CN108366983A - L-鸟氨酸苯乙酸盐制剂 - Google Patents

L-鸟氨酸苯乙酸盐制剂 Download PDF

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Publication number
CN108366983A
CN108366983A CN201680066488.5A CN201680066488A CN108366983A CN 108366983 A CN108366983 A CN 108366983A CN 201680066488 A CN201680066488 A CN 201680066488A CN 108366983 A CN108366983 A CN 108366983A
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CN
China
Prior art keywords
phenylacetylglutamine
plasma
phenylacetate
pharmaceutical formulation
oral pharmaceutical
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
CN201680066488.5A
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English (en)
Chinese (zh)
Inventor
L·王
L·S·格莱斯
S·布科夫策尔
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ocera Therapeutics Inc
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Ocera Therapeutics Inc
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.)
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Publication date
Priority claimed from US15/133,087 external-priority patent/US20160338982A1/en
Application filed by Ocera Therapeutics Inc filed Critical Ocera Therapeutics Inc
Priority to CN202111062923.6A priority Critical patent/CN113768863A/zh
Publication of CN108366983A publication Critical patent/CN108366983A/zh
Pending legal-status Critical Current

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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
    • A61K9/0012Galenical 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
    • A61K9/5073Microcapsules 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
    • 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)
CN201680066488.5A 2015-11-13 2016-11-11 L-鸟氨酸苯乙酸盐制剂 Pending CN108366983A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202111062923.6A CN113768863A (zh) 2015-11-13 2016-11-11 L-鸟氨酸苯乙酸盐制剂

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)

Application Number Title Priority Date Filing Date
CN202111062923.6A Division CN113768863A (zh) 2015-11-13 2016-11-11 L-鸟氨酸苯乙酸盐制剂

Publications (1)

Publication Number Publication Date
CN108366983A true CN108366983A (zh) 2018-08-03

Family

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CN201680066488.5A Pending CN108366983A (zh) 2015-11-13 2016-11-11 L-鸟氨酸苯乙酸盐制剂
CN202111062923.6A Pending CN113768863A (zh) 2015-11-13 2016-11-11 L-鸟氨酸苯乙酸盐制剂

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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)

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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 (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101102816A (zh) * 2004-11-26 2008-01-09 Ucl商业有限公司 用于治疗肝性脑病的含有鸟氨酸和苯基乙酸(phenylacetate)或苯基丁酸(phenylbutyrate)的组合物
CN101626769A (zh) * 2007-02-22 2010-01-13 赢创罗姆有限责任公司 含有活性物质基质与聚合物包衣的丸剂和制备所述丸剂的方法
CN102625699A (zh) * 2009-06-08 2012-08-01 Ucl商业有限公司 使用l-鸟氨酸苯乙酸盐治疗门静脉高压和恢复肝功能
CN103502203A (zh) * 2010-10-06 2014-01-08 欧塞拉治疗有限公司 制备l-鸟氨酸苯基乙酸盐的方法
CN103705490A (zh) * 2013-10-31 2014-04-09 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

Family Cites Families (10)

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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
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
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
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
CN107708684A (zh) * 2015-04-20 2018-02-16 欧塞拉治疗有限公司 L‑鸟氨酸苯乙酸盐制剂
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 (6)

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Publication number Priority date Publication date Assignee Title
CN101102816A (zh) * 2004-11-26 2008-01-09 Ucl商业有限公司 用于治疗肝性脑病的含有鸟氨酸和苯基乙酸(phenylacetate)或苯基丁酸(phenylbutyrate)的组合物
CN101626769A (zh) * 2007-02-22 2010-01-13 赢创罗姆有限责任公司 含有活性物质基质与聚合物包衣的丸剂和制备所述丸剂的方法
CN102625699A (zh) * 2009-06-08 2012-08-01 Ucl商业有限公司 使用l-鸟氨酸苯乙酸盐治疗门静脉高压和恢复肝功能
CN104434894A (zh) * 2009-06-08 2015-03-25 Ucl商业有限公司 使用l-鸟氨酸苯乙酸盐治疗门静脉高压和恢复肝功能
CN103502203A (zh) * 2010-10-06 2014-01-08 欧塞拉治疗有限公司 制备l-鸟氨酸苯基乙酸盐的方法
CN103705490A (zh) * 2013-10-31 2014-04-09 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

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万宏贵: "一种新型治疗肝性脑病的药物:L-鸟氨酸苯乙酸", 《CHINESE JOURNAL OF NEW DRUGS》 *

Also Published As

Publication number Publication date
AU2016353350A1 (en) 2018-05-10
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
JP7294807B2 (ja) 2023-06-20
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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Application publication date: 20180803