IL255269B - Preparations of obeticholic acid and methods of use - Google Patents

Preparations of obeticholic acid and methods of use

Info

Publication number
IL255269B
IL255269B IL255269A IL25526917A IL255269B IL 255269 B IL255269 B IL 255269B IL 255269 A IL255269 A IL 255269A IL 25526917 A IL25526917 A IL 25526917A IL 255269 B IL255269 B IL 255269B
Authority
IL
Israel
Prior art keywords
obeticholic acid
composition
pharmaceutically acceptable
tablet
less
Prior art date
Application number
IL255269A
Other languages
English (en)
Hebrew (he)
Other versions
IL255269A (en
Original Assignee
Intercept Pharmaceuticals Inc
Sumitomo Pharma Co Ltd
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57198868&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IL255269(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Intercept Pharmaceuticals Inc, Sumitomo Pharma Co Ltd filed Critical Intercept Pharmaceuticals Inc
Publication of IL255269A publication Critical patent/IL255269A/en
Publication of IL255269B publication Critical patent/IL255269B/en

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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/575—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • 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
    • A61K9/2022—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
    • A61K9/2004—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
    • A61K9/20—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
    • 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
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07J—STEROIDS
    • C07J9/00—Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of more than two carbon atoms, e.g. cholane, cholestane, coprostane
    • C07J9/005—Normal steroids containing carbon, hydrogen, halogen or oxygen substituted in position 17 beta by a chain of more than two carbon atoms, e.g. cholane, cholestane, coprostane containing a carboxylic function directly attached or attached by a chain containing only carbon atoms to the cyclopenta[a]hydrophenanthrene skeleton

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Virology (AREA)
  • Biophysics (AREA)
  • Communicable Diseases (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
IL255269A 2015-04-27 2016-04-26 Preparations of obeticholic acid and methods of use IL255269B (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562153040P 2015-04-27 2015-04-27
US201662317933P 2016-04-04 2016-04-04
PCT/US2016/029369 WO2016176208A1 (en) 2015-04-27 2016-04-26 Compositions of obeticholic acid and methods of use

Publications (2)

Publication Number Publication Date
IL255269A IL255269A (en) 2018-02-28
IL255269B true IL255269B (en) 2022-08-01

Family

ID=57198868

Family Applications (2)

Application Number Title Priority Date Filing Date
IL255269A IL255269B (en) 2015-04-27 2016-04-26 Preparations of obeticholic acid and methods of use
IL294575A IL294575A (en) 2015-04-27 2016-04-26 Compositions of obeticholic acid and methods of use

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL294575A IL294575A (en) 2015-04-27 2016-04-26 Compositions of obeticholic acid and methods of use

Country Status (25)

Country Link
US (9) US10052337B2 (enExample)
EP (3) EP3288958A4 (enExample)
JP (2) JP6941057B2 (enExample)
KR (1) KR20170140325A (enExample)
CN (1) CN107531742A (enExample)
AU (2) AU2016255045B2 (enExample)
BR (1) BR112017023161A2 (enExample)
CA (1) CA2983609C (enExample)
CL (1) CL2017002727A1 (enExample)
CO (1) CO2017011535A2 (enExample)
CR (1) CR20170492A (enExample)
EA (1) EA201792354A1 (enExample)
EC (1) ECSP17078433A (enExample)
IL (2) IL255269B (enExample)
MA (1) MA41999A (enExample)
MX (1) MX2017013805A (enExample)
NI (1) NI201700128A (enExample)
PE (1) PE20180690A1 (enExample)
PH (1) PH12017501956A1 (enExample)
SG (2) SG11201708606VA (enExample)
SV (1) SV2017005555A (enExample)
TN (1) TN2017000452A1 (enExample)
TW (1) TWI723017B (enExample)
WO (1) WO2016176208A1 (enExample)
ZA (1) ZA201707981B (enExample)

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JP6804438B2 (ja) 2014-10-17 2020-12-23 チルドレンズ ホスピタル メディカル センター 多能性幹細胞を使用するヒト小腸のｉｎ ｖｉｖｏモデル、並びにそれを作製、及び使用する方法
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KR20180125573A (ko) * 2016-03-31 2018-11-23 인터셉트 파마슈티컬즈, 인크. 유효 성분의 화학적 안정성이 뛰어난 필름 코팅정
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CN110382012B (zh) * 2016-11-04 2023-08-25 儿童医院医学中心 肝类器官疾病模型以及其制备和使用方法
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CN110062764B (zh) 2016-12-05 2024-07-02 儿童医院医学中心 结肠类器官及其制备和使用方法
CN108614038B (zh) * 2016-12-13 2022-05-17 亚宝药业集团股份有限公司 一种测定奥贝胆酸原料药有关物质的方法
CN106645497A (zh) * 2017-01-03 2017-05-10 山东省药学科学院 一种奥贝胆酸及其制剂中有关物质的检测方法
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Also Published As

Publication number Publication date
PE20180690A1 (es) 2018-04-23
US20200046735A1 (en) 2020-02-13
US20260000682A1 (en) 2026-01-01
EP3288958A4 (en) 2018-09-26
US10758549B2 (en) 2020-09-01
IL255269A (en) 2018-02-28
JP2018514534A (ja) 2018-06-07
EA201792354A1 (ru) 2018-03-30
US20200046736A1 (en) 2020-02-13
JP2021183651A (ja) 2021-12-02
CA2983609C (en) 2024-05-07
US20200054650A1 (en) 2020-02-20
MX2017013805A (es) 2018-09-06
SV2017005555A (es) 2019-01-18
AU2016255045B2 (en) 2020-04-16
CA2983609A1 (en) 2016-11-03
US20170035784A1 (en) 2017-02-09
CN107531742A (zh) 2018-01-02
SG10202003110PA (en) 2020-05-28
EP4371616A2 (en) 2024-05-22
WO2016176208A1 (en) 2016-11-03
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