AU2016353350B2 - Formulation of L-ornithine phenylacetate - Google Patents

Formulation of L-ornithine phenylacetate Download PDF

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Publication number
AU2016353350B2
AU2016353350B2 AU2016353350A AU2016353350A AU2016353350B2 AU 2016353350 B2 AU2016353350 B2 AU 2016353350B2 AU 2016353350 A AU2016353350 A AU 2016353350A AU 2016353350 A AU2016353350 A AU 2016353350A AU 2016353350 B2 AU2016353350 B2 AU 2016353350B2
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AU
Australia
Prior art keywords
phenylacetylglutamine
plasma
phenylacetate
pharmaceutical formulation
auco
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.)
Ceased
Application number
AU2016353350A
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English (en)
Other versions
AU2016353350A1 (en
Inventor
Stanley Bukofzer
Linda S. GRAIS
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
Priority claimed from US15/133,087 external-priority patent/US20160338982A1/en
Application filed by Ocera Therapeutics Inc filed Critical Ocera Therapeutics Inc
Publication of AU2016353350A1 publication Critical patent/AU2016353350A1/en
Application granted granted Critical
Publication of AU2016353350B2 publication Critical patent/AU2016353350B2/en
Priority to AU2021290236A priority Critical patent/AU2021290236A1/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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    • 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
    • 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
    • A61K9/5073Microcapsules 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
    • A61K9/5078Microcapsules 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
    • 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
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • 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
    • 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
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0087Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/02Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • 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
    • 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
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • 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

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Obesity (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
AU2016353350A 2015-11-13 2016-11-11 Formulation of L-ornithine phenylacetate Ceased AU2016353350B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2021290236A AU2021290236A1 (en) 2015-11-13 2021-12-21 Formulations of L-ornithine phenylacetate

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
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
US15/133,087 2016-04-19
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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2021290236A Division AU2021290236A1 (en) 2015-11-13 2021-12-21 Formulations of L-ornithine phenylacetate

Publications (2)

Publication Number Publication Date
AU2016353350A1 AU2016353350A1 (en) 2018-05-10
AU2016353350B2 true AU2016353350B2 (en) 2021-09-23

Family

ID=58695607

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016353350A Ceased AU2016353350B2 (en) 2015-11-13 2016-11-11 Formulation of L-ornithine phenylacetate
AU2021290236A Abandoned AU2021290236A1 (en) 2015-11-13 2021-12-21 Formulations of L-ornithine phenylacetate

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2021290236A Abandoned AU2021290236A1 (en) 2015-11-13 2021-12-21 Formulations of L-ornithine phenylacetate

Country Status (12)

Country Link
EP (1) EP3373923A4 (ja)
JP (2) JP7294807B2 (ja)
KR (1) KR20180086431A (ja)
CN (2) CN113768863A (ja)
AU (2) AU2016353350B2 (ja)
BR (1) BR112018009349A8 (ja)
CA (1) CA3004331A1 (ja)
IL (1) IL258630B2 (ja)
MX (2) MX2018005088A (ja)
RU (1) RU2018113801A (ja)
SG (1) SG11201802987UA (ja)
WO (1) WO2017083758A1 (ja)

Families Citing this family (4)

* 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
CU20200012A7 (es) 2017-08-14 2021-02-04 Axcella Health Inc Composiciones de aminoácidos para el tratamiento de enfermedad hepática
CN112839643A (zh) 2018-06-20 2021-05-25 胺细拉健康公司 用于治疗肌肉中脂肪浸润的组合物及方法
CA3157376A1 (en) * 2019-10-16 2021-04-22 Ocera Therapeutics, Inc. Dosages and uses of ornithine phenylacetate for treating hyperammonemia

Citations (3)

* 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
US8173706B2 (en) * 2009-04-03 2012-05-08 Ocera Therapeutics, Inc. L-ornithine phenyl acetate and methods of making thereof

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
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
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
TR201903978T4 (tr) 2010-10-06 2019-04-22 Ocera Therapeutics Inc L-ornitin fenil asetat yapım yöntemleri.
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 (3)

* 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
US8173706B2 (en) * 2009-04-03 2012-05-08 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

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BOSOI, C. R. et al., "Long term oral treatment of ornithine phenylacetate increases lean mass and attenuates brain edema in bile-duct ligated rats", Hepatology, (2015-10), vol. 62, no. Suppl. 1, page 953A *

Also Published As

Publication number Publication date
EP3373923A4 (en) 2019-07-03
MX2018005088A (es) 2019-05-16
CA3004331A1 (en) 2017-05-18
WO2017083758A1 (en) 2017-05-18
RU2018113801A (ru) 2019-12-16
AU2016353350A1 (en) 2018-05-10
SG11201802987UA (en) 2018-05-30
EP3373923A1 (en) 2018-09-19
MX2022001517A (es) 2022-11-16
IL258630B1 (en) 2023-04-01
BR112018009349A2 (pt) 2018-11-13
JP2022058446A (ja) 2022-04-12
CN108366983A (zh) 2018-08-03
JP7294807B2 (ja) 2023-06-20
KR20180086431A (ko) 2018-07-31
IL258630B2 (en) 2023-08-01
CN113768863A (zh) 2021-12-10
AU2021290236A1 (en) 2022-02-10
BR112018009349A8 (pt) 2019-02-26
IL258630A (en) 2018-06-28
JP2018533601A (ja) 2018-11-15

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