EP3373923A4 - FORMULATION OF L-ORNITHIN PHENYL ACETATE - Google Patents

FORMULATION OF L-ORNITHIN PHENYL ACETATE Download PDF

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Publication number
EP3373923A4
EP3373923A4 EP16865158.6A EP16865158A EP3373923A4 EP 3373923 A4 EP3373923 A4 EP 3373923A4 EP 16865158 A EP16865158 A EP 16865158A EP 3373923 A4 EP3373923 A4 EP 3373923A4
Authority
EP
European Patent Office
Prior art keywords
formulation
ornithine phenylacetate
phenylacetate
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.)
Withdrawn
Application number
EP16865158.6A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP3373923A1 (en
Inventor
Laurene WANG
Linda S. GRAIS
Stanley Bukofzer
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
Priority claimed from US15/133,087 external-priority patent/US20160338982A1/en
Application filed by Ocera Therapeutics Inc filed Critical Ocera Therapeutics Inc
Publication of EP3373923A1 publication Critical patent/EP3373923A1/en
Publication of EP3373923A4 publication Critical patent/EP3373923A4/en
Withdrawn legal-status Critical Current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
    • 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
    • A61K9/5073—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 having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—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 having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • 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
    • A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • 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
    • 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
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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

Landscapes

  • 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)
EP16865158.6A 2015-11-13 2016-11-11 FORMULATION OF L-ORNITHIN PHENYL ACETATE Withdrawn EP3373923A4 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562255300P 2015-11-13 2015-11-13
US201662276754P 2016-01-08 2016-01-08
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

Publications (2)

Publication Number Publication Date
EP3373923A1 EP3373923A1 (en) 2018-09-19
EP3373923A4 true EP3373923A4 (en) 2019-07-03

Family

ID=58695607

Family Applications (1)

Application Number Title Priority Date Filing Date
EP16865158.6A Withdrawn EP3373923A4 (en) 2015-11-13 2016-11-11 FORMULATION OF L-ORNITHIN PHENYL ACETATE

Country Status (12)

Country Link
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 (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006056794A1 (en) * 2004-11-26 2006-06-01 Ucl Business Plc Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
WO2010144498A2 (en) * 2009-06-08 2010-12-16 Ucl Business Plc Treatment of portal hypertension and restoration of liver function using l-ornithine phenylacetate
CN102993037A (zh) * 2012-11-20 2013-03-27 万红贵 一种l-鸟氨酸苯乙酸盐的制备方法
AU2014250643A1 (en) * 2009-06-08 2014-11-06 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
US8946473B2 (en) * 2010-10-06 2015-02-03 Ocera Therapeutics, Inc. Methods of making L-ornithine phenyl acetate
AU2015221466A1 (en) * 2009-04-03 2015-09-24 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
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
US10039735B2 (en) * 2014-11-24 2018-08-07 Ucl Business Plc Treatment of diseases associated with hepatic stellate cell activation using ammonia-lowering therapies
US20180221320A1 (en) * 2015-08-18 2018-08-09 Ocera Therapeutics, Inc. Treatment and prevention of muscle loss using l-ornithine in combination with at least one of phenylacetate and phenylbutyrate

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
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
DK3263100T3 (da) * 2009-04-03 2020-05-11 Ocera Therapeutics Inc L-ornithinphenylacetat og fremgangsmåder til fremstilling deraf
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
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

