AU2016252382A1 - Formulations of L-ornithine phenylacetate - Google Patents

Formulations of L-ornithine phenylacetate Download PDF

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Publication number
AU2016252382A1
AU2016252382A1 AU2016252382A AU2016252382A AU2016252382A1 AU 2016252382 A1 AU2016252382 A1 AU 2016252382A1 AU 2016252382 A AU2016252382 A AU 2016252382A AU 2016252382 A AU2016252382 A AU 2016252382A AU 2016252382 A1 AU2016252382 A1 AU 2016252382A1
Authority
AU
Australia
Prior art keywords
pharmaceutical formulation
phenylacetate
omithine
oral pharmaceutical
formulation
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.)
Abandoned
Application number
AU2016252382A
Other languages
English (en)
Inventor
James Bernstein
Mark Coffin
Gary Goodson
Kenneth RUETTIMANN
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 AU2016252382A1 publication Critical patent/AU2016252382A1/en
Priority to AU2021200740A priority Critical patent/AU2021200740A1/en
Abandoned legal-status Critical Current

Links

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)
  • Nutrition Science (AREA)
  • Physiology (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)
AU2016252382A 2015-04-20 2016-04-19 Formulations of L-ornithine phenylacetate Abandoned AU2016252382A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2021200740A AU2021200740A1 (en) 2015-04-20 2021-02-05 Formulations of L-ornithine phenylacetate

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
AU2021200740A Division AU2021200740A1 (en) 2015-04-20 2021-02-05 Formulations of L-ornithine phenylacetate

Publications (1)

Publication Number Publication Date
AU2016252382A1 true AU2016252382A1 (en) 2017-11-02

Family

ID=57144228

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016252382A Abandoned AU2016252382A1 (en) 2015-04-20 2016-04-19 Formulations of L-ornithine phenylacetate
AU2021200740A Abandoned AU2021200740A1 (en) 2015-04-20 2021-02-05 Formulations of L-ornithine phenylacetate

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2021200740A Abandoned AU2021200740A1 (en) 2015-04-20 2021-02-05 Formulations of L-ornithine phenylacetate

Country Status (13)

Country Link
US (2) US20160338982A1 (enExample)
EP (2) EP3285756B1 (enExample)
JP (2) JP2018513171A (enExample)
KR (1) KR20180006904A (enExample)
CN (2) CN113599350A (enExample)
AU (2) AU2016252382A1 (enExample)
CA (1) CA2983146C (enExample)
DK (1) DK3285756T3 (enExample)
ES (1) ES2944311T3 (enExample)
HK (1) HK1251149A1 (enExample)
MX (2) MX391167B (enExample)
RU (1) RU2755904C2 (enExample)
WO (1) WO2016172112A1 (enExample)

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PT2319581E (pt) 2004-11-26 2015-06-30 Ucl Business Plc Composições compreendendo ornitina e fenilacetato ou fenilbutirato para tratamento de encefalopatia hepática
CN106810464B (zh) 2009-04-03 2019-01-22 欧塞拉治疗有限公司 L-鸟氨酸苯乙酸盐及其制备方法
ES2517340T3 (es) 2009-06-08 2014-11-03 Ucl Business Plc Tratamiento de la hipertensión portal usando L-ornitina y fenilacetato
KR20230018526A (ko) 2014-11-24 2023-02-07 유씨엘 비즈니스 리미티드 암모니아-저감 치료를 이용한 간성상세포 활성화와 연관된 질병의 치료
JP6990170B2 (ja) 2015-08-18 2022-01-12 オセラ セラピューティクス， インコーポレイテッド Ｌ－オルニチンをフェニルアセテートおよびフェニルブチレートのうちの少なくとも１つと組み合わせて用いる筋肉喪失の治療および予防
US11219611B2 (en) 2015-11-13 2022-01-11 Ocera Therapeutics, Inc. Formulations of L-ornithine phenylacetate
WO2017083758A1 (en) * 2015-11-13 2017-05-18 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
MX389665B (es) 2017-05-11 2025-03-20 Ocera Therapeutics Inc Procesos para producir fenilacetato de l-ornitina
WO2019036471A1 (en) 2017-08-14 2019-02-21 Axcella Health Inc. AMINO ACIDS BRANCHED FOR THE TREATMENT OF LIVER DISEASE
EP3810123A1 (en) 2018-06-20 2021-04-28 Axcella Health Inc. Compositions and methods for the treatment of fat infiltration in muscle
CA3138914A1 (en) 2019-05-09 2020-11-12 Ocera Therapeutics, Inc. Methods of assessing and treating hepatic encephalopathy
US12697317B2 (en) 2019-10-16 2026-08-04 Amalive Limited Dosages and uses of ornithine phenylacetate for treating hyperammonemia
EP4096647A1 (en) 2020-01-30 2022-12-07 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
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
PT2319581E (pt) * 2004-11-26 2015-06-30 Ucl Business Plc Composições compreendendo ornitina e fenilacetato ou fenilbutirato para tratamento de encefalopatia hepática
CN106810464B (zh) * 2009-04-03 2019-01-22 欧塞拉治疗有限公司 L-鸟氨酸苯乙酸盐及其制备方法
AU2015221466B2 (en) * 2009-04-03 2017-02-02 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof
ES2517340T3 (es) * 2009-06-08 2014-11-03 Ucl Business Plc Tratamiento de la hipertensión portal usando L-ornitina y fenilacetato
AU2014250643B2 (en) * 2009-06-08 2016-07-14 Ocera Therapeutics, Inc. Treatment of portal hypertension and restoration of liver function using L-ornithine phenylacetate
EP2625162B1 (en) * 2010-10-06 2019-03-13 Ocera Therapeutics, Inc. Methods of making l-ornithine phenyl acetate

Also Published As

Publication number Publication date
MX2022003855A (es) 2023-03-02
JP2018513171A (ja) 2018-05-24
MX2017013170A (es) 2018-04-11
US20160338982A1 (en) 2016-11-24
RU2755904C2 (ru) 2021-09-22
US20220184014A1 (en) 2022-06-16
CN107708684A (zh) 2018-02-16
CA2983146A1 (en) 2016-10-27
AU2021200740A1 (en) 2021-03-04
RU2017137643A (ru) 2019-05-20
CA2983146C (en) 2023-09-12
EP3285756B1 (en) 2023-02-22
HK1251149A1 (zh) 2019-01-25
MX391167B (es) 2025-03-11
RU2017137643A3 (enExample) 2019-09-17
CN113599350A (zh) 2021-11-05
ES2944311T3 (es) 2023-06-20
EP4205735A1 (en) 2023-07-05
KR20180006904A (ko) 2018-01-19
WO2016172112A1 (en) 2016-10-27
JP2022101549A (ja) 2022-07-06
EP3285756A4 (en) 2019-01-23
DK3285756T3 (da) 2023-05-08
EP3285756A1 (en) 2018-02-28

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Legal Events

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MK5 Application lapsed section 142(2)(e) - patent request and compl. specification not accepted