JP7294807B2 - 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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JP7294807B2
JP7294807B2 JP2018524369A JP2018524369A JP7294807B2 JP 7294807 B2 JP7294807 B2 JP 7294807B2 JP 2018524369 A JP2018524369 A JP 2018524369A JP 2018524369 A JP2018524369 A JP 2018524369A JP 7294807 B2 JP7294807 B2 JP 7294807B2
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pharmaceutical formulation
immediate release
oral pharmaceutical
release oral
ornithine phenylacetate
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JP2018533601A (ja
JP2018533601A5 (enExample
Inventor
ワン,ローレン
エス. グレー,リンダ
ブコフツァー,スタンレー
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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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    • 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
    • A61K9/5073Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078Microcapsules 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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • 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
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • 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
    • 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
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Obesity (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
JP2018524369A 2015-11-13 2016-11-11 L-オルニチンフェニルアセテート製剤 Active JP7294807B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2021213640A JP2022058446A (ja) 2015-11-13 2021-12-28 L-オルニチンフェニルアセテート製剤

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
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
US15/133,087 2016-04-19
US15/133,087 US20160338982A1 (en) 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate
PCT/US2016/061678 WO2017083758A1 (en) 2015-11-13 2016-11-11 Formulation of l-ornithine phenylacetate

Related Child Applications (1)

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JP2021213640A Division JP2022058446A (ja) 2015-11-13 2021-12-28 L-オルニチンフェニルアセテート製剤

Publications (3)

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JP2018533601A JP2018533601A (ja) 2018-11-15
JP2018533601A5 JP2018533601A5 (enExample) 2019-12-19
JP7294807B2 true JP7294807B2 (ja) 2023-06-20

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JP2018524369A Active JP7294807B2 (ja) 2015-11-13 2016-11-11 L-オルニチンフェニルアセテート製剤
JP2021213640A Pending JP2022058446A (ja) 2015-11-13 2021-12-28 L-オルニチンフェニルアセテート製剤

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JP2021213640A Pending JP2022058446A (ja) 2015-11-13 2021-12-28 L-オルニチンフェニルアセテート製剤

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EP (1) EP3373923A4 (enExample)
JP (2) JP7294807B2 (enExample)
KR (2) KR20180086431A (enExample)
CN (2) CN108366983A (enExample)
AU (2) AU2016353350B2 (enExample)
BR (1) BR112018009349A8 (enExample)
CA (1) CA3004331A1 (enExample)
IL (1) IL258630B2 (enExample)
MX (2) MX389926B (enExample)
RU (1) RU2018113801A (enExample)
SG (1) SG11201802987UA (enExample)
WO (1) WO2017083758A1 (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20190146A1 (ar) 2016-12-19 2019-06-18 Axcella Health Inc تركيبات حمض أميني وطرق لمعالجة أمراض الكبد
MA49906A (fr) 2017-08-14 2020-06-24 Axcella Health Inc Acides aminés à chaîne ramifiée pour le traitement d'une maladie du foie
EP3810123A1 (en) 2018-06-20 2021-04-28 Axcella Health Inc. Compositions and methods for the treatment of fat infiltration in muscle
KR20220110727A (ko) * 2019-10-16 2022-08-09 오세라 테라퓨틱스, 아이엔씨. 고암모니아혈증의 치료를 위한 오르니틴 페닐아세테이트의 투여량 및 용도
WO2024261477A1 (en) 2023-06-20 2024-12-26 Yaqrit Limited Combination of tlr4 antagonist, ornithine and phenylacetate or phenylbutyrate

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
JP2018513171A (ja) 2015-04-20 2018-05-24 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

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US4783443A (en) 1986-03-03 1988-11-08 The University Of Chicago Amino acyl cephalosporin derivatives
PT2319581E (pt) * 2004-11-26 2015-06-30 Ucl Business Plc Composições compreendendo ornitina e fenilacetato ou fenilbutirato para tratamento de encefalopatia hepática
GB0426141D0 (en) * 2004-11-26 2004-12-29 Ucl Biomedica Plc Treatment
DE102007009243A1 (de) * 2007-02-22 2008-09-18 Evonik Röhm Gmbh Pellets mit einer Wirkstoff-Matrix und einem Polymerüberzug, sowie ein Verfahren zur Herstellung der Pellets
AU2015221466B2 (en) 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
DK3263100T3 (da) * 2009-04-03 2020-05-11 Ocera Therapeutics Inc L-ornithinphenylacetat og fremgangsmåder til fremstilling deraf
AU2014250643B2 (en) 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
MX360062B (es) * 2010-10-06 2018-10-22 Ocera Therapeutics Inc Metodos de elaboracion de fenilacetato de l-ornitina.
CN102993037B (zh) * 2012-11-20 2015-03-04 南京工业大学 一种l-鸟氨酸苯乙酸盐的制备方法
CN103705490B (zh) * 2013-10-31 2016-08-17 蚌埠丰原医药科技发展有限公司 一种门冬氨酸鸟氨酸的缓释制剂及其制备工艺
CN107206021B (zh) * 2014-11-24 2021-09-03 Ucl商业有限公司 使用降氨疗法治疗与肝星状细胞激活相关的疾病
EP3337473A4 (en) * 2015-08-18 2019-04-17 Ocera Therapeutics, Inc. TREATMENT AND PREVENTION OF MUSCLE WOUND BY L-ORNITHIN IN COMBINATION WITH AT LEAST ONE PHENYL ACETATE AND PHENYL BUTYRATE
WO2017053613A1 (en) * 2015-09-25 2017-03-30 Ocera Therapeutics, Inc. Treatment and prevention of neuronal cell loss using l-ornithine in combination with at least one of phenylacetate and phenylbutyrate

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
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
JP2018513171A (ja) 2015-04-20 2018-05-24 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

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Publication number Publication date
AU2016353350A1 (en) 2018-05-10
CN108366983A (zh) 2018-08-03
EP3373923A4 (en) 2019-07-03
IL258630A (en) 2018-06-28
CA3004331A1 (en) 2017-05-18
CN113768863A (zh) 2021-12-10
KR20250023993A (ko) 2025-02-18
IL258630B1 (en) 2023-04-01
JP2018533601A (ja) 2018-11-15
MX2022001517A (es) 2022-11-16
MX389926B (es) 2025-03-20
JP2022058446A (ja) 2022-04-12
SG11201802987UA (en) 2018-05-30
WO2017083758A1 (en) 2017-05-18
RU2018113801A (ru) 2019-12-16
AU2021290236A1 (en) 2022-02-10
MX2018005088A (es) 2019-05-16
BR112018009349A2 (pt) 2018-11-13
KR20180086431A (ko) 2018-07-31
AU2016353350B2 (en) 2021-09-23
IL258630B2 (en) 2023-08-01
EP3373923A1 (en) 2018-09-19
BR112018009349A8 (pt) 2019-02-26

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