JP2018513171A - Ｌ−オルニチンフェニルアセテート製剤 - Google Patents

Ｌ−オルニチンフェニルアセテート製剤 Download PDF

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Publication number
JP2018513171A
JP2018513171A JP2017554815A JP2017554815A JP2018513171A JP 2018513171 A JP2018513171 A JP 2018513171A JP 2017554815 A JP2017554815 A JP 2017554815A JP 2017554815 A JP2017554815 A JP 2017554815A JP 2018513171 A JP2018513171 A JP 2018513171A
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JP
Japan
Prior art keywords
pharmaceutical formulation
phenylacetate
ornithine phenylacetate
oral pharmaceutical
ornithine
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
JP2017554815A
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English (en)
Japanese (ja)
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JP2018513171A5 (OSRAM
Inventor
ルーティマン，ケニース
コフィン，マーク
バーンシュタイン，ジェームス
グッドサン，ギャリー
ワン，ローレンス
Original Assignee
オセラ セラピューティクス， インコーポレイテッド
オセラ セラピューティクス， インコーポレイテッド
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Application filed by オセラ セラピューティクス， インコーポレイテッド, オセラ セラピューティクス， インコーポレイテッド filed Critical オセラ セラピューティクス， インコーポレイテッド
Publication of JP2018513171A publication Critical patent/JP2018513171A/ja
Publication of JP2018513171A5 publication Critical patent/JP2018513171A5/ja
Priority to JP2022046762A priority Critical patent/JP2022101549A/ja
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic 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
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • 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
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5026—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A61K9/5047—Cellulose ethers containing no ester groups, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules 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
    • A61K9/5089—Processes
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • 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
    • A61P9/12—Antihypertensives
    • 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)
  • 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)
JP2017554815A 2015-04-20 2016-04-19 Ｌ−オルニチンフェニルアセテート製剤 Pending JP2018513171A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2022046762A JP2022101549A (ja) 2015-04-20 2022-03-23 Ｌ－オルニチンフェニルアセテート製剤

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022046762A Division JP2022101549A (ja) 2015-04-20 2022-03-23 Ｌ－オルニチンフェニルアセテート製剤

Publications (2)

Publication Number Publication Date
JP2018513171A true JP2018513171A (ja) 2018-05-24
JP2018513171A5 JP2018513171A5 (OSRAM) 2019-05-30

Family

ID=57144228

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2017554815A Pending JP2018513171A (ja) 2015-04-20 2016-04-19 Ｌ−オルニチンフェニルアセテート製剤
JP2022046762A Pending JP2022101549A (ja) 2015-04-20 2022-03-23 Ｌ－オルニチンフェニルアセテート製剤

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2022046762A Pending JP2022101549A (ja) 2015-04-20 2022-03-23 Ｌ－オルニチンフェニルアセテート製剤

Country Status (13)

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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018533601A (ja) * 2015-11-13 2018-11-15 オセラ セラピューティクス， インコーポレイテッド Ｌ−オルニチンフェニルアセテート製剤

Families Citing this family (14)

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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
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

Citations (1)

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JP2012529523A (ja) * 2009-06-08 2012-11-22 ユーシーエル ビジネス ピーエルシー Ｌ−オルニチンフェニル酢酸塩を用いる門脈圧亢進の治療及び肝機能の修復

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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
EP2625162B1 (en) 2010-10-06 2019-03-13 Ocera Therapeutics, Inc. Methods of making l-ornithine phenyl acetate

Patent Citations (1)

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JP2012529523A (ja) * 2009-06-08 2012-11-22 ユーシーエル ビジネス ピーエルシー Ｌ−オルニチンフェニル酢酸塩を用いる門脈圧亢進の治療及び肝機能の修復

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018533601A (ja) * 2015-11-13 2018-11-15 オセラ セラピューティクス， インコーポレイテッド Ｌ−オルニチンフェニルアセテート製剤
JP7294807B2 (ja) 2015-11-13 2023-06-20 オセラ セラピューティクス， インコーポレイテッド Ｌ－オルニチンフェニルアセテート製剤

Also Published As

Publication number Publication date
EP4205735A1 (en) 2023-07-05
RU2017137643A3 (OSRAM) 2019-09-17
CA2983146A1 (en) 2016-10-27
KR20180006904A (ko) 2018-01-19
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
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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