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

    • 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
    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/222Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin with compounds having aromatic groups, e.g. dipivefrine, ibopamine
    • 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
    • A61K9/5026Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/5047Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/5089Processes
    • 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
    • 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
    • A61P9/12Antihypertensives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures 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)
  • 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)
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 (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

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
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
EA201691430A1 (ru) * 2009-06-08 2017-02-28 ЮСиЭл БИЗНЕС ПиЭлСи Лечение портальной гипертензии и восстановление функции печени с помощью l-орнитинфенилацетата
MX360062B (es) 2010-10-06 2018-10-22 Ocera Therapeutics Inc Metodos de elaboracion de fenilacetato de l-ornitina.

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
CN107708684A (zh) 2018-02-16
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
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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MK5 Application lapsed section 142(2)(e) - patent request and compl. specification not accepted