CN111971030A - 贝派地酸的缓释制剂 - Google Patents

贝派地酸的缓释制剂 Download PDF

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Publication number
CN111971030A
CN111971030A CN201980025286.XA CN201980025286A CN111971030A CN 111971030 A CN111971030 A CN 111971030A CN 201980025286 A CN201980025286 A CN 201980025286A CN 111971030 A CN111971030 A CN 111971030A
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CN
China
Prior art keywords
acid
formulation
subject
dosage form
present disclosure
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Pending
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CN201980025286.XA
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English (en)
Chinese (zh)
Inventor
N.D.拉尔瓦尼
M.阿布德尔纳瑟
S.L.平科斯基
C.T.克拉默
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Esperion Therapeutics Inc
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Esperion Therapeutics Inc
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Publication of CN111971030A publication Critical patent/CN111971030A/zh
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    • 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
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/2013—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
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Gastroenterology & Hepatology (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)
CN201980025286.XA 2018-02-16 2019-02-15 贝派地酸的缓释制剂 Pending CN111971030A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862710417P 2018-02-16 2018-02-16
US62/710,417 2018-02-16
US201862774083P 2018-11-30 2018-11-30
US62/774,083 2018-11-30
PCT/US2019/018356 WO2019161307A1 (fr) 2018-02-16 2019-02-15 Formulations à libération prolongée d'acide bempedoique

Publications (1)

Publication Number Publication Date
CN111971030A true CN111971030A (zh) 2020-11-20

Family

ID=65685995

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201980025286.XA Pending CN111971030A (zh) 2018-02-16 2019-02-15 贝派地酸的缓释制剂

Country Status (15)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023093807A1 (fr) * 2021-11-24 2023-06-01 南京昕瑞再生医药科技有限公司 Composé et méthode de traitement de maladies hépatiques

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112437765A (zh) 2019-06-21 2021-03-02 艾斯柏伦治疗公司 贝派地酸的盐形式及其使用方法
CN111381270B (zh) * 2020-03-06 2023-04-18 广西田东力源宝科技有限公司 一种利用同位素示踪监控肥料分布的方法
WO2022256378A1 (fr) 2021-06-02 2022-12-08 Esperion Therapeutics, Inc. Compositions contenant de l'acide bempedoïque et du tolvaptan et thérapies les utilisant
AU2022342749A1 (en) 2021-09-13 2024-03-21 Synthon B.V. Pharmaceutical composition of bempedoic acid
WO2023217694A1 (fr) * 2022-05-09 2023-11-16 Renata Pharmaceutical (Ireland) Ltd Composition pharmaceutique d'acide bempédoïque

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101669948A (zh) * 2008-09-11 2010-03-17 北京科信必成医药科技发展有限公司 一种烟酸和洛伐他汀的缓释片及其制备方法
CN103142552A (zh) * 2013-02-22 2013-06-12 广州科的信医药技术有限公司 一种洛伐他汀肠溶缓释微丸胶囊及其制备方法
WO2017023165A1 (fr) * 2015-08-04 2017-02-09 Dezima Pharma B.V. Composition pharmaceutique et combinaison thérapeutique comprenant un inhibiteur de protéine de transfert d'ester de cholestéryle et d'un inhibiteur de citrate lyase d'atp–activateur d'ampk
CN107530308A (zh) * 2015-03-16 2018-01-02 艾斯柏伦治疗公司 用于治疗或降低心血管风险的包含etc1002及一种或多种他汀类药物的固定剂量组合

Family Cites Families (19)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
US4681583A (en) 1982-12-20 1987-07-21 Alza Corporation System for dispersing drug in biological environment
US4578075A (en) 1982-12-20 1986-03-25 Alza Corporation Delivery system housing a plurality of delivery devices
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
ES2594340T3 (es) 2003-01-23 2016-12-19 Esperion Therapeutics Inc. Compuestos de hidroxilo y composiciones para el control del colesterol y utilizaciones correspondientes
US20180338922A1 (en) * 2017-05-26 2018-11-29 Esperion Therapeutics, Inc. Fixed dose formulations

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101669948A (zh) * 2008-09-11 2010-03-17 北京科信必成医药科技发展有限公司 一种烟酸和洛伐他汀的缓释片及其制备方法
CN103142552A (zh) * 2013-02-22 2013-06-12 广州科的信医药技术有限公司 一种洛伐他汀肠溶缓释微丸胶囊及其制备方法
CN107530308A (zh) * 2015-03-16 2018-01-02 艾斯柏伦治疗公司 用于治疗或降低心血管风险的包含etc1002及一种或多种他汀类药物的固定剂量组合
WO2017023165A1 (fr) * 2015-08-04 2017-02-09 Dezima Pharma B.V. Composition pharmaceutique et combinaison thérapeutique comprenant un inhibiteur de protéine de transfert d'ester de cholestéryle et d'un inhibiteur de citrate lyase d'atp–activateur d'ampk

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
PD THOMPSON 等: "Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance", 《JOURNAL OF CLINICAL LIPIDOLOGY》 *
STEPHEN L. PINKOSKY等: "Liver-specific ATP-citrate lyase inhibition by bempedoic acid decreases LDL-C and attenuates atherosclerosis", 《NATURE COMMUNICATIONS》 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023093807A1 (fr) * 2021-11-24 2023-06-01 南京昕瑞再生医药科技有限公司 Composé et méthode de traitement de maladies hépatiques

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Publication number Publication date
CA3091259A1 (fr) 2019-08-22
IL276689A (en) 2020-09-30
TW202000191A (zh) 2020-01-01
PH12020551263A1 (en) 2021-07-05
AU2019221765A1 (en) 2020-09-10
BR112020016494A2 (pt) 2020-12-15
WO2019161307A1 (fr) 2019-08-22
JP2021513987A (ja) 2021-06-03
EP3752133A1 (fr) 2020-12-23
SG11202007825XA (en) 2020-09-29
MX2020008527A (es) 2020-09-18
RU2020129191A (ru) 2022-03-16
CL2020002101A1 (es) 2021-02-19
KR20200123181A (ko) 2020-10-28

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Application publication date: 20201120