
EP (1) EP3752133A1 (en)
JP (1) JP2021513987A (en)
KR (1) KR20200123181A (en)
CN (1) CN111971030A (en)
AU (1) AU2019221765A1 (en)
BR (1) BR112020016494A2 (en)
CA (1) CA3091259A1 (en)
CL (1) CL2020002101A1 (en)
IL (1) IL276689A (en)
MX (1) MX2020008527A (en)
PH (1) PH12020551263A1 (en)
RU (1) RU2020129191A (en)
SG (1) SG11202007825XA (en)
TW (1) TW202000191A (en)
WO (1) WO2019161307A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HUE072061T2 (en) 2019-06-21 2025-10-28 Esperion Therapeutics Inc Bempedoic acid production processes
CN111381270B (en) * 2020-03-06 2023-04-18 广西田东力源宝科技有限公司 Method for monitoring fertilizer distribution by utilizing isotope tracing
ES3017885T3 (en) * 2021-06-02 2025-05-13 Esperion Therapeutics Inc Compositions containing bempedoic acid alone or in combination with tolvaptan for use in a method for treating autosomal dominant polycystic kidney disease (adpkd)
EP4401708A1 (en) 2021-09-13 2024-07-24 Synthon B.V. Pharmaceutical composition of bempedoic acid
WO2023093807A1 (en) * 2021-11-24 2023-06-01 南京昕瑞再生医药科技有限公司 Compound and method for treating liver diseases
CA3256768A1 (en) * 2022-05-09 2023-11-16 Renata Pharmaceutical (Ireland) Ltd Pharmaceutical composition of bempedoic acid

Family Cites Families (23)

* Cited by examiner, † Cited by third party
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US3995631A (en) 1971-01-13 1976-12-07 Alza Corporation Osmotic dispenser with means for dispensing active agent responsive to osmotic gradient
US3865108A (en) 1971-05-17 1975-02-11 Ortho Pharma Corp Expandable drug delivery device
US3845770A (en) 1972-06-05 1974-11-05 Alza Corp Osmatic dispensing device for releasing beneficial agent
US3916899A (en) 1973-04-25 1975-11-04 Alza Corp Osmotic dispensing device with maximum and minimum sizes for the passageway
US4002173A (en) 1974-07-23 1977-01-11 International Paper Company Diester crosslinked polyglucan hydrogels and reticulated sponges thereof
GB1478759A (en) 1974-11-18 1977-07-06 Alza Corp Process for forming outlet passageways in pills using a laser
US4077407A (en) 1975-11-24 1978-03-07 Alza Corporation Osmotic devices having composite walls
US4008719A (en) 1976-02-02 1977-02-22 Alza Corporation Osmotic system having laminar arrangement for programming delivery of active agent
US4111202A (en) 1976-11-22 1978-09-05 Alza Corporation Osmotic system for the controlled and delivery of agent over time
US4207893A (en) 1977-08-29 1980-06-17 Alza Corporation Device using hydrophilic polymer for delivering drug to biological environment
US4327725A (en) 1980-11-25 1982-05-04 Alza Corporation Osmotic device with hydrogel driving member
US4519801A (en) 1982-07-12 1985-05-28 Alza Corporation Osmotic device with wall comprising cellulose ether and permeability enhancer
US4578075A (en) 1982-12-20 1986-03-25 Alza Corporation Delivery system housing a plurality of delivery devices
US4681583A (en) 1982-12-20 1987-07-21 Alza Corporation System for dispersing drug in biological environment
US5019397A (en) 1988-04-21 1991-05-28 Alza Corporation Aqueous emulsion for pharmaceutical dosage form
US5156850A (en) 1990-08-31 1992-10-20 Alza Corporation Dosage form for time-varying patterns of drug delivery
US6919373B1 (en) 1996-11-12 2005-07-19 Alza Corporation Methods and devices for providing prolonged drug therapy
EP2402300B1 (en) 2003-01-23 2016-05-25 Esperion Therapeutics Inc. Hydroxyl compounds and compositions for cholesterol management and related uses
CN101669948A (en) * 2008-09-11 2010-03-17 北京科信必成医药科技发展有限公司 Sustained release tablets of nicotinic acid and lovatatin and preparation method thereof
CN103142552A (en) * 2013-02-22 2013-06-12 广州科的信医药技术有限公司 Lovastatin enteric coated sustained-release pellet capsule and preparation method thereof
MA41793A (en) * 2015-03-16 2018-01-23 Esperion Therapeutics Inc FIXED DOSE ASSOCIATIONS INCLUDING ETC1002 AND ONE OR MORE STATINS TO TREAT OR REDUCE A CARDIOVASCULAR RISK
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
US20180338922A1 (en) * 2017-05-26 2018-11-29 Esperion Therapeutics, Inc. Fixed dose formulations

Also Published As

Publication number Publication date
BR112020016494A2 (en) 2020-12-15
KR20200123181A (en) 2020-10-28
MX2020008527A (en) 2020-09-18
EP3752133A1 (en) 2020-12-23
JP2021513987A (en) 2021-06-03
CN111971030A (en) 2020-11-20
AU2019221765A1 (en) 2020-09-10
CA3091259A1 (en) 2019-08-22
PH12020551263A1 (en) 2021-07-05
TW202000191A (en) 2020-01-01
IL276689A (en) 2020-09-30
SG11202007825XA (en) 2020-09-29
RU2020129191A (en) 2022-03-16
WO2019161307A1 (en) 2019-08-22

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