CN107708684A - 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
CN107708684A
CN107708684A CN201680036045.1A CN201680036045A CN107708684A CN 107708684 A CN107708684 A CN 107708684A CN 201680036045 A CN201680036045 A CN 201680036045A CN 107708684 A CN107708684 A CN 107708684A
Authority
CN
China
Prior art keywords
preparation
oral drug
drug preparation
ornithine phenyl
phenyl acetate
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
CN201680036045.1A
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English (en)
Chinese (zh)
Inventor
K·鲁特曼
M·科芬
J·伯恩斯坦
G·古德森
L·王
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
Original Assignee
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.)
Filing date
Publication date
Application filed by Ocera Therapeutics Inc filed Critical Ocera Therapeutics Inc
Priority to CN202110931620.7A priority Critical patent/CN113599350A/zh
Publication of CN107708684A publication Critical patent/CN107708684A/zh
Pending legal-status Critical Current

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    • 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
    • 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
    • A61K31/21—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

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Physiology (AREA)
  • Nutrition Science (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)
CN201680036045.1A 2015-04-20 2016-04-19 L‑鸟氨酸苯乙酸盐制剂 Pending CN107708684A (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110931620.7A CN113599350A (zh) 2015-04-20 2016-04-19 L-鸟氨酸苯乙酸盐制剂

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
CN202110931620.7A Division CN113599350A (zh) 2015-04-20 2016-04-19 L-鸟氨酸苯乙酸盐制剂

Publications (1)

Publication Number Publication Date
CN107708684A true CN107708684A (zh) 2018-02-16

Family

ID=57144228

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201680036045.1A Pending CN107708684A (zh) 2015-04-20 2016-04-19 L‑鸟氨酸苯乙酸盐制剂
CN202110931620.7A Pending CN113599350A (zh) 2015-04-20 2016-04-19 L-鸟氨酸苯乙酸盐制剂

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN202110931620.7A Pending CN113599350A (zh) 2015-04-20 2016-04-19 L-鸟氨酸苯乙酸盐制剂

Country Status (13)

Country Link
US (2) US20160338982A1 (https=)
EP (2) EP3285756B1 (https=)
JP (2) JP2018513171A (https=)
KR (1) KR20180006904A (https=)
CN (2) CN107708684A (https=)
AU (2) AU2016252382A1 (https=)
CA (1) CA2983146C (https=)
DK (1) DK3285756T3 (https=)
ES (1) ES2944311T3 (https=)
HK (1) HK1251149A1 (https=)
MX (2) MX391167B (https=)
RU (1) RU2755904C2 (https=)
WO (1) WO2016172112A1 (https=)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG158073A1 (en) 2004-11-26 2010-01-29 Ucl Business Plc Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
CA2757373C (en) 2009-04-03 2018-05-08 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
EA201691430A1 (ru) 2009-06-08 2017-02-28 ЮСиЭл БИЗНЕС ПиЭлСи Лечение портальной гипертензии и восстановление функции печени с помощью l-орнитинфенилацетата
US10039735B2 (en) 2014-11-24 2018-08-07 Ucl Business Plc Treatment of diseases associated with hepatic stellate cell activation using ammonia-lowering therapies
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
US11219611B2 (en) 2015-11-13 2022-01-11 Ocera Therapeutics, Inc. Formulations of L-ornithine phenylacetate
AU2016353350B2 (en) * 2015-11-13 2021-09-23 Ocera Therapeutics, Inc. Formulation of L-ornithine phenylacetate
JOP20190146A1 (ar) 2016-12-19 2019-06-18 Axcella Health Inc تركيبات حمض أميني وطرق لمعالجة أمراض الكبد
WO2018208677A1 (en) 2017-05-11 2018-11-15 Ocera Therapeutics, Inc. Processes of making l-ornithine phenylacetate
IL296055A (en) 2017-08-14 2022-10-01 Axcella Health Inc Amino acid compositions for the treatment of liver disease
MA52971A (fr) 2018-06-20 2021-04-28 Axcella Health Inc Compositions et procédés pour le traitement de l'infiltration de graisse dans le muscle
KR102852068B1 (ko) 2019-05-09 2025-08-28 오세라 테라퓨틱스, 아이엔씨. 간성 뇌증의 평가 및 치료 방법
WO2021076709A1 (en) * 2019-10-16 2021-04-22 Ocera Therapeutics, Inc. Dosages and uses of ornithine phenylacetate for treating hyperammonemia
WO2021152587A1 (en) 2020-01-30 2021-08-05 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 (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (6)

* 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
SG158073A1 (en) 2004-11-26 2010-01-29 Ucl Business Plc Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
CA2757373C (en) 2009-04-03 2018-05-08 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Non-Patent Citations (5)

* Cited by examiner, † Cited by third party
Title
BALASUBRAMANIYAN.V ET AL: ""Ammonia reduction with ornithine phenylacetate restores brain eNOS activity via the DDAH-ADMA pathway in bile duct-ligated cirrhotic rats"", 《AMERICAN JOURNAL OF PHYSIOLOGY-GASTROINTESTINAL AND LIVER PHYSIOLOGY》 *
JALAN.R ET AL: ""L-Ornithine phenylacetate (OP): A novel treatment for hyperammonemia and hepatic encephalopathy"", 《MEDICAL HYPOTHESES》 *
KRISTIANSEN.RG RT AL: ""L-Ornithine phenylacetate reduces ammonia in pigs with acute liver failure through phenylacetylglycine formation: a novel ammonia-lowering pathway"", 《AMERICAN JOURNAL OF PHYSIOLOGY-GASTROINTESTINAL AND LIVER PHYSIOLOGY》 *
VENTURA-COTS.M ET AL: ""Safety of Ornithine Phenylacetate in Cirrhotic Decompensated Patients An Open-label, Dose-escalating, Single-cohort Study"", 《JOURNAL OF CLINICAL GASTROENTEROLOGY》 *
YTREBO.LM ET AL: ""L-Ornithine Phenylacetate Attenuates Increased Arterial and Extracellular Brain Ammonia and Prevents Intracranial Hypertension in Pigs with Acute Liver Failure"", 《HEPATOLOGY》 *

Also Published As

Publication number Publication date
RU2017137643A3 (https=) 2019-09-17
JP2018513171A (ja) 2018-05-24
US20220184014A1 (en) 2022-06-16
US20160338982A1 (en) 2016-11-24
EP3285756A1 (en) 2018-02-28
ES2944311T3 (es) 2023-06-20
EP3285756B1 (en) 2023-02-22
HK1251149A1 (zh) 2019-01-25
RU2017137643A (ru) 2019-05-20
JP2022101549A (ja) 2022-07-06
CA2983146A1 (en) 2016-10-27
MX391167B (es) 2025-03-11
AU2016252382A1 (en) 2017-11-02
RU2755904C2 (ru) 2021-09-22
DK3285756T3 (da) 2023-05-08
CA2983146C (en) 2023-09-12
KR20180006904A (ko) 2018-01-19
AU2021200740A1 (en) 2021-03-04
CN113599350A (zh) 2021-11-05
EP4205735A1 (en) 2023-07-05
EP3285756A4 (en) 2019-01-23
MX2017013170A (es) 2018-04-11
MX2022003855A (es) 2023-03-02
WO2016172112A1 (en) 2016-10-27

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Application publication date: 20180216