CA2983146C - Formulations of l-ornithine phenylacetate - Google Patents

Formulations of l-ornithine phenylacetate Download PDF

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Publication number
CA2983146C
CA2983146C CA2983146A CA2983146A CA2983146C CA 2983146 C CA2983146 C CA 2983146C CA 2983146 A CA2983146 A CA 2983146A CA 2983146 A CA2983146 A CA 2983146A CA 2983146 C CA2983146 C CA 2983146C
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CA
Canada
Prior art keywords
phenylacetate
pharmaceutical formulation
controlled release
oral pharmaceutical
omithine
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.)
Active
Application number
CA2983146A
Other languages
English (en)
French (fr)
Other versions
CA2983146A1 (en
Inventor
Kenneth RUETTIMANN
Mark Coffin
James Bernstein
Gary Goodson
Laurene WANG
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
Publication of CA2983146A1 publication Critical patent/CA2983146A1/en
Application granted granted Critical
Publication of CA2983146C publication Critical patent/CA2983146C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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)
  • 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)
CA2983146A 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate Active CA2983146C (en)

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

Publications (2)

Publication Number Publication Date
CA2983146A1 CA2983146A1 (en) 2016-10-27
CA2983146C true CA2983146C (en) 2023-09-12

Family

ID=57144228

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2983146A Active CA2983146C (en) 2015-04-20 2016-04-19 Formulations of l-ornithine phenylacetate

Country Status (13)

Country Link
US (2) US20160338982A1 (OSRAM)
EP (2) EP3285756B1 (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)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2341120T3 (es) 2004-11-26 2010-06-15 Ucl Business Plc Composiciones que comprenden ornitina y fenilacetato o fenilbutirato para tratar encefalopatia hepatica.
EA023051B1 (ru) 2009-04-03 2016-04-29 Осера Терапьютикс, Инк. Кристаллические формы фенилацетата l-орнитина и их применение
EA025735B1 (ru) 2009-06-08 2017-01-30 ЮСиЭл БИЗНЕС ПиЭлСи Способ лечения портальной гипертензии с использованием l-орнитина в сочетании по меньшей мере с одним из соединений, выбранных из фенилацетата и фенилбутирата
DK3223829T3 (da) 2014-11-24 2020-02-10 Ucl Business Ltd Behandling af sygdomme associeret med hepatisk stellat-celleaktivering under anvendelse af ammoniak-sænkende terapier
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
RU2018113801A (ru) * 2015-11-13 2019-12-16 Осера Терапьютикс, Инк. Составы l-орнитин фенилацетата
JOP20190146A1 (ar) 2016-12-19 2019-06-18 Axcella Health Inc تركيبات حمض أميني وطرق لمعالجة أمراض الكبد
JP7126520B2 (ja) 2017-05-11 2022-08-26 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を製造する方法
CN111295187A (zh) 2017-08-14 2020-06-16 胺细拉健康公司 用于治疗肝脏疾病的氨基酸组合物
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
CA3138914A1 (en) 2019-05-09 2020-11-12 Ocera Therapeutics, Inc. Methods of assessing and treating hepatic encephalopathy
CN114786662A (zh) * 2019-10-16 2022-07-22 欧塞拉治疗有限公司 鸟氨酸苯乙酸盐用于治疗高氨血症的剂量和用途
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

Family Cites Families (8)

* 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
IL139728A (en) * 1995-01-09 2003-06-24 Penwest Pharmaceuticals Compan Aqueous slurry composition containing microcrystalline cellulose for preparing a pharmaceutical excipient
ES2341120T3 (es) * 2004-11-26 2010-06-15 Ucl Business Plc Composiciones que comprenden ornitina y fenilacetato o fenilbutirato para tratar encefalopatia hepatica.
EA023051B1 (ru) 2009-04-03 2016-04-29 Осера Терапьютикс, Инк. Кристаллические формы фенилацетата l-орнитина и их применение
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
EA025735B1 (ru) * 2009-06-08 2017-01-30 ЮСиЭл БИЗНЕС ПиЭлСи Способ лечения портальной гипертензии с использованием l-орнитина в сочетании по меньшей мере с одним из соединений, выбранных из фенилацетата и фенилбутирата
ES2720148T3 (es) 2010-10-06 2019-07-18 Ocera Therapeutics Inc Métodos de fabricación de fenilacetato de L-ornitina

Also Published As

Publication number Publication date
US20160338982A1 (en) 2016-11-24
CN107708684A (zh) 2018-02-16
RU2755904C2 (ru) 2021-09-22
EP3285756A1 (en) 2018-02-28
ES2944311T3 (es) 2023-06-20
CN113599350A (zh) 2021-11-05
JP2018513171A (ja) 2018-05-24
DK3285756T3 (da) 2023-05-08
AU2016252382A1 (en) 2017-11-02
MX2022003855A (es) 2023-03-02
EP4205735A1 (en) 2023-07-05
RU2017137643A3 (OSRAM) 2019-09-17
WO2016172112A1 (en) 2016-10-27
KR20180006904A (ko) 2018-01-19
AU2021200740A1 (en) 2021-03-04
MX2017013170A (es) 2018-04-11
MX391167B (es) 2025-03-11
US20220184014A1 (en) 2022-06-16
RU2017137643A (ru) 2019-05-20
CA2983146A1 (en) 2016-10-27
JP2022101549A (ja) 2022-07-06
EP3285756B1 (en) 2023-02-22
HK1251149A1 (zh) 2019-01-25
EP3285756A4 (en) 2019-01-23

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