KR20180006904A - L-오르니틴 페닐아세테이트의 제형 - Google Patents

L-오르니틴 페닐아세테이트의 제형 Download PDF

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Publication number
KR20180006904A
KR20180006904A KR1020177032260A KR20177032260A KR20180006904A KR 20180006904 A KR20180006904 A KR 20180006904A KR 1020177032260 A KR1020177032260 A KR 1020177032260A KR 20177032260 A KR20177032260 A KR 20177032260A KR 20180006904 A KR20180006904 A KR 20180006904A
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South Korea
Prior art keywords
ornithine phenylacetate
pharmaceutical formulation
phenylacetate
ornithine
oral pharmaceutical
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Ceased
Application number
KR1020177032260A
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English (en)
Korean (ko)
Inventor
케네스 루티만
마크 코핀
제임스 번스타인
게리 굿슨
로렌 왕
Original Assignee
오세라 테라퓨틱스, 아이엔씨.
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Publication of KR20180006904A publication Critical patent/KR20180006904A/ko
Ceased legal-status Critical Current

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    • 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
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089Processes
    • 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
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Emergency Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Obesity (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
KR1020177032260A 2015-04-20 2016-04-19 L-오르니틴 페닐아세테이트의 제형 Ceased KR20180006904A (ko)

Applications Claiming Priority (11)

Application Number Priority Date Filing Date Title
US201562150238P 2015-04-20 2015-04-20
US62/150,238 2015-04-20
US201562150676P 2015-04-21 2015-04-21
US62/150,676 2015-04-21
US201562211619P 2015-08-28 2015-08-28
US62/211,619 2015-08-28
US201562255300P 2015-11-13 2015-11-13
US62/255,300 2015-11-13
US201662276754P 2016-01-08 2016-01-08
US62/276,754 2016-01-08
PCT/US2016/028298 WO2016172112A1 (en) 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate

Publications (1)

Publication Number Publication Date
KR20180006904A true KR20180006904A (ko) 2018-01-19

Family

ID=57144228

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020177032260A Ceased KR20180006904A (ko) 2015-04-20 2016-04-19 L-오르니틴 페닐아세테이트의 제형

Country Status (13)

Country Link
US (2) US20160338982A1 (enExample)
EP (2) EP4205735A1 (enExample)
JP (2) JP2018513171A (enExample)
KR (1) KR20180006904A (enExample)
CN (2) CN107708684A (enExample)
AU (2) AU2016252382A1 (enExample)
CA (1) CA2983146C (enExample)
DK (1) DK3285756T3 (enExample)
ES (1) ES2944311T3 (enExample)
HK (1) HK1251149A1 (enExample)
MX (2) MX391167B (enExample)
RU (1) RU2755904C2 (enExample)
WO (1) WO2016172112A1 (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2319581E (pt) 2004-11-26 2015-06-30 Ucl Business Plc Composições compreendendo ornitina e fenilacetato ou fenilbutirato para tratamento de encefalopatia hepática
ES2791524T3 (es) 2009-04-03 2020-11-04 Ocera Therapeutics Inc Fenilacetato de L-ornitina y métodos de elaboración del mismo
EP3517110A1 (en) 2009-06-08 2019-07-31 UCL Business PLC Treatment of inflammation using l-ornithine phenylacetate
BR112017010761B1 (pt) 2014-11-24 2022-10-18 Ucl Business Plc Tratamento de doenças associadas à ativação de célula estrelada hepática com o uso de terapias de redução de amônia
CA2995823A1 (en) 2015-08-18 2017-02-23 Ocera Therapeutics, Inc. Treatment and prevention of muscle loss using l-ornithine in combination with at least one of phenylacetate and phenylbutyrate
KR20180086431A (ko) * 2015-11-13 2018-07-31 오세라 테라퓨틱스, 아이엔씨. L-오르니틴 페닐아세테이트의 제제
US11219611B2 (en) 2015-11-13 2022-01-11 Ocera Therapeutics, Inc. Formulations of L-ornithine phenylacetate
JOP20190146A1 (ar) 2016-12-19 2019-06-18 Axcella Health Inc تركيبات حمض أميني وطرق لمعالجة أمراض الكبد
EP3621947A4 (en) 2017-05-11 2021-03-10 Ocera Therapeutics, Inc. L-ORNITHINE PHENYLACETATE MANUFACTURING PROCESSES
BR112020002419A2 (pt) 2017-08-14 2020-07-28 Axcella Health Inc. aminoácido para o tratamento de doença do fígado
EP3810123A1 (en) 2018-06-20 2021-04-28 Axcella Health Inc. Compositions and methods for the treatment of fat infiltration in muscle
KR102852068B1 (ko) 2019-05-09 2025-08-28 오세라 테라퓨틱스, 아이엔씨. 간성 뇌증의 평가 및 치료 방법
BR112022007268A2 (pt) * 2019-10-16 2022-07-05 Ocera Therapeutics Inc Dosagens e usos do fenilacetato de ornitina para o tratamento da hiperamonemia
EP4096647A1 (en) 2020-01-30 2022-12-07 Yeda Research and Development Co. Ltd Treating acute liver disease with tlr-mik inhibitors
WO2024261477A1 (en) 2023-06-20 2024-12-26 Yaqrit Limited Combination of tlr4 antagonist, ornithine and phenylacetate or phenylbutyrate

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4783443A (en) 1986-03-03 1988-11-08 The University Of Chicago Amino acyl cephalosporin derivatives
IL116674A (en) * 1995-01-09 2003-05-29 Mendell Co Inc Edward Microcrystalline cellulose-based excipient having improved compressibility, pharmaceutical compositions containing the same and methods for the preparation of said excipient and of solid dosage form thereof
PT2319581E (pt) * 2004-11-26 2015-06-30 Ucl Business Plc Composições compreendendo ornitina e fenilacetato ou fenilbutirato para tratamento de encefalopatia hepática
ES2791524T3 (es) 2009-04-03 2020-11-04 Ocera Therapeutics Inc Fenilacetato de L-ornitina y métodos de elaboración del mismo
AU2015221466B2 (en) * 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
AU2014250643B2 (en) * 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
EP3517110A1 (en) * 2009-06-08 2019-07-31 UCL Business PLC Treatment of inflammation using l-ornithine phenylacetate
EP2625162B1 (en) 2010-10-06 2019-03-13 Ocera Therapeutics, Inc. Methods of making l-ornithine phenyl acetate

Also Published As

Publication number Publication date
EP4205735A1 (en) 2023-07-05
RU2017137643A3 (enExample) 2019-09-17
CA2983146A1 (en) 2016-10-27
HK1251149A1 (zh) 2019-01-25
RU2755904C2 (ru) 2021-09-22
RU2017137643A (ru) 2019-05-20
AU2021200740A1 (en) 2021-03-04
CA2983146C (en) 2023-09-12
EP3285756A4 (en) 2019-01-23
EP3285756B1 (en) 2023-02-22
AU2016252382A1 (en) 2017-11-02
CN113599350A (zh) 2021-11-05
ES2944311T3 (es) 2023-06-20
DK3285756T3 (da) 2023-05-08
MX2017013170A (es) 2018-04-11
JP2018513171A (ja) 2018-05-24
US20220184014A1 (en) 2022-06-16
US20160338982A1 (en) 2016-11-24
MX391167B (es) 2025-03-11
EP3285756A1 (en) 2018-02-28
JP2022101549A (ja) 2022-07-06
CN107708684A (zh) 2018-02-16
WO2016172112A1 (en) 2016-10-27
MX2022003855A (es) 2023-03-02

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