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006056794A1 (en) * 2004-11-26 2006-06-01 Ucl Business Plc Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
EP2153870B1 (en) * 2004-11-26 2013-12-25 UCL Business PLC Compositions comprising ornithine and phenylacetate or phenylbutyrate for treating hepatic encephalopathy
AU2015221466A1 (en) * 2009-04-03 2015-09-24 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
WO2010144498A2 (en) * 2009-06-08 2010-12-16 Ucl Business Plc Treatment of portal hypertension and restoration of liver function using l-ornithine phenylacetate
EP2799067A1 (en) * 2009-06-08 2014-11-05 UCL Business PLC Restoration of Liver Function using L-Ornithine Phenylacetate
AU2014250643A1 (en) * 2009-06-08 2014-11-06 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
US8946473B2 (en) * 2010-10-06 2015-02-03 Ocera Therapeutics, Inc. Methods of making L-ornithine phenyl acetate
CN102993037A (zh) * 2012-11-20 2013-03-27 万红贵 一种l-鸟氨酸苯乙酸盐的制备方法
US10039735B2 (en) * 2014-11-24 2018-08-07 Ucl Business Plc Treatment of diseases associated with hepatic stellate cell activation using ammonia-lowering therapies
US20180221320A1 (en) * 2015-08-18 2018-08-09 Ocera Therapeutics, Inc. Treatment and prevention of muscle loss using l-ornithine in combination with at least one of phenylacetate and phenylbutyrate
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

Non-Patent Citations (8)

* Cited by examiner, † Cited by third party
Title
ISKENDER SAYEK ET AL: "Cystic Hydatid Disease: Current Trends in Diagnosis and Management", SURGERY TODAY, 1 December 2004 (2004-12-01), Tokyo, pages 987 - 996, XP055533053, Retrieved from the Internet <URL:https://link.springer.com/article/10.1007%2Fs00595-004-2830-5> [retrieved on 2018], DOI: 10.1007/s00595-004-2830-5 *
JALAN R ET AL: "l-Ornithine phenylacetate (OP): A novel treatment for hyperammonemia and hepatic encephalopathy", MEDICAL HYPOTHESES, EDEN PRESS, PENRITH, US, vol. 69, no. 5, 27 April 2007 (2007-04-27), pages 1064 - 1069, XP029096478, ISSN: 0306-9877, DOI: 10.1016/J.MEHY.2006.12.061 *
M. MOKHTARANI ET AL: "Urinary phenylacetylglutamine as dosing biomarker for patients with urea cycle disorders", MOLECULAR GENETICS AND METABOLISM, vol. 107, no. 3, 1 November 2012 (2012-11-01), pages 308 - 314, XP055202395, ISSN: 1096-7192, DOI: 10.1016/j.ymgme.2012.08.006 *
RUNE GANGSØY KRISTIANSEN ET 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, 15 November 2014 (2014-11-15), United States, pages G1024 - G1031, XP055532599, Retrieved from the Internet <URL:https://www.physiology.org/doi/full/10.1152/ajpgi.00244.2014> DOI: 10.1152/ajpgi.00244.2014 *
See also references of WO2017083758A1 *
VAIRAPPAN BALASUBRAMANIYAN 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, vol. 302, no. 1, 1 January 2012 (2012-01-01), US, pages G145 - G152, XP055532625, ISSN: 0193-1857, DOI: 10.1152/ajpgi.00097.2011 *
VENTURA-COTS MERITXELL ET AL: "Safety of Ornithine Phenylacetate in Cirrhotic Decompensated Patients : An Open-label, Dose-escalating, Single-cohort Study", vol. 47, no. 10, 1 January 2013 (2013-01-01), pages 881 - 887, XP009507196, ISSN: 0192-0790, Retrieved from the Internet <URL:http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00004836-201311000-00013> DOI: 10.1097/MCG.0B013E318299C789 *
YTREBO LARS MARIUS ET AL: "L-ornithine phenylacetate attenuates increased arterial and extracellular brain ammonia and prevents intracranial hypertension in pigs with acute liver failure", HEPATOLOGY, JOHN WILEY & SONS, INC, US, vol. 50, no. 1, 1 July 2009 (2009-07-01), pages 165 - 174, XP009164051, ISSN: 0270-9139, [retrieved on 20090218], DOI: 10.1002/HEP.22917 *

Also Published As

Publication number Publication date
AU2016353350A1 (en) 2018-05-10
CN108366983A (zh) 2018-08-03
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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